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.