Abstract
The objective of the study was to evaluate the efficacy of device-guided breathing to lower blood pressure (BP) in hypertensive type II diabetic patients. A randomized controlled trial was carried out in four urban family practice clinics in Israel. Non-insulin-dependent diabetic, hypertensive patients with uncontrolled BP, receiving antihypertensive therapy or those non-medicated were enrolled. Baseline characteristics of the 66 patients who completed the study (33 intervention and 33 control) were: 62% men, age 62±8 years (mean±s.d.); body mass index 29±5 kg/m2; systolic BP 148±11 mm Hg and diastolic BP 81±9 mm Hg. The intervention group used a device (RESPeRATE), which interactively guides the user towards slow and regular breathing by synchronizing respiration voluntarily to musical tones for 15 min daily for an 8-week period. The control group continued with their regular treatment. BP was measured in the clinic at baseline, after 4 weeks and at 8 weeks. Medication was unchanged for 4 weeks prior to and during the study period. The main outcome measure was the office BP change from baseline to the end of the 8-week period. BP was reduced in the treatment group (mean±s.e.) systolic −10.0±1.8 mm Hg and diastolic −3.6±1.3 mm Hg (P<0.0001 and P<0.01), but not in the controls +1.6±2.1 and −1.0±1.4 mm Hg P>0.4 and P>0.4, respectively. Test for between group difference P<0.0001 and P=0.08. The subjects were highly compliant with the treatment, performing 75% of the requested exercise sessions. Greater BP reduction was observed with increased compliance with device usage (P=0.01 and P=0.001). It is concluded that self-treatment with device-guided breathing at home for 8 weeks by non-insulin-dependent diabetic patients was associated with a substantial reduction in office systolic BP.
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We thank Jeremy Kark and Joseph Herman for their valuable comments.
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Dr Benjamin Gavish is the Chief Scientist and Dr Ariela Alter is the Director of Clinical Regulatory Affairs at Intercure Ltd, the manufacturer of the RESPeRATE device, which supported this study.
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Schein, M., Gavish, B., Baevsky, T. et al. Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial. J Hum Hypertens 23, 325–331 (2009). https://doi.org/10.1038/jhh.2008.135
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DOI: https://doi.org/10.1038/jhh.2008.135
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