Given the acceptability of the treatment and the clinically relevant effect on function, there is a need for a definitive study to assess the clinical and cost effectiveness of adjunctive healthcare by a homeopath for patients with FMS.

Irritable bowel syndrome (IBS) is a chronic condition for which there is no consensus on the optimum treatment. Gastroenterology problems are some of the most common conditions treated by homeopaths, yet few trials have explored the effectiveness of individualised homeopathic treatment for IBS. A three-armed trial was conducted which compared: usual care, homeopathic treatment plus usual care and supportive listening plus usual care. The primary outcome was change in irritable bowel symptom severity score between baseline and 26 weeks, calculated using ANCOVA. An interim ANCOVA adjusted for baseline IBS severity, age and employment status found no statistically significant difference between the three arms. However, a post-hoc test comparing homeopathic treatment plus usual care to usual care alone found a statistically significant difference in favour of homeopathic treatment. In addition, 62.5 percent of patients in the homeopathic treatment arm (compared to 25.0 percent of those in the usual care arm), achieved a clinically relevant change in irritable bowel symptom severity score, which indicates a promising effect for homeopathic treatment, though these results should be interpreted with caution due to the low number of participants in the study.

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

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