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The Food
and Drug Administration has approved the over-the-counter
sale of a non-drug medical device that claims to reduce high
blood pressure without side effects by helping people perform
therapeutic breathing exercises.
According
to its manufacturer, InterCure, the device has been clinically
proven to reduce high blood pressure by coaching people using
interactive technology to do difficult breathing exercises
that when performed routinely can lower blood pressure.
InterCure
said its RESPeRATE device has been clinically validated to
significantly lower blood pressure by an average of 14 mmHg
systolic and 9 mmHg diastolic after 8 weeks of routine use
of 15 minutes per day, three to four times a week. Older patients
and those with higher baseline blood pressure were able to
achieve even greater average reductions.
Dr. Henry
Black, chairman of the department of preventive medicine at
Rush-Presbyterian St. Luke's Medical Center in Chicago and
a member of InterCure's Scientific Advisory Board, predicted
the device would have a major impact on how high blood pressure
is treated.
The battery-operated
device looks like a Walkman as users place an elastic belt
with a respiration sensor over their clothes around their
torso and listen through headphones.
The go-anywhere
device automatically analyzes the user's breathing rate and
pattern and then interactively guides the user through breathing
exercises that slows the breathing down to the therapeutic
zone of less than 10 breaths per minute with prolonged exhalation.
While
breathing returns to normal after each session, the beneficial
effects on the blood pressure accumulate and a significant
and sustained reduction in blood pressure can be achieved
with regular use. The device can be orderly directly from
InterCure for $299.
Source:
Hypertension
Week of July 21, 2002
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