A controlled multi center trial of fentonium bromide in duodenal ulcer

A double blind randomized trial of fentonium bromide in duodenal ulcer was carried out on a multicenter basis using a standardized protocol for patient selection, evaluation criteria, mode of treatment and other experimental modalities. Two comparable groups of patients were formed, 52 treated with placebo and 53 with fentonium bromide, of which 48 and 47 respectively completed the trial. Both inert and active treatments were given at the dose of 4 tablets daily for 4 weeks. In addition to the experimental treatment, all patients received a basic therapeutic regimen including correction of dietary and smoking habits, rest, free antacids, but no other drugs. Evaluated responses included: pain intensity and frequency, digestive discomfort, X ray findings and occult blood in feces. The improvement for each of these variables, either subjective or objective, was significantly more frequent for fentonium bromide than for placebo. Comparison of score values by covariance analysis also resulted in significant differences for each studied response. The advantage of fentonium bromide over placebo appeared to be greater in patients who previously smoked and cut their habit, and it appeared to be independent of patient's emotional status or hospitalization. Side effects were essentially similar in the 2 treatment groups. It was concluded that fentonium bromide is effective in promoting remission of duodenal ulcer without need to induce atropine like effects to ensure efficacy. (19 references).