Evaluation of colloidal bismuth (De-Nol) in the treatment of duodenal ulcer employing endoscopic selection and follow up.

A double-blind, placebo-controlled trial of colloidal bismuth (De-Nol) was performed on 20 patients with active duodenal ulceration employing endoscopic selection and follow up after a treatment period of 28 days. By these means it was shown that healing of ulcers was significant in those patients treated with the active compound. In addition a greater number (9/10) of patients treated with colloidal bismuth showed symptomatic improvement than those receiving placebo (6/10) but this difference did not reach statistical significance. The results of endoscopic and symptomatic assessment of the patients receiving colloidal bismuth were in complete agreement although there was a poor correlation between these results in those receiving the placebo. This supports the results from a previous study that endoscopic assessment of duodenal ulcer healing provides a more objective assessment than do clinical methods.

RCT Entities:   Population Interventions Outcomes