This news release claims that 80% of patients with panic attacks due to anxiety could get relief after 4 weeks of using a biofeedback device and training package known as Freespira. The device includes a sensor to measure carbon dioxide in the breath of a patient, and a tablet computer and an app to help them understand and change their breathing and potentially avoid panic attacks. The Freespira system is FDA cleared to market to patients for at-home use with physician guidance. But the release does not give us the date or publication of corroborating studies and simply says there was a presentation at a conference about these results. We are left unable to judge the news value of the latest study from such scant details.
To our knowledge, the most recent study about this biofeedback device was published a year ago.
Anxiety disorders are very common in the United States. The National Institutes of Mental Health estimates that almost one-third of adults will experience this once in a lifetime. But the release does not give readers enough information to judge whether there is new proof of effectiveness from a just completed research study, or whether this announcement is referencing old studies in a conference presentation.
Note: We reviewed a story in 2015 about this same device and reviewers then had some similar concerns about the evidence surrounding the device, but found the author did a responsible job reporting on the device.
The news release does not give us the cost of the Freespira treatment. This is especially troubling since the release claims that the treatment reduces overall costs “by 50%” after a year of treatment.
When we reviewed a news story about Freespira in 2015, the monthly cost was reported as $500.
The release does not give us absolute numbers for benefits. It offers some percentages for improvement, but does not show in detail how the improvement was measured to get those numbers.
Here are some of the percentages offered in the release:
“Two studies reported nearly 80% of Freespira-treated patients were panic attack free at 12 months post-treatment. Two additional studies reported that patients with mixed anxiety disorders and low exhaled CO2 at baseline were less responsive and/or discontinued treatment with Cognitive Behavioral Therapy or Acceptance Commitment Therapy.
“Early data from a fifth study reported on Freespira treatment for patients with Post-Traumatic Stress Disorder (PTSD). Ninety percent of patients in this study experienced a significant improvement in PTSD symptoms at two months and six months post-treatment.”
Unfortunately, the release provided no guidance on where to look for any of these these studies so those interested in the device could learn more or assess the study protocol of evidence.
The release does not mention harms.
(For a tutorial on how unsafe medical devices have been allowed into the marketplace, see our toolkit article.)
The release could have linked us to clinical research publications supporting the claims, but it did not do that. Without any access to those publications, the evidence quality is low.
There was no disease mongering.
We are not told the source of money for any specific clinical trials. The release was written by Palo Alto Health Sciences, the company that sells the Freespira system. But we aren’t told if the company supported any of the clinical trials financially and without access to the studies, we can’t look up any potential conflicts of interest disclosures.
The release does not discuss alternatives. Cognitive behavioral therapy, medications and startegies for managing stress are all known therapies for anxiety disorders. The release did not compare effectiveness of the device therapy with any other known therapies.
The device has apparently been commercially available for many years but this is not specifically addressed in the release.
The release does not provide proof of the claim that there is a “new” clinical research study supporting the headline.
The headline word “eliminates” seems unjustifiable. We aren’t given enough information about numbers of patients studied, or the long-term follow up that would justify that word.