A Medication-Free Anxiety Treatment

Briefly last week, I considered getting back on medication. My panic attacks have been relentless, my voices have been annoying, my thoughts have been in and out of this world. I went as far as going online to a pain center my previous psychiatrist worked at. She is long gone, but there are other great doctors there, and I have nothing bad to say about this particular institution of health professionals. They were informative, kind, and their offices are quiet, clean, bright, and overlook trees even though they’re one hundred feet from a freeway entrance.

While browsing their website to see if they conducted Telehealth appointments, I found a tab specified for panic disorder and within that tab they listed a new, medication-free treatment for anxiety. Curious, I investigated.

What is the treatment?

This treatment is the FDA approved “Freespira” developed by Palo Alto Health Sciences. For this section, I’ll be getting my information from the Freespira website and this patient brochure.

Firstly, Freespira is a breathing trainer. You receive a special Freespira tablet and medical censor that tracks your breathing rate and your Carbon Dioxide output. The hypothesis here is that those of us who panic have irregular breathing patterns even when we aren’t panicking. When we do get anxious, our breathing rate becomes even more so arrhythmic and we aren’t outputting as much carbon dioxide as is healthy. This physiological response cannot be addressed by therapy or drugs, and this is the response Freespira targets. The device teaches you how to regulate your breathing so that you exhale the proper amount of carbon dioxide. Their website says “by training panic suffers to permanently change their breathing patterns, panic attacks are dramatically reduced and, in many instances, completely eliminated.”

This takes a set amount of sessions over the course of a few weeks.

Why This Was Exciting

As a desperate panic sufferer, I know all too well of the tingling in the limbs, the racing heart, the feeling that death is imminent. I lost count how many times I’ve went into the ER because my hyperventilation threatened my consciousness. I won’t spend breathless paragraphs reiterating the doctors who accused me of drug use, who almost refused me treatment, who took my blood without consent to test for meth. The idea of an anxiety treatment that doesn’t including putting poorly tested chemicals in my body daily, or risking “as needed” medication becoming “need” medication and eventually, if not severe physiological dependence, than addiction, almost made me cry.

The statistics are promising. Their website states clinical results are as followed:

Protocol Adherence (meaning participants followed instructions correctly): 83%

Panic-Free immediately post treatment: 85%

Panic-Free 12 months post treatment: 81%

Reduction in panic symptoms 12 months post treatment: 94%

A Stanford trial in 2008 showed “positive changes in respiratory physiology, and strong evidence for safety and tolerability”. 68% of participants were panic free, 93% had a reduction in symptoms after 12 months.

Another trial showed similar results, with protocol adherence and freedom from panic ranging from 71% to 88%.

The last study they cite has no verifiable link on google.

These results are pale in comparison to those reflected by drug therapies and every other talk therapy except Cognitive Behavioral Therapy for panic disorders. It is easy, quick, self-administered, and finally puts to use all those breathing techniques you learned that felt useless. Suddenly, they’re not so useless because you have a tablet and sensor telling you they’re not.

So what’s the truth?

I hope you don’t feel as let down as I did.

In my excitement, I didn’t fall blind to the fraudulent world of psychology research. And so, I researched. My first hint that something was off came from the website healthnewsreview.org, a website dedicated to “improving your critical thinking about health care”.

Some of the noteworthy things they mentioned, briefly summarized because I love you guys, are:

1: The cost treatment is not discussed. In 2015, a news story reported the monthly cost as $500.*

2: No absolute numbers are released, just overall percentages states on the website.

3: No mention of what the harms could be, if any, and there were no links to the studies mentioned on the website. We’ll come back to this.

4: one of the most IMPORTANT: Freespira website DOES NOT discuss or post who funded these studies. We’ll come back to this too.

5: No alternatives discussed. I mentioned CBT earlier in this article, as it is one of the leading and most proven methods for treating panic disorder. A comparison is no where mentioned.

*link to the ‘news story’ on healthreview.org

By this point, I’d lost hope.

And so, I’ve done the nice, hard work of finding the studies Freespira reports as their evidence. They did indeed provide citations eventually of their sources, but I could only find them when I switched from desktop view to mobile view. I have linked them above.

The Results?

The “Stanford Study”

Let’s remember How to Read a Research Paper before continuing. I don’t know if this was actually conducted at Stanford, but Freespira lists this citation as the Stanford study they mentioned.

Not Freespira specific, but tested for the effectiveness of capnometry-assisted breathing therapy, the type of device freespira is purporting to be.

Methods and participants: 37 participants, 31 with panic disorder and agoraphobia, 6 with panic disorder and NO agoraphobia. 20 were randomly assigned to the treatment, 17 were wait-listed as a control group. Recruiting happened with community advertisements. You can read the study for more in depth description of the participants.

Treatment: educating patients on breathing, showing them problematic respiratory patterns, having them perform breathing maneuvers with feedback, teaching ways to control carbon dioxide levels, and having them practice breathing exercises daily. Twice daily, 17 minutes, at home. Read for more in depth description.

Results: Low attrition (drop out rate). 40% experienced no more panic attacks during the four weeks. 2 month follow up, 62% had experienced no further attacks, and 68% were panic free at 12 months. This shows brief capnometry breathing therapy can be therapeutic. Improvements were seen in the treated but not untreated participants and success improved as time passed. Non-respiratory mechanisms, such as treatment rationale (meaning they told the participants the point of the study) let the patients develop cognitive components needed to avoid catagstrophic thinking and gave patients a sense of control–one thing we lose in panic attacks. The breathing exercises triggered sensations similar to those we experience in panic attacks, and desensitization may have occurred to the bodily clues rather than respiratory changes being the sole drive. Need future studies testing viability (success of the treatment).

Limitations: The first thing you learn in an introductory research course is that when you are studying treatments for mental health disorders, you can’t simply pair the treatment with an untreated population. In order to test for something like viability, you need to compare your treatment to other treatments. This study did not do that, and lists it in their limitations section.

This study was supported by the NIMH.

The Multi-Center Trial

Freespira specific.

Methods and Participants: Primary diagnosis of Panic Disorder, 18-65, moderately ill or greater based on the Clinician Global Impression Scale, and were off medication or had been stable on medication for 3 months. Conducted at multiple non-academic clinical sites with different clinicians at different levels of expertise.

Procedure/Treatment: 4 weeks. Breathing sessions 17 minutes long with baseline stage (sitting quietly with eyes closed for 2 minutes), a pacing stage (monitoring of Carbon dioxide levels with breathing at a specific rate for ten minutes), and a transition stage (patient maintains breathing pattern with feedback for 5 minutes).

Results/discussion: 20% dropped out. Significant decrease in panic disorder severity over four weeks, early identical results to the previous study. Patient compliance was high as well as patient satisfaction. This treatment can be made largely available at a low cost. Side effects were rare, like mild dizziness or lightheadedness in the beginning training sessions.

Limitations: Again, no control group, not even a wait list. The study itself says “these results cannot be considered a definitive documentation of efficacy”, but instead “extends [the previous studies’] findings to document feasibility and utility in more naturalistic treatment settings.” It discusses no alternative reasons for why they may have seen significant results and a decrease in panic symptoms.

This study was funded by Palo Alto Health Sciences, the developers of Freespira.

Several of the doctors on this so-called study have received research grants and/or consulting fees from PAHS and Merck. This is listed as the Conflicts of interest. For obvious reasons.

Should You Try Freespira?

Results show the need for many, many more studies, but no real evidence of efficacy.

Try at your own risk. Especially if it means you’re paying out of pocket.

If you go in thinking it will work, it will probably work. if you go in remembering this evidence, it probably won’t.

If you have tried Freespira and it worked for you, leave your experience below or message me and let’s write about it! The same applies for if you have tried Freespira and it hasn’t worked for you.

Also, notice the degree of ethical practice reduces when the study is funded by the developer of the treatment. Keep that in mind for when we discuss the studies of psychotropic medications.

For conversation, support, and updates on research and posts, follow me:

Instagram: @written_in_the_photo

Twitter: @philopsychotic

If you enjoyed this post, please share, like, and follow ThePhilosophicalpsychotic. I appreciate every reader and commentator. You give me more reason to continue reporting bad science.