1. Device-guided breathing was not associated with improved blood pressure as compared to active controls such as sham devices or music therapy.
2. Device guided breathing exercises may be a costly alternative to freely available relaxation techniques that may be equally efficacious.
Evidence Rating Level: 2 (Good)
Study Rundown: Given the negative impact of long-standing hypertension on cardiovascular health, it is important to discover effective pharmacological and non-pharmacological interventions. Newer approaches include slowing of breathing through device-guided breathing (DGB) exercises. These devices use musical tones to train one to slow their breathing. Previous studies have shown small short-term effects against inactive controls. However, this study sought to investigate the DGB’s efficacy against active controls, such as musical therapy and sham devices.
This meta-analysis did not find a significant association between office blood pressure improvements within their primary and secondary analyses of individual patient data and data from published articles. Overall risk of bias analysis determined that the two studies initiated by the manufacturer of the DGB device had a high risk of selective outcome reporting, as the primary outcome was analyzed with methods not determined a priori. Strengths of the study include using statistical meta-analytic techniques to re-analyze individual patient level data from single or double blinded RCTs, and also comparing DGB to active controls. However, the study was limited to lower quality RCTs with short follow-up. Consequently, no long-term cardiovascular end points were analyzed, and two of five studies were found to have a high risk of bias.
In-Depth [meta-analysis]: This meta-analysis identified five RCTs that were either single or double-blinded and compared DGB to active controls (sham device or music therapy). Four studies compared DGB to music therapy and one to a sham device. The commercial DGB device, called RESPeRATE, was used in all five RCTs, two of which were conducted by RESPeRATE’s manufacturer, Inter-Cure Ltd. The primary outcome was a change in office systolic blood pressure between baseline and end of treatment period. The secondary outcome was a change in diastolic pressure. Ideally, the primary analysis would include all individual patient data from all studies. However, for studies where this data could not be attained, secondary meta-analysis would include the study’s published unadjusted data.
The primary analysis, when corrected for study group, age, sex and body mass index, showed non-significant mean differences in inverse variance (95% CI) of 1.7 mmHg (-3.1 to 6.5) in favour of the control for systolic blood pressure and -0.7 mmHg (-3.6 to 2.1) in favour of the DGB for diastolic blood pressure. When the two additional positive manufacturer studies were included in the secondary analysis, the non-significant results remained with a mean difference in inverse variance (95% CI) of 1.1 (-2.8 to 5.0) in favour of DGB. Additionally, when specifically compared to music therapy, DGB did not significantly lower systolic or diastolic blood pressure, with differences of 1.8 mm Hg (-2.8 to 6.3) in favour of DGB and 1.6 mmHg (-2.3 to 5.4) in favour of DGB.
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