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+/-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.
Schein
M H
MH
Department of Family Medicine and Braun School of Public Health and Community Medicine, Hebrew University-Hadassah Medical Center, Jerusalem, Israel. mhschein@yahoo.com
Gavish
B
B
Baevsky
T
T
Kaufman
M
M
Levine
S
S
Nessing
A
A
Alter
A
A
D000368:Aged; D001945:Breathing Exercises; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D026441:Mind-Body Therapies / Q000295:instrumentation / Q000379:methods; D010349:Patient Compliance; D016896:Treatment Outcome