Context.— Irritable bowel syndrome (IBS) is a common functional bowel disorder
for which there is no reliable medical treatment.
Objective.— To determine whether Chinese herbal medicine (CHM) is of any benefit
in the treatment of IBS.
Design.— Randomized, double-blind, placebo-controlled trial conducted during
1996 through 1997.
Setting.— Patients were recruited through 2 teaching hospitals and 5 private practices
of gastroenterologists, and received CHM in 3 Chinese herbal clinics.
Patients.— A total of 116 patients who fulfilled the Rome criteria, an established
standard for diagnosis of IBS.
Intervention.— Patients were randomly allocated to 1 of 3 treatment groups: individualized
Chinese herbal formulations (n=38), a standard Chinese herbal formulation
(n=43), or placebo (n=35). Patients received 5 capsules 3 times daily for
16 weeks and were evaluated regularly by a traditional Chinese herbalist and
by a gastroenterologist. Patients, gastroenterologists, and herbalists were
all blinded to treatment group.
Main Outcome Measures.— Change in total bowel symptom scale scores and global improvement assessed
by patients and gastroenterologists and change in the degree of interference
in life caused by IBS symptoms assessed by patients.
Results.— Compared with patients in the placebo group, patients in the active
treatment groups (standard and individualized CHM) had significant improvement
in bowel symptom scores as rated by patients (P =
.03) and by gastroenterologists (P = .001), and significant
global improvement as rated by patients (P=.007)
and by gastroenterologists (P=.002). Patients reported
that treatment significantly reduced the degree of interference with life
caused by IBS symptoms (P=.03). Chinese herbal formulations
individually tailored to the patient proved no more effective than standard
CHM treatment. On follow-up 14 weeks after completion of treatment, only the
individualized CHM treatment group maintained improvement.
Conclusion.— Chinese herbal formulations appear to offer improvement in symptoms
for some patients with IBS.