Pirenzepine versus ranitidine in gastroprotection during antiblastic chemotherapy: a double-blind study.

Corticosteroids and cytostatic drugs possess a documented lesive action on upper digestive mucosa, making epigastric pain and/or pyrosis common complaints among patients on antitumor treatment. The selective antimuscarinic pirenzepine and the H2-receptor antagonist ranitidine were tested against the ulcerogenic action of antiblastic chemotherapy. Thirty-eight patients affected with malignant lymphoproliferative disorders were endoscopically examined and the endoscopic pictures were quantified by using an arbitrary score. According to a double-blind randomized sequence, 19 out of the 38 patients received pirenzepine 100 mg/die/p.o. and the other 19 received ranitidine 300 mg/die/p.o. along with antitumoral therapy for periods of 3-6 months. Seven patients died of hematologic complications before ending the treatment. In the 31 surviving patients (13 pirenzepine- and 18 ranitidine-treated) a second endoscopic examination was performed at the end of the treatment and the lesion score repeated. No significant difference was found between initial and final scores in both groups. The antisecretive action of the two drugs may account for their effectiveness, but other mechanisms such as cytoprotection cannot be ruled out.

RCT Entities:   Population Interventions Outcomes