Abstract
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.
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