Impact of head of bed elevation in symptoms of patients with gastroesophageal reflux disease: a randomized single-blind study (IBELGA).

Background: The clinical impact of head-of-bed elevation in patients with gastro-oesophageal reflux disease is unclear, because of inconsistency and methodological limitations of previous studies.

Patients And Methods: A randomised single-blind single-centre controlled clinical trial with a 2x2 cross-over design, in 39 pharmacologically treated patients with gastro-oesophageal reflux disease. Active intervention was to use a head-of-bed-elevation of 20cm for 6 weeks and then to sleep without inclination for 6 additional weeks, with a wash-out of 2 weeks between periods. The primary outcome was a change ≥10% in RDQ score and secondary outcomes were a change ≥10% in SF-36 score, patient preference and frequency of adverse events.

Results: 27 (69.2%) patients who used the intervention reached the primary outcome vs 13 (33.3%) patients in the control group (RR: 2.08; 95 CI%: 1.19 - 3.61). No effect was found in SF-36 score (RR: 1.11; 95% CI: 0.47 - 2.60). Preference favouring the intervention was 77.1% and adverse event proportion was 54.0%.

Conclusion: Head-of-bed elevation improved reflux symptoms but there was no effect on quality of life. The finding of a non-optimal risk-benefit ratio warrants additional studies before this intervention can be recommended (IBELGA, ClinicalTrials.gov identifier NCT02706938).