Science journalist Jonah Lehrer posted an interesting article last week about aging star athletes' embrace of biologic medicine, "Why Did Kobe Go to Germany? An aging star and the new procedure that could revolutionize sports medicine". The article describes Regenokine, a relatively new procedure for treating joint and tendon problems that sounds similar to the platelet rich plasma (PRP) treatment I underwent for my right elbow nearly 5 years ago. I have enjoyed a nearly full recovery from the pain and limitations of chronic elbow tendinosis that had plagued me on and off for several years prior to treatment, and I enjoyed reading about others' successful treatment experiences and some of the studies about treatment alternatives.
"Biologic medicine" treatments all engage the body in healing itself, typically involving the extraction, manipulation and re-injection of the patient's own blood or other bodily fluid. Regenokine treatment involves withdrawing a small sample of blood from the patient, heating it and then spinning it in a centrifuge to separate the constituent elements; the resulting yellow colored middle layer is then extracted and injected into the patient's problem area (e.g., the knee). PRP involves withdrawing blood and spinning it in a centrifuge, but does not involve heating, and - as the name suggests - the platelet-rich layer is extracted for injection. Bone marrow injections, involving stem cells, use a similar approach.
Unfortunately, the article reports that PRP, Regenokine and other "biologic medicine" treatments face special challenges in securing FDA approval:
The reason Kobe, A-Rod, and other athletes travel to Germany for their biologic treatments involves a vague FDA regulation that mandates that all human tissues (such as blood and bone marrow) can only be "minimally manipulated," or else they are classified as a drug and subject to much stricter governmental regulations. The problem, of course, is figuring out what "minimal" means in the context of biologics. Can the blood be heated to a higher temperature, as with Regenokine? Spun in a centrifuge? Can certain proteins be filtered out? Nobody knows the answer to these questions, and most American doctors are unwilling to risk the ire of regulators.
The article profiles athletes Kobe Bryant and Alex Rodriguez, as well as Regenokine treatment providers Dr. Peter Wehling (Dusseldorf, Germany) and Dr. Chris Renna (Lifespan Medicine, Dallas & Santa Monica) - who are also co-authors of the book End of Pain - and PRP treatment providers Dr. Stephen Sampson (Orthohealing Center & UCLA) and Dr. Allan Mishra (Apex PRP & Stanford), the doctor who treated my elbow.
Lehrer offers a balanced perspective, noting that while a few famous athletes appear to have experienced healing after biologic medicine treatments, there is - as yet - little supporting evidence from rigorous clinical trials, and so these could represent "the latest overhyped medical treatments for desperate athletes". A 2006 article co-authored by Mishra described a pilot study showing the effectiveness of PRP for chronic elbow tendinosis (the problem I was suffering from), and a 2010 article co-authored by Sampson described another pilot study showing the effectiveness of PRP on knee osteoarthritis. However a 2010 article reported on a Dutch study that showed no significant benefit of PRP over saline injections for chronic Achilles tendonopathy. Another Dutch study, involving a double-blind randomized trial of PRP with 230 patients has been completed, but it could be another several years before the results appear in a peer-reviewed medical journal. Mishra's blog includes a recent post referencing other studies supporting the effectiveness of PRP.
I don't know of any studies of Regenokine, but a 2008 pilot study of interleukin-1 receptor antagonist
did not demonstrate significant benefit to treating knee osteoarthritis demonstrated "statistically significant improvement of KOOS [Knee injury and Osteoarthritis Outcome Score] symptom and sport parameters", and a 2009 study reports that Autologous conditioned serum (Orthokine) is an effective treatment for knee osteoarthritis. According to a December 2011 post about PRP and Regenokine in the Wordpress blog, Knee Surgery Newsletter (which offers no information about the author), Orthokine was the brand name under which Regenokine was previously marketed, and Regenokine and Orthokine are both brand names for interleukin receptor antagonist treatment.
The Lehrer article also highlights doubts - or what should be doubts - about the effectiveness of the traditional alternative to biologic medicine treatment - surgery - describing the results of a 2002 peer-reviewed study appearing in the New England Journal of Medicine, A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee:
Consider an influential 2002 trial that compared arthroscopic surgery for knee osteoarthritis to a sham surgery, in which people were randomly assigned to have their knee cut open but without any additional treatment. (The surgeon who performed all the operations was the orthopedic specialist for an NBA team.) The data was clear: there was no measurable difference between those who received the real surgery and those who received the fake one.
As I've noted before in the PRP thread here on my blog, I'm not a medical expert, and I don't even follow the medical literature about PRP or other treatments with any regularity (I discovered this article because I follow @jonahlehrer on Twitter). I have enjoyed a complete recovery of functionality and nearly pain-free use of my elbow following PRP therapy. I like to think that there is a causal relationship in my personal experience - especially after the failure of several other treatments I tried - but as noted in Lehrer's article, more evidence is required to support any general conclusions on the effectiveness of the treatment. Meanwhile, I'm happy that to see PRP and other biologic treatments gain greater recognition and awareness.