Eligible for inclusion were placebo-controlled randomised controlled trials (RCTs) that assessed the impact of proton-pump inhibitors in patients with gastro-oesophageal reflux disease. Eligible outcomes were sleep time and quality, which were measured using polysomnography (with scales such as the Apnoea Hypopnoea Index) and/or non-polysomnography (with the Epworth Sleepiness Scale and other health-related quality of life questionnaires).
Included trials were conducted from 2004 to 2011. Half the trials used the proton-pump inhibitor esomeprazole (dose 20 to 40mg once or twice daily); the rest used dexlansoprazole, omeprazole, rabeprazole, or pantoprazole (20 to 40mg once or twice daily). Some trials permitted the use of additional rescue antacids or sleep medications. The mean age of participants was 47.4 years; 56% were women; and their mean body mass index was 29.4 (where reported.
Polysomnography outcome measures were used in two trials and included total sleep time (minutes), sleep onset latency (minutes), sleep efficiency (%), arousal per hour, and rapid eye movement. Non-polysomnography outcome measures were assessed in all trials, including sleep quality or the impact of treatment on work productivity, work hours lost, and regular activities. Non-polysomnography outcomes were measured using history and/or validated measures (Epworth Sleepiness Scale, Functional Outcomes of Sleepiness Questionnaire, Pittsburgh Sleep Quality Index) and non-validated measures (diaries or visual analogue scales).
Four reviewers independently screened articles for inclusion.