Clinical Trials Validate the Therapeutic power of RESPeRATE

Finally. A Proven, Non-Drug Approach to Lowering High Blood Pressure

Achieving a significant blood pressure reduction using a breathing device can certainly sound too good to be true. This is why, InterCure, the maker of RESPeRATE, spent close to a decade and millions of dollars on rigorous clinical trials 1-7 (see Mechanism of Action) that repeatedly validated the therapeutic power of RESPeRATE.

RESPeRATE's non-drug promise, the evidence-based approach and impressive clinical results won the support of world- renowned hypertension specialists. In fact, the RESPeRATE eight member scientific advisory board includes former and current presidents of the American, European, International and Israeli societies of hypertension.

Mechanism of Action

Inappropriately high sympathetic nervous outflow from the central nervous system is believed to be an important component in the pathophysiology of acute and chronic hypertension that stimulates increases in cardiac output and peripheral resistance. Elevated sympathetic activity is often associated with desensitization of arterial and cardiopulmonary baroreceptors, which leads to increased BP fluctuation and sustained elevations in resting pressures.

Slow breathing (< 10 breaths/minute), especially with prolonged exhalation, appears to reduce sympathetic nerve traffic and thus causes arteriolar dilatation. The process is believed to be initiated by activated pulmonary mechanoreceptors, which respond to the increased tidal volume that accompanies slow breathing, and act in concert with cardiac mechanoreceptors to inhibit sympathetic outflow8.

RESPeRATE's Peer-reviewed Articles:

[1] "Treating hypertension with a device that slows and regularizes breathing: A randomised, double-blind controlled study." Schein M, Gavish B, Herz M, Rosner-Kahana D, Naveh P, Knishkowy B, Zlotnikov E, Ben-Zvi N, Melmed RN. Journal of Human Hypertension ; 2001, 15:271-278.

[2] "Breathing-control lowers blood pressure." Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Journal of Human Hypertension ; 2001, 15:263-269.

[3] "Device-guided breathing exercises reduce blood pressure - Ambulatory and home measurements." Rosenthal T, Alter A, Peleg E, Gavish B. American Journal of Hypertension ; 2001, 14:74-76.

[4] Nonpharmacologic Treatment of Hypertension by Respiratory Exercise in the Home Setting." E Meles, C Giannattasio, M Failla, G Gentile, A Capra, G Mancia. American Journal of Hypertension ; 2004, 17:370-374.

[5] "Graded Blood Pressure Reduction in Hypertensive Outpatients Associated with Use of a Device to Assist with Slow Breathing." W Elliott, J Izzo, Jr., WB White, D Rosing, CS Snyder, A Alter, B Gavish, HR Black. J Clin Hypertens ; 2004 6(10): 553-559.

[6] "Non-Pharmacological Treatment of Resistant Hypertensives by Device-Guided Slow Breathing Exercises." Viskoper , R, Shapira, I, Priluck, R, Mindlin, R, Chornia, L, Laszt, A, Dicker, D, Gavish, B, Alter, A. American Journal of Hypertension ; 2003; 16:484-487.

[7] "Blood pressure reduction with device-guided breathing: pooled data from 7 controlled studies." W.J. Elliott, H.R. Black, A. Alter, B. Gavish. Journal of Hypertension ; 2004, 22(2):S116.

[8] "Respiration and Blood Pressure." Parati G, Izzo JL Jr, Gavish B., Third Edition. JL Izzo and HR Black, Eds. Baltimore, Lippincott, Williams, and Wilkins in Hypertension Primer , 2003, Ch. A40, p117-120.

High Blood Pressure reductions with RESPeRATE

Seven separate studies 1-7 (see Mechanism of Action) have examined the decrease in office blood pressure for subjects who used the device for 15 minutes/day for 8 weeks, compared to “control” interventions (listening to relaxing music 1 or home BP monitoring 4-5 or both 2 ). Four studies were double-blind and randomized 1,2,5,8 , one was controlled and randomized 4 , and two were open-label experiences 3,6.

A total of 286 individuals participated in the seven studies: 55% were men; 78% were drug-treated, with average age of 58 years; Body Mass Index of 28 kg/m2; and initial office BP of 150/90 mmHg (9% pre-hypertensive; 25% Stage 2).

The decrease in office BP after 8 weeks of device-guided breathing among those with uncontrolled hypertension was 14/8 mmHg, compared to control treatment of 9/4 mmHg (p = 0.008 and p = 0.002, respectively for systolic and diastolic BPs). The difference was independent of gender and medication status. Control of BP (< 140/90 mmHg) was seen more commonly in the group that used the device: 26% vs. 4% of those with initial Stage 2 hypertension (> 160/100 mmHg, < 0.005); and 48% vs. 34% for those with initial Stage 1 hypertension (140-159/90-99 mmHg, p < 0.05). The drop in office BP was directly related to the duration of slow breathing during the 8 weeks of treatment; those who used the device to achieve slow breathing more than 15 minutes/day had the greatest lowering of office BPs. It usually takes 3-5 weeks to achieve a sustained reduction in home BP.

Larger decreases in office BPs were seen in older individuals and those with higher baseline BPs, whether taking antihypertensive medication or not. Verification of BP lowering has also been seen with home BP measurements (for up to 6 months of use7) and ambulatory BP monitoring3.