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Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial

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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Acknowledgements

We thank Jeremy Kark and Joseph Herman for their valuable comments.

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Correspondence to M H Schein.

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Conflict of interest

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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