A quality of life study in five hundred and eighty-one 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 (DU) disease. The recently developed and validated Quality of Life in Duodenal Ulcer Patients (QLDUP) questionnaire allowed the study of various dimensions according to treatment regimens. This study was conducted to compare QoL over a one-year follow-up period in DU patients randomized to two treatment regimens: maintenance versus intermittent (no maintenance) treatment with nizatidine. A total of 581 patients with endoscopic evidence of DU healing were randomly allocated to receive either nizatidine 150 mg/day for one year (Group A) or intermittent treatment (Group B). In both groups, symptomatic relapses were treated with nizatidine 300 mg/day for 6 weeks. The QLDUP questionnaire, which provides a QoL profile from 54 items divided up into 15 dimensions, was completed by all patients at entry and again at the time of a visit every 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 intent-to-treat analysis showed that patients in Group A had better QoL scores than those in Group B as regards 8 QoL dimensions, including ulcer-specific and non-specific dimensions. Differences between treatments 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 conclusion, maintenance treatment with nizatidine for DU improved QoL to a larger extent than when intermittent therapy was used.

RCT Entities:   Population Interventions Outcomes