Triletide and ranitidine for the management of chronic duodenal ulcer: a controlled clinical investigation.

Twenty out-patients with active, chronic duodenal ulcer were treated over a period of 6 weeks with either 0.6 g ranitidine per day or 2 g triletide per day, a new synthetic tripeptide shown to be effective in healing ulcers by increasing the mucosal defence mechanisms. Efficacy was assessed by scoring the intensity of day and night pain before, after 2 and after 6 weeks of treatment, and by endoscopy before and after. Tolerance was assessed by routine laboratory tests, physical examination and a survey of any accessory symptoms. Both drugs significantly relieved pain almost at the same rate and to the same extent, whereas endoscopy showed a not significantly greater improvement in the ranitidine group. It was found, however, that the patients in the triletide group had, on average, a significantly greater intensity of intractable factors on entry than those in the ranitidine group (+75%; p less than 0.02). After stratifying the intractability factor intensity, the 5 patients in the triletide sub-group comparable with those in the ranitidine group exhibited exactly the same behavior on pain relief and a very similar one on endoscopy findings (2 healed, 2 improved and 1 unchanged, compared with 7 healed and 3 improved, respectively). The sub-group with greater severity also showed improvements, both symptomatic and endoscopic, but to a lesser extent, indicating the need for prolonged treatment. Tolerance was good with both drugs. Two patients on triletide reported adverse effects; 1 of increased intensity of previous constipation and the other 1 of mild headache and dizziness, but these could not be related definitely to treatment.