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

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 +/- 5kg/m(2); 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 15min 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.