Acupuncture and knee osteoarthritis: a three-armed randomized trial.
BACKGROUND
Despite the popularity of acupuncture, evidence of its efficacy for reducing pain remains equivocal.


OBJECTIVE
To assess the efficacy and safety of traditional Chinese acupuncture (TCA) compared with sham acupuncture (needling at defined nonacupuncture points) and conservative therapy in patients with chronic pain due to osteoarthritis of the knee.


METHODS
Randomized, controlled trial.


METHODS
315 primary care practices staffed by 320 practitioners with at least 2 years' experience in acupuncture.


METHODS
1007 patients who had had chronic pain for at least 6 months due to osteoarthritis of the knee (American College of Rheumatology [ACR] criteria and Kellgren-Lawrence score of 2 or 3).


METHODS
Up to 6 physiotherapy sessions and as-needed anti-inflammatory drugs plus 10 sessions of TCA, 10 sessions of sham acupuncture, or 10 physician visits within 6 weeks. Patients could request up to 5 additional sessions or visits if the initial treatment was viewed as being partially successful.


METHODS
Success rate, as defined by at least 36% improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 26 weeks. Additional end points were WOMAC score and global patient assessment.


RESULTS
Success rates were 53.1% for TCA, 51.0% for sham acupuncture, and 29.1% for conservative therapy. Acupuncture groups had higher success rates than conservative therapy groups (relative risk for TCA compared with conservative therapy, 1.75 [95% CI, 1.43 to 2.13]; relative risk for sham acupuncture compared with conservative therapy, 1.73 [CI, 1.42 to 2.11]). There was no difference between TCA and sham acupuncture (relative risk, 1.01 [CI, 0.87 to 1.17]).


CONCLUSIONS
There was no blinding between acupuncture and traditional therapy and no monitoring of acupuncture compliance with study protocol. In general, practitioner-patient contacts were less intense in the conservative therapy group than in the TCA and sham acupuncture groups.


CONCLUSIONS
Compared with physiotherapy and as-needed anti-inflammatory drugs, addition of either TCA or sham acupuncture led to greater improvement in WOMAC score at 26 weeks. No statistically significant difference was observed between TCA and sham acupuncture, suggesting that the observed differences could be due to placebo effects, differences in intensity of provider contact, or a physiologic effect of needling regardless of whether it is done according to TCA principles.
Scharf
Hanns-Peter
HP
University of Heidelberg, Heidelberg, Germany.
Mansmann
Ulrich
U
Streitberger
Konrad
K
Witte
Steffen
S
Krämer
Jürgen
J
Maier
Christoph
C
Trampisch
Hans-Joachim
HJ
Victor
Norbert
N
D015670:Acupuncture Therapy / Q000009:adverse effects; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000150:complications*; D010146:Pain / Q000209:etiology; D059408:Pain Management; D010147:Pain Measurement; D010349:Patient Compliance; D026741:Physical Therapy Modalities / Q000009:adverse effects; D011446:Prospective Studies; D016037:Single-Blind Method
D000893:Anti-Inflammatory Agents