Injecting Relief (cont.)
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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