Pirenzepine in the treatment of duodenal ulcer.

The effectiveness and safety of pirenzepine (PRZ) at 150 mg daily in the treatment of active duodenal ulcer was studied in an open pilot clinical trial followed by a double-blind trial against placebo. The open pilot study showed that pirenzepine was well tolerated and promoted ulcer healing in the 45% of patients within 2 weeks of treatment and in 90% within 4 weeks. The double-blind trial against placebo (PL) Confirmed these results: 60% of the patients in PRZ group and 10% of the patients in PL group showed endoscopic ulcer healing after 2 weeks. This difference was significant. Ninety per cent of the PRZ patients and 50% of the PL patients were completely healed after 4 weeks. In the PRZ group, gastric secretory tests showed a significant decrease in B.A.O. (69%), M.A.O. (33%) and P.A.O. (34%) after 2 weeks. In the PL group, the same parameters had only a small decrease, without statistical significance. There were no pathological changes in laboratory findings in either the open or the double-blind studies. Mild and transient side-effects were observed in 7 of 30 patinets receiving pirenzepine (diplopia and dryness of the mouth).