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Treating hypertension in type II diabetic patients with device-guided breathing: a randomized controlled trial [with consumer summary]
Schein MH, Gavish B, Baevsky T, Kaufman M, Levine S, Nessing A, Alter A
Journal of Human Hypertension 2009 May;23(5):325-331
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 +/- SD); body mass index 29 +/- 5 kg/m2; systolic BP 148 +/- 11 mmHg and diastolic BP 81 +/- 9 mmHg. 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 +/- SE) systolic -10.0 +/- 1.8 mmHg and diastolic -3.6 +/- 1.3 mmHg (p < 0.0001 and p < 0.01), but not in the controls +1.6 +/- 2.1 and -1.0 +/- 1.4 mmHg 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.
Reprinted by permission from Journal of Human Hypertension, Macmillan Publishers Ltd.

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