Esophageal reflux disease proton pump inhibitor therapy impact on sleep disturbance: a systematic review.

OBJECTIVE To perform a systematic literature review that evaluates the impact of proton pump inhibitor treatment of gastroesophageal reflux disease on sleep disturbance-related outcomes. DATA SOURCES PubMed, Web of Science, and Cochrane databases were searched from 1989 (when omeprazole became available) to present; additional references gleaned from citations. REVIEW METHODS The search strategy identified all randomized placebo-controlled clinical trials published in English; both proton pump inhibitor use and outcome measures of sleep disturbance were reported for esophageal reflux disease patients. Using a preestablished systematic review protocol and data extraction format, 4 coauthors independently reviewed all articles. RESULTS The original search identified 20 articles; 9 were not directly relevant, and 3 were not placebo controlled. Sample sizes varied from 15 to 642; mean age was 47.4 ± 4.56 years; mean body mass index was 29.4 ± 2.9; the proportion of women varied widely across studies. Esomeprazole was studied most frequently. More than 50% of publications permitted rescue antacids. Two studies reported polysomnography outcomes, without statistically significant improvement. All studies reported non-polysomnography outcomes; 7 identified statistically significant improvements demonstrating drug treatment superiority over placebo. CONCLUSION The existing evidence supports the use of proton pump inhibitors as a treatment for esophageal reflux disease to improve quality-of-life sleep disturbance-related outcomes. Given the wide variability in proton pump inhibitor treatments and sleep disturbance-related outcomes reported, however, study-specific results cannot be directly compared or aggregated. This conclusion appears robust not only for 7 of 8 studies included but also for the 3 highest quality studies.