TREATMENT OF IRRITABLE-BOWEL-SYNDROME WITH CHINESE HERBAL MEDICINE - A RANDOMIZED CONTROLLED TRIAL

Context.-Irritable bowel syndrome (IBS) is a common functional bowel d isorder for which there is no reliable medical treatment. Objective.-T o determine whether Chinese herbal medicine (CHM) is of any benefit in the treatment of IBS, Design.-Randomized, double-blind, placebo-contr olled trial conducted during 1996 through 1997, Setting.-Patients were recruited through 2 teaching hospitals and 5 private practices of gas troenterologists, and received CHM in 3 Chinese herbal clinics. Patien ts.-A total of 116 patients who fulfilled the Rome criteria, an establ ished standard for diagnosis of IBS. Intervention.-Patients were rando mly allocated to 1 of 3 treatment groups: individualized Chinese herba l 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 herbal ist and by a gastroenterologist. Patients, gastroenterologists, and he rbalists were all blinded to treatment group. Main Outcome Measures.-C hange in total bowel symptom scale scores and global improvement asses sed by patients and gastroenterologists and change in the degree of in terference in life caused by IBS symptoms assessed by patients. Result s.-Compared with patients in the placebo group, patients in the active treatment groups (standard and individualized CHM) had significant im provement in bowel symptom scores as rated by patients (P = .03) and b y gastroenterologists (P = .001), and significant global improvement a s rated by patients (P = .007) and by gastroenterologists (P = .002), Patients reported that treatment significantly reduced the degree of i nterference with life caused by IBS symptoms (P = .03), Chinese herbal formulations individually tailored to the patient proved no more effe ctive than standard CHM treatment. On follow-up 14 weeks after complet ion of treatment, only the individualized CHM treatment group maintain ed improvement. Conclusion.-Chinese herbal formulations appear to offe r improvement in symptoms for some patients with IBS.