Pirenzepine in the treatment of benign gastroduodenal diseases. A double-blind controlled clinical trial.

Pirenzepine (PRZ, 75 mg/day for 10 days followed by 50 mg/day for 20 days) was compared with placebo (PL) in the treatment of endoscopically confirmed active gastroduodenitis or duodenal ulcer and with carbenoxolone (CB, 300 mg/day followed by 200 mg/day) in the treatment of gastric ulcer in a 30-day double-blind clinical trial. Ninety-seven of 112 outpatients completed the trial. The results can be summarized as follows: a) Gastroduodenitis. Complete normalization of the endoscopic picture was observed in 61% of the 28 patients on PRZ and in 30% of the 27 on PL. b) Duodenal ulcer. Complete endoscopic healing was observed in 75% of the 12 patients on PRZ and in 44% of the 9 on PL. In both studied PRZ induced improvement in clinical symptoms in more patients than PL. c) Gastric ulcer. PRZ and CB induced complete healing in a similar percentage of patients (64% of 11 and 70% of 10 patients). Better results in dyspepsia were observed in the PRZ group than the CB group. No major side-effects and no pathological changes in blood and urine analyses were observed in PRZ-treated patients.