Comparison of Xilei-san, a Chinese Herbal Medicine, and Dexamethasone in Mild/Moderate Ulcerative Proctitis: A Double-Blind Randomized Clinical Trial

Abstract

Xilei-san is a traditional Chinese herbal medicine that has proven to be of possible use in the treatment of ulcerative proctitis (UP) in a pilot study. This study was intended to compare Xilei-san with dexamethasone enemas in subjects with mild-to-moderate active UP. A double-blind randomized study was performed in 35 subjects. During the initial 8 weeks, the subjects received an enema of Xilei-san or dexamethasone at bedtime, then discontinued the treatment and were followed for 12 weeks. All of the subjects received 3 g/day oral mesalazine during the entire study. The disease activity was assessed at inclusion and at weeks 4, 8, and 20. Both treatments showed significant improvement in clinical, endoscopic, and histological grades in comparison with the baseline. Xilei-san enemas are comparable to dexamethasone enemas in this study. This medicine is safe, well accepted, and may be an alternative drug in the treatment of mild-to-moderate active UP.