title: Efficacy of a Chinese Herbal Medicine in Providing Adequate Relief of Constipation-predominant Irritable Bowel Syndrome: A Randomized Controlled Trial.
abstract: OBJECTIVE
  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.affiliation: National Institute of Complementary Medicine, University of Western Sydney, Campbelltown Campus, Penrith, Australia. Electronic address: a.bensoussan@uws.edu.au.
authors.forename: Alan
authors.initials: A
authors.lastname: Bensoussan
authors.affiliation: Gastrointestinal Investigation Unit, Sydney Medical School, University of Sydney, Department of Gastroenterology, Royal North Shore Hospital, St Leonards, Australia.
authors.forename: John E
authors.initials: JE
authors.lastname: Kellow
authors.affiliation: National Institute of Complementary Medicine, University of Western Sydney, Campbelltown Campus, Penrith, Australia.
authors.forename: Suzannah J
authors.initials: SJ
authors.lastname: Bourchier
authors.affiliation: School of Health and Science, University of Western Sydney, Campbelltown Campus, Penrith, Australia.
authors.forename: Paul
authors.initials: P
authors.lastname: Fahey
authors.affiliation: Gastrointestinal Investigation Unit, Sydney Medical School, University of Sydney, Department of Gastroenterology, Royal North Shore Hospital, St Leonards, Australia.
authors.forename: Lisa
authors.initials: L
authors.lastname: Shim
authors.affiliation: Gastrointestinal Investigation Unit, Sydney Medical School, University of Sydney, Department of Gastroenterology, Royal North Shore Hospital, St Leonards, Australia.
authors.forename: Allison
authors.initials: A
authors.lastname: Malcolm
authors.affiliation: Discipline of Psychiatry, Sydney Medical School, University of Sydney, Department of Psychiatry, Westmead Hospital, Wentworthville, New South Wales, Australia.
authors.forename: Philip
authors.initials: P
authors.lastname: Boyce
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001315:Australia; D003248:Constipation / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D029001:Herbal Medicine / Q000379:methods*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008516:Medicine, Chinese Traditional / Q000009:adverse effects / Q000379:methods*; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D010946:Plants, Medicinal / Q000009:adverse effects; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010919:Placebos
keywords: Clinical Trial; Complementary Medicine; Functional Bowel Disorder; Herbal Medicine