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Open Access Study protocol

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

Emily J Peckham1*, Clare Relton2, Jackie Raw3, Clare Walters3, Kate Thomas2 and Christine Smith3

Author Affiliations

1 School of Healthcare, University of Leeds, Leeds, UK

2 School of Health and Related Research, University of Sheffield, Sheffield, UK

3 Barnsley Hospital NHS Foundation Trust, Gawber Rd, Barnsley, UK

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BMC Complementary and Alternative Medicine 2012, 12:212  doi:10.1186/1472-6882-12-212

Published: 6 November 2012

Abstract

Background

Irritable 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/design

This 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.

Discussion

This trial has received NHS approval and results are expected in 2013.

Trial registration

Current Controlled Trials ISRCTN90651143

Keywords:
Irritable bowel syndrome; Homeopathic treatment; Attention control; Randomised controlled trial