PROSPECTIVE, RANDOMIZED, INVESTIGATOR-BLIND TRIAL OF HELICOBACTER-PYLORI INFECTION TREATMENT IN PATIENTS WITH REFRACTORY DUODENAL-ULCERS - HEALING AND LONG-TERM RELAPSE RATES

In this study, 26 patients with duodenal ulcers refractory to treatmen t with H-2-receptor antagonists for 8-12 weeks were randomly assigned to eight weeks of treatment with colloidal bismuth subcitrate (120 mg four times a day) alone (N = 12) or in combination with tetracycline h ydrochloride (500 mg four times a day, days 0-14) and metronidazole (5 00 mg three times a da days 15-28). Symptoms were scored and endoscopy , histology, and CLO tests were performed before, on completion of tre atment, and 3, 6, 12, and 18 months after treatment. Treatment was con sidered successful when Helicobacter pylori was not detected by CLO te sts and Warthin-Starry stains on gastric biopsies taken from antrum, b ody, and fundus. On triple therapy, ulcers healed in 12/14 patients (8 5.71%) and 10/14 (71.42%) patients became Helicobacter pylori-negative . On bismuth, only one patient became Helicobacter pylori-negative (8. 33%, P < 0.0001), but ulcers healed in 8/12 patients (67%, P = NS). Si x patients on bismuth, whose ulcers remained unhealed or relapsed earl y after healing, were offered triple therapy, which resulted in ulcer healing in three and Helicobacter pylori clearance in two patients. At 18 months, none of the Helicobacter pylori-negative patients had ulce r relapse. On the contrary, ulcers relapsed in all but one patient, wh o remained Helicobacter pylori-positive. Smoking and drinking did not influence the therapeutic outcome. The data confirm previous reports t hat many duodenal ulcers are infectious and therefore curable.