Double-blind trial of carbenoxolone sodium capsules in duodenal ulcer therapy, based on endoscopic diagnosis and follow-up

Abstract

A high-dose double-blind trial of carbenoxolone sodium capsules (Duogastrone) in the treatment of duodenal ulceration was combined with endoscopic diagnosis and follow-up. Thirty-one ambulant patients with an endoscopically visible duodenal ulcer were allocated at random to a 12-week course of treatment with either carbenoxolone sodium 300 mg daily or a placebo. Symptomatic and endoscopic follow-up was performed at 2-4 weeks, 6-8 weeks, and 12-16 weeks. Carbenoxolone was shown to increase the rate of healing of duodenal ulcers in the early stages of treatment, but by 12 weeks there was no difference between the two groups. There was no significant difference in symptomatic improvement between the two groups at any stage of treatment. Side effects, especially hypokalaemia, were prominent in the patients treated with carbenoxolone. There was a poor relation between endoscopic and symptomatic improvement in patients on either form of treatment.