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Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.
Clin Gastroenterol Hepatol 2015; 13(11):1946-54.e1CG

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.

Authors+Show Affiliations

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

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26133902

Citation

Bensoussan, Alan, et al. "Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: a Randomized Controlled Trial." Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, vol. 13, no. 11, 2015, pp. 1946-54.e1.
Bensoussan A, Kellow JE, Bourchier SJ, et al. Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015;13(11):1946-54.e1.
Bensoussan, A., Kellow, J. E., Bourchier, S. J., Fahey, P., Shim, L., Malcolm, A., & Boyce, P. (2015). Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial. Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association, 13(11), pp. 1946-54.e1. doi:10.1016/j.cgh.2015.06.022.
Bensoussan A, et al. Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015;13(11):1946-54.e1. PubMed PMID: 26133902.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial. AU - Bensoussan,Alan, AU - Kellow,John E, AU - Bourchier,Suzannah J, AU - Fahey,Paul, AU - Shim,Lisa, AU - Malcolm,Allison, AU - Boyce,Philip, Y1 - 2015/06/29/ PY - 2014/11/20/received PY - 2015/05/17/revised PY - 2015/06/10/accepted PY - 2015/7/3/entrez PY - 2015/7/3/pubmed PY - 2016/7/29/medline KW - Clinical Trial KW - Complementary Medicine KW - Functional Bowel Disorder KW - Herbal Medicine SP - 1946 EP - 54.e1 JF - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JO - Clin. Gastroenterol. Hepatol. VL - 13 IS - 11 N2 - 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. SN - 1542-7714 UR - https://www.unboundmedicine.com/medline/citation/26133902/Efficacy_of_a_Chinese_Herbal_Medicine_in_Providing_Adequate_Relief_of_Constipation_predominant_Irritable_Bowel_Syndrome:_A_Randomized_Controlled_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1542-3565(15)00846-0 DB - PRIME DP - Unbound Medicine ER -