An open-label randomized pragmatic non-inferiority pilot trial to compare the effectiveness of Dysentery compound with individualized homeopathic medicines in irritable bowel syndrome
| Autor: | Subhranil Saha, Munmun Koley, Abhijit Chattopadhyay, Laijun Nahar, Swapan Paul |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Pilot Projects law.invention Irritable Bowel Syndrome Young Adult 03 medical and health sciences 0302 clinical medicine Bloating Quality of life Randomized controlled trial law Surveys and Questionnaires Internal medicine medicine Humans Prospective Studies Adverse effect Irritable bowel syndrome business.industry Dysentery Homeopathy Middle Aged medicine.disease Confidence interval 030205 complementary & alternative medicine Complementary and alternative medicine Materia Medica Quality of Life Female 030211 gastroenterology & hepatology business |
| Zdroj: | Journal of Complementary and Integrative Medicine. 16 |
| ISSN: | 1553-3840 2018-0217 |
| DOI: | 10.1515/jcim-2018-0217 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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