BACKGROUND:Sleep disturbance is common in patients with GERD but there has been little evaluation of this problem in primary care in patients already taking therapy. AIM: To evaluate the impact of administering a questionnaire (PASS test) to identify patients with sleep problems and evaluate the efficacy of esomeprazole to improve sleep disturbance in patients with GERD. METHODS: This was a primary care based cluster-randomised, open-label study where practices were assigned to intervention or control groups. PASS test failures continued current therapy (control) or were switched to 4 weeks' once-daily esomeprazole 20 or 40 mg (intervention). Patients were evaluated at the end of 4 weeks and the outcomes that were assessed were the sleep questions from the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and the presence or absence of sleep disturbance from the PASS test questionnaire. RESULTS: A total of 1388 patients with evaluable data at 4 weeks were included in the analysis and 825 reported GERD-related sleep disturbance at baseline. At 4 weeks, 161 of 291 of control patients (55%) reported continued sleep disturbance compared to 120 of 534 (22.5%) of intervention patients [number needed to treat of 3: 95% confidence intervals (CI): 2.5-4]. There was a mean improvement in QOLRAD scores related to sleep in the intervention patients compared to control patients (mean improvement = 4.91; 95% CI: 3.73-6.09). CONCLUSION: A PASS strategy identifies GERD patients with sleep disturbance in primary care that will benefit from a change in acid-suppressive therapy. ClinicalTrials.gov identifier: NCT00392002; study code: D9612L00096.
RCT Entities:
BACKGROUND:Sleep disturbance is common in patients with GERD but there has been little evaluation of this problem in primary care in patients already taking therapy. AIM: To evaluate the impact of administering a questionnaire (PASS test) to identify patients with sleep problems and evaluate the efficacy of esomeprazole to improve sleep disturbance in patients with GERD. METHODS: This was a primary care based cluster-randomised, open-label study where practices were assigned to intervention or control groups. PASS test failures continued current therapy (control) or were switched to 4 weeks' once-daily esomeprazole 20 or 40 mg (intervention). Patients were evaluated at the end of 4 weeks and the outcomes that were assessed were the sleep questions from the Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire and the presence or absence of sleep disturbance from the PASS test questionnaire. RESULTS: A total of 1388 patients with evaluable data at 4 weeks were included in the analysis and 825 reported GERD-related sleep disturbance at baseline. At 4 weeks, 161 of 291 of control patients (55%) reported continued sleep disturbance compared to 120 of 534 (22.5%) of intervention patients [number needed to treat of 3: 95% confidence intervals (CI): 2.5-4]. There was a mean improvement in QOLRAD scores related to sleep in the intervention patients compared to control patients (mean improvement = 4.91; 95% CI: 3.73-6.09). CONCLUSION: A PASS strategy identifies GERDpatients with sleep disturbance in primary care that will benefit from a change in acid-suppressive therapy. ClinicalTrials.gov identifier: NCT00392002; study code: D9612L00096.