Non-pharmacological treatment of hypertension in diabetics by device-guided paced breathing:
A randomized controlled study
Moshe H Schein, MD1, Ariela Alter, PhD2 and Benjamin Gavish, PhD2. 1Family medicine, Hadassah - Hebrew University
Medical Center, Jerusalem, Israel and 2Clinical and Regulatory, InterCure Ltd, Lod, Israel.
Objective: To assess the efficacy of device-guided breathing to lower blood pressure in diabetic hypertensives.
Design and Methods: A randomized controlled study carried out in urban family practice clinics in Israel.
Non-insulin dependent diabetics with uncontrolled blood pressure (>130/80 mmHg), receiving antihypertensive therapy or
unmedicated, were enrolled. The intervention group used a device (RESPeRATE, InterCure Ltd, Israel), which interactively
guides the user towards slow and regular breathing by synchronizing breathing voluntarily to musical tones,
for 15-minutes daily at home for an 8-week period. The control group continued with their regular treatment.
Blood pressure (BP) was measured in the clinic at baseline, after 4 weeks and at termination at 8 weeks. Medication
was unchanged for 3 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. Concordance with treatment was measured by the average weekly time
spent in slow breathing (breathing rate<10 breaths/min) as percent of recommended (>45 min/wk).
Results: Baseline characteristics of 50 patients (25 treatment and 25 controls), 32M/18F were: age 63+9
years (mean+SD); BMI 30+3 kg/m2; 41/50 receiving antihypertensive medication; 31/50 receiving antidiabetic medication;
BP 146+10/81+8mmHg and heart rate 71+10 bpm. The difference in BP change (mean+SE) between the treatment and control
groups was significant for systolic BP (SBP) -7.5+1.7 vs +1.6+0.3 mmHg, p=0.003 for comparison between groups.
Greater systolic BP reduction was found to be significantly correlated with total time spent in slow breathing (p=0.02).
Concordance with treatment was good (88%).
| BP value at start and end of study (mean+SE, mmHg) | |||||||
| Treatment (N=25) | Control (N=25) | ||||||
| Start | End | p value | Start | End | p- value | p- value by group | |
| SBP | 148.1+2.1 | 140.6.3+2.9 | 0.002 | 144.2+1.7 | 145.8+3.2 | 0.53 | 0.003 |
| DBP | 81.2+1.9 | 78.1+2.6 | 0.06 | 81.0+1.4 | 78.8+1.2 | 0.17 | 0.7 |
Conclusion: Self-treatment with device-guided breathing at home for 2 months by non-insulin dependent
diabetic patients was associated with a significant reduction in office systolic BP. The patients demonstrated
good concordance with the treatment.
