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

Emily J Peckham,Christine Smith,Clare Walters,Jackie Raw,Clare Relton,Kate Thomas

doi:10.1186/1472-6882-12-212

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

Highlights

Irritable bowel syndrome is a chronic condition with no known cure
A one year prospective evaluation found that 50% of patients improved over the year, improvement was minor in terms of Irritable Bowel Syndrome (IBS) symptoms such as pain, constipation and diarrhoea [5]
Two randomised controlled trials (RCTs) assessing the effectiveness of one specific homeopathic medicine reported positive results associated with homeopathic medicine compared to placebo [20,21] and one found no difference between homeopathic treatment and usual care [22]

Summary

Background

Irritable Bowel Syndrome (IBS) is a common, chronic disorder that affects approximately 10% - 22% of the population [1]. A one year prospective evaluation found that 50% of patients improved over the year, improvement was minor in terms of IBS symptoms such as pain, constipation and diarrhoea [5]. This could lead to the patients’ quality of life being adversely affected resulting in depressed mood, sleep disturbance and fatigue [6,7]. Two randomised controlled trials (RCTs) assessing the effectiveness of one specific homeopathic medicine (asafoetida) reported positive results associated with homeopathic medicine compared to placebo [20,21] and one found no difference between homeopathic treatment and usual care [22]. There has been much debate as to whether or not this is an appropriate design to determine the efficacy of homeopathic treatment [23], in part because the traditional homeopathic medicine versus placebo medicine design fails to take into account any aspects

Participants Randomise

Methods

Findings

Discussion