The British Hypertension Society (BHS) issued a statement earlier this year regarding the use of medical devices to lower blood pressure. This statement was made following several queries about a new product listed in the Drug Tariff.
The statement refers to a systematic review and meta-analysis that was published in the Journal of Hypertension. This study identified 8 trials involving 494 patients using the RESPeRATE® device.
Collectively these trials demonstrated statistically significant reductions in systolic and diastolic blood pressure of 3.67mmHg (95% CI −5.99 to −1.39; P=0.002) and 2.51mmHg (95% CI −4.15 to −0.87; P=0.003) respectively. However, when 5 trials that were sponsored by or involved the manufacturers of the device were removed from the analysis no overall effect on blood pressure was evident.
The authors of the paper conclude that, "longer term, independent trials are required to validate this intervention". The BHS note that the longest trial duration was 9 weeks and that no effect was seen on pulse rate or quality of life. They advise that, "such small effects over very short durations of time do not provide sufficient evidence for this equipment to be recommended".
Action: Clinicians should be aware of the availability of this product. Such devices cannot be recommended based on the currently available evidence.
Thanks to Kevin Ashworth for spotting this article
|« $3 billion fine for GSK||SMC Update - July 2012 »|