[A multicenter study of Chinese patent medicine wenweishu/yangweishu in the treatment of Helicobacter pylori positive patients with chronic gastritis and peptic ulcer].

Objective: To evaluate the efficacy of Chinese patent medicine wenweishu /yangweishu in the treatment of Helicobacter pylori (H. pylori) positive patients with chronic gastritis and peptic ulcer.

Methods: A randomized, controlled and multicenter trial was conducted in 642 H. pylori positive patients with chronic gastritis or peptic ulcer. They were randomized to three groups: PCM group (n = 222, pantoprazole 40 mg twice a day, clarithromycin 500 mg twice a day, metronidazole 400 mg twice a day, for 7 days); PCM plus wenweishu group (n = 196); and PCM plus yangweishu group (n = 224). (14)C breath test was performed 4 weeks after therapy. For the patients with gastric ulcer, ulcer healing was determined by endoscopy after therapy.

Results: Intention-to-treat H. pylori eradication rate for PCM group, PCM plus wenweishu group, and PCM plus yangweishu group were 57.2% (127/222), 62.2% (122/196), 60.3% (135/224), respectively (P = 0.295, 0.512). Per-protocol H. pylori eradication rates were 62.3% (127/204), 70.1% (122/174), 65.2% (135/207), respectively (P = 0.108, 0.532).Per-protocol analysis gastric ulcer healing rate were 61.9% (13/21) 100.0% (18/18), 86.4% (19/22) respectively. The healing rate in PCM plus wenweishu groups was statistically significantly higher than the rate in PCM group (P = 0.004). The rates of symptom relief in PCM plus wenweishu groups and PCM plus yangweishu were statistically significantly higher than the rate in PCM group (both P < 0.01). Side-effects were rare and comparable between groups.

Conclusion: Although PCM combined with wenweishu or yangweishu in the treatment of H. pylori positive patients with chronic gastritis and peptic ulcer can not reach a significantly higher eradication rate, it can increase the rates of both gastric ulcer healing and symptom relief.