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Overview of the Paper

Outcomes of Obese, Clozapine-Treated InpatientsWith Schizophrenia Placed on a Six-Month Diet and Physical Activity Program

Increased level of appetite along with consequent gaining of weight is a common phenomenon among the schizophrenic patients who are under antipsychotic medication (Deng, 2013). One of the most recommended antipsychotic drugs which is recommended for the treatment of schizophrenia is Clozapine. This second-generation antipsychotic drug belongs to the class of dibenzodiazepine derivative and has low risk of extra-pyramidal side effects (Deng, Weston-Green & Huang, 2010).However, Clozapine has greatest potential to induce weight gain. The antipsychotic drug induced weight gain occurs through histamine H3 receptors. Drug induced decrease in the activity of the histamine H1 receptors decrease the specificity of the H3 autoreceptors, resulting in weight gain (Deng, Weston-Green & Huang, 2010). The increase in weight gain causes increase in the concentration of glucose, insulin, cholesterol and triglycerides in blood (Deng, 2013). In case of patient who are under long-term therapy under Clozaoine, significant decrease in the insulin like growth factor (IGF-1) has been observedleading to cardiac complications (Henderson, Vincenzi, Andrea, Ulloa& Copeland, 2015). This increase in weight gain arising out of the side-effects of medication in Schizophrenic patient is associated with non-compliance (Das, Mendez, Jagasia&Labbate, 2012). Non-compliance is associated with sudden discontinuation of the psychotic treatment leading to return of psychotic symptoms (Das, Mendez, Jagasia&Labbate, 2012). Therefore, it is important to strictly regulate weight among the patients who are under long-term treatment with Clozapine. The aim of this study is to regulate the weight gain among the Schizophrenic patients who are under long-term treatment with Clozapine. In the process of execution of control of weight gain, Mei-Kuei et al., observed dietary regulation and physical activity among the obese inpatients of Schizophrenia. The issue addressed in this paper is important because patients who are suffering from Schizophrenia are at an increase for getting affected with metabolic syndromes due to their uncommon lifestyle, suspected genetic predisposition and long-term exposure to antipsychotic drugs (Hasnain, Fredrickson, Vieweg&Pandurangi, 2010). Obesity and decrease in IGF-1 is associated with serious health threats. IGF1 and other growth hormones are important regulatory agents in maintaining effective functioning of the cardiovascular system. Free IGF-1 has anabolic, autocrine and endocrine functions so decrease in IGF-1 arising out of antipsychotic medication obesity can impose threats on the Schizophrenic patient.

The research showed that the management program of dietary control and physical activity is successful in reducing obesity among the Schizophrenic patients who are on oral medication of Clozarine. The regulated and physical activity was found to reduce the obesity related complications of these patients.

Issues Addressed in the Paper

The study showed that the an intervention program involving dietary control and mild physical exercise for about six months significantly decrease the body weight, waist and hip circumference and BMI index of the obese schizophrenic patient of the control group. It also helped in increasing the blood concentration of the IGFBP-3 levels along with increase in the molar ratio of IGF-1 to ICFBP-3. Increase in the ration of the IGF-1 is important in maintaining the balance of the healthy cardiac system (D'amario et al., 2011). The importance of the findings lies in the fact that it indentified that importance of monitoring weight among the obese patients who are suffering from Schizophrenia and are under the mediction of Clozapine for the past one year.

A randomized controlled study was observed in this research paper in order to elucidate the outcome of six months of non-stop dietary control and regulation of physical activity upon the weight gain of the obese patient suffering from Schizophrenia and is on Clozapine medication. The study critically analysed the biochemical and anthropometric parameters in an interval of three and six months. The major factors which were analysed under the banner of the anthropometric and biochemical parameters are triglyceride, serum glucose, cholesterol, cortisol, insulin, prolactin, growth hormones, IGF-1 and insulin-like growth factor–binding protein-3 (IGFBP-3). The dietary intervention was implemented on the target group via a professional dietician.

Men

Women

1600 to 1800 per day

1300 to 1500 per day

Table: Permissible kilo- calorie-intake

The physical activity was observed for six months at a stretch with a plan of three days per week. The physical activities were selectively chosen in order to effectively fit within the hospital environment and include walking and warm. The study was performed in accordance with the Declaration of Helsinki and was simultaneously approved by the veterans of the Yu-Li Hospital’s Ethic review committee. The results thus obtained wasanalyzed via variance and covariance analysis (ANCOVA) and the effectiveness of the data obtained was accessed via SPSS statistical software (version 10.0) on general linear model.

The randomized control trial consisted of 753 hospitalized inpatients. The patients who were hospitalised during the tenure of 2003 September to 2004 February are considered for this randomized control trial. All the patients who were included under the focus group has tested positive for Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV) test. DSM-IV is diagnostic criteria for schizophrenia and associated disorders.   Theage brackets of the patients were broad and lie in between 18 to 65 years. The main inclusion criteria taken for this study was- patients who are taking oral Clozapine dosage of 300mg for the past one year with a body mass index (BMI) greater than 27kg/m2 are considered appropriate for the focus group. Here the importance of the BMI lies in the fact that Asian originals who have BMI greater than the above mentioned value (27kg/m2) are considered to be obese (Huxley, Mendis, Zheleznyakov, Reddy & Chan, 2010).

Patients who are using lipid lowering medication

Suffering from abnormal ambulatory complications or organ failure

Suffering from chronic mental illness

Pregnant or lactating

Disability in locomotion

Unwilling to participate in the study

Outcome of the Research

After apply this inclusion and exclusion criteria, only 56 patients were screened out and used for the final study of them 25 patients was referred as placebo.

Under the anthropometric measurements, there was no significant different between the BMI, waist circumference, waist-to-hip ratio among the control and the study group. Moreover, when the data was separately tallied between the male and the female participants on the basis of the fat percentage of free fat mass, no significant change was observed. However, BMI, weight of the body and hip circumference experienced significant changes within the first three months and the change in the circumference of the hip was observed after the six months.

In the domain of the metabolic analysis and enzyme immunoassay, no significant difference was observed at the baseline when the obtained results were compared with the control and the trial groups. Cholesterol, serum glucose, prolactin, cortisol and insulin did not changed significantly upon the intervention. However, at the end of six months, there was a significant change in the blood concentration level of the triglycerides and cortisol between the control and focused group was observed. Triglyceride level was found increasing among the control group during the transition between three to six months. Decrease in the insulin level was only observed after six months in comparison to that with the three month assay.vNo significant difference in the assay of IGF-1 was observed during the entire stretch of six months however, concentration of IGFBP-3 was found significantly lower in the placebo group.

Thus, the findings of the study can be summarized as follows: There lies a significant benefit of six-month weight control intervention upon the obese schizophrenic patients who are under clozapine medication for the past one year. The benefits are reflected via integrated dietary control and regular physical activity. The study showed a significant decrease in BMI, percentage of body fat and hip to wait circumference. The study also showed that restricted calorie intake along with period physical exercise also improve the metabolic profiles of insulin, IGFBP3 and IGF-1 to IGFBP-3 molar ratio and triglycerides. This improvement of the in insulin like growth factor level promotes health cardiac functioning thereby reducing fatal threats on the obese Schizophrenia patients (Henderson, Vincenzi, Andrea, Ulloa& Copeland, 2015).

The study did not able to show the significant variance in the concentration of IGF-1 in blood in six months and hence future studies are required to be undertaken in order to ascertain the affect on the concentration of IGF blood upon the observance of the physical activity and calorie restricted diet. Moreover, several benefits of the metabolites of the diet were not realised and hence long term adherence of such programs is necessary to study their effects. The future research also needs to ascertain the affect of the other lifestyle changes on the obesity of the schizophrenic patients so that they can successfully avoid the obesity related abnormalities.

Study Design

In the exclusion criteria, patients who are using lipid lowering medication were excluded from the focus group. Future research studies are needed to be undertaken if the lifestyle changes could aggravate the overall weight loss regime of the obese schizophrenic patients when observed alongside with the lipid lowering medication.

The result obtained in this study is not that confounding. It is already known that the management of weight via restricted calorie diet cumulated with regular physical activity helps in weight loss and thus preventing the chances of morbidity among the obese individuals. However, previous studies, which were conducted in regards to weight management regime for the schizophrenic patients with clozapine medication showed contradictory results.  Nevertheless, the study is indeed significant as it gave a clear light towards successful weight loss regime among the obese Schizophrenic patients who are under oral clozapine. It also showed that such weight loss is not associated with any negative side effects or require any administration of other extra drugs. Though weight loss is previously initiated via the application of number of pharmacological interventions like metformin, aripiprazole, fluvoxamine, and topiramate appear to be beneficial but are associated with negative side effects (Whitney, Procyshyn, Fredrikson& Barr, 2015).

The results are conducted via taking a large age group encompassing 18 to 65 years old and hence there must be a chance of getting affected via chance variation. Moreover, effectiveness of the subsequent treatment was analyzed  via applying variance and covariance analysis (ANCOVA) method with the help of SPSS statistical software (version 10.0). The entire analysis is based on the general linear model.  Chance variance or chance error is an inherent error in any predictive statistical model and this model is not an exception (Busk &Marascuilo, 2015).

The conclusion derived from the study is clearly represented via citing relevant statistical data obtained from the six months old study. The data generated after metabolic, anthropometric and hormonal study from the       focus group were thoroughly tallied with the data generated from the placebo group. This comparison of the data was done during the onset of the scientific assessment and after the completion of three months and six months of the trial respectively. The data obtained towards the onset of the study, baseline data or initial data were cited as covariate. The comparative analysis was done with repeated application of ANCOVA which helped in the critical adjustment of the baseline values. In this study, the researchers have employed a two-way mixed design of ANCOVA to correct the confounding variables and to analyse the relation between the variables. In all the cases taken for statistical analysis, 0.5 was considered as o value in order to make the data free from chance error and statistically significant.

Study Population

The sampling of the focus group undertaken for the randomized control trial was done based on the approach stated by the CONSORT 2010 checklist(Moher et al., 2010). 

CONSORT

Source: CONSORT, 2010

The principal aim of the epidemiology is associated with the assessment of the cause of the disease. However, the majority of the epidemiological studies are observational than experimental and so is this study carried out by Mei-Kuei Wu et al. Thus an observed statistical association between the risk factor and the disease does not lead to a causal relationship between the two entities. However, in this study, there lies a stronger strength of association between the risk and the outcome for example here the risk is the increase in the obesity and the outcome shows decrease in the hip and waist circumference thus, showing a significant degree of association. Moreover, there also lies a consistency of findings among the different population. Here the population bracket that have been selected for the study is large encompassing 18 to 65 years, both male and females and hence making the population large. There is also a specificity of the association that is one to one relationship between the cause and the outcome that is maintenance of the calorie restricted diet and physical exercise helps in weight loss. There is also a temporal sequence of association along with biological gradient. Moreover, there also lies a coherence that is the relationship agrees with the present knowledge of the natural history. Here the relationship is, restricted diet and regular physical exercise promotes weight loss. Moreover, the removal of the exposure alters the frequency of the desired outcome as shown by the placebo group. So there is no plausible causal association between the exposure and the outcome (Von Elm et al., 2014).

The findings of the study are consistent. The majority of the factors, which are undertaken for the analysis of the weight loss regime showed significant results by the end of six months trial. However, no special interaction or mechanism was illustrated in this study. This is due to the fact that it is an epidemiological study and is based on observation and not on experiments(Von Elm et al., 2014).

The findings can be effectively applied to the source population. Here the source population means the population from which the focus group of the study population was derived. The study was carried with the inpatients who are under the clozapine medication for the past one year and are suffering from Schizophrenia.  So the source population that is the population who are suffering from the Schizophrenia and are under antipsychotic medication of clozapine will be effective in applications of the interventions elucidated from the studies. However, the main criterion is, the individual must be suffering from obesity and that obesity has been generated as an after affect of long term clozapine treatment.

Exclusion Criteria

Study here has taken certain exclusion criteria and one significant one Schizophrenic patient who are using lipid lowering medication are excluded from the study. So the relevancy of the results obtained in this study may get affect if studies over an obese population who are under both clozapine and lipid lowering medication.

The study results can also be applied to other population who are suffering from the obesity arising out of the antipsychotic medication of the mental disorder. Moreover, since the experimental plan undertaken in this study is restricted calorie diet along with regular physical activity, the results can also be applied to general population who are suffering from obesity due to lifestyle related problems.

References

Busk, P. L., &Marascuilo, L. A. (2015). Statistical Analysis in Single-Case Research. Single-Case Research Design and Analysis (Psychology Revivals): New Directions for Psychology and Education, 159.

D'amario, D., Cabral-Da-Silva, M. C., Zheng, H., Fiorini, C., Goichberg, P., Steadman, E., ...&D'alessandro, D. A. (2011). Insulin-Like Growth Factor-1 Receptor Identifies a Pool of Human Cardiac Stem Cells With Superior Therapeutic Potential for Myocardial RegenerationNovelty and Significance. Circulation research, 108(12), 1467-1481.

Das, C., Mendez, G., Jagasia, S., &Labbate, L. A. (2012). Second-generation antipsychotic use in schizophrenia and associated weight gain: a critical review and meta-analysis of behavioral and pharmacologic treatments. Annals of Clinical Psychiatry, 24(3), 225-239.

Deng, C. (2013). Effects of antipsychotic medications on appetite, weight, and insulin resistance. Endocrinology and metabolism clinics of North America, 42(3), 545-563.

Deng, C., Weston-Green, K., & Huang, X. F. (2010). The role of histaminergic H1 and H3 receptors in food intake: a mechanism for atypical antipsychotic-induced weight gain?. Progress in Neuro-Psychopharmacology and Biological Psychiatry, vol. 34(1), pp. 1-4.https://doi.org/10.1016/j.pnpbp.2009.11.009

Hasnain, M., Fredrickson, S. K., Vieweg, W. V. R., &Pandurangi, A. K. (2010). Metabolic syndrome associated with schizophrenia and atypical antipsychotics. Current diabetes reports, vol. 10(3), pp. 209-216. https://doi.org/10.1007/s11892-010-0112-8

Henderson, D. C., Vincenzi, B., Andrea, N. V., Ulloa, M., & Copeland, P. M. (2015). Pathophysiological mechanisms of increased cardiometabolic risk in people with schizophrenia and other severe mental illnesses. The Lancet Psychiatry, 2(5), 452-464.

Huxley, R., Mendis, S., Zheleznyakov, E., Reddy, S., & Chan, J. (2010). Body mass index, waist circumference and waist: hip ratio as predictors of cardiovascular risk—a review of the literature. European journal of clinical nutrition, 64(1).

Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gøtzsche, P. C., Devereaux, P. J., ...& Altman, D. G. (2010). CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Bmj, 340, c869.

Von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., Vandenbroucke, J. P., & Strobe Initiative.(2014). The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. International Journal of Surgery, 12(12), 1495-1499.

Whitney, Z., Procyshyn, R. M., Fredrikson, D. H., & Barr, A. M. (2015). Treatment of clozapine-associated weight gain: a systematic review. European journal of clinical pharmacology, 71(4), 389-401.

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