Effect of oral bismuth subsalicylate on Campylobacter pylori and on healing and relapse rate of peptic ulcer.

A controlled, open clinical trial was performed to compare the effect of oral bismuth subsalicylate (600 mg three times daily) with that of cimetidine (800 mg/d) on Campylobacter pylori, ulcer healing, and rate of ulcer relapse in 49 patients with peptic ulcer. At the first endoscopic examination (to confirm the diagnosis) and at the second (after 4 weeks of treatment), biopsy specimens were taken from the gastric antrum; the presence of C. pylori in culture and the rate of ulcer healing were determined. The rate of ulcer relapse was determined by a 9-month follow-up examination. After cessation of treatment a significant rate of healing was seen in both treatment groups: 73% in the bismuth group and 65% in the cimetidine group. Ulcer healing was confirmed by endoscopic examination. Before therapy the number of C. pylori-positive cases (61%) was identical from the two groups; however, after 4 weeks of treatment, 75% of the previously culture-positive cases in the bismuth group reverted to negative (a statistically significant change), whereas only 40% of those in the cimetidine group reverted (not statistically significant). The rate of clearance of C. pylori was statistically significant for the 29 patients with healed ulcers and correlated strongly with ulcer healing in the bismuth group only. The rate of relapse after 9 months of follow-up was 13% in the group treated with bismuth subsalicylate--a figure significantly lower than the 54% rate of relapse in the group treated with cimetidine.

RCT Entities:   Population Interventions Outcomes