Treatment of duodenal ulcer with carbenoxolone sodium: a double-masked endoscopic trial.

In a double-masked trial, 43 patients with an endoscopically confirmed, symptomatic duodenal ulcer were allocated at random to treatment with either carbenoxolone sodium or placebo, both provided in identical "positioned-release" capsules. The 40 patients who satisfactorily completed the trial were evenly distributed between the two treatment groups. The groups were well matched with regard to clinical features and initial ulcer size. Endoscopic review of ulcer healing after six weeks' treatment showed that 12 patients (60%) receiving carbenoxolone had healed ulcers, compared with five (25%) receiving placebo (P = 0.05). Symptomatic remission occurred by the fourth week in 17 patients (85%) receiving carbenoxolone, compared with six (30%) receiving placebo (P less than 0.001). The mean (geometric) serum carbenoxolone level in patients with healed ulcers was 31.11 microgram/mL compared with 17.75 microgram/mL in those with unhealed ulcers (P less than 0.005). Side effects of carbenoxolone therapy were observed, but they did not necessitate withdrawal of the drug and were readily controlled in every instance. These results confirm the therapeutic efficacy of carbenoxolone sodium in duodenal ulcer. In addition, a relationship between serum carbenoxolone levels and the occurrence of ulcer healing was observed.