Pirenzepine versus cimetidine in duodenal ulcer treatment. A clinical and microbiological study.

The therapeutic efficacy of pirenzepine (PIR) and cimetidine (CIM) in duodenal ulcer and their effects on the intragastric milieu have been studied in a double-blind multicentre trial. Seventy-nine patients with endoscopically proven duodenal ulcer were randomly allocated to 4 weeks' treatment with either 50 mg PIR twice daily or 400 mg CIM twice daily. In addition to clinical and endoscopic evaluation and registration of side effects and laboratory test results, endoscopically obtained gastric juice was cultured and its nitrite concentration was measured before and at the end of the treatment. Seventy-five patients completed the study. The treatment groups were comparable with regard to age, sex, smoking habits, and consumption of coffee and alcohol. After 4 weeks, 27 of 37 patients (73%) in the PIR group were completely healed, compared with 29 of 38 (76%) in the CIM group (NS). The number of patients with side effects was similar in both groups, but side effects of antimuscarinic type were more frequently reported by patients in the PIR group. Intragastric microbial concentrations increased significantly during treatment in both groups but remained well within normal limits. No single nitrite concentration before or after treatment exceeded the normal range. In conclusion, the two drugs were about equally effective in the short-term treatment of duodenal ulcer disease. In the doses given they did not adversely affect the intragastric milieu.

RCT Entities:   Population Interventions Outcomes