SAN ANTONIO — Acupuncture has shown itself to be an effective adjunct in the treatment of osteoarthritis of the knee in a large phase III study funded by the National Center for Complementary and Alternative Medicine.
In a randomized clinical trial that compared traditional Chinese acupuncture with sham acupuncture or an educational program, statistically significant improvements were seen in pain and function with true acupuncture, Marc C. Hochberg, M.D., said at the annual meeting of the American College of Rheumatology.
The study included 570 patients with symptomatic knee osteoarthritis (OA), defined as moderate to severe pain on a 5-point Likert scale despite therapy with analgesics and anti-inflammatory agents.
The mean age of the patients was 65.5 years, 69% were white, and 64% were women.
True acupuncture intervention consisted of insertion of needles at 5 local points and 4 points distal to the knee, said Dr. Hochberg, professor of medicine, University of Maryland, Baltimore. The acupuncture points were determined according to the precepts of traditional Chinese medicine, which classifies all types of arthritis as “Bi syndrome.”
Additionally, low frequency electrical stimulation was applied at a single point in the infrapatellar area.
Patients received acupuncture treatments twice a week for 8 weeks, then weekly for 2 weeks, every other week for 4 weeks, and monthly for 3 months, for a total of 25 treatments over 26 weeks.
The validated sham acupuncture intervention consisted of the tapping of needles, without insertion, at the same acupuncture points, insertion of needles at 2 nonacupuncture points on the abdomen, and a mock TENS unit was applied to the infrapatellar point.
Patients randomized to the education group underwent the Arthritis Self-Help course attending 2 hours of classes weekly for 12 weeks and had monthly telephone calls for the duration of the study.
The primary outcome measures were the pain and function subscales of the Western Ontario and McMasters Universities (WOMAC) OA index. Ranges for the pain subscale are 0- 20, while those for the function subscale are 0–68.
By week 26 significant differences in pain and function were seen for the true acupuncture group compared to the sham acupuncture group. (See box.)
On secondary outcome measures, statistically significant differences were seen on patient global assessment between the true and sham acupuncture groups, though not on the SF-36 subscale or the 6-minute walk test, he said.
“The effect size is rather small, at about .25,” Dr. Hochberg said. This is similar to that reported for intra-articular injections of hyaluronic acid (JAMA 2003; 290:3115–21).
Adverse events were uncommon and did not differ by treatment group. No adverse events were attributed to acupuncture.
This “is clearly the most definitive study to date looking at acupuncture for arthritis and it supports the suggestion from previous, smaller and less well-designed trials that acupuncture can have adjunctive benefit in the management of osteoarthritis pain,” Sharon Kolasinski, M.D., noted in an interview.
“Certainly, this study strengthens the argument that it is reasonable to consider acupuncture among the adjunctive therapies available to us for management of osteoarthritis pain,” said Dr. Kolasinski, chief of clinical services in the Department of Rheumatology at the University of Pennsylvania. Although the effect size was small, Dr. Kolasinski emphasized that the patients were already being treated by standard interventions and still had inadequate control of symptoms.
“Despite the fact that it's a small effect size, one must recognize that this is added onto background therapy, which in the majority of these patients included NSAIDs with or without additional analgesics,” Dr. Hochberg added.
A repeated measures analysis was conducted in order to “look at the pattern of response, and we anticipated that we would see a similar early response to sham and traditional acupuncture, corresponding to the placebo effect, and that the curves would then separate out over time,” he said.
Dr. Kolasinski added that a second NIH-funded trial currently being conducted at the University of Pennsylvania comparing physical therapy to physical therapy plus acupuncture for osteoarthritis of the knee “should give us additional information about the optimal use of acupuncture for osteoarthritis.
