Efficacy of device-guided breathing for hypertension in blinded, randomized, active-controlled trials: A meta-analysis of individual patient data

IMPORTANCE: Device-guided breathing (DGB) is recommended by the American Heart Association for its blood pressure-lowering effects. Most previous studies that showed beneficial effects on blood pressure had low methodological quality and only investigated short-term blood pressure effects. OBJECTIVE: To assess the efficacy of DGB on blood pressure in a meta-analysis of individual patient data from blinded, randomized controlled trials with an active control group. DATA SOURCES: MEDLINE, EMBASE, clinicaltrials.gov, and the Cochrane Library. STUDY SELECTION: Included were randomized studies of at least 4 weeks' duration, with a single- or double-blind design and an active control group. Bias was assessed with the Cochrane risk of bias tool, and analyses were performed with linear mixed models. DATA EXTRACTION AND SYNTHESIS: Articles were searched in MEDLINE (using PubMed), EMBASE, and the Cochrane Library. MAIN OUTCOMES AND MEASURES: Office blood pressure. RESULTS: From the 15 selected abstracts, 5 studies were suitable for inclusion. Individual patient data from 2 of 5 studies were not provided. The effect of DGB on office systolic blood pressure compared with music therapy or a sham device was 2.2 mm Hg (95% CI, -2.7 to 7.0) in favor of the control group; DGB did not significantly lower office diastolic blood pressure (0.2 mm Hg [95% CI, -2.8 to 3.1] in favor of DGB). CONCLUSIONS AND RELEVANCE: All trials included in the analysis had a short follow-up period; therefore, no recommendations could be made regarding hypertension treatment. Treatment with DGB did not significantly lower office blood pressure compared with a sham procedure or music therapy