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

BMC Complementary and Alternative Medicine

Christine Smith²  Kate Thomas¹  Clare Walters²  Jackie Raw²  Clare Relton¹  Emily J Peckham³ 

[1] School of Health and Related Research, University of Sheffield, Sheffield, UK;Barnsley Hospital NHS Foundation Trust, Gawber Rd, Barnsley, UK;School of Healthcare, University of Leeds, Leeds, UK

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

Others  :  1231508
DOI  :  10.1186/1472-6882-12-212

 received in 2012-02-09, accepted in 2012-10-25,  发布年份 2012

【 摘 要 】

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

【 授权许可】

   
2012 Peckham et al.; licensee BioMed Central Ltd.

【 图 表 】

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