Arsenic Round the World by Mandal and Suzuki - Assignment Example

Research Methods Introduction Groundwater contamination by arsenic is a global problem affecting major continents. Therefore, has affected millions of people around the world by causing various illnesses (Mandal and Suzuki, 2002). Several attempts are being made to provide arsenic-free drinking water at affordable costs. Potentised homeopathic remedies have been identified to be cheap, easy to administer, effective in low doses and have no toxic effects. Micro doses of Arsenicum Album administered to rats have yielded encouraging results to mobilise arsenic levels (Khuda-Bukhsh, 2005). This paper is an evaluation of an article by Belon et al.,(2007) discussing research methodology and implications for research in homeopathy. Internal validity Groundwater arsenic contamination poses a great risk to millions of people worldwide. Since supply of arsenic free water is inadequate, a pilot study was conducted to determine if homeopathic remedies Arsenicum Album 30 and Arsenicum Album 200 have beneficial effects on a random population of Ghetugachi and Dakshin Panchpota, which are arsenic contaminated villages (Khuda-Buksh et al.,2005). Improvement in their general health as well as blood toxicity levels was observed on administration of homeopathic therapies (Milazzo, et al., 2006). However, during the investigation, the volunteers were strictly advised to refrain from taking arsenic contaminated water. This created doubt as to whether the changes observed were due to the homeopathic remedies or intake of the arsenic free water (Moffett et al., 2006). Therefore the present study by Belon et al,.(2007), was organised in an arsenic-contaminated village where arsenic free drinking water was unavailable. The parameters used in the study are either directly or indirectly implicated to the development of hapato-toxicity, and are important toxicity biomarkers. A hepato-toxic change is a primary feature associated with chronic arsenic poisoning and can lead to modulation of lipid peroxidation (LPO), which is associated with tissue damage and necrosis. Selection of subjects 39 subjects comprising of 20 males and 19 females, showing no initial signs or symptoms of arsenic poisoning from the village of Dasdiya which has been recently marked as an arsenic-contaminated village, in Haringhata block under Nadia District, West Bengal volunteered by signing a consent form. Nevertheless, initially some participants were initially reluctant. The volunteers represented a subset of the population making Belon’s procedure convenient. It may be costly for an entire population to participate in a study. Most arsenic victims were weak and anaemic and were afraid of giving blood at a regular interval. The victims showed skin lesions, suffered from either gastrointestinal system disorders, pains and burning sensation in muscle and joints and were generally emotionally frustrated. They were to undertake the randomized placebo-controlled study for two months, later which the placebo fed subjects were to receive the verum and were requested to provide urine and blood samples. 50 similar bottles, 25 containing Arsenicum Album-30 and 25 containing sugar globules soaked with Alcohol 30 were marked with numerical codes and kept on a tray. There might be unevenly distributed treatments and unequal group members with this kind of arrangement. The subjects were to pick up vial as per their choice and after two months, a sample collection camp was held in the village to collect their urine and blood. Only 25 subjects, 13 males and 12 females, turned up to submit their urine and blood samples for laboratory tests. This is approximately 36% dropout before the completion of the study. This should be a concern since 20% dropout is conventionally accepted. When the subjects who did not turn up were contacted, they responded that they were no longer interested to continue since they did not find the remedy effective enough to bring any ameliorative changes despite that they were informed on the possibility of receiving ‘placebo’. It turned out that the of the 22 subjects who received verum, of whom 20 turned up for the second camp while out of 17 who received the placebo, only 5 turned up for the second camp. As a result, the sample size for placebo became very small, only 5 against a total of 20 fed Arsenicum Album 30. There were no reasons as to why the study should be rejected due to the high dropout rates. The subjects who received the placebo were the positive control in this study. To understand the impact of arsenic contamination and various parameters through the study, subjects who provided their blood samples in consecutive camps were analysed in relation to some 18 subjects, 14 male and 4 female from a distant village Padumba-san in Midnapur (East) District, also known to be arsenic free and away from the Gangetic belt. This is a negative control since the effect of arsenic toxicity where the water was contaminated. This makes Belon’s method reliable. Assessment It is clear that blinding was initially ensured among both participants and researchers by marking the bottles with numerical codes. However, due to a high dropout rate, the participants were ‘unblinded’ after treatment by deciphering the numerical codes. Blinding is important since the study will be free from bias (Chow and Liu, 2014). In both conventional medicine and homeopathy, bias could be seen in the placebo-controlled trials. Despite the origin, whether negative or positive samples, the outcome of the blinded sample were random and did not fit well with the anticipated findings. Some controls were very active while other active samples lacked effect on the biological structure. Collection of blood samples was done in two vials: one containing anti-coagulant (EDTA) and the other had no anti-coagulant. Blood with no EDTA was centrifuged at 8000xg for 10 minutes and serum was obtained, which was used for the biomarkers. Blood with EDTA was used for determination of ESR, PCV and Hemoglobin content. Hemoglobin content was determined by Sahli’s method with a hemometer. To determine creatinine, the standard modified Jaffe’s Kinetic method was followed. For the study of AST, ALT, LPO and GSH from blood serum. Uncoagulated blood was subjected to diagnostic kit for analysis of G-6-PD activity and GGT. Arsenic content of first void morning urine and fasting blood of volunteers of different age groups and sexes was determined by a Perkin Elmer Analyst (AA200) USA Atomic Absorption Spectrophotometer adopting the standard AAS protocol. Arsenicum Album 30 was prepared by following the homeopathic procedure of dilutions and successions. Results Students‘t’ test was used to determine the significant differences before and after placebo administration for data analysis. Differences between the groups were analysed for significance by ‘two-sample‘t’ test using Minitab software. Statistical analysis revealed significant differences among the negative control and the arsenic exposed subjects. However, the paper does not state how the data was stored, when it was analysed and who analysed the data. Arsenic exposed subjects had elevated levels of ESR, creatinine, PCV, and eosinophils and decrease in neutrophil percentage. In addition, there were higher levels of AST, ALT, LPO and GGT activities and that of GHS and G-6-PD at a lower level. The negative controls, the urine and blood did not contain arsenic in detectable range. Consequently, chronic arsenic poisoning results to physiological damage in randomly tested subjects. Treatment Subjects were advised to take 8 medicine-soaked globules twice daily for about two weeks and withdrawal for 10-12 days. The cycle was maintained till the blood and urine was collected after 2 months of first administration of homeopathic remedy. In relation to the assessment, the detail is not sufficient to tell exactly when the treatment was taken (Flaws and Sionneau, 2001). Outcome measures The outcome measures were appropriate since the graphs could establish comparison between variables such as the arsenic content in urine and blood of male and female subjects who were fed both placebo and verum. Nonetheless, storage of the blood samples is not mentioned considering the area under study was a rural area, requirement of facilities such as refrigeration could have been mentioned (Gallin and Ognibene, 2012). The article does not state at what time during the day the urine samples were first void, where the blood samples were after fasting and where the analysis was carried out for all biomarkers. Results in the article were poorly presented; for instance, the graphs were mislabeled and the results in some tables were incomplete. Belon et al., (2007) claim that all the result indicates that there is significant difference and it is contrary to what is demonstrated in the tables and graphs and this might lead to misinterpretation (Rondel and Varley, 1999). Implications Belon et al. (2007) confirm that in their earlier research, they had uncovered the encouraging ameliorating capacity of Ars Alb 30 in opposition to arsenic toxicity in people living in communities where they drink arsenic-free water. Also, in this present study, the authors establish familiar results gotten from their experiment conducted on people residing in the two villages reported to have arsenic-contaminated water. The study was done to a limited number of subjects but managed to show the benefits of homeopathic therapies to people living in regions with arsenic contaminated water. More large scale trials should be done to confirm or refute these findings. The dramatic changes caused by diluted micro doses are unknown in various parameters. Potentised remedies can act by switching on and off of genes in correcting the functions of regulatory genes (Khuda-Bukhsh, 2006). The drug has a possibility of being used as an interim relief measure particularly in remote areas. However, the government should work on providing arsenic-free drinking water or better strategies to manage the problem (Caroline Eyles, et al., 2010). References Belon, P., Banerjee A.,Karmakar, S. R., Biswas, S. J., Choudhury, S. C., Banerjee, P., Das, J. K., Pathak, S., Guha, B., Paul, S., Bhattacharjee, N., Khuda-Bukhsh, A. R., 2007. Homeopathic remedy for arsenic toxicity?: Evidence-based findings from a randomized placebo-controlled double blind human trial. Science of the Total Environment, 384, pp. 141-150. Belon, P., Banerjee A.,Karmakar, S. R., Biswas, S. J., Choudhury, S. C., Banerjee, P., Das, J. K., Pathak, S., Guha, B., Paul, S., Bhattacharjee, N., Khuda-Bukhsh, A. R., 2006. Can Administration of Potentized Homeopathic Remedy, Arsenicum Album, Alter Antinuclear Antibody (ANA) Titer in People Living in High-Risk Arsenic Contaminated Areas? I. A Correlation with Certain Hematological Parameters. Evidence-Based Complementary and Alternative Medicine, 3(1), pp. 99-107. Chow, S.-C., & Liu, J.-P. (2014). Design and analysis of clinical trials concepts and methodologies. Hoboken, N.J., Wiley. Eyles,C., Leydon, G. M., Lewith and Brein, S., 2010. A grounded theory study of homeopathic practitioner’s Perceptions and Experiences of the Homeopathic Consultation. Evidence Based Complementary and Alternative Medicine, 2011, pp 1-12 Flaws, B., & Sionneau, P. (2001). The treatment of modern Western diseases with Chinese medicine: a textbook & clinical manual. Boulder, Colo, Blue Poppy Press. Gallin, J. I., & Ognibene, F. P. (2012). Principles and practice of clinical research. London, Elsevier/Academic Press. Khuda-Bukhsh AR, Pathak S, Guha B, Roy Karmakar S, Das JK, Banerjee P, et al.,2005. Can homeopathic arsenic remedy combat arsenic poisoning in humans exposed to groundwater arsenic contamination: a preliminary report on first human trial. Evid Based Comp Alt Med, 11, pp. 537-48. Mandal, B. K., Suzuki K. T., 2002. Arsenic round the world: a review. 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