Scandinavian journal of gastroenterology. Supplement vol:80 pages:23-30
In a randomised open study of 28 outpatients with endoscopically proven duodenal ulcers, 14 patients were treated with colloidal bismuth subcitrate (CBS) and 14 patients with cimetidine tablets. Clinical and endoscopic assessments were made before starting therapy and then four and six weeks after the commencement of therapy. The trial was carried out in adult patients and included 21 men and 7 women. After four weeks treatment, 9 of the CBS-treated ulcers (64%) and 8 of the cimetidine treated ulcers (57%) were completely healed. After 6 weeks of therapy, complete ulcer healing was seen in 86% of ulcers in each group. In both groups the reduction of the pain scores after 4 and 6 weeks was highly significant. No adverse reactions were observed in respect of blood pressure or the various laboratory data. The blood bismuth levels after four and six weeks treatment with CBS remained within the safety limits. To determine the ulcer relapse rate, 20 of the 24 completely healed ulcer patients (10 of each group) were followed-up for a period of three months. Endoscopic control showed that recurrent ulcer was found in one CBS-treated patient and in three cimetidine-treated patients. The results showed that CBS tablets are as effective as cimetidine in the treatment of duodenal ulcer. Our results confirm the previously reported CBS efficacy in duodenal ulcer after using the liquid preparation.