NEW YORK (Reuters Health) - A device that plays a melody in an attempt to slow people's breathing didn't lower the blood pressure of people with diabetes, according to a new study.
"Given the results and the studies available, you can conclude that there is not enough evidence to use this device," said Dr. Gijs Landman, the study's lead author from the Isala Clinics in The Netherlands.
Past research on the U.S. Food and Drug Administration-approved RESPeRATE device, however, has produced mixed results.
Last year, a review of eight studies that evaluated the device found it lowered the participants' blood pressure, but that benefit disappeared when the researchers excluded studies sponsored by RESPeRATE's maker - InterCure Ltd.
For the new study, Landman and his colleagues recruited 24 adults with diabetes and high blood pressure to use the device for 15 minutes per day over eight weeks.
Another 24 people with diabetes and high blood pressure were also recruited to act as a comparison group by using an identical device without the therapeutic melody.
At the start of the study, all the participants had systolic blood pressure (the top number) of about 151 millimeters of mercury (mm Hg), and their diastolic blood pressure (the bottom number) was about 82 mm Hg.
The American Heart Association recommends that a person's systolic blood pressure should be less than 120 mm Hg, and their diastolic blood pressure should be less than 80 mm Hg.
At the end of the study, the researchers found no significant differences in the participants' blood pressure in either the intervention or comparison group.
What's more, three participants using RESPeRATE didn't complete the study. Two dropped out because of side effects that could have been related to their use of the device, according to the researchers in JAMA Internal Medicine.
InterCure did not respond to a request for comment before deadline. Landman told Reuters Health the company did supply his team with the devices, which cost between $300 and $420.
Dr. Kamal R. Mahtani, who was not involved with the new study but led last year's analysis, said the new findings back up their earlier findings.
"There is no clear evidence for clinical benefit and this new paper is interesting because it's highlighting a potential harm," said Mahtani, from the Center for Evidence Based Medicine at The University of Oxford in the UK.
He added that he would not recommend the device to his patients and encourages people considering using this device to speak with their doctor first.
Mahtani said the treatment of high blood pressure often depends on a person's risk of heart disease, but could include lifestyle changes or medication.
Landman also told Reuters Health that he would not recommend the device, because - on top of not providing a benefit - it's time-consuming to use.
"You have to listen to the music for 15 minutes every dayâ¦ I don't think it's feasible," he said.
SOURCE: http://bit.ly/17Fu3CG JAMA Internal Medicine, online June 10, 2013.