Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease: a Randomized Single-blind Study

Detailed Summary

BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and absenteeism. Head of bed elevation, as a low-cost non pharmacologic anti-reflux treatment is nowadays recommended, but its clinical impact in patients with nocturnal symptoms remains unknown due to inconsistent results and methodological limitations among different clinical trials, most of which were performed before the widespread use of proton pump inhibitors in clinical practice. HYPOTHESIS: Head of bed elevation is a useful treatment for patients with gastroesophageal reflux disease and nocturnal symptoms, and has a positive impact in quality of life in these patients. STUDY OBJECTIVE: To assess the effectiveness of head of bed elevation for treatment of patients with gastroesophageal reflux disease and nocturnal symptoms, and to determine the impact of this intervention in quality of life of these patients. METHODS: Randomized single-blind single-centre controlled clinical trial with a 2x2 cross-over design. A sample of 42 patients attending to the outpatient gastroenterology unit at Clínica Fundadores in Bogotá city, who met the inclusion criteria and had no exclusion criteria were selected to participate. Included patients were randomized to raise the head of bed with standard 20 cm-height wooden blocks or to sleep without bed inclination during the first 6 week period. After a 2 week washout period, allocation was crossed and participants were followed again during a second 6 week period. During the trial, every patient received standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate. After allocation concealment, the researchers in charge of statistical analysis and reporting results were blinded for the non pharmacological intervention under study. Primary outcome was a significant symptom change according to Reflux Disease Questionnaire (RDQ) validated form. Secondary outcomes include impact on quality of life according to Short Form 36 (SF-36) validated questionnaire, patient preference and adverse events of non-pharmacological intervention. Statistical analysis was carried out with STATA 13.0 (Special Edition) for Windows. Differences with a p\<0,05 were accepted as statistically significant.

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