pain relief and improves function for people with osteoarthritis of the
knee and serves as an effective complement to standard care. This
landmark study was funded by the National Center for Complementary and
Alternative Medicine (NCCAM) and the National Institute of Arthritis
and Musculoskeletal and Skin Diseases (NIAMS), both components of the
National Institutes of Health. The findings of the study — the longest
and largest randomized, controlled phase III clinical trial of
acupuncture ever conducted — were published in the December 21, 2004, issue of the Annals of Internal
The multi-site study team, including
rheumatologists and licensed acupuncturists, enrolled 570 patients,
aged 50 or older with osteoarthritis of the knee. Participants had
significant pain in their knee the month before joining the study, but
had never experienced acupuncture, had not had knee surgery in the
previous 6 months, and had not used steroid or similar injections.
Participants were randomly assigned to receive one of three treatments:
acupuncture, sham acupuncture, or participation in a control group that
followed the Arthritis Foundation's self-help course for managing their
condition. Patients continued to receive standard medical care from
their primary physicians, including anti-inflammatory medications, such
as COX-2 selective inhibitors, non-steroidal anti-inflammatory drugs,
and opioid pain relievers.
"For the first time, a clinical trial with
sufficient rigor, size, and duration has shown that acupuncture reduces
the pain and functional impairment of osteoarthritis of the knee," said
Stephen E. Straus, M.D., NCCAM Director. "These results also indicate
that acupuncture can serve as an effective addition to a standard
regimen of care and improve quality of life for knee osteoarthritis
sufferers. NCCAM has been building a portfolio of basic and clinical
research that is now revealing the power and promise of applying
stringent research methods to ancient practices like acupuncture."
"More than 20 million Americans have
osteoarthritis. This disease is one of the most frequent causes of
physical disability among adults," said Stephen I. Katz, M.D., Ph.D.,
NIAMS Director. "Thus, seeking an effective means of decreasing
osteoarthritis pain and increasing function is of critical importance."
During the course of the study, led by Brian M.
Berman, M.D., Director of the Center for Integrative Medicine and
Professor of Family Medicine at the University of Maryland School of
Medicine, Baltimore, Maryland, 190 patients received true acupuncture
and 191 patients received sham acupuncture for 24 treatment sessions
over 26 weeks. Sham acupuncture is a procedure designed to prevent
patients from being able to detect if needles are actually inserted at
treatment points. In both the sham and true acupuncture procedures, a
screen prevented patients from seeing the knee treatment area and
learning which treatment they received. In the education control group,
189 participants attended six, 2-hour group sessions over 12 weeks
based on the Arthritis Foundation's Arthritis Self-Help Course — a
proven, effective model.
On joining the study, patients' pain and knee
function were assessed using standard arthritis research survey
instruments and measurement tools, such as the Western Ontario
McMasters Osteoarthritis Index (WOMAC). Patients' progress was assessed
at 4, 8, 14, and 26 weeks. By week 8, participants receiving
acupuncture were showing a significant increase in function and by week
14 a significant decrease in pain, compared with the sham and control
groups. These results, shown by declining scores on the WOMAC index,
held through week 26. Overall, those who received acupuncture had a 40
percent decrease in pain and a nearly 40 percent improvement in
function compared to baseline assessments.
"This trial, which builds upon our previous
NCCAM-funded research, establishes that acupuncture is an effective
complement to conventional arthritis treatment and can be successfully
employed as part of a multidisciplinary approach to treating the
symptoms of osteoarthritis," said Dr. Berman.
Acupuncture — the practice of inserting thin
needles into specific body points to improve health and well-being —
originated in China more than 2,000 years ago. In 2002, acupuncture was
used by an estimated 2.1 million U.S. adults, according to the Centers for Disease Control and
Prevention's 2002 National Health Interview Survey**. The
acupuncture technique that has been most studied scientifically
involves penetrating the skin with thin, solid, metallic needles that
are manipulated by the hands or by electrical stimulation. In recent
years, scientific inquiry has begun to shed more light on acupuncture's
possible mechanisms and potential benefits, especially in treating
painful conditions such as arthritis.
Center for Complementary and Alternative Medicine (NCCAM) is dedicated
to exploring complementary and alternative medical (CAM) practices in
the context of rigorous science, training CAM researchers, and
disseminating authoritative information to the public and
professionals. For additional information, call NCCAM's Clearinghouse
toll free at 1-888-644-6226, or visit the NCCAM Web site at nccam.nih.gov.
of the National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) is to support research into the causes, treatment, and
prevention of arthritis and musculoskeletal and skin diseases, the
training of basic and clinical scientists to carry out this research,
and the dissemination of information on research progress in these
diseases. For additional information, call NIAMS's Clearinghouse toll
free at 1-877-22-NIAMS, or visit the NIAMS Web site at www.niams.nih.gov.
* Berman BM, Lao L, Langenberg P, Lee WL,
Gilpin AMK, Hochberg MC. Effectiveness of Acupuncture as Adjunctive
Therapy in Osteoarthritis of the Knee: A Randomized, Controlled Trial. Annals
of Internal Medicine. 2004; 141(12):901-910.
** Barnes P, Powell-Griner E, McFann K,
Nahin R. CDC Advance Data Report #343. Complementary and
Alternative Medicine Use Among Adults: United States, 2002. May 27, 2004.