A controlled clinical trial with De-Nol (tripotassium dicitrato bismuthate) in patients with gastric ulcer.

The efficacy of local-acting De-Nol liquid (tripotassium dicitrato bismuthate) was investigated in patients with endoscopically verified gastric ulcer. In a prospective-type clinical trial, 16 outpatients received De-Nol and 24 outpatients received an antacid mixture (sodium bicarbonate, calcium carbonate, magnesium trisilicate in equal parts). The period of study was 4 weeks, the endoscopy being performed on the 14th and 28th day after commencement of treatment. We Registration was made of the degree of ulcer healing (ulcer is healed, or not healed but reduced by 50%, or slightly healed, or unchanged), the degree of pain (0 = none, 1 = slight, 2 = moderate, 3 = severe), body weight, different biochemical and haematological examinations, side-effects and some other parameters. Of those patients given De-Nol treatment, the ulcer healed in 69% within four weeks, as compared with 33% of those given antacid therapy. There was also a significant (p less than 0.001, p less than 0.02) difference between the two groups in the size of the ulceration which remained and in the decrease of pain. Side-effects were not recorded. These data suggest the beneficial effect of De-Nol liquid in the treatment of patients with gastric ulceration.