New treatment for aches.
Oct. 2, 2000 -- Aching knees were keeping 64-year-old Mickey Irgang off the racquetball courts, but he balked at arthroscopic surgery -- especially the six-month recovery period. Instead, at the recommendation of a friend, the Hollywood, Fla., importer flew to Chicago for a little-known treatment with a peculiar name: prolotherapy. There, a doctor thrust a needle into Irgang's problem joint and injected a solution that was designed to actually inflame it.
Almost immediately after the injections, the pain that had troubled Irgang for nearly a decade began to abate. "I was off the table in three or four hours, and I started to feel relief," he says.
After a follow-up treatment on his left knee, Irgang, 64, now plays racquetball, works out three times a week, and can manage squats again. "I used to hear a lot of clinking and cracking from my knees, but I don't any more. Maybe my hearing's going, but I think it was the treatment."
More and more patients are seeking this treatment, also known as sclerotherapy, which is practiced by several hundred doctors in the United States. Proponents call it a cheap, safe, and effective option for a wide range of conditions, including back pain, osteoarthritis, migraine headaches, fibromyalgia, tennis elbow, temporomandibular joint (TMJ) dysfunction, and tendinitis.
Typically, the mixture injected includes a smidgen of local anesthetic, dextrose (a sugar derived from corn), and Sarapin, a nerve-soothing extract from the pitcher plant. The number of injections per session ranges from one to more than 100, and some patients may require sedation to weather the pain. No less prominent a figure than former U.S. Surgeon General C. Everett Koop says that prolotherapy banished his intractable low back pain. In fact, he was so taken with the technique that he learned it himself and has used it on patients.
Detractors, however, call the theories behind prolotherapy speculative, caution there is scant evidence that it works and warn it may be dangerous, especially when performed by inexperienced practitioners.
How Is Prolotherapy Supposed to Work?
It's easy to see why prolotherapy inflames some doctors. One theory underpinning the treatment is that many standard pain relief measures advocated by the medical establishment -- including ice packs, steroids, and anti-inflammatory drugs like aspirin and ibuprofen -- may actually hamper recovery. By suppressing inflammation, advocates of prolotherapy argue, these treatments stifle the very process that promotes healing and ultimately alleviates pain.
"Prolotherapy is saying 'inflammation is good,' " says Ross Hauser, MD, whose Caring Medical and Rehabilitation Services in Oak Park, Ill., treated Irgang and administers about 1,000 prolotherapy injections each day.
The second premise of prolotherapy is that the host of seemingly disparate conditions for which it is used -- from migraine headaches to tennis elbow -- share a common cause: loose ligaments or tendons. For example, Hauser says, if the ligaments that stabilize the knee become lax, the joint will wobble and painful degenerative arthritis may develop. And while other physicians might not agree, migraines, he says, can result from slack ligaments in the neck.
That's where the shots come in. According to K. Dean Reeves, MD, a prolotherapist and director of research at Meadowbrook Rehabilitation Hospital in Gardner, Kan., the injections work because they galvanize the release of growth factors -- chemical mediators that promote the repair of ligaments and tendons. As these connective tissues tighten, the joint stabilizes and pain eases, he says. Animal studies, he adds, have found increased bulk and strength in ligaments and tendons treated with prolotherapy. (See, for instance, the journal Connective Tissue Research, vol. 11, 1983.)
Prolotherapy also provokes regrowth of cartilage within the joint, Hauser believes. He says that injections into the hip joint, for example, can spur the growth of enough new cartilage to spare patients hip-replacement surgery.
A Dose of Skepticism
Not surprisingly, many physicians are skeptical of these theories. While weak ligaments certainly can lead to arthritis, there is no evidence that they are behind most cases of joint pain, says David Diduch, MD, an orthopedic surgeon at the University of Virginia Medical Center in Charlottesville.
Kevin Coupe, MD, an orthopedist at the University of Texas-Houston Medical Center, doubts whether promoting inflammation can produce long-term joint healing. What really happens, he thinks, is that the injections trigger the formation of scar tissue, which temporarily braces the joint but can eventually degrade. "You'll see some transient success, but I'll bet it won't last," he says.
Critics attack prolotherapy on another front -- the lack of supporting studies. "The marketing of prolotherapy is way ahead of the research," says John Renner, MD, a professor of family medicine at the University of Missouri, Kansas City, and president of the National Council for Reliable Health Information. In fact, there have been only five placebo-controlled, randomized, double-blind trials of prolotherapy, four of which found positive effects.
The best-known of these -- appearing in the prestigious British journal Lancet on July 18, 1987 -- came from the Sansum Medical Clinic and Research Foundation in Santa Barbara, Calif. Of 81 patients with chronic low back pain, the 40 who received prolotherapy reported the greatest reduction in pain and disability scores after six months. A more recent study by Reeves and Khatab Hassanein, PhD, chairman of the biometry department at the University of Kansas Medical Center in Kansas City, showed similar results for knee arthritis. Patients who got prolotherapy had greater reductions in pain while walking, had fewer episodes of knee buckling, and gained a greater range of motion than did those who got placebo injections, according to findings published in the March 2000 issue of Alternative Therapies.
Though the Sansum study is often cited as strong evidence for prolotherapy, Wallace Sampson, MD, editor of the Scientific Review of Alternative Medicine, points out a serious flaw in its design. The experimental group also received vigorous spinal manipulation and more anesthetic on the first day of the trial. The study is really testing a combination of treatments, he says, and can't be used as evidence that prolotherapy works on its own. Though the Reeves and Hassanein study is stronger, this slim body of evidence doesn't validate prolotherapy, says Renner.
There are risks to prolotherapy, as well: In the 1950s, two patients died and three became paralyzed after undergoing the treatment. With proper training and the milder solutions used today, complications are rare, says Reeves, but they can include infection, spinal injury, and even a punctured lung.
Skepticism about prolotherapy also extends to the Health Care Financing Administration (HCFA), which runs Medicare. Though many insurance companies do cover the treatment, HCFA refuses to pay for it -- a sore point among supporters. Citing the paucity of research and faults in existing studies, last September HCFA reaffirmed its stance and called for more research to determine whether the technique is truly safe and effective.
Until that work is done, Renner says he wouldn't recommend prolotherapy for his patients. And he has some pointed advice for anyone considering the treatment: "Be careful. Be very careful."
Mitch Leslie writes about science and medicine from Albuquerque, N.M. His work has appeared in Science, Science Now, and Modern Drug Discovery.
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