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An open-label randomized pragmatic non-inferiority pilot trial to compare the effectiveness of Dysentery compound with individualized homeopathic medicines in irritable bowel syndrome

  • Laijun Nahar EMAIL logo , Swapan Paul , Abhijit Chattopadhyay , Munmun Koley and Subhranil Saha
Published/Copyright: June 14, 2019
Journal of Complementary and Integrative Medicine
From the journal Journal of Complementary and Integrative Medicine Volume 16 Issue 4

Abstract

Background

Irritable Bowel Syndrome (IBS) is a prevalent gastro-intestinal disorder characterized by recurrent abdominal pain, bloating, altered bowel function and myriad of gastro-intestinal symptoms. Dysentery compound (DC), a ‘bowel nosode’, is one of the homeopathic medicines to treat IBS, but remained under-researched. We hypothesized that DC would be non-inferior to individualized homeopathy (IH) in treatment of IBS.

Method

An open, randomized (1:1), parallel arms, pragmatic, non-inferiority, pilot trial was conducted to compare the effectiveness of DC with IH medicines in 60 IBS patients. IBS Quality of Life (IBS-QOL) questionnaire was used as the outcome measure; assessed at baseline and after 3 months. Comparative analysis was carried out on the primary outcome to detect non-inferiority by one-tailed t test at alpha=5% with a prefixed margin (Δ) of 1.0 based on assumption.

Results

Six subjects dropped out. Groups were comparable at baseline (all p>0.01). Though intra-group changes were higher favoring IH over DC, group differences were statistically non-significant (all p>0.01). Non-inferiority was not demonstrated by DC against IH over 3 months (mean difference= −3.3, SE=5.2, lower 95% confidence limit −11.9, t= −0.453, p=0.674). No adverse events were reported from either group.

Conclusion

Non-inferiority of DC against IH in treatment of IBS was not demonstrated though it appeared as safe; still, being a pilot trial, no definite conclusion could be drawn. Further exploration of both efficacy and effectiveness of either of the therapies is necessary by adequately powered trials and independent replications. Trial registration: CTRI/2017/05/008480; UTN: U1111-1196-1004.

Keywords: Dysentery compound; homeopathy; irritable bowel syndrome; randomized controlled trial

Acknowledgments

The authors are grateful to institutional heads, both academic and hospital section for allowing us to conduct the trial. We sincerely thank the fellow postgraduate trainees, staff, pharmacists, and the patients for their sincere participation in the study.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission. The trial was carried out as the postgraduate thesis of the corresponding author under guidance of Dr. Swapan Paul, Lecturer, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy. Prof. (Dr.) Abhijit Chattopadhyay was the Head, Dept. of Homoeopathic Materia Medica, National Institute of Homoeopathy. MK and SS were independent researchers.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

[1] Gwee KA, Wee S, Wong ML, Png DJ. The prevalence, symptom characteristics, and impact of irritable bowel syndrome in an Asian urban community. Am J Gastroenterol 2004;99:924–31.10.1111/j.1572-0241.2004.04161.xSearch in Google Scholar PubMed

[2] Basseri RJ, Weitsman S, Barlow GM, Pimentel M. Antibiotics for the treatment of irritable bowel syndrome. Gastroenterol Hepatol 2011;7:455–93.Search in Google Scholar

[3] Adeyemo MA, Spiegel BMR, Chang L. Meta-analysis: do irritable bowel syndrome symptoms vary between men and women? Aliment Pharmacol Ther 2010;32:738–55.10.1111/j.1365-2036.2010.04409.xSearch in Google Scholar PubMed PubMed Central

[4] Kang JY. Systematic review: the influence of geography and ethnicity in irritable bowel syndrome. Aliment Pharmacol Ther 2005;21:663–76.10.1111/j.1365-2036.2005.02396.xSearch in Google Scholar PubMed

[5] Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology 2002;123:2108–31.10.1053/gast.2002.37095Search in Google Scholar PubMed

[6] Husain N, Chaudhry IB, Jafri F, Niaz SK, Tomenson B, Creed F. A population-based study of irritable bowel syndrome in a non-Western population. Neurogastroenterol Motil 2008;20:1022–9.10.1111/j.1365-2982.2008.01143.xSearch in Google Scholar PubMed

[7] Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol 2012;10:712–21.10.1016/j.cgh.2012.02.029Search in Google Scholar PubMed

[8] Makharia GK, Verma AK, Amarchand R, Goswami A, Singh P, Agnihotri A, et al. Prevalence of irritable bowel syndrome: a community based study from Northern India. Neurogastroenterol Motil 2011;17:82–7.10.5056/jnm.2011.17.1.82Search in Google Scholar PubMed PubMed Central

[9] Gwee KA, Ghoshal UC, Chen M. Irritable bowel syndrome in Asia: pathogenesis, natural history, epidemiology, and management. J Gastroenterol Hepatol 2018;33:99–110.10.1111/jgh.13987Search in Google Scholar PubMed

[10] Gwee KA. Irritable bowel syndrome in developing countries – a disorder of civilization or colonization? Neurogastroenterol Motil 2005;17:317–24.10.1111/j.1365-2982.2005.00627.xSearch in Google Scholar PubMed

[11] Gwee KA, Lu CL, Ghoshal UC. Epidemiology of irritable bowel syndrome in Asia: something old, something new, something borrowed. J Gastroenterol Hepatol 2009;24:1601–7.10.1111/j.1440-1746.2009.05984.xSearch in Google Scholar PubMed

[12] Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology 2006;130:1480–91.10.1053/j.gastro.2005.11.061Search in Google Scholar PubMed

[13] Maxion-Bergemann S, Thielecke F, Abel F, Bergemann R. Costs of irritable bowel syndrome in the UK and US. Pharmacoeconomics 2006;24:21–37.10.2165/00019053-200624010-00002Search in Google Scholar PubMed

[14] El-Salhy M, Gundersen D, Hatlebakk JG, Hausken T. Irritable bowel syndrome. New York: Nova scientific Publisher, 2012.Search in Google Scholar

[15] Katiraei P, Bultron G. Need for a comprehensive medical approach to the neuroimmuno-gastroenterology of irritable bowel syndrome. World J Gastroenterol 2011;17:2791–800.Search in Google Scholar PubMed

[16] Wu JCY. Complementary and alternative medicine modalities for the treatment of irritable bowel syndrome: facts or myths? Gastroenterol Hepatol 2010;6:705–11.Search in Google Scholar

[17] Yi-Hao A, Nahas SR. Complementary and alternative medicine for treatment of irritable bowel syndrome. Can Fam Physician 2009;55:143–8.Search in Google Scholar PubMed

[18] Tindle HA, Davis RB, Phillips RS, Eisenberg DM. Trends in use of complementary and alternative medicine by US adults: 1997-2002. Altern Ther Health Med 2005;11:42–9.Search in Google Scholar PubMed

[19] Cauffield JS. The psychosocial aspects of complementary and alternative medicine. Pharmacotherapy 2000;20:1289–94.10.1592/phco.20.17.1289.34898Search in Google Scholar PubMed

[20] Peckham EJ, Relton C, Raw J, Walters C, Thomas K, Smith C, et al. Interim results of a randomized controlled trial of homeopathic treatment for irritable bowel syndrome. Homeopathy 2014;103:172–7.10.1016/j.homp.2014.05.001Search in Google Scholar PubMed

[21] Peckham EJ, Nelson EA, Greenhalgh J, Cooper K, Roberts ER, Agrawal A. Homeopathy for treatment of irritable bowel syndrome (Review). Cochrane Lib 2013. Art. No.: CD009710. DOI: 10.1002/14651858.CD009710.pub2.Search in Google Scholar

[22] Uchiyama-Tanaka Y. Case study of homeopathic bowel nosode remedies for dysbiotic Japanese patients. J Altern Complement Med 2018;24:187–92.10.1089/acm.2017.0061Search in Google Scholar PubMed

[23] Paterson J. The bowel nosodes. Br Homeopath J 1950;40:153–62.10.1016/S0007-0785(50)80005-4Search in Google Scholar PubMed

[24] Kishore J. Evolution of homoeopathic repertories and repertorization. Ch. Evaluation of symptoms. Revised, 1st ed. New Delhi: B. Jain Publishers (P) Ltd., 2004:189–90.Search in Google Scholar

[25] Sarkar BK Essays on Homoeopathy Ch. Homoeopathic repertories and repertorization, 5th ed. New Delhi: Birla Publications (P) Ltd., 2004–2005:467.Search in Google Scholar

[26] Roberts HA. Principles and art of cure by homoeopathy. Ch. VIII. Taking the case. Reprint ed. New Delhi: Indian Books and Periodicals Publishers, 2006:78.Search in Google Scholar

[27] Andrae DA, Patrick DL, Drossman DA, Covington PS. Evaluation of the irritable bowel syndrome quality of life questionnaire (IBS-QOL) in diarrhoea predominant irritable bowel syndrome patients. Health Qual Life Outcomes 2013;11:208.10.1186/1477-7525-11-208Search in Google Scholar PubMed PubMed Central

[28] Patrick D, Drossman D, Frederick I, Dicesare J, Puder K. Quality of life in persons with irritable bowel syndrome development and validation of a new measure. Dig Dis Sci 1998;43:400–11.10.1023/A:1018831127942Search in Google Scholar PubMed

[29] Drossman D, Patrick D, Whitehead W, Toner B, Diamant N, Hu Y, et al. Further validation of the IBS-QOL: a disease specific quality of life questionnaire. Am J Gastroenterol 2000;95:999–1007.10.1111/j.1572-0241.2000.01941.xSearch in Google Scholar PubMed

[30] Drossman D, Morris CB, Hu Y, Toner BB, Diamant N, Whitehead WE, et al.. Characterization of health related quality of life (HRQOL) for patients with functional bowel disorder (FBD) and its response to treatment. Am J Gastroenterol 2007;102:1442–53.10.1111/j.1572-0241.2007.01283.xSearch in Google Scholar PubMed

[31] Schulz KF, Altman DG, Moher D. for the CONSORT group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Bmj 2010;340:c332.10.1136/bmj.c332Search in Google Scholar

[32] Dean ME, Coulter MK, Fisher P, Jobst K, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Homeopathy 2007;96:42–5.10.1016/j.homp.2006.11.006Search in Google Scholar PubMed

[33] Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG. for the CONSORT group. Reporting of non-inferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. Jama 2012;308:2594–604.10.1001/jama.2012.87802Search in Google Scholar

[34] Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Roniger H, Frye J, et al. Model validity of randomised placebo-controlled trials of individualised homeopathic treatment. Homeopathy 2017;106:194–202.10.1016/j.homp.2017.07.003Search in Google Scholar PubMed

[35] Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Frye J, Manchanda RK, et al. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med 2016;25:120–5.10.1016/j.ctim.2016.01.005Search in Google Scholar PubMed

[36] Saha S, Koley M, Ganguly S, Rath P, Roy Chowdhury P, Hossain SI. Developing the criteria for evaluating quality of individualization in homeopathic clinical trial reporting: a preliminary study. J Integr Med 2014;12:13–9.10.1016/S2095-4964(14)60009-1Search in Google Scholar PubMed

Supplementary Material

The online version of this article offers supplementary material (DOI:https://doi.org/10.1515/jcim-2018-0217).

Received: 2018-11-18
Accepted: 2019-01-24
Published Online: 2019-06-14

© 2019 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/jcim-2018-0217
Keywords for this article
Dysentery compound; homeopathy; irritable bowel syndrome; randomized controlled trial

Articles in the same Issue

  1. Reviews
  2. A review on the management of asthma in the Avicenna’s Canon of Medicine
  4. Yogic practices on oxidative stress and of antioxidant level: a systematic review of randomized controlled trials
  5. Pre-clinical studies
  6. The effect of different partitions of seaweed Sargassum plagyophylum on depression behavior in mice model of despair
  8. Adverse reproductive effects of ethanolic root extract of Waltheria indica in male Wistar rats
  9. Antidiabetic and antioxidative properties of the hydro-methanolic extract (60:40) of rhizomes of Curcuma amada roxb. (Zingiberaceae) in streptozotocin-induced diabetic male albino rat: a dose-dependent study through biochemical and genomic approaches
  10. Antibacterial activity of cuminaldehyde on food-borne pathogens, the bioactive component of essential oil from Cuminum cyminum L. collected in Thailand
  11. Antibacterial, anthelmintic, and analgesic activities of Piper sylvaticum (Roxb.) leaves and in silico molecular docking and PASS prediction studies of its isolated compounds
  12. Curative effects of Distemonanthus benthamianus Baillon. Trunk-bark extracts on enteropathogenic Escherichia coli 31-induced diarrhea in rats
  13. Pharmacodynamic interaction of cumin seeds (Cuminum cyminum L.) with glyburide in diabetes
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  18. The combined effect of vitamin C and omega-3 polyunsaturated fatty acids on fatigue following coronary artery bypass graft surgery: a triple-blind clinical trial
  19. An open-label randomized pragmatic non-inferiority pilot trial to compare the effectiveness of Dysentery compound with individualized homeopathic medicines in irritable bowel syndrome
  20. Parental attitude toward children’s mental disorders and its relationship with help seeking behaviors
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  22. Comparison of the effect of Myrtus communis herbal and anti-hemorrhoid ointments on the hemorrhoid symptoms and quality of life in postpartum women with grade I and II internal hemorrhoid: A triple-blinded randomized controlled clinical trial
  23. Role of antioxidant supplementation in oxidant/antioxidant status and hepatotoxic effects due to aflatoxin B1 in wheat miller workers
  24. Case report
  25. Cutaneous lymphoid hyperplasia induced by Hirudo medicinalis (leeches)
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