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Clin Gastroenterol Hepatol. 2015 Nov;13(11):1946-54.e1. doi: 10.1016/j.cgh.2015.06.022. Epub 2015 Jun 29.

Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.

Author information

1
National Institute of Complementary Medicine, University of Western Sydney, Campbelltown Campus, Penrith, Australia. Electronic address: a.bensoussan@uws.edu.au.
2
Gastrointestinal Investigation Unit, Sydney Medical School, University of Sydney, Department of Gastroenterology, Royal North Shore Hospital, St Leonards, Australia.
3
National Institute of Complementary Medicine, University of Western Sydney, Campbelltown Campus, Penrith, Australia.
4
School of Health and Science, University of Western Sydney, Campbelltown Campus, Penrith, Australia.
5
Discipline of Psychiatry, Sydney Medical School, University of Sydney, Department of Psychiatry, Westmead Hospital, Wentworthville, New South Wales, Australia.

Abstract

BACKGROUND & AIMS:

Irritable bowel syndrome (IBS) is the most common chronic functional bowel disorder, with few treatment options. IBS affects 10%-20% of the population; as many as 58% of patients have constipation-predominant IBS (IBS-C). We evaluated efficacy and safety of a standardized, specifically formulated Chinese herbal medicine (CHM) preparation in treatment of patients with IBS-C.

METHODS:

We performed a double-blind trial of 125 patients with IBS-C (according to Rome III criteria), who were recruited from 13 medical centers or clinics in Australia from July 2009 through February 2012. Patients were randomly assigned to groups given a standardized extract of 7 selected CHM ingredients (n = 61) or placebo (controls, n = 64) for 8 weeks (5 capsules, twice daily). Subjects were then followed for 16 weeks. Chemical definition, standardization, and stability testing of the formulation were completed. Subjects completed a self-administered, validated binary questionnaire of global symptom improvement at weeks 2, 4, 8, and 16 (primary outcome). Secondary outcomes included results from the self-administered IBS Symptom Severity Scale and the Bristol Stool Form Scale (BSFS), which were completed at weeks 4, 8, and 16.

RESULTS:

There was statistically and clinically significant (per protocol analyses) improvement among subjects who received CHM (n = 50) vs controls (n = 58) for 8 weeks. A greater proportion of subjects receiving CHM reported adequate relief (P = .010). Compared with controls, the CHM group had improved bowel habits vs controls at week 8, including lower IBS Symptom Severity Scale scores (P < .001), reduced straining during defecation (P = .002), and a significant decrease in hard lumpy stools (P = .031). The CHM group also had increased stool consistency, which was based on the Bristol Stool Form Scale (week 8, P < .001). There was no statistically significant difference between groups in abdominal pain at week 8 (P = .692). The CHM was well-tolerated.

CONCLUSIONS:

In a prospective, controlled study, CHM reduced symptoms of IBS-C, increased bowel satisfaction and stool consistency, and reduced straining and hard lumpy stools, compared with placebo. Clinical trial registration no: ACTRN12609000558224.

KEYWORDS:

Clinical Trial; Complementary Medicine; Functional Bowel Disorder; Herbal Medicine

PMID:
26133902
DOI:
10.1016/j.cgh.2015.06.022
[Indexed for MEDLINE]

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