Clinical efficacy of the traditional Chinese herbal formula, (Tong Bian Decoction) on laxative dependence constipation in elderly persons: A randomized, multicenter, controlled trial

Constipation is a common problem particularly for older people. This study was designed to evaluate the efficacy and safety of treating laxative dependence constipation patients with the Traditional Chinese Herbal Formula (Tong Bian Decoction). Of 160 patients randomised to the trial, 80 cases in the control group were given an oral administration of mosapride, while the other 80 cases were allocated Tong Bian Decoction. Symptom scores of constipation, rectal pressure, and the assessment of patients with constipation on their quality of life and side-effects were evaluated. Of the 160 patients, 80 completed the trial. At follow-up, there were remarkable differences between the TBD treatment group and mosapride treatment group for the following parameters: difficult defecation, fecal character, defecation time, endless and dilatation feeling, frequency and abdominal distension scores (P < 0.05); anal rest pressure, maximum systolic pressure and rectal maximum threshold of the rectal pressure (P < 0.05); physical, worry and satisfaction domain of the PAC-QOL (P < 0.05). Tong Bian Decoction appeared to be clinically effective on symptoms, the rectal pressure and the PAC-QOL of long-term laxative dependence constipation in elderly persons. There were also fewer side effects.