A protocol for a trial of homeopathic treatment for irritable bowel syndrome

Abstract

BackgroundIrritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome.Methods/designThis is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks.From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis.DiscussionThis trial has received NHS approval and results are expected in 2013.Trial registrationCurrent Controlled Trials ISRCTN90651143

Irritable bowel syndrome: The evolution of multi-dimensional looking and multidisciplinary treatments

“…Homeopathy is claimed effectively to treat IBS. Now a three-arm trial based on 5 sessions of true homeopathic treatment plus usual care vs placebo-homeopathy plus usual care vs usual care alone is undergoing in United Kingdom and the final result is expected to resolve whether homeopathy is truly effective to treat IBS [180] . Regarding IBS patients who failed all conventional treatments, CAM may be considered as a supplement or alternative with expected efficacy equal to enhanced placebo effect if they do not have any intolerable or serious side effects.…”