Effects of Dexlansoprazole MR on Sleep Quality and Health-Related Quality of Life (HRQOL) in Patients with Symptomatic Nonerosive GERD: 30
Abstract
Purpose: Nocturnal heartburn (HB) and sleep disturbances commonly occur in patients (pts) with GERD and impact daytime performance and health-related quality of life (HRQOL). This study evaluated the effects of dexlansoprazole MR (DEX), a PPI with a Dual Delayed ReleaseTM formulation, on sleep quality and HRQOL in GERD pts with nighttime symptoms and GERD-related sleep disturbances. Methods: A multicenter, randomized, double-blind, placebo controlled, parallel group trial in patients aged 18-66 with symptomatic GERD, a history of nocturnal HB and GERD associated sleep disturbances, with no esophageal erosions based on endoscopy. Patients enrolled had moderate to very severe nocturnal HB and GERD-related sleep disturbances for at least 3 of 7 nights based on twice daily diary entries, and were randomized within 4 days after this 7 night diary qualification. Patients received DEX 30mg or placebo (PBO) orally, every morning for 4 weeks. Patients completed the Pittsburgh Sleep Quality Index (PSQI) and the Nocturnal Gastroesophageal Reflux Disease Symptom Severity and Impact (NGERD) Questionnaire at baseline and at the end of week 4. The PSQI is a validated, reliable instrument to measure sleep quality over the last month. Items yield a global score ranging from 0-21. Higher scores represent worse sleep quality; scores >5 and <5 distinguish populations of poor and good sleep quality, respectively. The NGERD questionnaire is a validated HRQOL instrument to assess the severity and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 305 participants or records.
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