PRESENTING CHARACTERISTICS OF PATIENTS WITH DUODENAL-ULCER AND OUTCOME OF MEDICAL-TREATMENT IN CONTROLLED CLINICAL-TRIALS USING CIMETIDINE AND DIETHYLAMINE PERSILATE TO TREAT ULCER ATTACK AND DIETHYLAMINE PERSILATE AND PLACEBO TO PREVENT RELAPSESE

A double-blind controlled clinical trial on the medical treatmentof the acute episode of duodenal ulcer and the prevention of symptomatic relapses was performed. A total of 164 patients with active duodenal ulcer were either treated with cimetidine 1 g/day (70 patients), diethylaminepersilate (DAP) 1.5 g/day (64 patients) or DAP 2.5 g/day (30 patients). DAP is an allegedly protective agent stimulating mucosal prostaglandin synthesis. Cumulative healing rates after 4 weeks in the 3 groups were 66, 28 and 28% and after 8 weeks 94, 70 and 63%, respectively. One hundred and five patients with healed duodenal ulcer received, in a second double-blind study, either DAP 0.5 g/day or placebo. Thus, ulcer healing was more rapid with cimetidine than with DAP. DAP did not prevent relapses. No presenting characteristic was associated with slow healing. Three presenting characteristics-smoking, teetotalling and bleeding episode in the past-were associated with early symptomatic relapse. The present study was compared with a previous study performed by the same group of investigators using a similar study protocol. In both trials, an early relapse was associated with smoking. No other presenting characteristic was identified which in both trials was associated with slow healing or early symptomatic relapse. Thus, smoking appears to be the only one of the commonly available presenting characteristics which allows a prediction of the course of duodenal ulcer disease.