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

Background: 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. Objectives: This study was intended to compare Xilei-san with dexamethasone enemas in subjects with mild-to-moderate active UP. Methods: 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. Results: Both treatments showed significant improvement in clinical, endoscopic, and histological grades in comparison with the baseline. Conclusions: 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.