A QUALITY-OF-LIFE STUDY IN 581 DUODENAL-ULCER PATIENTS - MAINTENANCE VERSUS INTERMITTENT TREATMENT WITH NIZATIDINE

Quality of life (QoL) is commonly assessed for evaluating the process and outcome of treatment but has not been studied in duodenal ulcer (D U) disease. The recently developed and validated Quality of Life in Du odenal Ulcer Patients (QLDUP) questionnaire allowed the study of vario us dimensions according to treatment regimens. This study was conducte d to compare QoL over a one-year follow-up period in DU patients rando mized to two treatment regimens: maintenance versus intermittent (no m aintenance) treatment with nizatidine. A total of 581 patients with en doscopic evidence of DU healing were randomly allocated to receive eit her nizatidine 150 mg/day for one year (Group A) or intermittent treat ment (Group B). In both groups, symptomatic relapses were treated with nizatidine 300 mg/day for 6 weeks. The QLDUP questionnaire, which pro vides a QoL profile from 54 items divided up into 15 dimensions, was c ompleted by all patients at entry and again at the time of a visit eve ry 2 months for one year. The one-year symptomatic relapse rates were 8.0% and 33.5% in Group A and Group B, respectively (p < 0.001). The i ntent-to-treat analysis showed that patients in Group A had better QoL scores than those in Group B as regards 8 QoL dimensions, including u lcer-specific and non-specific dimensions. Differences between treatme nts were significant after 4 months, and this was sustained until the one-year assessment. The overall gain in QoL was significantly greater in Group A than in Group B with respect to 11 QoL dimensions. In conc lusion, maintenance treatment