Read Original Release

Little studied joint pain therapy stresses celebrity endorsement, not evidence

Rating

2 Star

Arthrokinex Announces IRAPjoint Product, a Non-Drug, Non-Surgical Joint Pain Management Solution Made From Your Own Blood.

Our Review Summary

This news release heralds the creation of a new treatment for osteoarthritis (OA) patients and those with joint pain. The therapy, called IRAPjoint, consists of withdrawing a patient’s blood, heating it, and then re-injecting it into the painful joint.

The theory behind this practice, which has been done for several years in Europe, is that heat increases the number of anti-inflammatory proteins (also called anti-inflammatory cytokines) in the blood, which then combat inflammation at the re-injection site. While increasingly popular with professional athletes (and horses), there is little actual scientific evidence that this treatment works. Anecdotal evidence can be important, and for top athletes whose careers depend on healthy joints, the gamble and steep price tag may be worth it. But for the general public, there is no high-quality scientific literature that shows this as a credible alternative to existing OA treatments.

 

Why This Matters

Joint pain can be caused by different conditions. Though not explicitly mentioned in this news release, the treatment discussed, IRAPjoint, is targeted to individuals with joint inflammation due to arthritic disease. This may be due to overuse (such as professional athletes and “weekend warriors”) or simply wear and tear due to aging.

Osteoarthritis (OA) affects millions of Americans, and is the most common chronic joint condition. It can be especially debilitating in older patients, many of whom experience constant pain and loss of mobility. A safe, effective treatment that doesn’t involve the use of harsh steroids or constant pain medications would be welcome and improve the quality of life for many.

But the release is not clear about just who should get this treatment. It  provides almost no information on the data to support this product and in whom it should be used (other than professional athletes).

Criteria

Does the news release adequately discuss the costs of the intervention?

Satisfactory

This news release highlights the cost of the treatment — $2,000, compared to the price of $10,000 for an unnamed foreign competitor. The New York Times wrote a piece on a company in Germany supplying a similar treatment in 2012 when the cost of the procedure was about $7,500 out of pocket, so the news release seems to be relatively in the ballpark. 

Although this new treatment may be less expensive that the foreign competitor mentioned, it is likely more expensive than steroid or hyaluronic acid injections and as a non-FDA approved treatment it is unlikely to be covered by American insurance companies.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The news release gives no numbers to help readers assess the new therapy’s benefit. In fact, it says very little about the therapy benefit at all besides the fact that “success has been achieved” by using the treatment, and that the new treatment is “significantly better” than a rival European treatment. 

There was no study mentioned in this news release. On the website of Arthokinex, the joint pain clinic that has released the new treatment, there is a link to a 2015 study published in the journal Cytokine by one of the clinic’s doctors. The study looked retrospectively at the charts of 53 of the clinic’s patients who had undergone this treatment, and concluded that the treatment was effective in treating mild to moderate osteoarthritis. 

As noted in this news release, the use of a patient’s own blood as a treatment option has been available for some time. However, evidence demonstrating its benefit compared to placebo or other injections is very limited. Instead, the release implies benefit by referring to the use of this type of treatment by professional athletes.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

This release mentioned no potential harms of the treatment, and emphasized multiple times the supposed safety of the treatment as a “non-drug, non-surgical treatment derived from your own blood.” 

But just because it’s from your body doesn’t mean it’s inherently safe—further study would be necessary to determine the safety and risk of adverse reactions.

Though probably safe if done in a sterile fashion, there is no information on the long-term impact of this treatment on the arthritic joint.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

As mentioned above, no study was provided along with the news release to show the efficacy of the treatment, and the release made no mention of this crucial missing piece. The actual study (linked above) had several weaknesses—it was a retrospective study, and had a small sample size of only 53 patients. 

And there aren’t many other studies available for learning more about the therapy. A 2013 review of literature of this treatment (also called autologous conditioned serum and Orthokine) found only eight scientifically valid articles (not including the one by Arthokinex) of this specific treatment method. Though the treatment may seem anecdotally and conceptually legitimate, there just simply isn’t enough valid research backing up that claim.

Does the news release commit disease-mongering?

Satisfactory

This was a tough call and we gave them the benefit of the doubt on this criteria. Although the release doesn’t disease monger about joint pain, without a clear indication of who should get this injection, it may imply that anyone with joint pain could consider this treatment. And that’s not the case.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

This news release was sent out by the clinic that developed and now markets this treatment, so the conflict of interest is fairly obvious. Another big conflict of interest should have been noted, but wasn’t. The one research trial published on this therapy was conducted by a physician who has ownership in the clinic and sits on the company’s board of directors. This fact, which was disclosed in the published study but not the news release, forms a clear conflict of interest.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release doesn’t name any alternatives for joint pain. For patients with mild symptoms, over-the-counter oral medicines like ibuprofen and naproxen can help. For some, physical treatments can help strengthen muscles and can improve function of the joint. At the other end of the spectrum, for patients with very severe arthritis, joint replacement is an invasive but effective option. However, for many with moderate symptoms, there is a need for treatments than can control symptoms. Injections into affected joints with other medicines including steroids and hyaluronic acid have been available for a long time. These treatments can have short-term benefit for some individuals, but don’t help everyone

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The specific treatment in the news release is only offered at one clinic in the U.S., but the news release didn’t mention if any other clinics or companies offer a similar therapy. The release also makes it sound like this treatment is available for anyone with bad joints, though theoretically there would be people who do not qualify for the treatment based on their symptoms or medical history.

Does the news release establish the true novelty of the approach?

Satisfactory

The release does a good job here. It emphasizes the novelty of this approach, especially in the United States. Reviews of published literature show that this has not been a well-explored field yet.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The sensational language here is subtle (no explicit talk of a “breakthrough”), but still may lead a reader to be over-confident in the treatment and its abilities based on the quality of evidence. The news release emphasizes several times that the treatment is “natural” since it is derived from the patient’s own blood. And one of the last sentences of the news release stood out as particularly heavy-handed: “Finally, a U.S. based company has a solution for America’s professional and weekend athletes as well as those struggling with aching or arthritic joints.”

Total Score: 3 of 10 Satisfactory

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