Author Archives: author

Countering Expect Despair after Release from Prison: A Mind Genomics Cartography from the ‘Outside In’

DOI: 10.31038/PSYJ.2021333

Abstract

Respondents were introduced to a hypothetical situation of an individual being released from prison. The test stimuli were vignettes comprising information about WHO the released prisoner is, WHAT the person did in prison, WHAT kind of people were in prison with the released individual, and WHAT efforts were made in prison to help the prisoner adjust after release. Respondents projected their impression of the described former prisoners, using an anchored 9-point scale, from 1=feeling hopeful to 9=feeling suicidal. When viewing the scale from the point of view of “Suicide,” two mind-sets emerged: MS1, responding to lack of preparation for release, and MS2, someone who is middle class with nothing to do in prison, surrounded by drug addicts. When viewing the scale from the point of “Hopefulness,” two other mind-sets emerge: MS3, hopeful after release and when in prison had daily schedule, and MS4, hopeful when took preparatory courses in prison. The experimental design allows the creation of a PVI, personal viewpoint identifier, to assign a person to one of each mind-set.

Background

Increasingly, we come to hear of the difficulties faced by people who, having served their sentences, are released from prison, only to find a wall of obstacles in front of them as they try to reconstruct their lives. The anguish is great, and occasionally one reads of the despair, which may lead to the use of drugs and often to suicide. The suicides are among otherwise decent people who, having served their time, are attempting to re-enter society [1-3]. We read these stories, feel saddened by them, and, at the same time, we are often fascinated by these individuals and by why they committed suicide. It is a bit of what in German might be called Schadenfreude, the interest of others in a person’s misfortune. The great sociologist, Emil Durkheim, talked about suicides, finding from his statistical analysis of the frequency of suicide, that those with a structured religious life (e.g., Catholics) showed fewer suicides than those with a less well-structured religious life (e.g., Protestants) [4].

The notion of understanding the situation which might lead to suicide prompted a discussion among the two senior authors, Ari Zoldan and Howard Moskowitz, and a separate discussion with author Arthur Kover. The issue was whether there was a “wisdom of the masses” which could inform about what details of a situation might likely be the cause for a released prisoner to commit suicide. The answers were not clear, and so the discussion led to a small Mind Genomics cartography, an attempt to understand the conditions leading to suicide (viz., despair) versus hopefulness, albeit from the ‘outside-in,’ from the response of the general population to presentation of material about released prisoners. This is called a Mind-Cart ‘cartography’ (Harizi et. al., 2020).

The literature dealing with the emotions of released prisoner is extensive. Most of the literature is descriptive, dealing with the measurement of recidivism and even suicide. Issues include WHO the released prisoner is (viz., [5-7]. Other topics include the prison environment [8], the other prisoners with whom the individual socialized in prison, including violence which occurred [9,10], and the prisoner’s thoughts and preparations for release while in prison [11-16]. Finally, the literature deals with the follow-up situation and activities of the released prisoner [17], and ongoing efforts to maintain contact with the released prison to integrate the prisoner into society [18].

The literature is primarily sociological in nature, looking at the situation which exists. We propose a ‘next step,’ namely looking into how people feel about the nature of the feeling of the released prisoner, one year after release. This first paper deals with the ‘wisdom of crowds’ [19], using external respondents to read vignettes about the released prisoner, and based upon the vignette, estimate the feeling that the individual will have one year after release.

How Mind Genomics and the ‘Wisdom of the Masses’ Combine Approach the Problem

We use the newly emerging science of Mind Genomics, a branch of experimental psychology, to understand why “suicide.” The approach, a version of “wisdom of masses,” presents the respondent with combinations of messages, descriptions of the “case,” and instructs the respondents to rate the likely outcome, adjustment to suicide. The science of Mind Genomics is appropriate to study how people think about these topics.

Mind Genomics emerged from the desire to study the experience of the “every day,” using the techniques of experimental psychology (actual experiments, conducted with the aid of computers), consumer research (focusing on the real world of experience, rather than on a situation distorted in the interests of the experiment), and experimental design (focusing on so-called within-subjects design). The topics of Mind Genomics already studied range from disease and recovery, internal war and peace, law, education, food, social distancing in time of COVID-19 , and a host of others [20,21]. The worldview of all these studies is the same: study how people make decisions with the ordinary information to which they are exposed, information known to everyone. It is the focus on the daily life, on the situations to which one pays conscious attention, the absolute ordinary, which constitutes the hallmark of Mind Genomics.

Mind Genomics follows a series of well-defined steps, starting with choice of topic, elucidation of different “granular aspects” of the topic, how people respond, and concluding with the discovery of underlying mind-sets, mental genomes, viz., fundamentally different ways that people think about the same aspects of the topic [22,23]. The later applications of Mind Genomics have been presented by [20,21].

Step 1: Select Raw Materials (Topic, Four Questions, Four Answers to Each Question)

The basis of Mind Genomics is the deconstruction of responses to mixtures of ideas, these ideas representing answers to relevant questions. Figure 1 shows the templated version. The researcher is given the form, which is structured, and comprises several screens. All the respondent must do is type in the topic at the start of the study, then type in the four questions (Figure 1, left panel), and then the four answers to each question (Figure 1, right panel).

Figure 1: The set up-template for the Mind Genomics study, showing the input form for the four questions, and the input form for the four answers from question #2.

Table 1 shows the raw material created for the topic of feeling after being released from prison. The four questions are not engraved in stone. Rather, they are “first guesses,” aspects that can be fine-tuned or even discarded in subsequent easy and affordable iterations. The Mind Genomics experiment can be modified quickly, after the initial data have been collected, and executed once again, virtually immediately after the study materials have been updated.

Table 1: The four questions and the four answers for each question.

Step 2: Select a Rating Scale

The rating scale dictates the nature of the experiment. The rating scale is shown below. The scale deals with the likelihood of what will happen 12 months after the person is discharged from prison.

Rating question: What will happen in 12 months?

Low Anchor: Rating question 1=hopeful

High Anchor: Rating question 9=suicidal

Figure 2 two other tempates. The left panel in Figure 2 shows the orientation page. The right panel show the rating scale, including number of scale points (9), and the anchors for each scale point.

Figure 2: The templates, for respondent instructions (left panel), and for rating scale (right panel).

Step 3: Create the Vignettes, Combinations of Elements to be Tested

The vignette, a combination of 24 elements, becomes the “stimulus” that the researcher presents, and the respondent responds by following a rating scale introduced in Step 2. The vignettes are created according to a systematically designed set of combinations, “the experimental design.” [22-24]. The underlying experimental design for this so-called 4×4 design of Mind Genomics (4 questions, 4 answers/question) prescribes exactly 24 combinations. The combinations are of three types: combinations with one element from two questions (2-element vignette), one element from three questions (3-question vignette), or one element from four questions (4-question vignette). By design each question can contribute at most one element, but often no elements. Furthermore, each respondent evaluates a different set of combinations, permutations of the main design [25].

The rationales for the design and the permutations follow:

a. The experimental design ensures that each respondent evaluates the appropriate vignettes, designed for OLS (ordinary least squares) regression. OLS regression builds a model or an equation, of the form: Dependent Variable = k₀ + k₁(A1) + k₂(A2) … k₁₆(D4)

b. The systematic permutation of the design ensures that the structure of the combinations is the same for all respondents, but each respondent tests different combinations. In effect, the permuted design ensures that the Mind Genomics experiment covers many of the possible combinations. The approach of testing many combinations, each with “noise,” rather than testing a limited number of combinations with the noise averaged out through replication, represents a dramatic departure from conventional statistics and design. Conventional design suppresses noise or averages out the noise. Permuted designs accept the noise at each point but cover most of the design space, thereby allowing the underlying pattern to emerge. The best metaphor is the difference between a high resolution X-ray of a single area, with a single X-ray impression, versus the MRI, magnetic resonance imaging, which takes many pictures of the tissue from different angles, and combines the different pictures later on. Metaphorically speaking, Mind Genomics is an “MRI of the mind.”

c. In order for the rating scale to work, it must be applied to the description of a person. Only with combinations of elements is there a real, albeit sparse, description of a person and situation. The rating scale will not be meaningful when applied to each of the 16 elements, in a one-by-one fashion. There is no context in the format which presents one element at a time, despite the attractiveness of doing so. By presenting the test elements in a one-by-one fashion, one allows the respondent to alter the criterion for judgment to fit the nature of the test element being evaluated. The experimental design combines elements, forcing the respondent to maintain one criterion, and preventing “gaming” the interview.

Step 4: Define the Dependent Variables

The raw data from Mind Genomics are the ratings on the anchored 9-point scale (see Step 2), and the response time. The response time is defined as the number of seconds between the presentation of the test vignette and the rating assigned by the respondent. The response time is easily measured by the underlying computer program.

The original ratings on the 9-point scale are hard for managers to understand, despite their seeming simplicity. The typical question encountered is: “What does <rating X> mean?” “Rating X” could be a 3, a 7, or any of the numbers on the scale. As simple as the scale is, the reality in practice is that the scale has no intrinsic meaning to the manager, except at the very top or bottom.

The convention in traditional consumer research has been to divide the scale into two points, to denote NO versus YES. For these data we divide the scale two ways:

Top3: The scale is divided so that ratings of 7-9 are transformed to 100 to denote “suicide YES” (whether thoughts or expected action), and ratings of 1-6 are transformed to 0 to denote “hopefulness YES”). A small random number is added to the transformed ratings to introduce minute variability, a statistical requirement for OLS (ordinary least-squares) regression analysis. The small random number, assigned to each transformed number, ensures the necessary but vanishingly low variability in the dependent variable.

Bot3: The scale is divided so that ratings of 1-3 are transformed to 100 to denote “hopefulness YES,” and ratings of 4-9 are transformed to 0 to denote “hopefulness NO.” A random number is once again added to each transformed rating.

The Mind Genomics program, BimiLeap, measures the response time, defined as the time between the appearance of the vignette and the time that the rating is assigned. The response time is also treated as a dependent variable, but not transformed. For the analysis, the response times from vignettes 13-24 will be the only ones used for analysis. The use of data from the second half of the vignettes for response time, but the use of data from all 24 vignettes for the binary transformed variables (Top3 and Bot3), comes from the striking observation in Figure 3. The average response time drops as the respondent becomes more acquainted with the task, and more practiced. In contrast, the average rating on the 9-point scale does not change. Figure 3 shows the average values by each of the 24 positions in the experiment for the four prospective dependent variables, respectively. It is clear that there is no order dependency for the average rating, a clear decreasing function for response time, and a very “noisy,” but possibly decreasing function for both Top3 and Bot3.

Figure 3: Average value of the four dependent variables for each of the 24 positions (test order) in the Mind Genomics experiment. Position 1 is the vignette tested in the first position, position 10, for example, is the vignette tested in the 10^th position.

Step 5: Build the Model (Equation) Relating the Presence/Absence of Elements

It is the contribution of the elements to the response which constitutes the key information afforded by the Mind Genomics experiment. That contribution is provided by the coefficient of the model, relating the presence/absence of the 16 elements to the dependent variable.

The equation is estimated using the well accepted method of OLS (ordinary least-squares) regression, or so-called “curve fitting.” The analysis focused on three equations, relating to Top3, Bot3, and response time. The equation for the rating was not calculated because it is contained within the analysis of Top3 (Suicide) and Bot3 (Hopeful).

The basic equation is expressed as an additive constant (k₀) and 16 coefficients (k₁-k₁₆), respectively.

Top3 = k₀ + k₁(A1) + k₂(A2) … k₁₆(D4)

Bot3 = k₀ + k1(A1) + k₂(A2) … k₁₆(D4)

RT (Response Time ) = k₁(A1) + k₂(A2) … k₁₆(D4)

The additive constant is the estimated value of the dependent variable (e.g., Top3 or Bot3) in the absence of elements. The experimental design ensured that each vignette would be comprised of 2-4 elements, meaning that the additive constant is a purely estimated parameter. The additive constant can be thought of as the baseline value of Top3 or Bot3. If the metaphor is a statue, then the additive constant is the base, viz., not part of the statue itself, but a basic, fixed contribution to the height.

Above the baseline or additive constant will be the separate contributions of the elements, given by the coefficients. The coefficients are positive (the element contributes to the the value of Top3 or Bot3), zero (no effect), or negative (the element takes away from the value of Top3 or Bot3). For the sake of clarity and to allow the patterns emerge, we will estimate the coefficients, but only show the positive or non-zero coefficients. It is the pattern of these positive coefficients which tell the “story.”

Step 6 – Results from the Total Panel

The total panel comprises all the vignettes from all the respondents. Keep in mind that the analysis generated two models, one looking at suicide (not further defined; Top3), the other looking at hopefulness (not further defined; Bot3). Again, keep in mind that we are dealing with the wisdom of the masses, viz, a guess about the behavior based upon the vignette. Yet, we surmise that an average judgment, given by many people, may provide a good sense of what people believe regarding how a recently released prisoner might feel after 12 months. Table 2 shows the positive coefficients driving either suicide/despair (Top3) or hopefulness (Bot3).

The additive constant represents the expected feeling of the person described, in the absence of any additional information. The expected proportion of responses “suicide”(ratings 7-9) in the absence of information is 24. Of course, all vignettes by design comprised 2-4 elements, so the addiive constant is a purely estimated parameter. Nonetheless, we get a sense that about a quarter of the responses will be that the person described will contemplate suicide. In contrast, for feelings of hopefulness, Table 2 suggests that 44% of the time, i.e., almost half of the responses, the person described will feel hopeful.

Table 2: Parameters of the models relating the presence/absence of the 16 elements to the thought of suicide (Top3) or hopefulness(Bot3). Strong performing elements (8 or higher) are shown in shaded cells. Only positive coefficients are shown, to reveal the patterns.

It is in the elements that we see some situations which drive the feeling of suicide. The only elements we show are positive ones because we are interested in what drives the feelings of suicide, rather than what does not drive the feeling of suicide. The two strongest elements are having been in prison with SITUATION IN PRISON: drug addicts, and an element described as RELEASE PREPARATION: no support in prison. Both of these elements have high coefficients of 11, meaning that when they are included in the description of the released person, an additional 11% of responses are that the person will fee “suicidal” (ratings 9, 8, 7). If the person leaving is a 21-year old, with a second conviction for drugs, an additional 7% feel there could be suicide behavior.

The data suggest that two strong elements are thought to drive a feel of hopefulness: RELEASE PREPARATION: optional courses to prepare for jobs, and ACTIVITIES: 4 hours of forced library. There is a sense that forcing the prisoner to do things to improve the mind should help.

Step 7: Response Time (Reflection of Degree of Engagement of Responder) as a Dependent Variable

The response time, defined as the time between the presentation of the vignette and the rating, may represent time needed to process the information. Response time is not directly under the cognitive control of an individual, who is simply reading the vignette (if that), and assigning a rating.

Figure 3 above shows the systematic decrease in the average response time. The average response time in the aggregate, by test position (postion 1 to position 24), shows a dramatic pattern which makes sense. As respondents get increasingly experienced with the task, even without feedback, their average time to read and rate the vignette decreases, at first dramatically. The response time eventually stabilizes near the end of the experiment.

Graphs similar to these appear in virtually any study, leading to the introduction of a “practice first vignette,” the response to which is discarded. In this study we discard that first vignette, which is not part of the design, measure the response times for the 24 vignettes, and build models for the total set of 24 vignettes, followed by models for the first half of th vignettes vs the second half (vignette 1-12 vs 13-24).

The deconstruction of the response time for the total vignette into the component response times is done using the same type of regression equation , but without the additive constant. The rationale for this analysis, called “forcing the model through the origin” comes from the recognition that in the absence of elements there is no response at all.

Response Time = k₁(A1) + k(A2) … k₁₆(D4) (Note: no additive constant)

Table 3 shows the coefficients for response time, first for the total set of vignettes (Vig 1-24), then for the first 12 vignettes (Vig 1-12) and finally for the last 12 vignettes (Vig. 13-24). The final column (Sec-First) shows the change in estimated response time (seconds) by element, for the total panel. The important thing to notice is the changes are not the same. There is a dramatic range.

Table 3: Response times for the 16 elements, showing the response time for the total panel over 8 second for all 24

The response times are not highly correlated, but they are positively correlated, all except one being shorter for the second half of the 24 vignettes, and being longer for the first half of the vignettes. That element, B3, ‘ACTIVITIES: 4 hours of forced library’ is important because it becomes more engaging as the respondents are exposed to it. It may be that the message becomes increasingly meaningful with repeat exposures. It may be these types of elements which are most important to recognize. Their meaning may “sink in” over time, rather than become diluted (Figure 4).

Figure 4: Relation between the coefficients for response time for the first vs the second half of the set.

Step 8: Create New Groups of Respondents (Mind-sets), based upon the Patterns of Their Coefficients

A continuing hallmark finding of Mind Genomics is that people differ in the way they think. The finding is not surprising and often glossed over as a characteristic of “subjective data,” such as ratings of opinions, and certainly ratings of opinions of the Mind Genomics vignettes.

Mind Genomics studies often reveal that what seems to be a “flat” data set with few strong elements is stronger than one might believe at first glance. The mind-sets can be thought of as different patterns of interesting elements. When one group of people is interested in a set of elements, but another group is not, often the result is flat and noisy when the coefficients of the elements are plotted against each other. The plot is “noisy,” with the coefficients darting about with no pattern emerging. Such is the general problem in research when one deals with groups of people with radically different points of view towards the same topic. What could be rich veins of information, rich patterns of “color” are discarded because at first glance the general impression is a boring monochrome. Only when one looks more closely do the intricate patterns reveal themselves, patterns which otherwise intertwine, interdigitate, and produce a dull gray.

The process to uncover the mind-sets comprises simple steps, described elsewhere [26]. Here is a list of the steps:

a. Create a model for each respondent. This is possible because of the underlying experimental design, used to create the vignettes for each respondent.

b. Cluster the respondents based upon the pattern of their coefficients.

c. For clustering, use the metric (1-Pearson Correlation) as the measure of “distance” or “dissimilarity” between pairs of respondents.

d. Extract two and then three clusters, the mind-sets.

e. Create the models for all respondents in a specific cluster or mind-set. Thus the analysis creates two new models for the two-mind set solution, three new modesl for the three mind-set solution.

f. Inspect the models for interpretability, viz., do the data “tell a coherent story?”

The clustering program was run twice, first for the models for Top3 (suicide), and second for the individual models for Bot3 (hopefulness). The analysis, run twice, allows us to look at these two feelings separately, viz. treating the data anew, once from the viewpoint of feelings about suicide and once, and entirely separately, from the point of view of feelings about hopefulness.

Table 4 shows the results of two sets of cluster analyses: MS1 and MS2, based on suicide (Top3); MS3 and MS4, based on hopefulness (Bot3). Table 4 shows only the positive coefficients for each, in the interests of readability and to detect the underlying patterns. The strongest performing elements are shown in shaded cells. The “names” for the mind-sets are shown in the second row. These names were assigned by the researchers based upon the “story” which the strong performing elements appeared to provide.

Table 4: The two pairs of mind-sets, based upon clustering coefficients for suicide (Top3, left two columns) and coefficients for hopefulness (Bot3, right two columns)

Pairwise Interactions – What Situation Drives a Rating of “Suicide”

The underlying exoerimental design using Mind Genomics ensures that all of the elements are statistically independent of each other. Yet, despite that, some combinations naturally “enhance each other,” when they appear together, despite being statistically independent. The permuted design used here (Gofman & Moskowitz, 2010) allows us to discover these synergistic combinations, or more correctly, to discover how a set of elements performs when one of the elements is held constant with different options. This analysis shows the change in the performance of a set of elements when we systematically “cycle through” the elements in one question.

In order to discover these synergistic combinations we simpy divide the data for any question (e.g, WHO the person is, question A) into the five levels or strata (A=0 viz., A does not appear in the vignette; A=1 in the vignette, A=2 in the vignette, A=3 in the vignette, and A=4 in the vignette, respectively). The vignettes in each strata comprise an experimental design that can be analyzed. The value of A is held constant in the stratum. Thus, A no longer acts as a source of four independent variables (A1-A4). We are now left with 12 independent variables, B1-B4, C1-C4, and D1-D4, respectively.

Table 5 shows the coefficients which are very strong for independnt variables B1-D4, when A is “cycled through,” viz., A0 (A absent), A1, A2, A3 and A4, respectively. Only the very strong performing coefficients appear in Table 5. The analysis was done for suicide (Top3) as the dependent variable. It is clear that there are synergies between WHO the person is and the situation in prison. Of course, these are inferred by the respondent. We are relying on the ‘‘wisdom of the masses” to give us a sense of the pattern Nonetheless, the data suggest some patterns, such as the perceived synergy between a middle class released prisoner and an experience with drug addicts in prison.

Table 5: Synergistic combinations in which the coefficient for the situation is very strong. The dependent variable is Top3 (suicide)

Finding These Individuals in the Population

A key output of most Mind Genomics studies is the continuing discovery that the mind-sets do not vary in a straightforward way with the typical geo-demographics that fill the databases of people. We know a lot about the behavior of people. However, despite being able to measure their behaviors at many touchpoints and in many situations, we cannot say that we know the attitude of a person in a granular way for any topic which arises. Everyday experience suggests that people differ. Although we might hazard a guess about the way people make decisions regarding issues in a specific topic, these are guesses, not facts. Indeed, just a bit of thinking will reveal that people dramatically differ, often to the surprise of those who question them and believe they know the answer before it is given. The reason for the surprise is that how a person thinks is not related to, except in the most obvious cases, who the person is.

Table 6 below shows the distribution of mind-sets for both Top3 (suicidal) and Bot3 (hopeful). There were two mind-sets extracted for each. There is no clear relation between mind-sets in either case analysis to gender or age. Indeed, there is no clear relation between membership in segments created for suicidal vs segments created for hopeful, even though the people were the same, the ingoing data were the same, and all that differed was the way the data in the scale were treated.

Table 6: Distribution of mind-sets for Suicidal (Top3) and for Hopeful (Bot3)

Unable to generalize the discoveries of Mind Genomics, our ability to understand what the mind-sets mean in terms of behavior and how they relate to mind-sets of other studies is limited. The mind-sets here can be used to understand how one thinks of the feelings of released prisoners. The results would be far stronger if the study could be administered to prisoners a year after their release or to prisoners from different socio-economic classes with the objective to assign a new individual (ex-prisoner) to one of the two mind-sets.

Recently, authors Gere and Moskowitz developed an approach to assign new people to the mind-sets discovered through Mind Genomics. The approach, called the PVI (Personal Viewpoint Identifier), uses a combination of Monte Carlo Simulation with added variability, and Decision Tree analysis. The PVI creates a set of six questions, using the elements and coefficients shown in the left part of Table 4 (mind-sets created from Top3, viz., Suicide). The table, comprising both positive and negative coefficients, is “perturbed” by added, random variability. The PVI then identifies the optimal set of six elements, taken directly from the study, the patterns of response which best reproduce the original mind-sets. The elements are presented to the new person on a 2-point scale. The pattern of responses to these six questions, based on the elements, assigns the new person to one of the two (or three) mind-sets, empirically uncovered by the study.

It should be kept in mind that the PVI works with granular data, with data used to create the vignettes in the first place. Thus, the PVI does not need to be “interpreted” by experts, who take macro segmentation of an entire topic and change the focus to a micro-topic. The PVI works automatically, without training, and is set up in minutes based upon the proper input from the study.

Figure 5 shows the PVI. The first part of the PVI (left side) contains a section to obtain demographics, allowing the researcher to understand who the respondent IS, when the PVI is completed, and so forth. Many of these questions can be suppressed for a shorter interview. The second part comprises two PVI’s, one for Suicide, and the other for Hopefulness. The respondent simply answers the 12 questions. The data are stored in a database, showing the demographics, the mind-set for each PVI (suicide, hopefulness), and the original ratings. The PVI is set up for rapid, easy deployment, and for fast answers.

Figure 5: The PVI. The left panel shows the first part, which acquires the demographics. The right panel shows the two PVI questionnaires, for the two pairs of mind-sets.

The PVI for the study. The left panel shows the demographics section. The right panel shows the two PVIs comprising six questions each, one for suicide (study 1), the other for hopefulness (study 2). The PVI structure allows the researcher to randomize the order of the studies, and within a study randomize the order of the questions. There is a third option to randomize all 12 questions so that questions of hopefulness may be mixed with questions of suicide.

The PVI, showing two panels. The left panel obtains the demographics. The right panel presents two sets of six questions each, designed to assign a person separately to the one mind-set from the first pair of mind-sets (regarding suicide), and at the same time assign a person to one mind-set from the second pair of mindsets (regarding hopefulness).

Discussion and Conclusions

With increased experience in applying the methods of Mind Genomics, the researcher can gain valuable insights into the minds of people. In contrast to the typical approach of science, which addresses “holes” in the literature, the Mind Genomics approach proceeds in a purely inductive, exploratory way. With a Mind Genomics experiment, there is no hypothesis to be tested and either corroborated or falsified in the classical manner of science as described by Karl Popper [27]. Rather, the science here is simply observing a situation and formalizing a way to understand the different aspects of that situation [28].

What is important in this paper is the discovery of the two mind-sets for suicide thoughts and the two mind-sets for hopeful thoughts. It should be noted that rather than interviewing recently released prisoners (viz., after a year), we began this project in the spirit of “wisdom of the masses” and engaged in a gedanken or “thought” experiment.

If the approach presented here is acceptable to the scientific community as a way of understanding our perception of others, then the Mind Genomics approach provides an interesting way to introduce new topics into the world of research, topics which are appropriate for specific groups but must be first explored with the world at large. Mind Genomics offers many benefits. The results can be directly integrated into a larger database. The data is self-evident. Patterns emerge from the data. Some are meaningful and some are not. By following many iterations and fine-tuning the questions and answers that received the most responses in an earlier iteration, the researcher arrives at the truth. This is the science of psychology in its most basic form: looking at all possibilities, sorting out the emerging patterns, searching for differing mind-sets, and predicting which mind-set someone new will belong to. By repeating this methodology for dealing with questions of economics or feelings or everyday occasions, the researcher will gather the data to formulate a “wiki of the mind” and understand how mind type and behavior are related.

Acknowledgement

Attila Gere thanks the support of Premium Postdoctoral Research Program of the Hungarian Academy of Sciences.

References

Kariminia A, Law MG, Butler TG, Levy MH, Corben SP, et al. (2007) Suicide risk among recently released prisoners in New South Wales, Australia. Medical Journal of Australia 187: 387-390. [crossref]
Pratt D, Piper M, Appleby L, Webb R, Shaw J (2006) Suicide in recently released prisoners: a population-based cohort study. The Lancet 368: 119-123. [crossref]
Pratt D, Appleby L, Piper M, Webb R, Shaw J (2010) Suicide in recently released prisoners: a case-control study. Psychological Medicine 40: 827-835. [crossref]
Stark R, Doyle DP, Rushing JL (1983) Beyond Durkheim: religion and suicide. Journal for the Scientific Study of Religion 120-131.
Harizi A, Trebicka B, Tartaraj A (2020) A Mind Genomics Cartography of Shopping Behavior for Food Products During the Covid-19 Pandemic. European Journal of Medicine and Natural Sciences 4: 25-33.
Opsal T (2012) ‘Livin’on the Straights’: Identity, Desistance, and Work among Women Post‐ Sociological Inquiry 82: 378-403.
Steiner B, Wooldredge,J (2008) Inmate versus environmental effects on prison rule violations. Criminal Justice and Behavior 35: 438-456.
Camp SD, Gaes GG (2005) Criminogenic effects of the prison environment on inmate behavior: Some experimental evidence. Crime & Delinquency 51: 425-442.
Hochstetler A, Murphy DS, Simons RL (2004) Damaged goods: Exploring predictors of distress in prison inmates. Crime & Delinquency 50: 436-457.
Lahm KF (2008) Inmate-on-inmate assault: A multilevel examination of prison violence. Criminal justice and behavior 35: 120-137.
Dhami MK, Mandel DR, Loewenstein G, Ayton P (2006) Prisoners’ positive illusions of their post-release success. Law and Human Behavior 30: 631-647. [crossref]
Craig DE, Rogers RD (1993) Vocational training in prison: A case study of maximum feasible misunderstanding. Journal of Offender Rehabilitation 20: 1-20.
Holbrook MI (1997) Anger management training in prison inmates. Psychological Reports, 81: 623-626. [crossref]
Suarez A, Lee DY, Rowe C, Gomez AA, Murowchick E et al. (2014) Freedom project: Nonviolent communication and mindfulness training in prison. Sage Open 4: 2158244013516154.
Visher CA, O’Connell DJ (2012) Incarceration and inmates’ self-perceptions about returning home. Journal of Criminal Justice 40: 386-393.
Winnick TA, Bodkin M (2008) Anticipated stigma and stigma management among those to be labeled “ex-con”. Deviant Behavior 29: 295-333.
Baldry, Eileen, Desmond McDonnell, Peter Maplestone, Manuel Peeters. (2002) “Ex-prisoners and accommodation: What bearing do different forms of housing have on social reintegration for ex-prisoners.” In Housing, Crime and Stronger Communities Conference convened by the Australian Institute of Criminology and the Australian Housing and Urban Research Institute, Melbourne 6-7.
Johnson Listwan S, Colvin M, Hanley D, Flannery D (2010) Victimization, social support, and psychological well-being: A study of recently released prisoners. Criminal justice and behavior 37: 1140-1159.
Surowiecki J, (2005) The wisdom of crowds. Anchor.
Milutinovic V, Salom J (2016) Mind Genomics: A Guide to Data-Driven Marketing Strategy. Springer.
Moskowitz HR, Wren J, Papajorgji P (2020) Mind Genomics and the Law , LAP LAMBERT Academic Publishing 13: 17-21.
Moskowitz HR, (2012) ‘Mind genomics’: The experimental, inductive science of the ordinary, and its application to aspects of food and feeding. Physiology & Behavior 107: 606-613. [crossref]
Moskowitz HR, Gofman A, Beckley J, Ashman H (2006) Founding a new science: Mind genomics. Journal of Sensory Studies 21: 266-307.
Box GE, Hunter WH, Hunter S (1978) Statistics for experimenters. New York: John Wiley and sons.
Gofman A, Moskowitz H (2010) Isomorphic permuted experimental designs and their application in conjoint analysis. Journal of Sensory Studies 25: 127-145.
Dubes R, Jain AK (1980) Clustering methodologies in exploratory data analysis. Advances in Computers 19: 113-228.
Popper K (2005) The logic of scientific discovery. Routledge.
Kell DB, Oliver SG (2004) Here is the evidence, now what is the hypothesis? The complementary roles of inductive and hypothesis‐driven science in the post‐genomic era. Bioessays 26: 99-105. [crossref]

Energy Deficiency Leading to Predisposition of Formation of Malignant Ovary Tumor Secondary to Chronic Use of Hormones to Treat Acne

Leave a reply

DOI: 10.31038/IGOJ.2021433

Abstract

Introduction: Malignant ovary tumor is the one of highest mortality rate in gynecology cancer and the induction of this ovary cancer is related to metabolism and exposure to estrogen.

Purpose: To demonstrate that the use of hormones to treat acne is not safe, mainly in patient with energy deficiency in the chakras’ energy centers and the possibility of inducing cancer in the ovaries could be one of the reasons to reduce the indication of these medications to treat acne.

Methods: One case report, 29-years-old women with pain in the abdomen and after doing one ultra-sound that revealed an alteration in the right ovary that was bigger than normal and the surgery was scheduled to see what could be.

Results: In the surgery, it was done biopsy that revealed malignant tumor in the right ovary. The patient needs to take out all the womb and part of the ovary due to malignance. The patient was submitted to chemotherapy, radiotherapy and started treatment with acupuncture with apex ear bloodletting and did the chakras’ energy measurement that revealed that all the chakras’ were in the lowest level of energy. Homeopathy was used according to the theory Constitutional Homeopathy of the Five Elements based on Traditional Chinese Medicine and crystal-based medications to replenish the energy of the chakras’ energy centers. The patient said that she was taking hormones for ten years to treat acne in the skin. Today, she still working at the local secretary and have to put a hair wig due to hair loss when using chemotherapy.

Conclusion: The chronic use of hormones can induce the formation of malignant ovary tumor especially when the patient has lack of energy of the chakras’ energy centers diagnosed by radiesthesia procedure. The treatment of this lack of energy using Chinese dietary counseling, auricular acupuncture and homeopathies medications according to Constitutional Homeopathy of the Five Elements based in traditional Chinese medicine and crystal-based medications is the major importance to restore the energy of the patient that was low, even after the treatment using surgery, chemotherapy and radiotherapy. There is a need to prescribe very carefully hormones in the treatment of any pathology nowadays due to lack of energy of the entire population, leading to increase risks to formation of any type of cancer, in this case, the formation of malignant ovary tumor.

Keywords

Malignant ovary tumor, Hormones, Acne, Diet, Acupuncture, Traditional Chinese medicine, Chakras, Homeopathy.

Introduction

Cancer is the most common cause of mortality in most parts of the world, and currently is the most common impediment to achieving desirable life expectancy in most countries. Ovarian cancer is one of the most common gynecologic cancers that rank third after cervical and uterine cancer. It also has the worst prognosis and the highest mortality rate [1].

Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal. The high mortality rate of ovarian cancer is caused by asymptomatic and secret growth of the tumor, delayed onset of symptoms, and lack of proper screening that result in it diagnosis in the advanced stages [1].

Like many cancers, the incidence of ovarian cancer varies across the world. The epidemiological diversity of ovarian cancer in different regions can be attributed to the risk factors that account for the occurrence of ovarian cancer. The highest prevalence of ovarian cancer is seen in non-Hispanic white women (12.0 per 100,000), followed by Hispanic (10.3 per 100,000), non-Hispanic black (9.4 per 100,000), and Asian/Pacific Islander women (9.2 per 100,000) [1].

According to Globocan, 295,414 cases of ovarian cancer have been identified in 2018, accounting for 3.4% of all cancer cases in women. In 2018, 184,799 deaths occurred due to ovarian cancer, accounting for 4.4% of the entire cancer-related mortality among women [1].

Purpose

The purpose of this study is to demonstrate that patients with malignant ovary tumor have chakras’ energy centers deficient in energy, predisposing them to have malignant cancer when using chronically hormones to treat acne.

Methods

Through an extensive search for articles indexed in PubMed in Western medicine and in traditional Chinese medicine regarding malignant ovary cancer and in acne formation and through one case report of patient that had malignant ovary tumor formation after remove taking ten years of hormones to treat the acne.

The patient is a 29-year-old woman that had a history of since the age of 18 years-old, was using oral contraceptive for the treatment of her face acnes. In June 2019, she went to a routine appointment but had some discomfort such as cramps spaced out and a lot of desire to go to the bathroom, she felt that her bladder was not emptying as it should, despite never having problems with colic, even before doing use of the contraceptive, which she used exclusively to treat his acne, correctly following the dosage of the medication, made only blood tests and Papanicolaou test, which apparently was all right.

In July 2019, nothing had changed and she was convinced that she had a urine infection and decided to go to the doctor on duty, so she did more tests and nothing was found, until she had a transvaginal ultrasound where it was detected that there was a pelvic mass and a lot of liquid in the abdominal cavity. She did more tests and came to the conclusion that surgery would be necessary, where they could give her a more accurate diagnosis. The doctor did the biopsy and she was diagnosed with malignant epithelial cancer of stage IIIC ovary. A total hysterectomy and administration of chemotherapy and also radiotherapy was required, where 6 cycles and maintenance therapy were performed.

During the chemotherapy sessions, she also went to my clinic, as her parents were also my patients. I measured her chakras’ energy centers through radiesthesia procedure that revealed that all her five massive organs were without any energy (rated in one), only the spiritual chakra (seventh chakra) was normal (rated in eight) that was already expected, since the cause of cancer in TCM is energy deficiency and formation of internal Heat.

The first step in her treatment to improve her energy was to change her dietary habits according to Chinese dietary counseling, to do not imbalance even more the energy of the patient that was already very low. I recommended to her to avoid all dairy products, raw foods, sweets and cold drinks to do not imbalance the Spleen-pancreas meridian that is responsible for the absorption of nutrients and production of Blood. I also suggest to the patient to do not drink soda, coffee and mate tea to do not imbalance even more the Kidney meridian, responsible for the production of Yin and Yang energy inside the body. Lastly, to do not eat fried foods, chocolate, honey, coconut, eggs, alcoholic beverages and melted cheese to do not imbalance the Liver and Gallbladder meridian because these foods can induce the formation of more internal Heat.

She also did some acupuncture session with me and I used auricular acupuncture associating apex ear bloodletting. The auricular acupuncture points used in her treatment were: Shen-men; Kidney, Liver, Spleen, Lungs, Heart, Large intestine, Occiput, Hunger point, endocrine. It was also used moxibustion therapy in some points in the belly and in the lumbar region, to increase the production of Yin and Yang energy.

And I also prescribe to her; homeopathies medications according to the theory created by me (2020) entitled Constitutional Homeopathy of the Five Elements Based on Traditional Chinese Medicine. The use of highly diluted medication in this situation is very pertinent and I will explain in the discussion section why patients nowadays, need to use highly diluted medications instead of highly concentrated medications, in the discussion section.

Due to the COVID-19 pandemic, she suspended the acupuncture sessions for one year or more and in September 2020, she was discharged from the treatment where Blood and imaging tests were carried out to prove the remission of the disease.

However, in January 2021, when carrying out control tests, she did not have such satisfactory results, the disease had a relapse where it was necessary to return with chemotherapy treatment and she did not return again to continue her energy based treatment, probably due to the fear of COVID-19 infection, as she was considered immunosuppressed patient, due to cancer diagnosis.

According to the patient herself, the treatment with acupuncture and homeopathies helped a lot during the treatment with chemotherapy, not allowing her to have so many side effects and with a good mental health, making the results of the Western treatment better.

Discussion

This article will be written following Hippocrates (460 bce – 375 bce) oath that said that it is important to consider older ancient medical traditions prior to the knowledge we have nowadays [2].

So, to understand in the deeper sense what could be happening in this specific patient that was using chronically hormones to treat acne, for more than 10 years, it is important to understand what could be happening in this patient in the energy level, to establish the preventive measurements and not just treating the symptom itself, that is the ovary cancer formation [3].

Estrogens are implicated as causative factors of ovarian carcinogenesis Estrogens have long been suspected as etiologic factors of ovarian carcinoma. Although usage of estrogen-based oral contraceptives is known to reduce ovarian carcinoma risk, its effect is primarily attributed to reduction in ovulation frequency. Further wise literature from breast cancer research has demonstrated direct genotoxic effects of estrogen. Hence, it is logical to speculate that genomic damage of ovarian surface epithelium cells, covering the ovulating follicles or in inclusion cysts may, in part, be caused by the high levels of estrogen in the follicular fluid or in the ovarian stroma [4].

The first studies showed that the adult female acne lesions were located mainly on the lower part of the face, including the mandibular region, the perioral region and the chin, conferring a U-shape, in addition to the anterior cervical region. It is characterized by inflammatory lesions, papules and pustules, of mild to moderate intensity, with the presence of few closed comedowns or micro cysts. Post inflammatory hyperpigmentation is common and scars can occur in 20% of affected women. In addition, the skin may be more sensitive than that of adolescents, with less tolerance to topical medications [5].

Adult female acne is a therapeutic challenge because it presents a tendency to relapse, even after cycles of oral antibiotics or isotretinoin. The typical evolution of adult female acne, with frequent relapses, makes maintenance treatment essential [5].

But in this article, I will show a different point of view of carcinogenesis and briefly about acne, following what Hippocrates said that “Foolish the doctor who despites the knowledge acquired by the ancients”, I will show how could be the formation of cancer induced by the chronic ingestion of hormones, according to the traditional Chinese medicine point of view [3].

The reasoning used to treat all my patients was based in one case I treated in 2006 and changed completely the way of thinking after this specific case, that I will describe now [6].

This patient was a 70-year-old-male patient, who reported pain in the legs and was using anti-inflammatory medications for about 6 months without any improvement. He was diagnosed with Kidney-Yang deficiency, according to TCM. He received treatment with Chinese dietary Counseling, acupuncture and auricular acupuncture associated with apex ear bloodletting [6].

With the treatment done, the pain in the legs diminished and the patient was submitted to an interview after 30 days of the treatment. The patient revealed that his eye pressure had also lowered from 40 mmHg to 17 mmHg with the treatment he received for his leg pain, as his ophthalmologist confirmed. During the treatment, he had not reported to be treating glaucoma in the last 40 years with no improvement of his condition [6].

This unusual case became the cornerstone of all my studies in the field, trying to comprehend how the treatment focused on the root of the problem could treat different diseases and symptoms simultaneously and using the same method [7].

For this, I need to show some concepts and theories of TCM, for a better comprehension. I will use this tree like figure that is a metaphor of what level Western and a traditional Chinese medicine is treating nowadays, to us to know what we need to do. Western medicine looks to the part above the ground, with the branches and leaves; each branch represents one medical specialty and the leaves of this branch are the symptoms and diseases related to each specialty. So, in this case, the acne is one leaf of the dermatology branch and the ovarian tumor is one leaf of the gynecology branch. For the other hand, TCM looks to the entire tree, including the root that is what is nourishing and maintaining the health of the entire tree, and also, receiving the influences of the external pathogenic factors, which can begin the process of formation of disease, according to traditional Chinese medicine Figure 1 [7].

Figure 1: Tree metaphor of Western and traditional Chinese medicine.

On the root of the tree, there are two theories in traditional Chinese medicine, that are Yin and Yang theory and the Five Elements theory. Yin and Yang are the two opposite forces that are believed to be present in all phenomena in the world. According to TCM, Yin and Yang are composed by four aspects: they are opposites; they are interdependent; they are mutually transformative, one always transforming into the other in a cyclical way; they are mutually consuming as well, because one side is always consuming the other, aiming to increase, as you can see in the Figure 2 [7].

Figure 2: Yin and Yang symbol.

In TCM terms, Blood functions are to nourish and vitalize the whole body. To maintain the Blood’s free flowing state another energy force must work in harmony with it and this energy is Qi. Qi is the vital energy that invigorates Blood to keep it circulating throughout the body. Blood and Qi have a very important relationship and are mutually dependent. Qi prevents Blood stagnation and Blood nourishes Qi. The aim of all treatments is to achieve a balanced state between Yin, Yang, Qi and Blood to achieve health, as you can see in the Figure 3 [7].

Figure 3: The Yin, Yang, Qi and Blood schematic relationship.

When there is an energy deficiency between one and a combination of these four energies, there is the formation of internal Heat, as you can see in the Figure 4. It can also be caused by incorrect diet, such as the constant consumption of fried foods, melted cheese, eggs, chocolate, coconut, honey and alcoholic beverages. The second reason for the increase production of internal Heat could be the emotional factors such as excessive anger. The internal Heat is one of the energy imbalances that is necessary to produce cancer, according to traditional Chinese medicine and written by me (2020) in the article entitled The Importance of Treating Energy Imbalances and Chakras Replenishment for Prevention and Treatment of Cancer. In this article, I am showing the importance of treating the energy deficiency state of three cases reports, the first two patients have diagnosis of thyroid cancer and pap smear alteration grade IV respectively, and were cued only doing energy rebalancing and replenishing the chakras’ energy centers that were deficient in energy in both patients. And in the third case report, the patient, it was a male patient with Lung cancer diagnosis and only improved his metastasis condition, disappearing them when treating his energy deficiencies using the tools recommended in this article such as Chinese dietary counseling, auricular acupuncture with apex ear bloodletting and the use of highly diluted medications to improve the vital energy of the patient that was already low that was worsening with the use of chemotherapy or radiotherapy. When this third case report was using only chemotherapy, his metastasis was reducing in size but always appearing in another site of the body [3,7].

Figure 4: Internal Heat formation when there is energy deficiency.

The second main theory basing traditional Chinese medicine is the Five Elements theory. The Five Elements theory states that there are five elements present in everything in the world, including our bodies. These elements are Water, Wood, Fire, Earth and Metal and inside the human body, these elements will be represented by five specific massive organs. These organs have extremely important functions to produce internal energy to allow adequate functioning of the human body. The Wood element corresponds to the Liver, the Fire element corresponds to the Heart, the Earth element corresponds to the Spleen, the Metal element corresponds to the Lungs, and the Water element corresponds to the Kidney, as you can see in the Figure 5 [8].

Figure 5: Five Elements theory.

The chakras are energy concentrations that you cannot see by the naked eyes. There are seven chakras and each one is responsible for sending energy to one specific organ that they command. There are studies in the literature correlating chakras’ with the Five Elements theory in traditional Chinese medicine such as the study wrote by Chase (2018) entitled The Geometry of Emotions: Using Chakra Acupuncture and 5-Phase Theory to Describe Personality Archetypes for Clinical Use, that this author is correlating the five elements with the chakras’ energy centers and for this reason, when I measure the chakras’ energy centers, I am measuring the five internal massive organs energy and I will know if the organ has energy or not to work and production of energy that each one is responsible, as showed in the Figure 6 [9].

Figure 6: Chakra’s and correspondence with Five Elements.

There are seven main chakras present in the body and their relationship among themselves is extremely important for the body’s health. As there are seven chakras and five elements, the seventh chakra (spiritual) is ruled by the first (Wood or Liver), and the sixth chakra (memory and concentration) is ruled by the second (Water or Kidney). The fifth chakra is ruled by Earth (Spleen-Pancreas) and it is responsible for Stomach, Spleen, Pancreas, Thyroid, Breasts. The fourth is ruled by Metal (Lung) and it is responsible for the skin, hair and sense of smell and distribution of energy. The third chakra is ruled by Fire or Heart and it is responsible for speech and communication and sleeping process. The second is ruled by Water (Kidney) and it is responsible for the youth, hearing, memory and concentration, teeth, bones, reproduction and sexual function. The first chakra is ruled by Wood or Liver and it is responsible for distribution of energy in the entire body. The energy alteration could be happening before beginning the hormone treatment and was harmed even more after the hormone to treat acne begins because hormones is considered highly concentrated medications and according to Arndt-Shultz Law, can reduce even more this vital energy, leading to have more propensity to have cancer formation [10].

The first step used by me in all my treatments was the changes in the dietary aspects of the patient, to promote an equilibrium between the Yin and Yang and also, the five elements of the Five Elements theory. The dietary changes were well explained in the article Why Are Diabetic Patients Still Having Hyperglycemia Despite Diet Regulation, Antiglycemic Medication and Insulin? [7].

The second step in the treatment were the use of acupuncture associating with apex ear bloodletting, because is a very important tool used by me to regulate the Yin, Yang, Qi and Blood, as I showed the meaning of each auricular point used in the treatment of this patient in the article entitled How Do You Treat Back Pain in Your Practice? [10].

Moxibustion is another toll used by Chinese medicine to increase the vital energy of the patient and in the case of this patient that was in treatment of malignant ovary tumor using highly concentrated medications, her vital energy was reduced and the use of moxibustion in this case would benefit the patient, increasing her energy to fight against the malignant cell production [11].

After these concepts been briefly introduced, we can talk about the acne and mainly about ovarian tumor formation. According to TCM, acne is caused by internal Heat retention and invasion of Dampness. And cancer is formed by energies deficiencies and Heat retention. Both studies about these subjects were written by me (2020) in the article entitled Energies Imbalances and Chakras’ Energies Deficiencies in the Treatment of Acne and in the second article entitled The Importance of Treating Energy Imbalances and Chakras Replenishment for Prevention and Treatment Chakras Replenishment for Prevention and Treatment of Cancer among many others [3,12].

What I am saying in all these articles about cancer formation is that they all have in the back ground, energy deficiencies in the chakras’ energy centers and the treatment replenishing these energy is very important to improve the immune system of them allowing the body to fight against the production of malignant cell, that usually occurs every day, according to the study written by me (2020) entitled The Importance of Treating Energy Imbalances and Chakras Replenishment for Prevention and Treatment of Cancer [3].

In the article written by Cooper (2000) entitled The Development and Causes of Cancer, he is saying that the increase incidence of cancer with age suggests that cancer comes from the development of multiples abnormalities that accumulates over many years [13].

In this case reported in this article, the patient was using hormones for more than 10 years to treat acne and as I showed in the article (2020) entitled Energies Imbalances and Chakras’ Energies Deficiencies in the Treatment of Acne, patients with acne also have chakras’ energy centers deficient in energy and when introducing hormones to treat acne, the hormones is considered highly concentrated medications, that according to Arndt-Shultz Law ( Figure 7) , can reduce the vital energy of the patient that was already low, leading to increase chance of having cancer in the future [12,14].

Figure 7: Arndt-Schultz Law.

The reason why the use of this kind of medication can increase the chance of having cancer in the future is explained by me in the Table 1. In this table, I am showing that the evolution from health to disease is divided in five phases, where the first three phases are characterized by the energy alterations (less energy) but the laboratorial exams are normal. In the phase four, the patient has symptoms and the laboratorial exams have some alterations but the phase five is characterized by the irreversible lesion caused by cancer formation. In the case of the patient reported in this article, when she began to have acne, probably that her energy was low and when it was prescribed the use of hormones to treat this acne condition, the energy dropped even more, reducing the vital energy that was important to fight against the formation of malignant cells, developing cancer after 10 years of using this kind of medication [3].

Table 1: Evolution from health to disease formation.

Phase	Organ	Exams	Energy Reserve	Symptom
1	Slowing down of organ functions	Normal	Normal	Without critical symptoms
2	Slowing down of organ functions	Normal	Consumption of internal energy reserves	Without symptoms in other organ
3	Slowing down of organ functions	Normal	Consumption of external energy reserves	With symptoms in same organ
4	Reversible cellular lesion	Little alterations	Consumption of blood reserves	Curable disease
5	Irreversible cellular lesion	Excessive alteration	Metabolic Exhaustion	Incurable disease

In the article written by me (2021) entitled What Are the Markers That Predict the Development of Having Cancer in the Future Without Laboratory or Radiological Tests? I am saying that the measurement of energy in the chakras’ energy centers is a very important toll nowadays, to predict the evolution of the patient to cancer in the future because, what Western medicine is doing nowadays, is to do laboratory or radiological exams to do the diagnosis of cancer in the beginning of cancer formation. In my opinion, this kind of exam is not preventing the cancer formation but only doing cancer diagnosis in the early phase of the formation of cancer [15].

In the article I wrote (2021) entitled Energy Alterations and Chakras’ Energy Deficiencies and Propensity to SARS-CoV-2 Infection, I did a research measuring the energy of 1000 patients during 2015 to 2020 and what I found was that 90% of all my patients, including babies, children, adolescents, young adults and older people, are in the lowest level of energy in all internal massive organs, as I am showing in the Table 2. In this study, I am demonstrating the majority of the population nowadays could be high risks to have cancer in some near future because energy is important to prevent the formation of cancer that usually grows when there is energy deficiency for long time [16].

Table 2: Research doing the chakras’ energy centers measurement of 1000 patients in Brazil.

Ages Chakras	2-19	20-59	60-79
7	8	8	8
6	1	1	1
5	1	1	1
4	1	1	1
3	1	1	1
2	1	1	1
1	1	1	1
Total of Patients	26	170	86
Main Western diagnoses	Anxiety	Anxiety	Anxiety
Main Western diagnoses	Depression	Headache	Knee Pain
Main Chinese diagnoses	Yin/Yang	Yin	Yin
	Yin/Blood	Yin/Yang	Yin/Internal Heart
			Yin/Yang/Internal Heart

The aim to treat the energy of this patient reported in this article was to increase the vital energy that was already low, even receiving the chemotherapy and radiotherapy, because she was doing a localized treatment for the malignant ovary tumor, but the energy deficiency that had in the back ground and cannot see by the naked eyes was not treated yet. For this reason, the patient used other tools to increase her immunity (energy) to become stronger and allowing her body to fight against malignant cell formation even in use of chemotherapy [3].

Patients with cancer that it is in use of chemotherapy or radiotherapy, should be treated using medications to increase the vital energy such as the homeopathies according to the theory Constitutional Homeopathy of the Five Elements based on Traditional Chinese Medicine, showed in the Table 3. The medications need to be used according to the results made by radiesthesia procedure and the given according to the Generation cycle, as you can see in the Figure 8 [8].

Table 3: Homeopathy medications used in the treatment of lack of energy in the internal five massive organs.

Chakras	Five Elements	Homeopathy Medications	Crystal-based medications
1° Chakra	Wood/Liver	Phosphorus	Garnet
2° Chakra	Water/Kidney	Natrum muriaticum	Orange calcite
3° Chakra	Fire/Heart	Sulphur	Rhodochrosite
4° Chakra	Metal/Lung	Silicea	Emerald
5° Chakra	Earth/Spleen	Calcarea Carbonica	Blue Quartz
6° Chakra	Water/Kidney	Tone 2° Chakra	Sodalite
7° Chakra	Water/Liver	Tone 1° Chakra	Tiger eye

Figure 8: Generation Cycle of the Five Elements theory.

The homeopathy medications are recommended to use for one year or more (I think that if the high authorities do not have any action to see other possible ways to have modern technology of telecommunication, the use of this kinds of medications should be for the entire life of the patients), because of the influences of the 5G technology, leading to reduction of this vital energy that is low in quite the majority of the people in this world. I am doing a correlation between what I found in my patients in Brazil because the cause of this reduction in the energy in the five internal massive organs is caused by the electromagnetic radiation, that all people in this globe is suffering every day [16,17].

In this patient reported in this article, she had relapse of her malignant ovary tumor, when stopping the energy based treatment when begin the COVID-19 pandemic. This is to show the importance to strength the vital energy to prevent the formation of metastasis of this patient and other complications from the use of highly concentrated medications to treat the cancer itself [3].

In another article written by me (2021) entitled is there a Greater Risk in the Use of Hormones Nowadays? I am saying that the use of hormones by women should be made with precautions because of this new energy pattern of the population, that was different from people before 2015, when I am saying that patient have energy at that time, as I wrote (2021) in the article entitled Is the Population in the World the Same as in the Past? [18,19].

I would like to emphasize that Acupuncture and Homeopathy are considered medical specialties since 1995 and 1980, respectively by the Federal Medical Council in Brazil [20].

That is why it is important to emphasize the importance of increasingly integrating Western and traditional Chinese medicine, as in this metaphor with the symbol of Yin and Yang one representing the Western medicine (Yin energy) that is materialized energy and traditional Chinese medicine represents Yang energy that is non-materialized energy, as you can see in the Figure 9. Both medicines can work together to understand better how disease is formed in the deepest level, and the importance of treating the leaf level but also, the root level of the tree, showed in the Figures 1 and 2 [7].

Figure 9: Yin and Yang of Western and traditional Chinese medicine metaphor.

Conclusion

The conclusion of this study is that the use in the hormones can induce the formation of malignant ovary tumor in person with chakras’ energy centers deficient in energy. The correction of the lack of energy (diagnosed by radiesthesia procedure) is a very important tool nowadays, to reduce the chance of having any chronic diseases and reduce of evolution to any type of cancer formation, in this case, malignant ovary cancer. The use of Chinese dietary counseling, auricular acupuncture with apex ear bloodletting and use of highly diluted medications according to Constitutional Homeopathy of the Five Elements based in Traditional Chinese Medicine and crystal-based medications, are very important step in the treatment of this kinds of diseases because can prevent complications from the use of treatment in Western medicine and also, reducing the chance of having relapses or even the formation of new type of cancer, if this patient still do not treat the energy deficiency state.

References

Momenimovahed Z, Tiznobaik A, Taheri S, Salehiniya H (2019) Ovarian cancer in the world: epidemiology and risk factors. Int J Womens Health 11: 287-299. [crossref]
Craik E (2014) The “Hippocratic” Corpus: Content and Context. Routledge 344.
Huang Wei Ling (2020) The Importance of Treating Energy Imbalances and Chakras Replenishment for Prevention and Treatment Chakras Replenishment for Prevention and Treatment of Cancer. Advances in Cancer Research & Clinical Imaging 3.
Ho SM (2003) Estrogen, progesterone and epithelial ovarian cancer. Reprod Biol Endocrinol 1: 73-80. [crossref]
Bagatin E, Freitas THP De, Rivitti-Machado MC, Ribeiro BM, Nunes S, et al. (2019) Adult female acne: a guide to clinical practice. An Bras Dermatol 94: 62-75. [crossref]
Huang Wei Ling (2019) The Importance of Correcting Energy Imbalances and Chakras Energy Deficiencies in the Treatment of Patients with Glaucoma. Clin Res Ophthalmol 2: 1-9.
Huang Wei Ling (2019) Why Are Diabetic Patients Still Having Hyperglycemia despite Diet Regulation, Antiglycemic Medication and Insulin? Int J Diabetes Metab Disord 4: 1-14.
Huang Wei Ling (2020) Constitutional Homeopathy of Five Elements Based on Traditional Chinese Medicine. Acta Scientific Medical Sciences 4: 57-69.
Chase CR (2018) “The Geometry of Emotions: Using Chakra Acupuncture and 5-Phase Theory to Describe Personality Archetypes for Clinical Use”. Medical Acupuncture 30: 167-178. [crossref]
Huang Wei Ling (2018) “How Do You Treat Back Pain in Your Practice? Part 2”, Medical Acupunture 30: 46-53. [crossref]
Deng H, Shen X (2013) The Mechanism of Moxibustion: Ancient Theory and Modern Research. Evid Based Complement Alternat Med 2013: 379291. [crossref]
Huang WL (2020) Energies Imbalances and Chakras’ Energies Deficiencies in the Treatment of Acne. Clinic Res Dermatol 3: 1-9.
Cooper GM (2000) The Development and Causes of Cancer. Sunderland (MA): Sinauer Associates.
Arndt Schultz Law and its applications in Homeopathy | Homeopathy Resource by Homeobook.com [Internet]. [cited 2020 Aug 5].
Huang WL. What Are the Markers That Predict the Development of Having Cancer in the Future Without Laboratory or Radiological Tests? Journal of Cancer and Cancer Prevention 1.
Huang Wei Ling (2021) “Energy Alterations and Chakras’ Energy Deficiencies and Propensity to SARS-CoV-2 Infection”. Acta Scientific Microbiology4: 167-196.
Huang WL (2021) The Influence of Cell Phones and Computers on Our Immune System. Ann Immunol Immunother 3: 000141.
Huang Wei Ling (2021) “Is there a Greater Risk in the Use of Hormones Nowadays?”. Acta Scientific Women’s Health 3.8: 08-10.
Huang Wei Ling (2021) “Is the Population in the World the Same as in the Past?”. Acta Scientific Clinical Case Reports 2: 6.
Homeopatia e acupuntura reconhecidas e procuradas – Cremepe [Internet]. [cited 2020 Dec 9].

Comparison of Postoperative Opioid Use in Mothers with Neonates in the Neonatal Intensive Care Versus in the Regular Nursery or Rooming In

Leave a reply

DOI: 10.31038/IGOJ.2021432

Abstract

Objective: To evaluate if post cesarean section opioid usage is greater for mothers with neonates in the Neonatal Intensive Care Unit (NICU) versus in mothers with neonates in the well born nursery who were encouraged to “room in” with their mothers (WBN).

Methods: This was a retrospective chart review that analyzed 8136 records of women delivering at an urban academic institution. The study period was from January 1, 2013, through December 12, 2018. Daily post-operative opioid usage was assessed. Chi-square analysis was used to evaluate for differences between the groups.

Conclusions: Post-operative mothers with neonates in the NICU did not have greater opioid usage versus those with neonates in the WBN. However, post cesarean section mothers with neonates who required major surgery for life threatening diagnoses had significantly greater opioid usage.

Clinical Trial Registration: “Opioid use by Postpartum Mothers” (s19-01134).

Keywords

Opioid, Postpartum, Neonates, NICU

Introduction

The prevalence of opioid abuse disorder has markedly increased over the past years, having doubled in occurrence between 1988 to 2011 [11]. It has now become a national emergency [2,20] leading to multiple organizations and institutions focusing on with how to prevent, diagnose and treat this crisis [12,20].

Post-operative opioid use presents pain management dilemmas for mothers as it affects their ability to be alert and engaged in order to nurture their newborns. Mothers with neonates in the NICU may have additional stresses and thus desire “round the clock” pain management as opposed to “as needed” as a means to avoid the distractor of postpartum pain.

Although other areas of opioid use have been extensively studied including those at greater risk for substance abuse [1,2,4,7,8,10,11,14,20,30] and provider prescription patterns [14-16,19,22], no research to date has focused on whether there is a difference in postoperative opioid use in women with neonates in the NICU versus the WBN.

The aim of our study is to determine whether neonatal NICU admission poses an additional stressor for post-operative mothers and results in increased use of opioids during this vulnerable period.

Methods

After receiving IRB approval, a retrospective chart review of 8136 women who delivered at an urban academic institution from January 2013-December 2018 was performed. Information regarding daily post-operative opioid use as well as the location of the neonate (NICU versus WBN) was collected. Post-operative opioid usage for mothers with neonates in WBN (Group A) was compared to usage in mothers with neonates in the NICU (Group B). Opioid usage was stratified into 24-hour blocks. Substance abusers and chronic opioid users were excluded.

A subgroup analysis was performed for the indication of the NICU admission. Chi-square was used to analyze the data.

Results

All post-operative patients (n =8136, comprised of 6509 patients in group A [WBN] and 1627 patients in group B [NICU]) were prescribed both opioids and non-narcotic analgesics. Both agents were used by 84% of mothers while 16% used only non-narcotic analgesics. No patients exclusively used opioids alone.

During each 24 hour block, there were no statistically significant differences in opioid usage between the mothers with babies in the NICU versus the WBN (43% vs 45%, Post-Operative Day (POD) 1, 81% vs 80%, POD2, 72% vs 70%, POD3, 20% vs 23%, POD4) (Table 1).

Table 1: Opioid usage between Groups A and B.

Hospital days	Group A (n=6509)	Group B (n=1627)	P-value
POD1	43% (n=2799)	45% (n=732)	0.184
POD2	81% (n=5272)	80% (n=1302)	0.144
POD3	72% (n=4686)	70% (n=1139)	0.112
POD4	20% (n=1302)	23% (n=372)	0.142

Group A: mothers with neonates in the regular nursery.
Group B: Mothers of infants in NICU.

The most common indications for NICU admissions included prematurity (12%), sepsis (4%), and neonates requiring major surgery for life threatening anomalies (3%) while other diagnoses included hypoglycemia, transient tachypnea of newborn, meconium aspiration and observation for other benign conditions represented smaller proportions (Table 2).

Table 2: Indications for admission and Opioid usage in Group B.

	POD1	POD2	POD3	POD4
Prematurity	39%(n=76)	79%(n=154)	65%(n=127)	19%(n=37)
12%(n=195)
Sepsis	41%(n=27)	74%(n=48)	67%(n=44)	22%(n=14)
4%(n=65)
Serious problems	58% (n=28)	89%(n=44)	81%(n=40)	32%(n=16)
3%(n=49)
Other	43% (567)	78%(n=1028)	68%(n=896)	21%(n=277)
81%(n=1318)

Other: Hypoglycemia, meconium aspiration, mild respiratory distress, r/o infection

Mothers of NICU neonates (Group B) with life-threatening anomalies and who required corrective surgery (Group B1) had increased opioid usage on POD 1 and 4 when compared to those in Group A; this trend was also seen when compared to mothers whose babies were in the NICU but who did not have life threatening conditions on POD 1-4. (Group B2) (Tables 3 and 4).

Table 3: Opioid usage between Groups A and B1.

Hospital days	Group A (n=6509)	Group B1 (n=49)	P-value
POD1	43% (n=2799)	58% (n=21)	0.004
POD2	81% (n=5272)	89% (n=44)	0.113
POD3	72% (n=4686)	81% (n=40)	0.134
POD4	20% (n=1302)	32% (n=16)	0.027

Group A: mothers with neonates in Well Born Nursery.
Group B1: Mothers of Infants with Serious problems.

Table 4: Opioid usage between Groups B1 and B2.

Hospital days	Group B1 (n=49)	Group B2 (n=195)	P-value
POD1	58% (n=21)	39% (n=76)	0.0215
POD2	89% (n=44)	79% (n=154)	0.0833
POD3	81% (n=40)	65% (n=127)	0.026
POD4	32% (n=16)	19% (n=37)	0.0379

Group B1: Mothers of Infants with Serious problems.
Group B2: Mothers of infant’s prematurity.

At the time of discharge, all mothers received a prescription for narcotics, regardless of their choice of analgesics during the hospitalization, i.e. combinations of narcotics and non-narcotics, or only non-narcotics.

Discussion

Opioid use often starts with the treatment of acute pain [6,10,12] and it has been well documented that a single exposure can lead to persistent dependence [19]. For many women, their first exposure to opioids follows childbirth. Approximately 1 in 10 women suffer severe postpartum pain within the first 36 hours after delivery. Opioids are generally the mainstay of treatment at this time [14]. Multiple studies have documented inpatient use of opioids rates up to 58% for vaginal deliveries and 100% for cesarean sections [22] with 24% of patients continuing to use opioids even in the last 24 hours of hospitalization [2].

As many patients’ first exposure to opioids likely occurs during the post-operative period, our study sought to better understand opioid use in mothers who would be expected to undergo additional stresses due to their neonates being separated from their babies while admitted to the NICU. Interestingly, we did not find that these mothers had increased post-operative narcotic usage unless they were in the small subgroup of women whose babies were undergoing surgery for life threatening conditions.

Strengths of our study included the large sample size from a single academic institution with an existing standardized postpartum order set. Limitations of our study include lack of analysis of opioid use for women whose babies were briefly in the NICU but were transferred to the well-baby nursery or roomed in prior to mother’s discharge as well as an overall small sample size of mothers with neonates with “life threating” issues.

Conclusion

To our knowledge, this is the first study focusing on comparison of opioid use in mothers with neonates in the NICU versus in the newborn nursery or rooming in. This study illustrates that despite the perceived greater stresses of being separated from their neonates, only those mothers whose neonates had severe life-threatening conditions needing corrective surgery used more opioids on a “round the clock” basis. Given the findings that all patients received a narcotic prescription at discharge, even though 16 % had never used a narcotic during the hospitalization, further attention should be paid towards avoiding arbitrary prescribing narcotics in these circumstances. These findings should inform post-operative pain management plans in that mother whose babies are in the NICU may not require additional narcotics unless the neonates are undergoing corrective surgery for life threatening conditions. In addition, if mothers of neonates admitted to the NICU have not utilized narcotic prescriptions during the post-operative period they should not receive such prescriptions at discharge, as this will help to avoid the occurrence of chronic substance abuse.

References

Ailes EC, Dawson AL, Lind JN, Gilboa SM, Frey MT, et al. (2015) Centers for Disease Control and Prevention (CDC). Opioid prescription claims among women of reproductive age–United States, 2008-2012. MMWR Morb Mortal Wkly Rep 64: 37-41. [crossref]
Badreldin N, Grobman WA, Yee LM (2018) Inpatient opioid use after vaginal delivery. Am J Obstet Gynecol 219: 608.e1-608.e7. [crossref]
Baker DW (2017) History of the Joint Commission’s Pain Standards: Lessons for Today’s Prescription Opioid Epidemic. JAMA 317: 1117-1118. [crossref]
Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, et al. (2016) Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women. Am J Obstet Gynecol 215: 353.e1-353.e18. [crossref]
Becker NV, Gibbins KJ, Perrone J, Maughan BC (2018) Geographic variation in postpartum prescription opioid use: Opportunities to improve maternal safety. Drug Alcohol Depend 188: 288-294. [crossref]
Carvalho B, Butwick AJ (2017) Postcesarean delivery analgesia. Best Pract Res Clin Anaesthesiol 31: 69-79. [crossref]
Centers for Disease Control and Prevention (CDC) (2010) Adult use of prescription opioid pain medications – Utah, 2008. MMWR Morb Mortal Wkly Rep 59: 153-157. [crossref]
Deyo RA, Hallvik SE, Hildebran C, Marino M, Dexter E, et al. (2017) Association Between Initial Opioid Prescribing Patterns and Subsequent Long-Term Use Among Opioid-Naïve Patients: A Statewide Retrospective Cohort Study. J Gen Intern Med 32: 21-27. [crossref]
Ko JY, Tong VT, Haight SC, Terplan M, Snead C, et al. (2020) Obstetrician-gynecologists’ practice patterns related to opioid use during pregnancy and postpartum-United States, 2017. J Perinatol 40: 412-421. [crossref]
Komatsu R, Ando K, Flood PD (2020) Factors associated with persistent pain after childbirth: a narrative review. Br J Anaesth 124: e117-e130. [crossref]
Maeda A, Bateman BT, Clancy CR, Creanga AA, Leffert LR (2014) Opioid abuse and dependence during pregnancy: temporal trends and obstetrical outcomes. Anesthesiology 121: 1158-1165. [crossref]
Mills JR, Huizinga MM, Robinson SB, Lamprecht L, Handler A, et al. (2019) Draft Opioid-Prescribing Guidelines for Uncomplicated Normal Spontaneous Vaginal Birth. Obstet Gynecol 133: 81-90. [crossref]
Nørgaard M, Nielsson MS, Heide-Jørgensen U (2015) Birth and Neonatal Outcomes Following Opioid Use in Pregnancy: A Danish Population-Based Study. Subst Abuse 9: 5-11. [crossref]
Osmundson SS, Min JY, Grijalva CG (2019) Opioid prescribing after childbirth: overprescribing and chronic use. Curr Opin Obstet Gynecol 31: 83-89. [crossref]
Osmundson SS, Raymond BL, Kook BT, Lam L, Thompson EB, et al. (2018) Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial. Obstet Gynecol 132: 624-630. [crossref]
Osmundson SS, Wiese AD, Min JY, Hawley RE, Patrick SW, et al. (2019) Delivery type, opioid prescribing, and the risk of persistent opioid use after delivery. Am J Obstet Gynecol 220: 405-407. [crossref]
Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, et al. (2012) Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA 307: 1934-1940. [crossref]
Porter J, Jick H (1980) Addiction rare in patients treated with narcotics. N Engl J Med 302: 123. [crossref]
Rogers RG, Nix M, Chipman Z, Breen M, Dieterichs C, et al. (2019) Decreasing Opioid Use Postpartum: A Quality Improvement Initiative. Obstet Gynecol 134: 932-940. [crossref]
Shah A, Hayes CJ, Martin BC (2017) Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use – United States, 2006-2015. MMWR Morb Mortal Wkly Rep 66: 265-269. [crossref]
Tobon AL, Habecker E, Forray A (2019) Opioid Use in Pregnancy. Curr Psychiatry Rep 21: 118. [crossref]
Sanchez Traun KB, Schauberger CW, Ramirez LD, Jones CW, Lindberg AF, et al. (2019) Opioid prescribing trends in postpartum women: a multicenter study. Am J Obstet Gynecol MFM 1: 100055. [crossref]

Rivaroxaban Failure in a SARS-CoV-2 (COVID-19) Positive Patient

Leave a reply

DOI: 10.31038/JPPR.2021433

Introduction

Atrial fibrillation is the most common sustained arrhythmia in clinical practice. Patients with atrial fibrillation are at increased risk of hospitalization, death, heart failure, and thromboembolic event [1]. Development and embolization of thrombus can occur with atrial fibrillation. Ischemic stroke is most common location of embolization of thrombus, although it can embolize to other locations [2]. Chronic oral anticoagulation is recommended in most of the valvular and non-valvular atrial fibrillation and should be started after careful consideration for embolic risk, bleeding risk and overall risks verses benefit should be assessed. Novel anticoagulants (NOAC) such as rivaroxaban, apixaban, dabigatran is recommended and are being increasingly used over warfarin for patients with non-valvular atrial fibrillation [3].

Case Presentation

This patient is an 85-year old female with an extensive past medical history of atrial fibrillation on rivaroxaban, breast cancer status post-mastectomy, dementia and hypertension presented to the ED from an assisted living facility with slurring of speech that started about 4 hours prior to presentation associated with confusion. Upon arrival to the emergency department, she was saturating 97% on room air and later required 2L nasal cannula to maintain oxygenation above 92%, heart rate of 70 beats per minute with an irregular rhythm, blood pressure of 147/63 mmHg was noted. On physical examination, she was alert, oriented to person and place but not time. She was not in any acute respiratory distress. Dry oral mucosa was noted. Lungs were clear to auscultation and S1 and S2 were heard. National Institute of health and stroke scale (NIHSS) score was 4 with not answering any questions scoring 2, dysarthria as 1, and right finger to nose dysmetria of 1. Cranial nerves and reflexes were grossly intact. Code stroke was activated, and the patient was immediately taken for a non-contrast Computer tomography (CT) scan of the head which revealed chronic microvascular and atrophic changes. Computer Tomography Angiography (CTA) was unable to be performed due to the infiltration of IV during the scan. The patient was deemed not a candidate for tissue plasminogen activator because she was out of the therapeutic window and no neurosurgical intervention was indicated because the patient was already on anticoagulation with rivaroxaban. Her white blood cell count was 14 K/CMM with no neutrophilia or bands, Prothrombin time was 16 and the International normalized ratio (INR) was 1.4. Blood chemistry was within normal limits. Urinalysis was negative for leukocyte esterase or nitrites but positive for (+) 5700 bacteria. SARS-COV-2 PCR assay was positive. The patient was subsequently admitted to the medical floor. She was treated with ceftriaxone for 5 days for UTI. Magnetic Resonance Angiogram (MRA) of the brain revealed acute infarction of the left corona radiata and right frontal white matter. She was shifted from rivaroxaban to apixaban therapeutic dose for secondary prevention of stroke. Further hospital course remained uneventful and the patient was discharged back to assisted living. Follow-up after 2 months via phone call revealed that patient had no further episodes of stroke and her speech abnormality via therapy was gradually improving.

Discussion

Coronavirus (SARS-CoV-2) is a global health emergency affecting 33 million population with more than 1 miilion deaths. Despite rapidly growing literature on COVID-19 inducing clinical pro-coagulant effect causing arterial and venous thromboembolism [4], exact pathophysiology of derangements in hemostatic system is not well elucidated. There is no evidence of intrinsic procoagulant effect of SARS-CoV-2. Most reasonable hypothesis is the inflammatory cascade activating coagulation pathway, similar to that observed in sepsis [5]. The mechanism of rivaroxaban failure in COVID positive patients is not well understood. Mechanism of action of rivaroxaban is dose dependent and compliance of medication, especially taken with food is increases the bio-availability especially at higher doses [6]. This patient was compliant with the medication and it was confirmed with the assisted living facility staff. Rivaroxaban is a competitive inhibitor of factor Xa, it binds directly and reversibly to factor Xa. It is metabolized through hepatic cytochrome system via CYP 3A4/5 and CYP2J2. One of the proposed mechanisms of rivaroxaban failure is coadministration of cytochrome inducers and thus reducing the bioavailability of the medication, resulting in treatment failure [7]. Mechanism of rivaroxaban failure in SARS CoV-2 is not well understood. There has been studies which has proved the apixaban is more effective in prevention of stroke in patients with atrial fibrillation [8]. Lack of laboratory availability to quantitatively measure rivaroxaban levels makes it difficult to determine the efficacy in this patient. Further research is required to develop a standard laboratory marker as either drug level or coagulation profile to identify the therapeutic level of the drug. There are no definite guidelines for treatment of patients with novel anticoagulation failure, further research is required to assess if switching to a different NOACs or different class of anticoagulation such as warfarin would be beneficial.

Conclusion

Rivaroxaban failure in patients with atrial fibrillation and COVID-19 positive should be recognized. Apixaban can be used as an alternative for secondary prevention of stroke.

Financial Support and Sponsorship

Nil

Conflict of Interest

None declared.

References

Benjamin EJ, Wolf PA, D’Agostino RB, Silbershatz H, Kannel WB, et al. (1998) Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 98: 946-952. [crossref]
Wolf P A, Abbott R D, Kannel W B (1991) Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 22: 983-988. [crossref]
Heidbuchel H, Verhamme P, Alings M, Antz M, Diener H-C, et al. (2015) Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 17:1467-1507. [crossref]
Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, et al. (2020) COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. Journal of the American College of Cardiology. 75: 2950-2973. [crossref]
Iba T, Levy JH (2018) Inflammation and thrombosis: roles of neutrophils, platelets and endothelial cells and their interactions in thrombus formation during sepsis. Journal of Thrombosis and Haemostasis. 16: 231-241. [crossref]
J S, D K, M B, W M (2013) The effect of food on the absorption and pharmacokinetics of rivaroxaban. Int J Clin Pharmacol Ther. 51: 549-561. [crossref]
Kaur J, Rizvi S, Tewari P, Tamer S, Nafsi T (2016) Rivaroxaban Treatment Failure From Possible Drug Interaction: A Case Report. CHEST 149.
Fralick M, Colacci M, Schneeweiss S, Huybrechts KF, Lin KJ, et al. (2020) Effectiveness and Safety of Apixaban Compared With Rivaroxaban for Patients With Atrial Fibrillation in Routine Practice. Annals of Internal Medicine. 172: 463-473. [crossref]

An End of the COVID-19 Pandemic in Sight?

Leave a reply

DOI: 10.31038/IDT.2021222

Abstract

We have set out to assess the data on the intensity of the COVID-19 pandemic with a view to making plausible predictions of its decline. A plot of “% COVID-19 Associated Death per Day” versus the timing and extent of the roll out of national vaccination campaigns in Sweden, Denmark, Netherlands, United Kingdom, France, Germany, Italy and USA shows that the decline in the severity of the COVID-19 pandemic was well advanced noticeably before vaccinations began or could have become a significant contributory factor. Israel is an outlier in its manifest decline pattern, yet the data also demonstrate that vaccination has had no discernible impact at all on % Deaths per Day in Israel.

Human societies throughout recorded history have been ravaged by suddenly appearing regional epidemics and in more recent centuries by epidemics that have been observed to spread globally [1,2]. The COVID-19 pandemic caused by coronavirus SARS-CoV-2 has caused serious global health emergencies and associated social and economic destruction on the citizens of many countries on a hitherto unprecedented scale. The disease emerged suddenly in Oct-Nov 2019 in Hubei region of Central China [3].

Pandemics as always emerge without any warning, cause their toll havoc and then predictably subside. They usually last in a severe form no more than a few years – as the data relating to the “Spanish Flu” of 1918-1919 clearly attests. The termination process of pandemics is not clearly understood, but it is generally assumed to be a combination of herd immunity, attenuation of the pathogen (leading to ill-defined mechanisms of endemicity) and its degradation in the physical environment. Thus, there are likely to be a wide range of factors in varying from country to country that contributes to the decline in disease severity and eventual its disappearance. We have attempted in this note to quantitatively measure the progress of the COVID-19 pandemic in a number of Northern Hemisphere countries from available public data from the time of its onset to the present day (August, 2021). We chose “% COVID-19 Associated Death per Day” as an objective end-point of the measure of severity of SARS-Co-V-2 induced disease. Such an index may reasonably allow a comparison across countries over and above country specific variable factors such as country-and region-specific technical and demographic variations in the application of the diagnostic PCR genomic test as a primary indicator of infection.

We report here a simple observation on the current status of the COVID-19 pandemic (as 15 Aug 2021) that could have a bearing on the timing of the likely end of the pandemic. We chose two straightforward metrics from data that are publicly available at Coronavirus websites (see Source Data URL links below). We selected those countries where much new Cases per Day data are available and where the Vaccination Campaign is ostensibly substantially advanced. The Cases (and Deaths) per Day by Country are at Google: Search “Coronavirus disease statistics”. Vaccination Rates by Country are Google Search “COVID-19 vaccination rates by country”. We largely chose key time points associated with the clear successive rolling epidemic peaks of new Cases per Day in each country. We then assumed a 14-day lag at that time point before the severe COVID-19 outcome of “Death” as an objective response rate (ORR) metric. These key time-point data were entered into an Excel spread sheet and primary graphic plots were developed for each country, and resulting figure of % Death per day versus % Population Vaccinated generated by standard Excel software. These primary plots were then adjusted for scale (mainly on the Y-axis for % Vaccination rate in that country) to allow a visual comparison with the % COVID-19 associated Death rate per Day at that time point.

Thus, the reference date along the X-axis in the summary country plots in Figure 1 (below) refers to the time point for new Cases per Day. The reader can draw their own conclusions but a clear trend is evident in all the data – the decline in % COVID-19 associated reported deaths was manifestly well advanced before the roll out of the intra-muscular mRNA expression vector vaccine program was begun or had become substantially advanced (e.g. significant in impact, say >20% population vaccinated). The USA is a vast country and its data may need to be analyzed State-by-State for granular trends in localized regions to become better apparent-like the countries of Europe chosen here. Israel is also a clear outlier in the basic trend – as that country did not suffer the same levels of % COVID-19 associated deaths as the others, even in the first wave in March-April 2020. However, the vaccination program on the basis of this data appears to have had no discernible impact at all on % Deaths in Israel. In many cases the waning of the death rates are seen to have progressed before the vaccination rates rose to substantial levels, probably pointing to the development of natural herd immunity as the most reasonable principal cause.

Figure 1: %COVID-19 Deaths per Day versus % Full Vaccination by Country at key times during the epidemic waves.

We refrain from further discussion of the many likely factors and variables that would need to be considered in a more exhaustive analysis. To conclude we leave the reader with two crucially important questions that urgently need to be dispassionately addressed. What do these plots mean for possibly heralding the termination of the pandemic? Is the long-awaited end really in sight across the world in mid-August 2021? And does a new world order beckon?

Source Data

COVID-19 Cases per Day, Deaths, Vaccination Rates 15 August 2021

Cases and Deaths per Day site.

Google: “Coronavirus disease statistics” URL is

shorturl.at/cdQS9

This gives you the “Australia” dashboard (from there you can choose your country in the menu bar scroll)

Vaccination Rates by Country Google “covid-19 vaccination rates by country”

shorturl.at/oFJS4

This gives you the “Australia” dashboard (from there you can choose your country in the menu bar scroll).

References

Creighton C (1891) History of Epidemics in Great Britain. Cambridge University Press.
Beveridge WIB (1977) The Last Great Plague. W. Heinemann, London.
Pekar J, Worobey M, Moshiri N, Scheffler K, Wertheim JO (2021) Timing the SARS-CoV-2 index case in Hubei province. Science 372: 412-417.

Hydatid Disease during Pregnancy, the Challenging Management: Case Report and Review of Literature

Leave a reply

DOI: 10.31038/IGOJ.2021431

Abstract

Human echinococcosis is a parasitic infestation of human by a tapeworm called Echinococcus granulosus. It can affect pregnant women at a low incidence. Mainly asymptomatic, it has a variety of presentations. Its main location is in the liver. Hydatid disease requires multidisciplinary care especially in pregnant patients. It can be treated medically or surgically according to each case.

We present a case of 27-year-old woman, G4 P3 with three previous cesarean sections, known to have hydatid cyst disease, presenting at 32 weeks of gestation, complaining of intermittent crampy right upper quadrant abdominal pain. Abdominal ultrasound done at 11 weeks of gestation, showed hepatomegaly along with a 9 cm × 6 cm mass suggestive of hydatid cyst that was followed by ultrasounds frequently. The patient was followed by a multidisciplinary team when she was then started on Albendazol 400 mg twice daily starting 32 weeks until delivery, then for two days post operatively. She did well and was discharged home in good condition.

Hydatid disease has a special consideration when associated with pregnancy. Many cases have been reported in literature yet only few reviews of literature and one meta-analysis have been reported. Management decision is quite meticulous. It depends on cystic nature and activity on one side and on the clinical picture of the patient on the other side. In all cases, cesarean section is advised. In spite of all recommendations, further prospective studies using larger samples are needed for clear-cut algorithmic guidelines for hydatid disease management in pregnancy.

Introduction

Human echinococcosis, or hydatid disease, also known as “cyst full of water” as described by Hippocrates, is a parasitic infestation of human by a tapeworm called Echinococcus granulosus [1-4]. This disease can be seen in all population including pregnant women [5,6]. Despite that, it is currently classified among the most neglected parasitic disease [1,5]. Hydatid cyst has a variety of presentations. It may remain asymptomatic for many years and may be discovered incidentally by radiography [3,4]. The most common site of hydatid cyst is the liver [4,6]. It might be found also in any part of the body including lungs, bones and soft tissues [3,5,7]. Hydatid cyst in pregnancy is rare, and usually affects the liver [3,6]. Its diagnosis in pregnancy might not be difficult, but the management is problematic [4]. It requires multidisciplinary care [2]. Both medical and surgical treatment are available but each case should be individualized due to the limited experience, lack of standardized consensus and paucity of information in the literature as only data from case reports are available [6]. For that, obstetricians should be more aware of the clinical features, diagnosis and treatment of this unusual disease [2].

Here we present a case of a pregnant woman with a huge liver hydatid disease.

Case Presentation

A 27-year-old woman G4 P3 with previous three cesarean sections, known to have hydatid cyst disease, presented to the outpatient department at 32 weeks of gestation with an intermittent crampy right upper quadrant abdominal pain, not related to oral intake, not relieved by any position, and not associated with any nausea or vomiting, anorexia, jaundice, or pruritis. She was diagnosed recently with recurrent hydatid cyst disease during pregnancy, for which she was referred to “high risk pregnancies clinic” [8-10].

Her history of hydatid disease goes back to her second pregnancy, at 6 weeks gestational age; when she underwent a laparotomy for excision of hepatic hydatid cyst, after which she didn’t receive any medical treatment. Four years later, the patient had recurrent disease which was managed by cystectomy in segments IV and VII of the liver in addition to lung cystectomy. Post operatively, the patient received Albendazole that was continued for 2 months.

Beside the hydatid disease, she was having a smooth course of pregnancy. During this pregnancy the patient was followed at an outside clinic, where serology of Echinococcus granulosus (IgG and IgM) was requested in the first trimester and came back negative. Serial abdominal ultrasounds were done. The first one, done at 11 weeks of gestation, showed a 9 cm × 6 cm lobulated cystic formation at the level of segment IV of the liver and having small wall calcifications. Repeated at 13+6 weeks of gestation, it showed: two contiguous lobulated cystic structures, at the level of the dome of the liver. The first cyst in segment VIII was extending to segment IV: 3.4 cm in transverse diameter, demonstrating peripheral hyperechoic rim that was not associated with post attenuation and most likely not corresponding to calcification. In addition, hyperechoic content was identified in the first cyst corresponding to post enhancement. It was concluded that the hyperechoic content could represent hydatid sand, and thus, this cystic structure in the context of hydatid disease was classified as CE1 according to WHO classification. The presence of a larger cyst with lobulated contours in segment VII and VIII was also noted measuring 6.5 cm × 6.5 cm with identification of anechoic content and few septations in the periphery particularly at its posterior aspect. The clear pattern of daughter cyst could not be identified thus a CE2 cyst couldn’t be suggested with certainty. The third US, done at 22 weeks of gestation, showed that the largest cyst previously seen in segment VIII was stable in size, demonstrating internal septations with identification of daughter cyst-like structures posteriorly. Moreover, when compared to previous report, the other lobulated cyst in segment VIII and IV having lobulated contours increased in size to 5 × 3.4 cm (compared to 3.4 × 3.2 cm). It was still showing a sand-like hyperechoic content, and demonstrating peripheral hyperechoic rim with posterior enhancement. The liver was enlarged to 17 cm in size.

Upon presentation, the patient had unremarkable vital signs. Her physical exam was limited due to obesity. It showed, however, right subcostal incision scar upon inspection, hepatomegaly with dullness but soft and non-tender abdomen.

The case was discussed by the multidisciplinary team members including the obstetrician, the maternal medicine, and the infectious diseases specialists. A decision to start Albendazol 400 mg twice daily till delivery (for three) weeks, was taken. Abdominal ultrasound was repeated just before cesarean section that showed three liver hydatid cysts, one of them decreasing in size from 6 cm to 5 cm, and two other stable cysts of 3 cm. Nevertheless, we couldn’t confirm if the cysts are stable or in active phase. There was no indication to operate those cysts at the time of C-section.

The patient continued medical treatment till cesarean delivery scheduled at 37 weeks; and for two days post operatively. She was did well post op and was discharged home on day two postop. The patient was seen one-week thereafter and was doing well. She continued to be followed by ID team and was planned to repeat abdominal US 6 months after delivery.

Discussion

As previously mentioned hydatid cyst disease is a parasitic infestation by a tapeworm most commonly by Echinococcus granulosus [10-15]. Contaminated food and water by feces of definitive infective host or poor hygiene in infestation areas are the main roots of exposure. The occurrence of this disease in pregnancy is low with a prevalence of 1/20,000 to 1/30,000.

Hydatid disease is mostly asymptomatic [10] but affected individuals can present with abdominal pain, abdominal mass or vague abdominal symptoms [11,14] which may mimic the usual symptoms occurring in pregnancy.

It is important to note that blood tests are nonspecific. Many serologic tests are available mainly IgG ELISA test and Indirect Hemagglutination Test [10,14], yet negative tests cannot rule out the disease.

Ultrasound is the primary diagnostic imaging tool. However, it cannot distinguish a benign cystic form from an abscess [9,11]. CT scan is the best imaging modality, being able to determine accurately the anatomical location and assess other [9,11,14].

There are five subtypes of cystic echinococcosis according to the WHO and Gharbi classification systems (Table 1).

Table 1: WHO and Gabri classification system for cystic echinococcosis cysts.

WHO-IWGE 2001	Gharbi 1981	Description	Stage
CE1	Type I	Unilocular unechoic cystic lesion with double line sign	Active
CE2	Type III	Multiseptated, “rpsette-like” “honeycomb cyst	Active
CE3 A	Type II	Cyst with detached membranes (water-lily-sign)	Transitional
CE3 B	Type III	Cyst with daughter cysts in solid matrix	Transitional
CE4	Type IV	Cyst with heterogenous hypoechoic/hyperechoic contents. No daughter cysts	Inactive
CE5	Type V	Solid cyst with calcified wall	Inactive

There are three management modalities depending on the activity of the cyst [11]. The first one is the surgical management requires opening the cyst, injecting a solicidal agent, evacuating the cyst and pericystectomy. It is best used for ruptured cysts, cysts with biliary fistulae, cysts compressing vital structures, cysts with secondary infection or hemorrhage, or cysts with multiple daughter cysts [11,14]. Other indications include cysts larger than 10 centimeters and superficial cysts which carry a risk of rupture [14]. Preoperative and postoperative use of Albendazole decreases the viability of cysts at the time of surgery and significantly reduces the chances of cyst recurrence. Albendazole for three 28-day courses of 10 mg/kg/day in divided doses separated by 2-week intervals post operatively is usually used [11-14]. Surgical management carries 2-25% risk of recurrence.

The second therapeutic modality is the percutaneous treatment is based on destroying the germinal layer with a solicidal agent, a process that requires puncture, aspiration, injection and reaspiration [11,14]. This method is done under CT or ultrasound guidance for CE1 and CE3-A cysts which do not contain daughter cysts [11,14]. It is avoided in complicated or superficial cysts due to the risk of rupture [11]. The last modality is the medical treatment based on Albendazole administration.

Hydatid disease has a special consideration when associated with pregnancy. Many cases have been reported in literature yet only few reviews of literature and one meta-analysis have been reported.

Hydatid disease in pregnancy is a rare condition occurring in parts of the world. It is usually diagnosed incidentally during an obstetrical ultrasound [8].

A pregnant patient may complain of abdominal discomfort and pain in the right upper quadrant area. In large cysts cases, nausea, vomiting and early satiety may be felt due to a mass effect [8].

The main challenge in pregnancy is in regards to treatment modality which is affected by cyst classification. Types 1 and 2 are usually treated by ultrasound guided percutaneous aspiration [8]. Types 3 and 4, with the exception of calcified cysts are mainly surgically treated [8]. However, due to scarcity of data, there is no standardized approach. Below, an algorithm will be stated for managing hydatid disease in pregnancy based on the only meta-analysis published on 2018 (Figure 1) [8].

Figure 1: Approach and treatment algorithm for pregnancy complicated with Hidatid disease. HD Hydatid Disease; b HCG beta-human chorionic gonadotropin;*Ultrasound-based classification of cyst hydatid according to Gharbi et al.; PAIR percutaneous aspiration irrigation and re-aspiration (8).
Celik, S. et al. Archives of Gynecology and Obstetrics 298 (2018): 103-110.

The main medical therapy for echinococcal cysts is based on Benzimidazole, namely Albendazole. It acts on inhibiting glucose uptake by the parasite, thus generating metabolic and structural alteration leading to parasitic death. It is categorized as category C by the FDA [8]. Thus, it is not recommended for use in first trimester [8,14], yet it can be used afterwards.

According to Celik et al. a thin walled, large, peripherally located cyst in the liver is more likely to rupture than a small, centrally located cyst. Therefore, women with cysts characterized as at high risk of rupture should be referred at some point for intervention (surgery or PAIR) [8]. If no intervention is to be performed, then delivery by cesarean section is preferred. In optimal condition, a monthly close follow up is recommended. If conditions are worsened, intervention is considered after 20-24 weeks of gestation to allow for fetal maturation [8].

Concerning our patient, she started Albendazole 400 mg per os twice daily three weeks before her scheduled repeat cesarean section at 37 weeks of gestation. Her repeat ultrasound showed three cysts, one cyst decreased in size from 6 to 5 centimeters, the other two cysts were stable in size at 3 centimeters, yet nature could not be confirmed. Plan was to omit hydatid cystectomy due to stability of the patient and to continue same dose of Albendazole till delivery. She had smooth cesarean delivery and medical management was stopped two days after delivery. The patient did not manifest any symptoms afterwards.

Conclusion

In conclusion, hydatid disease is rarely combined with pregnancy. It can be primarily manifested incidentally on obstetrical ultrasound or due to abdominal pain from compression of a gravid uterus. It poses a challenge in regards to management during pregnancy. There are three modalities of management. Medical therapy using Albendazole is advised following the first trimester [8,14] either alone for stable, deep cysts or for those decreasing in size, or in conjunction with intervention aiming to shrink the mass. Percutaneous treatment is used mainly for cysts which do not have daughter cysts. Finally, surgical excision is reserved for ruptured cysts, cysts with biliary fistulae, cysts compressing vital structures, cysts with secondary infection or hemorrhage, or cysts with multiple daughter cysts. Management decision is quite meticulous. It depends on cystic nature and activity and on the stability of the patient. In all cases, cesarean section is advised [8]. In spite of all recommendations, further prospective studies are needed to put clear-cut algorithmic guidelines for hydatid disease management in pregnancy.

References

Ahmed Al-Ani, Abdul-Naser Elzouki, Rashid Mazhar (2013) An Imported Case of Echinococcosis in a Pregnant Lady with Unusual Presentation. Case Reports in Infectious Diseases 2013: 753-848. [crossref]
Thompson A, Chiodini PL, Stewart F (2012) Hydatid liver cyst in pregnancy: a case report. British Medical Journal 97: A65.
Anandita, Shweta, Bhardwaj S, Sehra A (2015) Pregnancy with Hydatid Cyst of Liver. JCR 5: 542-545.
Ghosh JK, Goyal SK, Behera MK, Dixit VK, Jain AK (2014) Hydatid Cyst of Liver Presented as Obstructive Jaundice in Pregnancy; Managed by PAIR. Journal of clinical and experimental Hepatology 4: 366-369. [crossref]
Maria A Grácio, António J Santos Grácio (2019) Hydatid Disease and Pregnancy: A Short Note. Integr Gyn Obstet J 2: 1-2.
Akbaş A, Daşıran F, Dagmura H, Daldal E, Özsoy Z, et al. (2019) Primary hydatid cyst localized in soft tissue during pregnancy. J Surg Case Rep 2019: rjy324.
Ünalp H, Aydin Ç, Yavuzcan A, et al. (2008) Surgical treatment of hepatic hydatic disease during pregnancy: report of two cases. Gynecol Surg 5: 243-245.
Celik S, Okyay O, Karaman E, Sert ÖZ, Cim N, et al. (2018) Analysis of factors affecting outcomes of pregnancy complicated by Echinococcus: an algorithm for approach and management. Arch Gynecol Obstet 298: 103-110. [crossref]
Pedrosa I, Saíz A, Arrazola J, Ferreirós J, Pedrosa C (2000) Hydatid Disease: Radiologic and Pathologic Features and Complications. Hydatid Disease: Radiologic and Pathologic Features and Complications, The Journal of continuing medical education in radiology 20: 795-817. [crossref]
Cennet O, Tirnaksiz MB, Dogrul A, Abbasoglu O (2019) Surgical treatment of cyst hydatid disease of the liver in the era of percutaneous treatment, HPB 21: S568eS676.
Sozuer E, Akyuz M, Akbulut S (2014) Open surgery for hepatic hydatid disease. Int Surg 99: 764-769. [crossref]
Shams-Ul-Bari, Arif SH, Malik AA, Khaja AR, Dass TA, et al. (2011) Role of albendazole in the management of hydatid cyst liver. Saudi J Gastroenterol 17: 343-347. [crossref]
Horton RJ (1989) Chemotherapy of Echinococcus infection in man with albendazole. Trans R Soc Trop Med Hyg 83: 97-102. [crossref]
Dandan I, Soweid A, Abiad F (2019) Hydatid Cysts. Medscape.
Pedro M (2019) Clinical Manifestations and Diagnosis of Echinococcus.

Automated Hand Hygiene Monitoring Systems: Current Issues, Developments and Perceived Benefits

Leave a reply

DOI: 10.31038/MIP.2021214

Abstract

Healthcare-Associated Infections (HCAIs) are among the leading causes of death in the United States affecting about one in every 20 hospitalised patients [1]. Furthermore, at least 50% of these infections are preventable [2]. Healthcare Workers (HCWs) practicing good Hand Hygiene (HH) is fundamental to preventing HCAI transmission, as HH compliance and HCAI rates are closely linked [3]. Though this association is well established, maintaining high levels of HH compliance is a perennial problem in all healthcare settings. When independently audited, HH compliance has been shown to be in the region of 50% at best [4]. Compliance is particularly poor when staff are busy and experiencing burnout [5] which has been mirrored in a recent report that found hospital transmission of COVID-19 accounted for 20-25% of cases [6]. Stressed and overworked HCWs perform less HH, thereby inadvertently increasing the risk of COVID-19 transmission and other HCAIs. Simply blaming HCWs is not the answer. Though maintaining adequate patient to staff ratios is essential, providing staff with unbiased and opportunistic feedback on their HH practice is also key to mitigating HCAI risk.

Accurately monitoring HH compliance is an important quality improvement and patient safety control strategy. Good HH compliance should be rewarded and celebrated. Equally, areas for improvement must be identified and educational resources allocated accordingly. The World Health Organisation (WHO) currently recommends that the gold standard for monitoring HH is by direct observation (DO) of HCWs using trained, independent auditors. In its technical manual, the WHO provides detailed guidance on the audit process stressing the value of immediate personalised feedback to HCWs [7]. Whilst DO is widely accessible and requires minimal financial investment, it is labour intensive and yet only produces small quantities of data [8]. A plethora of evidence demonstrates that the quality of DO data is impeded by the Hawthorne effect as well as observer and selection bias [9]. It has been estimated that the full hand hygiene audit cycle, including data input and feedback, can cost £28,800 per year in staff time using DO [10]. This could be considered a high price to pay for low quality data that ultimately gives Infection Prevention and Control (IPC) teams an unclear picture of the HCAI risk in their organisation. Whilst these issues are widely acknowledged in the IPC community, HCWs are also cognisant of the problems with DO. A survey conducted in 2020 found that 58% of 1,120 staff questioned did not strongly endorse DO as a method of monitoring HH [11]. “The Hawthorne Effect” was cited by HCWs as one of the reasons for not trusting HH data presented to them [11]. However, the same respondents were open to the introduction of innovative HH technologies. Though staff attitudes to new HH monitoring technologies have not always been reported to be so positive, other surveys have typically involved very small staff numbers and have not represented all staff groups [12,13]. Staff does appear to recognise that they change their HH behaviour when they are aware they are being audited by DO. Hence, if staff does not believe that HH compliance data reflects the real clinical environment they are working in, it then becomes easy to dismiss such skewed data and thus positive behavioural change is never achieved. Equally, getting front-line workers to buy-in to new approaches to HH monitoring, addressing their concerns about the accuracy of novel technologies and how this data will be used are also recognised as difficult challenges [14].

A number of automated hand hygiene monitoring systems (AHHMS) have been commercially developed to address these issues [15]. These systems use sensor technology to remotely monitor HH compliance, therefore reducing the need for human auditors, instead capturing large volumes of non-judgemental quantitative data. This benefit has already been realised by healthcare organisations that use AHHMS. One healthcare system was able to capture 35 million hand hygiene opportunities within the first six months of the COVID-19 pandemic [16]. The authors reported that their rich dataset allowed them to understand when changes in HH behaviour occurred and how long improvements in HH were sustained. Such robust data in similar quantities would not be achievable with DO alone, particularly when IPC staff resources were likely being diverted to COVID-19 containment measures.

There are three broad categories of AHHMS: group monitoring systems, badge-based systems, and video monitoring systems [8]. Group monitoring systems track usage of HH dispensers (soap and gel) to give an idea of HH events in a given location. Data produced from these systems can ‘nudge’ groups of staff to increase their usage of HH dispensers, but they cannot provide the personalised feedback that empowers HCWs to change their own practice [17]. Badge-based monitoring systems typically require HCWs to wear an additional tracking device that communicates with dispenser-based sensors. This extra layer of data is able to provide personalised feedback on HH behaviour both to the individual HCW, but also to managers and IPC teams. Implementing these types of AHHMS can be challenging because, due to their very nature, staff are required to wear an extra piece of equipment, which ultimately places an additional demand on staff to change their behaviour. In a study by Levin et al. [18], 44% of staff reported that wearing an additional tracking device was “inconvenient” to them. Both group monitoring and badge-based systems are usually unable to determine which WHO HH moment is being performed. They typically identify WHO moments one and four (before touching a patient and after touching a patient) [19]. This may be a useful surrogate in hospitals that have a high proportion of single rooms, however in many healthcare institutions (e.g. the National Health Service in the United Kingdom (UK)) this is not the case. Therefore, even where there is a successful implementation of an AHHMS, the continuous monitoring of HH events should be complemented by targeted DO to provide further qualitative insights into HCW HH behaviour; such as hand washing technique and types of HH opportunities missed.

Thirdly, video camera-based AHHMS can provide video footage that serves to replace human auditors. Video footage enables observation of all WHO five moments of hand hygiene and hand washing technique; however these systems have largely been confined to research rather than used commercially [20]. We expect this is due to patient privacy issues that may arise when video footage captures HH events in close proximity to patients. These privacy concerns could be alleviated through automated video auditing (AVA) which does not require storage or transfer of video data for analysis [21].

To our knowledge, there are currently 29 commercially available AHHMS, 75% of which are manufactured by companies based in the USA [15]. Over the last 10 years, uptake of these systems has remained stable, yet low, at around 4% [22,23]. A small survey of Directors of Infection Prevention and Control (DIPCs) in the UK found that these systems were perceived to be expensive and not guaranteed to produce a return on investment [15]. In order for an IPC intervention to be considered cost-effective, it should reduce HCAI incidence by 15% [24]. Therefore, evidence is needed to demonstrate that AHHMS are able to reduce HCAI rates before these systems are likely to be adopted more widely. A recent survey on this issue found that only one AHHMS has randomised control trial (RCT) level evidence supporting its ability to reduce HCAI rates [15]. Here, a group monitoring AHHMS used a specialised stepped wedge cluster RCT (SWCRCT) study design to demonstrate a significant reduction in healthcare-associated methicillin-resistant Staphylococcus aureus rates when implemented as part of a multimodal IPC strategy [25]. Other infection types showed no significant change during the study. As this was a group-based monitoring system, it could be argued that improvements in HCAI rates were limited by the inability to provide personalised feedback to HCWs. Individualised feedback, whether given publicly or privately, has been repeatedly shown to improve HH compliance [26,27]. Whilst this particular SWCRCT was a promising start, more are needed where the AHHMS is a single intervention being investigated. This will hopefully provide the evidence needed to determine whether an AHHMS is likely to be a cost-effective method of driving down HCAI rates.

Alternatively, an AHHMS can be evaluated by assessing its impact on HH compliance as a primary end-point. A 2019 review of AHHMSs found that only one system has RCT-level evidence demonstrating its ability to increase HH compliance [28]. When this badge-based system was implemented it led to a small 6.8% increase in HH compliance [29]. Non-adherence to badge-wearing was, again, an issue in this study, with 21% of participants not wearing their device as required.

Whether improved HH compliance or reduced HCAI rates (or both) are the desired end-points for such systems, more RCT-level evidence is needed for each of the 29 systems currently available in the marketplace [30]. We expect that uptake of such systems will remain patchy until the evidence base improves.

In summary, the importance of both staff consultation on new approaches to improving HH compliance, and immediate personalised feedback to staff with individualized action planning cannot be overemphasized [27,31]. Furthermore, we would suggest that goal setting with reward incentives are incorporated into HH improvement strategies if they are to effect behavioural change [32]. AHHMSs are useful tools and well placed to achieve these aims as they can provide large volumes of quantitative data offering insights to IPC teams on HCW HH behaviour. Badge-based systems promise to deliver personalised feedback to staff on their performance, yet repeated studies have shown staff to be reluctant to wear said extra badges due to the inconvenience they cause. However, new developments in AHHMS need to ensure that they have no impact on staff workflow and that personalized staff feedback on HH performance becomes the norm. In addition, more RCT-level studies are required to demonstrate the efficacy of individual AHHMSs in reducing HCAIs. This will allow IPC professionals to make informed, evidence-based procurement decisions on whether a system is likely to be cost-effective for their organisation. Overall, there should be optimism about new developments in AHHMSs provided these can be aligned with an improved research and development supporting programme.

Keywords

Hand hygiene, Automated monitoring systems, Issues, Benefits

References

US Department of Health and Human Services (2013). National action plan to combat healthcare acquired infections-a road to elimination. Chapter 8: Long-Term Care facilities.
Zimlichman E, Henderson D, Tamir O, Franz C, Song P, et al. (2013). Health care–associated infections. A meta-analysis of costs and financial impact on the US healthcare system. JAMA Internal Medicine 173: 2039-2046. [crossref]
Sickbert-Bennett EE, DiBiase LM, Willis TMS, Wolak ES, Weber DJ, et al. (2016) Reduction of Healthcare-Associated Infections by Exceeding High Compliance with Hand Hygiene Practices. Emerging Infectious Diseases 22: 1628-1630. [crossref]
Pan, SC, Tien, KL, Hung, IC, Lin, YJ, Sheng WH, et al. (2013) Compliance of Healthcare Workers with Hand Hygiene Practices: Independent Advantages of Overt and Covert Observers. PLoS ONE 8: 53746. [crossref]
Manomenidis G, Panagopoulou E, Montgomery A. (2017) Job Burnout Reduces Hand Hygiene Compliance Among Nursing Staff. Journal of Patient Safety 15: 70-73. [crossref]
Scientific Advisory Group for Emergencies (2021) PHE and LSHTM: The contribution of nosocomial infections to the first wave.
World Health Organisation. (2009) Hand Hygiene Reference Technical Manual. Geneva, Switzerland: World Health Organisation.
Boyce JM. (2019) Current issues in hand hygiene. American Journal of Infection Control 47: 46-52. [crossref]
‌Jeanes A, Coen PG, Gould D, Drey NS (2019) Validity of hand hygiene compliance measurement by observation: A systematic review. American Journal of Infection Control 47: 313-322. [crossref]
Jeanes A, Coen PG, Wilson AP, Drey NS, Gould DJ. (2015) Collecting the data but missing the point: validity of hand hygiene audit data. Journal of Hospital Infection 90: 156-162. [crossref]
Cawthorne KR, Cooke RPD. (2020) Healthcare workers’ attitudes to how hand hygiene performance is currently monitored and assessed. Journal of Hospital Infection 105: 705-709. [crossref]
Blomgren P-O, Lytsy B, Hjelm K, Swenne CL. (2021) Healthcare workers’ perceptions and acceptance of an electronic reminder system for hand hygiene. Journal of Hospital Infection 108: 197-204. [crossref]
Tarantini C, Brouqui P, Wilson R, Griffiths K, Patouraux P, et al. (2019) Healthcare workers’ attitudes towards hand -hygiene monitoring technology. Journal of Hospital Infection 102: 413-418.
Conway LJ. (2016) Challenges in implementing electronic hand hygiene monitoring systems. American Journal of Infection Control 44: 7-12. [crossref]
Cawthorne K-R, Cooke RPD. (2021) A survey of commercially available electronic hand hygiene monitoring systems and their impact on reducing healthcare-associated infections. Journal of Hospital Infection 111:40-6. [crossref]
Moore LD, Robbins G, Quinn J, Arbogast JW. (2021) The impact of COVID-19 pandemic on hand hygiene performance in hospitals. American Journal of Infection Control 49(1):30–3. [crossref]
‌Hysong SJ, Best RG., Pugh JA. (2006) Audit and feedback and clinical practice guideline adherence: Making feedback actionable. Implementation Science 1(1). [crossref]
‌Levin PD, Razon R, Schwartz C, Avidan A, Sprung CL, et al. (2019) Obstacles to the successful introduction of an electronic hand hygiene monitoring system, a cohort observational study. Antimicrobial Resistance & Infection Control 8(1).
Cheng VCC, Tai JW, Ho SK, Chan JFW, Hung KN et al. (2011) Introduction of an electronic monitoring system for monitoring compliance with Moments 1 and 4 of the WHO “My 5 Moments for Hand Hygiene” methodology. BMC Infectious Diseases 11.
Mckay KJ, Shaban RZ, Ferguson P. (2020) Hand hygiene compliance monitoring: Do video-based technologies offer opportunities for the future? Infection, Disease & Health 25(2):92–100. [crossref]
Lacey G, Zhou J, Li X, Craven C, Gush C. (2020) The impact of automatic video auditing with real-time feedback on the quality and quantity of handwash events in a hospital setting. American Journal of Infection Control 48: 162-166. [crossref]
Braun BI, Kusek L, Larson E. (2009) Measuring adherence to hand hygiene guidelines: A field survey for examples of effective practices. American Journal of Infection Control 37: 282-288. [crossref]
Durant DJ, Willis L, Duvall S. (2020) Adoption of electronic hand hygiene monitoring systems in New York state hospitals and the associated impact on hospital-acquired C. difficile infection rates. American Journal of Infection Control 48: 733-739. [crossref]
Guest JF, Keating T, Gould D, Wigglesworth N. (2019) Modelling the costs and consequences of reducing healthcare-associated infections by improving hand hygiene in an average hospital in England. BMJ Open 9: 029971.
‌‌Leis JA, Powis JE, McGeer A, Ricciuto DR, Agnihotri T et al. (2020) Introduction of Group Electronic Monitoring of Hand Hygiene on Inpatient Units: A Multicenter Cluster Randomized Quality Improvement Study. Clinical Infectious Diseases 71: 680-685. [crossref]
Fish L, Bopp D, Gregory D, Kerley KD, Gakhar S et al. (2021) Hand hygiene feedback impacts compliance. American Journal of Infection Control 49: 907-911. [crossref]
Stone SP. (2018) Time to implement immediate personalised feedback and individualized action planning for hand hygiene. JAMA Network Open 1: 183422. [crossref]
Meng M, Sorber M, Herzog A, Igel C, Kugler C (2019) Technological innovations in infection control: A rapid review of the acceptance of behavior monitoring systems and their contribution to the improvement of hand hygiene. American Journal of Infection Control 47: 439-447. [crossref]
Fisher DA, Seetoh T, May-Lin HO, Viswanathan S, Toh Y, et al. (2013) Automated Measures of Hand Hygiene Compliance among Healthcare Workers Using Ultrasound: Validation and a Randomized Controlled Trial. Infection Control & Hospital Epidemiology 34: 919-928. [crossref]
Cawthorne K-R, Cooke RPD. (2020) Are electronic hand hygiene monitoring systems cost-effective? Stepped wedge cluster randomized controlled trials are needed to assess their impact on reducing healthcare-associated infections. Journal of Hospital Infection 106: 200-201. [crossref]
Cooke RPD, Corke C. (2020) Staff surveys will unlock the key to better hand hygiene performance. Lancet Infectious Diseases 20: 167-168. [crossref]
Luangasanatip N, Hongsuwan M, Limmathurotsakul D, Lubell Y, Lee AS, et al. (2015) Comparative efficacy of interventions to promote hand hygiene in hospital: systematic review and network meta-analysis. BMJ 351: 3728.

AGP Related Evaluation of Medical Nutrition Therapy for Diabetes Management (AMEND) – A Real World Observation Study

Leave a reply

DOI: 10.31038/EDMJ.2021522

Abstract

Purpose: To evaluate 24 hour glycaemic profile using AGP in patients with type 2 diabetes who are eligible for meal replacement therapy over a period of 14 days.

To assess whether a precise meal replacement plan as an add on to standard of care will make a difference in smoothening out post-prandial peaks and increasing time spent in the desired (70 mg/dl-180 mg/dl) range compared to baseline time in range and post-prandial blood glucose level.

Methods: Patients were mounted with AGP asked to follow the regular diet for 6 days. On the 7^th day, based on the AGP report, the most troubled meal was replaced with protein rich, calorie counted, low-carb and fiber enriched meal supplement for the next 6 days. On day 14, the AGP data were collected.

Results: The analysis of full cohort (n=566) showed reduction in eA1c and eAG by 11.9% (from 7.84% to 6.90%) and 15.10% (from 178.41 mg/dL to 151.47 mg/dL), respectively when regular meal diet was compared with the replaced meal diet. The average TIR was improved by 23.56% (from 41.38 to 51.13) in full cohort, post-intervention with replaced meal.

Conclusion: The glycemic profile of patients with type 2 diabetes was improved by meal replacement therapy over period of 14 days.

Keywords

Medical nutrition therapy, Meal replacement, Diabetes, Protein supplement

Introduction

Diabetes mellitus is a non-communicable, complex and chronic lifestyle-related disorder. It demands continuous medical care with voracious risk-reduction strategies beyond modest glycaemic control. In terms of the sheer prevalence and incidence globally, it may be called a “pandemic”, although it is obviously not contagious. Malnutrition, both under- and over-nutrition, is another pandemic and the two co-exist making this a syndemic. Add to this the current COVID-19 pandemic which is more severe in uncontrolled diabetes patients and in those who are overweight or obese.

The recent IDF-2019 report shows that there were ~ 463 million adults (20-79 years) living with diabetes; by 2045 this will rise to 700 million [1]. This shows that the incidence of type 2 diabetes mellitus (T2DM) is increasing by leaps and bound across the world. In India, there were >77 million people living with diabetes in 2019, which is expected to be 101.5 million by 2030 and 134.2 million by 2045 [2]. Moreover, according to a 10-Year Follow-up of the Chennai Urban Rural Epidemiology Study (CURES), among individuals with normal glucose tolerance (NGT), the rate of conversion from prediabetes to diabetes was recorded highest at 18% [3], indicating that India may overtake China in the near future and become the diabetes capital of the world.

Since, diabetes is a metabolic disorder, food and lifestyle changes play major role in management of diabetes. Even textbooks and standard guidelines have always mentioned that lifestyle modification needs to be attempted even before metformin, and of late, medical nutrition therapy (MNT) has become a discipline by itself in the management of diabetes.

DiRECT study was the first to provide evidence from a randomised trial of a dietary and lifestyle intervention where type 2 diabetes remissions were the primary outcome [4]. The recent EASD-ADA consensus document released at the EASD meeting in Berlin in October 2018 [5] gives a lot of emphasis on MNT even before metformin.

The Ministry of Health and Family Welfare (MOHFW) has published data that Indians on an average are protein deficient (11% protein in their diet as against the requisite 15-20%, carbohydrate content in diet is >65% as against the needed 55-60%) [6].

Many studies have shown that increasing protein intake particularly by whey protein and following portion control with meal replacement plans will benefit diabetes patients by reducing postprandial blood glucose and HbA1c [4,7,8].

Whey protein has essential amino acids that improve insulin secretion as well as sensitivity and when digested, bioactive peptides are formed which have effects on the incretin axis (GLP-1, GIP), they suppress the only orexigenic hormone, Ghrelin, and increase gut anorexigenic hormones such as CCK, NPY and Peptide YY, all of which induce satiety [8-15].

The study was based on the hypothesis that when diabetic patients (uncontrolled with oral anti-diabetic drugs/insulin) were put on protein enriched, low calorie and carbohydrate counted meal replacement plan, will come towards goal HbA1c with reduction in average blood glucose, reduction in estimated A1c (glucose management indicator), and increase in time in range (TIR).

The aim of the study was to carry out a real world evaluation of Medical Nutrition Therapy (MNT) in Patients with Type 2 Diabetes (AMEND – AGP related evaluation of MEdical Nutrition therapy for Diabetes management).

The primary objective was to evaluate 24 hour glycaemic profile using AGP in patients with type 2 diabetes who are eligible for meal replacement therapy over a period of 14 days. The secondary objective was to assess whether a precise meal replacement plan as an add on to standard of care will make a difference in showing how it smoothens out post-prandial peaks and increases time spent in the desired (70 mg/dl-180 mg/dl) range compared to baseline time in range and post-prandial blood glucose level.

Subjects

The study enrolled patients with diabetes who were 18 years old male or female and preferably overweight (BMI ≥24 or metabolically obese normal weight). The newly diagnosed patients with type 2 diabetes or patients already on treatment were also eligible. Participating participants were physically and mentally able to give valid informed written consent form.

The exclusion criteria for subjects were as below. 1) HbA1c >10%, BMI >38, EGFR <45 (any one of this will not allow participants to be eligible for the study). 2) Participants suffering from any acute illness, CVD, renal complications, bowel disorders or eating disorders like anorexia or bulimia. 3) Participants who are consuming anti-psychotics, steroids or GLP-1 analogues.4) Participant whose diabetes was diagnosed > 10 years ago or who has undergone bariatric surgery. 5) Participants who are unable or unwilling to take prescribed precise meal replacement plan and/or not willing to sign the informed consent form. 6) Pregnant or lactating women, cancer patients. 7) Participants who are already on some diet plan or following fast during the study or consuming protein supplements or consuming alcohol on daily basis or are allergic to the ingredients of the Simetri meals or Prototal. 8) Participants are not allowed to make any significant change in the daily routine or physical activities.

Materials and Methods

In a real world setting, when the patient with type 2 diabetes visited the doctor, after taking the consent, they were enrolled in the routine evaluation. After completion of all screening assessments (i.e., demographic, anthropometric and clinical data) and obtaining signed informed consent forms, eligible patients were mounted with flash glucose monitoring system (Free Style Libre from Abbott for 14 day) to check their Ambulatory Glucose Profile (AGP). Patients were given a food log sheet and asked to fill the same for the next 14 days.

The first 6 days were considered as a baseline phase where patients continued on their regular food without any major changes. The 7^th day was the meal replacement phase when the patient visited the doctor and on the basis of the AGP report, investigator replaced – the most troubled meal (the one which was associated with the most post-prandial glycaemic excursions) – regular food with a customized meal replacement diet which included Simetri meals (From Eris Lifesciences – a calorie counted, protein enriched, ready to eat meal – details in supplement material) and or ProTotal (From Eris Lifesciences – a whey protein supplement – 14 gm whey protein, 6.6 gm of fibre with other macro and micronutrients). The most troubled meal was identified as the maximum post-prandial peak seen in the AGP report on day 7^th. Patients were asked to consume Simetri and/or ProTotal for the next 7 days (replaced meal phase) without any change in their medications. Here, the same patient has served as the control for himself which could be more accurate than a parallel group design (inter-individual variation). Throughout the study period (14 days) the investigator did not make any change in the pharmacological treatments.

AGP device was mounted on subject by investigator on day 1 of the study. The AGP device has been carried by the subject till day 14 of the study. The data was extracted from the device by investigator in a timely manner, i.e., on day 7 and day 14.

Given the observational nature of the study, no sample size estimation was done. Statistical analysis was carried out as and when required. The level of significance was 0.05. P values of less than 0.05 were considered as a statistically significant difference.

Ethical Conduct of the Study

The clinical study protocol (Dated 01/02/2019), informed consent form, subject diary (Version No. 00,Dated 12 Apr 2019) and all other relevant study documentation were reviewed and approved by the responsible ethics committee.

The study commenced only after a written approval was obtained from the ethics committee. The study was conducted in accordance with the protocol, International Council for Harmonisation (ICH) (Step 5) ‘Guidance on Good Clinical Practice’ (E6) and ‘Declaration of Helsinki’. All associates assisting in the conduct of study were informed regarding their obligations.

Results

There were total 660 patients enrolled and out of them 566 patients were involved in the final analysis. We have divided patients in various groups for the purpose of better analysis.

Total 94 (14.24%) non-adhered patients were excluded from efficacy analysis. Non-adherent patients were defined as the one who had consumed the provided replaced meal (Simetri and Prototal) for ˂4 days. The adherence to diet was observed in 85.76% of total 660 patients.

In all patients age was found to be in a range of 20-86 years with a mean of 53.49 ± 11.80 years, mean weight was 73.77 ± 14.33 kg, and mean BMI was 27.81 ± 5.52 kg/m². The mean HbA1c was 9.10 ± 1.66%.

a. Full cohort

The analysis of full cohort (n=566) showed reduction in average eA1c (Figure 1) from 7.84 on regular diet to 6.90 on replaced diet, indicating an eA1c (estimated A1c – it was estimated because the total duration is only 14 days) reduction by 11.99%, p<0.001. Similarly, estimated average glucose (eAG) on regular diet was 178.41 mg/dL which reduced to an avg. of 151.47 mg/dL after following replace diet, indicating reduction by 15.10%, p<0.001. The average TIR on regular diet was 41.38 which improved to an avg. of 51.13 after following replace diet, indicating an improvement by 23.56% (Figure 2). This improvement showed statistical significant change (p ˂0.001).

Figure 1: Full cohort analysis of eA1c.

Figure 2: Full cohort analysis of TIR.

b. Sub-group analysis

The age group analysis (Table 1) showed that patients >60 years had better improvement in eAG and eA1c -16.73% and 13.10% respectively when compared to age group of <40 years and 40-60 years (14.35% and 11.46% vs. 14.47% and 11.54%, respectively)

The sub-group analysis for various BMI indicated that group of patients with BMI between 25 to 29.9 kg/m² had 15.02% and 11.88% reduction in eAg and eA1c when replaced meal was consumed whereas patients with BMI ˃30 kg/m² had comparatively less improvement in eAG (11.09%) and eA1c (8.79%) on replaced meal where p< 0.001, as shown in Table 1. However, improvement in TIR was slightly greater in patients with higher BMI (23.19% vs. 21.58%).

Analysis was also carried out based on the duration of diabetes. Patients with diabetes duration between 1 to 6 years and > 6 years showed better improvement than patients with diabetes duration <1 year. Improvement in eAG, eA1C and TIR was 15.54%, 12.33% and 24.46% respectively in patients with diabetes duration 1 to 6 years, while in patients with >6 years the improvement was by 15.46%, 12.36% and 25.82% respectively (Table 1).

When patients were divided based on the avg. baseline HbA1c < 7.5% and >7.5%, the result showed that patients whose avg. baseline HbA1c was <7.5% there was decrease in eAG from 144.25 mg/dL on regular diet to 117.27 mg/dL on replaced diet indicating a decrease by 18.70%. In the same group, eA1c decreased by 14.14%, p<0.001. On the other hand, patients’ whose avg. baseline HbA1c was >7.5% also showed significant improvement with p<0.001 in eAG and eA1c (14.85% and 11.82% respectively).

As it was a real world study, a few of the patients were consuming either Simetri or ProTotoal and most of them were consuming both Simetri and ProTotal. There was also a small group of patients who were consuming more than two replaced diet in a day. The analysis was carried out to observe the effect of single meal replacement vs. two meal replacements in a day. As shown in the Table 1, patients consuming two replaced diets in a day showed better results in terms of all the evaluated parameters.

Table 1: eAG, e1c and TIR values of various sub-group analysis.

Subgroup	No. of subjects	eAG (mg/dL)		TIR (%)		eA1c (%)		p value
Subgroup	No. of subjects	Regular diet	Replaced diet	Regular diet	Replaced diet	Regular diet	Replaced diet	p value
BMI<24.9 kg/m²	161	185.62	151.93	37.79	48.09	8.09	6.92	<0.001
BMI=25-29.9 kg/m²	242	173.13	147.12	43.42	52.79	7.66	6.75	<0.001
BMI > 29.9 kg/m²	151	175.46	156.01	43.25	53.28	7.74	7.06	<0.001
< 40 years	71	181.13	155.13	44.37	53.81	7.94	7.03	<0.001
40-60 years	326	181.99	155.65	39.41	48.84	7.97	7.05	<0.001
>60 years	169	170.36	141.86	43.94	54.41	7.56	6.57	<0.001
DD<1 year	28	128.99	113.63	64.43	73.39	6.12	5.59	<0.001
DD 1-6 years	179	179.19	151.34	42.32	52.67	7.87	6.9	<0.001
DD > 6 years	343	183.08	154.78	38.62	48.59	8.01	7.02	<0.001
eA1c reg diet<7.5%	295	133.97	118.46	62.06	66.27	6.3	5.75	<0.001
eA1c reg diet>7.5%	271	226.78	187.41	18.88	34.65	9.53	8.16	<0.001
One meal replacement	170	166	144.76	45.48	54.21	7.41	6.67	<0.001
Two meal replacement	392	183.82	154.28	39.74	49.96	8.03	7	<0.001

DD: Diabetes Duration.

We also evaluated patients whose one replaced meal was ProTotal to see the benefits of whey protein on eAG, eA1c and TIR. The results are presented in Table 2.

Table 2: Evaluation parameters when single replaced meal is ProTotal.

Parameters	*One meal replacement with ProTotal* (N=64)**
eAG difference	16.68 mg/dL
% Reduction in eAG	10.23%
eA1c difference	0.17
% Reduction in eA1c	2.33%
TIR improvement	18.82%
P value	<0.001

Discussion

From the latest figures of IDF we know that India ranks second highest among people with diabetes after China [2]. The worrisome part is that as per the National Results of the SITE (Screening India’s Twin Epidemic) study, of the diabetic population already aware of their condition, almost two-of-every three (70%) had ‘uncontrolled’ diabetes (Hba1c levels >7%) [16].

This figure raises a question that in spite of availability of a vast range of pharmacological treatments, why does a patient has uncontrolled diabetes and what is the missing link? The answer can be obtained from the STARCH study [17] and PRODIGY survey [18] which showed that protein intake in India is very less and there hardly any difference exists between diets of a non-diabetic patient to that of a diabetic patient. It was observed that around 9 out of 10 consumers had a diet deficient in proteins. This was regardless of the gender and the socio-economic group [18]. Even the MoHFW (Ministry Of Health and Family Welfare) stated that Indians on an average are protein deficient (11% protein in their diet as against the requisite 15-20%) [5].

As diabetes is a metabolic and lifestyle related disease, controlling patients’ diet is one of the key success factors. In fact, lifestyle modification including MNT should be started even before metformin. Unfortunately by the time patients get diagnosed for diabetes, they have already lost 50-80% beta cell function [19]. Therefore, in this study, we asked patient to replace one or two of their meals with the specially designed, protein-enriched, carbohydrate-counted meal, without changing any pharmacological treatment.

The study enrolled a total of 660 patients. Based on the AGP report at the end of first 6 days, patients were asked to replace the most troubled meal with either Simetri or ProTotal or both for the next 7-8 days. Out of these 660 patients, 94 patients did not follow the study protocol and consumed replaced diet only for a period of <4 days. These 14.24% patients were not included in the analysis. This showed that rate of adherence to diet change was 85.76%. As diet is the hardest thing to change, the significant adherence to given product suggested that the palatability and ease of consumption for Simetri and ProTotal is very high. As it was a real world observation study, there was no control over patients’ lifestyle (food choice, exercise pattern, sleeping pattern etc.). The only change was replacing one or two meal with either ProTotal or Simetri or both and there was no strict control over what the patients consume in the entire day.

In the full cohort, eA1c was reduced by 0.94% (from 7.84% to 6.90%; % improvement 11.99%, p<0.001). The results were similar to that obtained with GLP-1 agonist in AMIGO study where exenatide 10 μg resulted in a mean HbA1c reduction of -0.8% to -0.9% [20]. As whey protein also improves GLP-1 secretion, it can mimic the action of GLP-1 agonist [8]. This indicates that, even a small change in a diet for only a short duration of 7 days has very positive impact on eA1c and if patient continues following the suggested meal replacement plan it will serve like a pharmacological therapy. Even the UKPDS study has shown that intensive glucose control can significantly reduce any diabetes related end-point [21].

As per the recommendations from the international consensus on time in range (TIR), adults with type 1 or type 2 diabetes should have >70% of TIR. In our study, when patients were on regular diet and average TIR was only 41.38% which increased to 51.13% after consuming replaced diet. This indicates that, if patients continue following the replaced diet there will be much improvement in TIR. Though in the current study, patient consumed replaced diet only for 7 days, still an increase in TIR is really significant (relative % improvement of 23.56%, p< 0.0001).

The replace diet not only improved TIR but also decreased the eAG from 178.41 mg/dL to 151.47 mg/dL, p< 0.001 in a full cohort.

The similar result were obtained when different sub-group analysis were carried out, i.e., based on the BMI, baseline HbA1c and the number of replaced meals.

There was no difference seen in male and female patients with reference to improvement. It means the replaced diet causes the similar effect on both the gender. The meal replacement period was only for short duration of days hence change in weight was not included in the evaluation parameter and measuring HbA1c was also not possible.

The results from DiRECT and DiRECT 2 studies support that total diet replacement for initial 12-20 weeks followed by gradual food reintroduction and then support for weight loss maintenance has helped type 2 diabetes patients to achieve remission and sustained it at 24 months for more than a third of people with type 2 diabetes [22].

The AMEND study results were also in line with these studies. Although the study duration was very short and hence measuring a change in body weight was not feasible, the eAG, eA1c and TIR results suggested that if the treatment was continued for longer duration, there are chances that blood glucose and HbA1c will be in the controlled range.

AMEND study results were also supported by David King (2018) study which concluded that whey protein before meals improved post-prandial glycemia, stimulated insulin release, and increased satiety in men with type 2 diabetes [23].

The protein quantity and quality of foods are contributing factors to their effects on glucose control, but foods are much more complex than a single nutrient, or even the sum of their individual nutrients. Many dietary factors, nutritive and/or bioactive, mediate the relationship between food intake and health. Lastly, in order to optimize protein intake for glucose regulation, the amount, source, and type of food product or supplement should be personalized to match to the individual’s lifestyle, medications, gluco-regulatory abilities, and disease status.

Conclusion

This AMEND study showed that the efficacy of replaced diet for calorie restriction remains a significant in humans. Although this data was only for 14 days, the study can give significant and detailed data on effect of replaced diet in patients with diabetes if therapy continues for longer period of time. Improving diet of a patient will not only help them in better management of a disease but will also be cost-effective for the country [24].

Therefore, it can be concluded from the present study that, replacing a diet with protein enriched, calorie counted meal does not only improve the blood glucose level and TIR but can also decrease eA1c significantly.

Acknowledgement

We would like to thank all physicians who have helped in the study. We would also like to extend our gratitude to CRO – Ethicare for their help in data analysis.

Declaration

Funding

Eris Lifesciences Pvt. Ltd

Conflicts of Interest/Competing Interests

Not applicable

Ethics approval

Approved. Aastha Ethics Committee has given the approval.

Informed Consent

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Each author has given their consent for publication.

Availability of data and material

Not applicable.

Code availability

Not applicable.

References

IDF Diabetes Facts and Figures. IDF Diabetes Atlas Ninth edition 2019. https://www.idf.org/aboutdiabetes/what-is-diabetes/facts-figures.html. Accessed 17 June 2020.
IDF Diabetes Atlas 9th edition, 2019. https://diabetesatlas.org/en/sections/demographic-and-geographic-outline.html. Accessed 17 June 2020.
Ranjit A, Coimbatore R, Mohan D, Rajendra P, Vasudevan S, Haridas N, et al. (2015) Incidence of diabetes and prediabetes and predictors of progression among asian indians: 10-year follow-up of the Chennai Urban Rural Epidemiology Study (CURES). Diabetes Care 38(8): 1441-8. [crossref]
Michael L, Wilma L, Alison B, Naomi B, George T, Lousie M, et al. (2018) Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet 391: 541-551. [crossref]
Melanie Davies, David D, Judith F, Walter K, Chantal M, Geltrude M, et al. (2018) Management of hyperglycaemia in type 2 diabetes. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), Diabetologia, Springer Publications, EASD and ADA. Diabetologia 61: 2461-2498. [crossref]
Press Information Bureau Government of India Ministry of Health and Family Welfare, Nutritional Level. 13-March-2015.
Bhatt A, Choudhari K, Mahajan R, Sayyad G, Pratyush D, Hasan I, et al. (2017) Effect of a low-calorie diet on restoration of normoglycemia in obese subjects with type 2 diabetes. Indian J Endocr Metab 21: 776-80. [crossref]
Linda M, Tongzhi W, Michael H, Christopher R (2015) Whey protein: The “whey” forward for treatment of type 2 diabetes? World J Diabetes 6(14): 1274-84.
Hall L, Millward J, Long J, Morgan M (2003) Casein and whey exert different effects on plasma amino acid profiles, gastrointestinal hormone secretion and appetite. Br J Nutr 89: 239-48. [crossref]
Nilsson M, Holst J, Björck M (2007) Metabolic effects of amino acid mixtures and whey protein in healthy subjects: studies using glucose-equivalent drinks. Am J Clin Nutr 85(4): 996-1004. [crossref]
Salehi A, Gunnerud U, Muhammed J, Ostman E, Holst J, Björck I, et al. (2012) The insulinogenic effect of whey protein is partially mediated by a direct effect of amino acids and GIP on β-cells. Nutr Metab 9: 48. [crossref]
Kevin C, Gonca P (2016) Emerging evidence for the importance of dietary protein source on glucoregulatory markers and type 2 diabetes: different effects of diary, meat, fish, egg and plant protein foods. Nutrients 8: 446. [crossref]
Nicole K, Melinda C, Gayle S, Christopher R (2014) Effect of dietary prebiotic supplementation on advance glycation, insulin resistance and inflammatory biomarkers in adults with pre-diabetes: a study protocol for a double-blind placebo-controlled randomised crossover clinical trial. BMC Endocrine Disorders 14: 55. [crossref]
Cristina T, Harriët S, Timothy D, John C (2017) The microbiota-gut-brain axis in obesity. Lancet Gastroenterol Hepatol 2(10): 747-56. [crossref]
Blaak E, Antoine M, Benton D, Björck I, Bozzetto L, Brouns F, et al. (2012) Impact of Postprandial Glycaemia on Health and Prevention of Disease. Obesity Reviews 13(10): 923-84. [crossref]
National results of nearly 16, 000 patients surveyed for Sanofi’s SITE study show that 70% of the known diabetic population have uncontrolled diabetes. Media release by Sanofi India on 7 November 2011.
Shashank J, Anil B, Sarita B, Subodh B, Mala D, Shachin G, et al. (2014) Results from a dietary survey in an Indian T2DM population: a STARCH study. BMJ Open 4(10): e005138. [crossref]
Manish Mahajan (2015) Protein Consumption in Diet of Adult Indians: A General Consumer Survey (PRODIGY). Indian Medical Gazette 149-50.
Baptist Gallwitz (2006) The Fate of Beta-cells in Type 2 Diabetes and the Possible Role of Pharmacological Interventions. Rev Diabetic Stud 3(4): 208-16. [crossref]
Dilip S, Suril V, Shivani V, Kiran K, Vinod T (2018) Recent updates on GLP-1 agonists: Current advancements & challenges. Biomed Pharmacother 108: 952-962. [crossref]
Paromita K, Ian P, Richard D (1999) The UK Prospective Diabetes Study (UKPDS): clinical and therapeutic implications for type 2 diabetes. Br J Clin Pharmacol 48(5): 643-8. [crossref]
Michael L, Wilma L, Alison B, Naomi B, George T, Louise M, et al. (2019) Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol 7(5): 344-55. [crossref]
David K, Mark W, Matthew C, Leigh B, Emma S, Daniel W (2018) A small dose of whey protein co-ingested with mixed-macronutrient breakfast and lunch meals improves postprandial glycemia and suppresses appetite in men with type 2 diabetes: a randomized controlled trial. Am J Clin Nutr 107(4): 550-7. [crossref]
Lee Y, Mozaffarian D, Sy S, Huang Y, Liu J, Wilde PE, et al. (2019) Cost-effectiveness of financial incentives for improving diet and health through Medicare and Medicaid: A microsimulation study. PLoS Med 16(3): e1002761. [crossref]

About Climate, Flooding and Underwater Technologies

Leave a reply

DOI: 10.31038/GEMS.2021335

Waters enclosed in reservoirs in front of hydroelectric power plants are also devoid of natural functions – they evaporate from the surface, bloom with algae, but most of it breaks on turbine blades. The destroyed and unused structure of water evaporates into the atmosphere without fulfilling its mission. These vapors are supplemented by all waters taken from nature for irrigation, technological and communal processes. There is more evaporation of such waters than evaporation from biota. The fumes emanating from other than biota can be called artificial. Their volumes, evaporation rate and quality become commensurate with natural fumes or fumes from plants and living organisms. Therefore, the climate is changing and natural disasters occur. Flood spills are a major source of artificial evaporation. How do we feel about rivers? Within the boundaries of cities and towns, we straighten the banks, cover the river beds with concrete and stones. We dump garbage and waste into the water. By their nature, rivers must regularly affect the banks – meandering or interacting with the soil. This is necessary in order to dissolve minerals, organics in water and supply them to animals and plants. Everything dissolved in water is a building material for biota. Water trapped in concrete banks loses its function. It cannot dissolve minerals from the soil in itself and convey it to the consumer. We do the greatest harm to the river by dumping waste and garbage into it. The volumes of discharges raise the river bottom quite strongly. Especially downstream of settlements. It is this circumstance that leads to the overflow of water from the coast during abnormal precipitation, devastating floods and extensive spills. To maintain the carrying capacity of the river bed, it is necessary to periodically clean the bottom of sediments or maintain the historical depth.

The existing technology of deepening the river bottom with dredges and various dredgers is quite metal-consuming, requires significant expenditures of energy, funds and pollution of coastal areas. The main energy required with these methods is spent on holding the agent itself against the current. Considering the possibility of impact on the bottom of the rivers, it is possible to find the moments when gullies and depressions are formed around the sunken ship. Is it possible to use the forces of the movement of the water itself. If we take this principle as a basis, then the simplest special device arises that will clean and deepen the bottom of the river. An ordinary parallelepiped without a bottom and ends, installed at the bottom of the river, will have almost no effect on the flow. Water freely enters one end and exits through the other. But, if a damper is installed inside it to turn the water flow to the bottom, then it becomes possible to displace the bottom particles along the flow. Moving the device downstream, these particles move further. If the device is moved forward and backward by means of a cable, an underwater longitudinal channel can be obtained. By moving it from coast to other coast, it is possible to move bottom sediments into the transverse shaft. If necessary, the shaft can be lifted to the surface. By reducing the movement of water across the entire width of the river, and by increasing the underwater channel, it is possible to increase the carrying capacity of the entire river. By diverting the main stream away from the collapsing coast, this collapse can be excluded. Thus, influencing the water flows, it becomes possible to change the river bed according to the given parameters. To preserve water for the summer, it is enough to keep the existing ratios of rifts – rapids and reaches – depressions. An increase in these volumes is achieved by a corresponding deepening of the bottom in these places. To increase the speed of the recess, a lead screw can be added to increase the flow of the impact to the bottom. Deepening to the design depth will not allow water to overflow the banks with maximum precipitation. The simplest device can prevent floods. The shown device is primitive in execution, does not require a lot of metal and is not energy intensive. The power to drive the lead screw is hundreds of times less than on dredges. Thus, the manufacture of the device is available to any coastal economy. The idea of impacting the bottom by the current itself goes far beyond a simple deepening. For large river depths, it is possible to manufacture a device with a small power plant, a lead screw, autonomous control, and an underwater life support cabin. A device or Underwater Universal Machine (PUM) has been developed. The uplift and transfer of bottom sediments makes it possible to create new technologies for underwater operations. For example, gold mining. Sorting and disintegration can be carried out directly in the shown closed cavity without bringing the materials to the air. Of course, designers will have to work hard to develop new devices for such work. It becomes possible to search for and recover sunken objects goods without destroying the bottom surface. Conversely, it is possible to remove the bottom layer and transport it to the surface, for example, to obtain sapropel. Repair of underwater structures, such as pipelines, is possible. With completely closed dampers at the ends, it becomes possible to completely stop the movement of water and create an air bell. The version with a lead screw can be used for reservoirs with stagnant or sedentary water – lakes, swamps, seas.

Keywords

Artificial evaporation, Water functions, Deepening of the bottom, New technology, Underwater work.

Earth Science Needs Thorough Introspective Analysis and Renovation

Leave a reply

DOI: 10.31038/GEMS.2021334

Abstract

Despite several breakthrough discoveries, earth science needs modification especially related to its deeper parts of the planet where temperature and pressure have been presumed to be high. Based on the concept of earth’s expansion, the author considers that the mantle of the unexpanded ocean-less earth was considerably fluid owing to incorporation of ocean-forming water. In such a globe gravitational pull from an extraterrestrial planetary body would cause expansion triggered by swelling up of the semi-fluid mantle and consequent formation of a number of expansion cracks on the crust. Through these cracks or mid-oceanic ridges extensive molten magma would expel out and deposit on both sides of the crack to form ocean basins. Matching thickness of the earth’s fluid outer core with the extent of expansion points out that owing to massive expansion original core-mantle conjunction of the planet was ruptured along which a void zone, identified as outer core of the prevalent concept, was gradually opened up. Such disposition of occurrence of two discrete geospheres separated by a virtually void zone would give rise to the phenomenon of reverse gravity in the deep interior of the planet thereby sustaining a low pressure and low temperature zone at depth.

Introduction

The author of this article, who is a geologist by love, education and commitment, while studying various features of earth science noticed that certain aspects of the studies call for introspective analysis and revamping and in a few cases rejection. Authur’s study was conducted covering right from the crustal layer of the planet to its deepest part, including the enigmatic outer core. When the first authentic map of the globe was prepared in 1570 by Abraham Ortilius [1], which conspicuously exhibited parallel shore lines between Africa and South America. The pioneer cartographer not only noted this remarkable feature, but also for the first-time proposed occurrence of continents in the past in a conjoined manner. After that several observers, such as Antonio Snider-Pellegrini [2] of France as well as Alfred Wegener [3] of Germany and several other geologists attempted for continental adjustment. However, all such models were found to be untenable from the point of strict scientific study as they had liberally distorted the boundary of the relevant continents. I. O. Yarkovskii [4] of Russia for the first-time suggested Earth’s expansion in 1888 while after that many scientists, some of them independently, conceived the idea of expansion of the Earth. In contrast to the adjustment done in an unaltered dimension of the earth, Hilgenberg [5] of Germany in 1933 showed that in a model of earth reduced to two/third of its original dimension perfect adjustment of continents could be achieved (Figure 1). This information evidently supports earth expansion theory to be a genuine concept suitable for explaining major global phenomena, while, for explaining such phenomena in a globe of unchanged dimension throughout the past geological ages requires several fabricated assumptions.

Figure 1: O. C. Hilgenberg of Germany in 1933 showed that if the radius in a model of Earth could be reduced to two-third of its radial thickness, all the continental blocks could be adjusted in a perfect manner. It can be noted that in the primordial small Earth, there were no oceans although lakes were present. Hence, it can be conceived that at that time the ocean-forming water was associated with the Mantle turning it considerably fluid and predominantly suitable for expansion (Sen, 1984-2007).

All the World Loves a Fairytale

In “The Problems of Philosophy” Bertrand Russell [6] expressed:

“Is there any knowledge in the world which is so certain that no reasonable man could doubt it? When we have realized the obstacles in the way for a straightforward and confident answer, we shall be well launched on the study of philosophy – for philosophy is merely the attempt to answer such ultimate questions, not carelessly and dogmatically as we do in ordinary life and even in the sciences, but critically after exploring all that makes such questions puzzling, and after realizing all the vagueness and confusion that underlies our ordinary ideas”. Regarding apparently unquestionable notions, Sir Bertrand further pointed out that “Yet, all these may be reasonably doubted and all of it requires much careful discussions before we can be sure that we have stated it in a form that is wholly true.” The present author considers that many of our concepts and axioms which are extensively been applied in earth sciences for a long time as authentic and of paramount importance, require sensible evaluation, and, if necessary, modification. The author would be satisfied if he can utilize the rich scientific heritage developed through protracted studies by the scientists from all over the globe in an honest and meaningful manner avoiding fairy tale-like imagination and dogma. Since the view of constant dimension earth throughout the past geological time has been rejected as per the reasoning earlier mentioned, the concept of plate tectonics would also be automatically discarded. However, plate tectonics [7] happen to be one of the most popular views – or, perhaps the most remarkable concept ever developed in earth science that enjoys support from a large section of geo-scientists. Hence, for rejecting such a popular view it is necessary to discuss the drawbacks of the concept. Essentially plate tectonics is based on the concept of uniform earth dimension or unchanged dimension of the globe throughout the past geological ages and requires several fabricated assumptions for explaining only a few features of the earth system, restricted mainly to the crust of the planet. The concept does not convey any idea regarding the origin of continents or oceans, neither it gives information on interior of the planet. To keep the dimension of the planet constant it views that while a plate or solid continental fragment plunges into another solid part of the earth in a smooth conveyer belt like manner, in another part of the planet new plates are emerged, defying basic principles of physics. The process is operated owing to a convection current that occurs in the mantle which is solid and rigid as confirmed by propagation of seismic waves. The movement, though occurs in extremely slow manner, is capable of drifting the continents to great distances, concurrently driving a geo-dynamo, responsible for magnetic features of the planet.

Unified Global Tectonics

The concept of unified global tectonics (Sen, 1984, 1986, 2003, 2007) [8-11] has been developed based on the earth expansion theory of Hilgenberg (1933) [5] which envisages that if we could reduce the radius of the earth to two-third of its present thickness, all the continental blocks would be perfectly adjusted in the resultant small globe. Such small globe would be devoid of ocean basins although a few epicotinental seas or lakes were present. Therefore, it can be deduced that the ocean-forming water at that stage must have been associated with the mantle. Under such a set up, the original mantle material would be considerably fluid and consequently highly suitable for the manifestation of expansion, leading to continental fragmentation and various related features. The view is based on the results of experimental studies conducted by Roy and Tuttle (1961) [12] confirming depression of melting point of silicate rocks under hydrothermal and high pressure condition. As evidenced by the tidal pull of Moon, it is rational to conclude that the reason of the earth’s expansion is the gravitational pull exerted by the Moon causing periodical bulging of the semi-fluid mantle. However, with progress of the process due to escape of volatiles from the mantle consisting chiefly of water, the ocean basins would be filled up with water simultaneously reducing the fluidity of the mantle which would eventually turn into a rigid geosphere. As explained above, the Moon – responsible for causing earth’s expansion by exerting tidal pull – was originally an independent small planet which was captured by the earth when it was approaching the latter. Initially due to the Moon’s magnetic influence exerted over the magnetic core of the earth, the latter’s spatial orientation was drastically changed, causing major alteration in earth’s climatic features. It has been conceived that originally in the small earth the solid iron core and mantle – initially which was adequately fluid – were juxtaposed to each other. As has been discussed, an appropriate gravitational force from an extra-terrestrial planetary body – the Moon – was responsible for the earth’s expansion by bulging up of the semi-fluid mantle causing rupture of the original core-mantle conjunction. Also, due to such bulging of the semi-fluid mantle a number of expansion cracks – that eventually turned into mid-oceanic ridges – were produced over the solid sialic crust through which large quantum of basic magma disgorged and spread on both sides of the cracks to form ocean basins. Matching thickness of the fluid outer core with that of the extent of expansion, strongly supports the view that in consequence of prolonged expansion, along the ruptured core-mantle conjunction a void zone, identified as outer core in the prevalent concept, was gradually opened up. In due course the void zone would turn into a pseudo-fluid or virtually void geosphere owing to influx of fine particles from the adjoining mantle. The above mentioned arguments lead us to envision that two rocky and metallic geospheres separated by a non-solid and virtually void zone occur in the deep interior of the planet (Figure 2). This sort of internal setup would give rise to the phenomenon of reverse gravity generating low temperature and low pressure zones in the earth’s deep interior. This simple and down to earth concept explained here is in complete agreement with all the major fundamental features, including several hitherto unexplained ones encountered in the planetary interior. Evidences of low temperature and low pressure zones in the planet’s deep interior are exhibited in meteorites which are considered to be broken fragments of a pre-existing planet. These evidences include strong magnetic nature of some meteorites, texture of iron meteorites, presence of minerals with hydrocarbons, amino acid and water in some rocky meteorites, as well as, globular shape of chondrules – all of which unmistakably confirm low temperature and low pressure condition in the deep interior of the planet. With the new concept the picture that emerges on the interior of the earth is this that during the Precambrian era, when the planet’s core and mantle were juxtaposed to each other, extra-terrestrial magnetic influence caused movement of the iron-core, as a result of which the planet as a whole was tilted or deflected in space. Because of such alteration in spatial orientation of the planet, remarkable changes in the geographical features in various parts of the globe occurred, signatures of which, like the polar region revamping in to a hot zone and vice-versa, are documented over the global surface (Figure 3b). In contrast, when the pseudo-fluid or void geosphere attained adequate thickness due to prolonged expansion, (Figure 3d), instead of deflection of the entire earth, only its magnetic iron core started to execute smooth and secular movements, including reversal of the poles, which are precisely documented over the surface rocks (Figure 3). It is understandable that in case of expansion, the sialic super-continent would be fragmented because of development of a number of expansion cracks, followed by widespread expulsion of basaltic magma through the cracks that would occupy the new space generated along the cracks forming rudimentary ocean basins. Under such circumstances instead of collision, the fragmented parts would tend to move away from one another causing enhancement of the ocean basins. Geological records, on the other hand, confirm collisions of continental plates have actually occurred at certain places during the past geological periods. In unified global tectonics this has been attributed due to the force generated by rotation of the planet along its axis of rotation which would be maximum around the equator and minimum near the poles. This sort of force generated due to rotation or spin of the planet was not only responsible for continental collision forming colossus structures like the Himalayas but also caused major revamping of the continental fragments and ocean basins.

Figure 2: Overall structure of the earth (not to scale) showing trend of gravitational attraction on surface and interior of the planet. At the centre of the planet the trend of gravitational attraction would be oppositely directed. With separation of original semi-fluid mantle from the iron core due to planetary expansion and formation of a virtually void zone in between – the so called outer core of the prevalent view -, it is reasonable to conceive that around the inner core oppositely or reversely directed force of gravitational attraction would prevail forming a low pressure low temperature zone at depth.

Figure 3: Before expansion of the planet, the solid iron core and semi-fluid mantle were juxtaposed to each other (Figure 3a). Due to expansion the original core-mantle conjunction was ruptured (Figure 3b) and along the ruptured surface a void zone was developed which gradually grew into a pseudo-fluid geosphere, i.e., the earth’s fluid outer core (Figure 3c). This view supports that two geospheres of rocky and metallic composition, separated by a non-solid and virtually void zone, occur in the deep interior of the planet. Such disposition of the planet would give rise the phenomenon of reverse gravity in the planet’s deep interior and core generating low temperature and low pressure zones in the earth’s core and deeper parts. After development of the broad pseudo-fluid or virtually void geosphere (Figure 3d), the iron-core would remain within it in a suspended condition. Hence at this stage, pertaining to younger geological periods, in response to extra-terrestrial magnetic influences, new geomagnetic phenomena, like, polar wandering, pole reversal and west-ward drift could take place.

Remarks and Conclusions

The author in the book “Earth – Planet Extraordinary” has advanced the following new concepts:

The globe in its present outward appearance shows occurrence of continents in disjointed form which cannot be adjusted in appropriate manner whereas in a smaller globe, reduced to two-third of its present radial dimension (Hilgenberg, 1933), proper fitting of the continents can be achieved. This unmistakably demonstrates that the earth is an expanded planet, though in case of solid and rigid condition of the mantle planetary expansion and continental drift would not be possible.
The author has pointed out that since the small earth of unexpanded stage was devoid of oceans, the mantle at that stage must have been sufficiently fluid or semi-fluid owing to incorporation of ocean-forming water – an essential requirement for earth’s expansion or continental drift. The view has been developed based on the work of Roy and Tuttle (1961) [12] who showed that melting point of a silicate rock under hydrothermal and high pressure condition would be depressed or, in other words, it would develop considerable fluid characteristic.
It has been postulated that a planetary body came near the earth and was eventually captured by the latter, thereby turning the former a solitary satellite of the earth, the Moon. Since then the Moon started to rotate around the earth and due to its gravitational attraction on the earth, chiefly affecting the semi-fluid mantle, caused its expansion. As the Moon was revolving around the earth and the Moon too was rotating around its own axis of rotation, the earth’s expansion was manifested in a uniform manner.
It was owing to expansion earth’s solid sialic crustal cover developed a number of long sinuous cracks along which the planet’s super-continent was fragmented forming several units of continents.

References

Ortelius Abraham (1570) Thesaurus Geographicus (in Latin) 3rd Edition, Antwerp Plantin. OCLC 214324616.
Snider-Pellegrini Antonio (1858) La Creation et ses Mysters Devoiles, Librarie A. Franck & Dentu, Paris.
Wegener Alfred (1912) Die Entstehung der kontinente, Petermann Mitteilungn, 185-195,253-256,305-309.
Yarkovsky, Ivan Osipovich (1888) Hypothese cinetique de la Gravitation universelle et connexion avec la formation des elements chimiques, 134p, Moskau.
Hilgenberg OC (1933) Vom Wachsenden Erdball, Berlin: Giessmann & Bartsch.
Russell, Bertrand (1912) The Problems of Philosophy, Home University Library, Oxford University Press paperback, 1959 Reprinted, 1971-1972.
Dietz Robert S (1977) Plate tectonics: A revolution in geology and geophysics. Tectonophysics. 38: 1-6.
Sen Subhasis (1984) Unified global tectonics – a new qualitative approach in Earth sciences, Indian Science Congress, Geology and Geography Section, Ranchi, January 3-8, 71st Session, Abstract, p.23-24,.Also in Jour. Met. & Fuels 32: 20-22.
Sen Subhasis (1986) A new concept on the Earth’s interior, geomagnetism and crustal fragmentation, International Symp. on Neotectonics in South Asia, Survey of India, Dehra Dun, Feb.18-21, Proceedings, p.83-94.
Sen Subhasis (2003) Unified global tectonics: structure and dynamics of the total Earth system, Indian Science Congress, Earth System Sciences, Bangalore, January 3-8, 2003, 90th Session, Abstract, p.57-58,. Also in Jour. Met. & Fuels 51: 351-355.
Sen Subhasis (2007) Earth – The Planet Extraordinary, Allied Publishers Ltd., New Delhi, 232.
Roy R, Tuttle OF (1961) Investigation under hydrothermal conditions, In Ahrens, I.H., Rankama, A.K. and Runcorn, SK (eds.) Physics and Chemistry of the Earth 1: 138-180 Pergamon Press, New York.