Endoscopic evaluation of the effect of Ulcerone and placebo on duodenal ulcers.

Fifty courses of tripotassium di-citrato bismuthate (Ulcerone) and placebo were administered to ambulant patients with duodenal ulcers in a double-blind trial for 6 weeks. Duodenoscopy was used for initial assessment and to judge improvement. The ulcers of 20 out of 30 patients (67%) healed completely with Ulcerone treatment for 6 weeks, while another 7 patients showed partial improvement. The ulcers of 4 out of 20 patients (20%) on placebo showed healing. The difference is highly significant (chi2 = 20,0; P less than 0,001). Ulcerone is a collodial bismuth substance which is said to act by coating the ulcer by becoming incorporated into granulating tissue at an acid pH. No side-effects of Ulcerone occurred. It is considered to be a safe and effective oral therapeutic substance for ambulant patients with duodenal ulcers.