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

<p>Abstract</p> <p>Background</p> <p>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...

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Main Authors: Peckham Emily J, Relton Clare, Raw Jackie, Walters Clare, Thomas Kate, Smith Christine
Format: Article
Language:English
Published: BMC 2012-11-01
Series:BMC Complementary and Alternative Medicine
Subjects:
Online Access:http://www.biomedcentral.com/1472-6882/12/212
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author Peckham Emily J
Relton Clare
Raw Jackie
Walters Clare
Thomas Kate
Smith Christine
author_facet Peckham Emily J
Relton Clare
Raw Jackie
Walters Clare
Thomas Kate
Smith Christine
author_sort Peckham Emily J
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>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.</p> <p>Discussion</p> <p>This trial has received NHS approval and results are expected in 2013.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN90651143</p>
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spelling doaj.art-20f55340aa1e4b7ea3d02ad6d83f949c2022-12-22T03:17:47ZengBMCBMC Complementary and Alternative Medicine1472-68822012-11-0112121210.1186/1472-6882-12-212A protocol for a trial of homeopathic treatment for irritable bowel syndromePeckham Emily JRelton ClareRaw JackieWalters ClareThomas KateSmith Christine<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/design</p> <p>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.</p> <p>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.</p> <p>Discussion</p> <p>This trial has received NHS approval and results are expected in 2013.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN90651143</p>http://www.biomedcentral.com/1472-6882/12/212Irritable bowel syndromeHomeopathic treatmentAttention controlRandomised controlled trial
spellingShingle Peckham Emily J
Relton Clare
Raw Jackie
Walters Clare
Thomas Kate
Smith Christine
A protocol for a trial of homeopathic treatment for irritable bowel syndrome
BMC Complementary and Alternative Medicine
Irritable bowel syndrome
Homeopathic treatment
Attention control
Randomised controlled trial
title A protocol for a trial of homeopathic treatment for irritable bowel syndrome
title_full A protocol for a trial of homeopathic treatment for irritable bowel syndrome
title_fullStr A protocol for a trial of homeopathic treatment for irritable bowel syndrome
title_full_unstemmed A protocol for a trial of homeopathic treatment for irritable bowel syndrome
title_short A protocol for a trial of homeopathic treatment for irritable bowel syndrome
title_sort protocol for a trial of homeopathic treatment for irritable bowel syndrome
topic Irritable bowel syndrome
Homeopathic treatment
Attention control
Randomised controlled trial
url http://www.biomedcentral.com/1472-6882/12/212
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