Acupuncture plus routine care were effective in controlling the pain of knee and hip osteoarthritis (OA), and results were maintained for 6 months, according to the results of a randomized controlled trial reported in the October 30 Early View issue of Arthritis & Rheumatism.

"In routine care, a broad variety of acupuncture styles is used, and acupuncture is often administered in conjunction with other treatments," write Claudia M. Witt, MD, of the Charité University Medical Center in Berlin, Germany, and colleagues. "To date there has been little information about the effectiveness of acupuncture treatment provided as an adjunct to routine medical care.... Based in part on the results of the present study, the German Federal Committee of Physicians and Health Insurers proposed in April 2006 that acupuncture will be reimbursed by statutory health insurance funds."

This study enrolled 3633 patients with chronic pain due to OA of the knee or hip, of whom 357 were randomized to receive up to 15 sessions of acupuncture in a 3-month period; 355 were randomized to a control group receiving no acupuncture; and 2921 did not consent to randomization and underwent acupuncture treatment. Mean age was 61.8 ± 10.8 years; and 61% of patients were female. All patients received usual medical care in addition to the study treatment. Outcome measures were clinical OA severity (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and health-related quality of life (Short-Form 36) at baseline and after 3 and 6 months of treatment.

At 3 months, the mean WOMAC had improved by 17.6 ± 1.0 in the acupuncture group and by 0.9 ± 1.0 in the control group (3-month scores, 30.5 ± 1.0 vs 47.3 ± 1.0; difference in improvement, 16.7 ± 1.4; P < .001). Quality-of-life improvements were also more dramatic in the acupuncture group than in the control group (P < .001). These improved outcomes with acupuncture were maintained for 6 months, and they were comparable to those of nonrandomized patients who received acupuncture.

"These results indicate that acupuncture plus routine care is associated with marked clinical improvement in patients with chronic OA-associated pain of the knee or hip," the authors write. "Physician characteristics, such as the level of formal acupuncture training or certification, did not influence treatment outcomes."

Study limitations include lack of blinding, treatment regimens varying greatly among patients, broad inclusion criteria with possibly some diagnostic misclassification, and the indicators used might not adequately reflect the quality of treatment delivered by the clinician.

"Acupuncture should be considered as a treatment option for patients with knee or hip OA-associated chronic pain," the authors conclude.

Various statutory health insurance funds in Germany supported this study (Techniker Krankenkasse, Betriebskrankenkasse [BKK] Aktiv, Bosch BKK, DaimlerChrysler BKK, Bertelsmann BKK, BKK BMW, Siemens-Betriebskrankenkasse, BKK Deutsche Bank, BKK Hoechst, HypoVereinsbank BKK, Ford BKK, Betriebskrankenkasse der Allianz Gesellschaften, Vereins-und Westbank BKK, and Handelskrankenkasse, and Innungskrankenkasse Hamburg).

In an accompanying editorial, Tao Liu, MD, and Chen Liu, MD, of the 2nd Teaching Hospital, Jilin University in Changchun, People's Republic of China, note that acupuncture has a different conceptual and theoretical basis from that of biomedicine.

"In real-world primary care, few patients with OA seek acupuncture as the sole treatment, and due to the inconclusive information regarding its efficacy, acupuncture is very likely an undervalued treatment option as an element of a multidisciplinary integrative approach to treating this disorder," Drs. Liu and Liu write. "Given that the biologic mechanism of acupuncture is still unclear, the study by Witt et al furthers our understanding of acupuncture and adds to the accumulated evidence supporting its efficacy. Such evidence warrants extensive use of acupuncture in various chronic pain conditions."

Arthritis Rheum. Published online October 30, 2006.

Learning Objectives for This Educational Activity

Upon completion of this activity, participants will be able to:

• Compare the effect of acupuncture and usual care with usual care only on OA of the hip or knee.
• List predictors of good response to acupuncture in randomized vs nonrandomized patients with OA of the hip or knee.

Clinical Context

OA has a major impact on patient physical functioning and mobility, and the knee and hip are the most common sites, with anti-inflammatory drugs and surgery being treatment options. According to the current authors, there is some evidence that acupuncture compared with sham acupuncture is better at improving pain and function in OA of the knee, but there is little information on the use of acupuncture compared with usual care for knee or hip OA.

The current study is a combined open-randomized and nonrandomized trial comparing the use of acupuncture provided by clinicians combined with usual care for knee and/or hip OA. It was conducted on patients covered by a group of statutory health insurances and includes about 10% of the German population.

Study Highlights

• 1417 clinicians and 3553 patients were included in analysis.
• Inclusion criteria for patients were age 40 years or older, insured by one of the participating health insurance funds, presentation with OA of the knee or hip to a clinician, OA for at least 6 months, at least 15 days of pain in the preceding 30 days, and considered suitable for acupuncture by patient or clinician.
• Inclusion criterion for clinicians was an A-diploma in acupuncture (at least 140 hours of certified acupuncture training).
• Patients willing to be randomized were offered up to 15 acupuncture sessions during 3 months from their clinician.
• Patients not willing to be randomized also received up to 15 sessions of acupuncture from their own clinician during 3 months.
• Patient who were in the control group were permitted to be treated with acupuncture after 3 months.
• Data from 322 patients in the acupuncture, 310 in the control, and 2921 in the nonrandomized acupuncture group were analyzed.
• The number of needles used and acupuncture points were determined by the treating clinician, ie, individually determined protocols.
• Only single-disposable needle acupuncture was permitted. Laser and electroacupuncture and moxibustion were not permitted.
• Primary outcome was WOMAC index in the most painful joint at 3 and 6 months.
• Secondary outcomes were change in WOMAC index, percentage who showed improvement of at least 50% (treatment responders), and SF-36 score for health-related quality of life.
• Mean age of patients was 61 years, 60% were female, 16% had OA of the hip, 54% had OA of the knee, and 30% had both.
• The evaluated joint was 27% for the hip and 73% for the knee.
• 77% of patients underwent 5 to 10 sessions, 21% more than 10 sessions, and 2.2% had fewer than 5 sessions.
• At 3 months, the WOMAC index improved more for the randomized acupuncture than the control group, 30.5 vs 47.3 (difference between groups, 16.7; P < .001).
• The proportion of responders was 34.5% in the acupuncture vs 6.5% in the control group (P < .001).
• Results were similar in the OA hip and knee groups.
• There were no differences in proportion of patients prescribed medications for OA during the 3 months of randomization (36.2% vs 35.8%).
• At 3 months, improvements in the nonrandomized group were similar to those in the randomized acupuncture group (score, 30.3 vs 30.5).
• The proportion of responders in the nonrandomized group was 35.7% vs 34.5% in the randomized group (P = .660).
• Improvement in the WOMAC score was greater in those with younger age and with higher baseline physical or mental quality of life in all treatment groups.
• SF-36 score was significantly higher (P < .001) in the randomized and nonrandomized acupuncture groups, and the improvements were sustained at 6 months.

Pearls for Practice

• Acupuncture with usual treatment compared with usual treatment alone for hip or knee OA is associated with greater improvements in WOMAC and quality of life at 3 and 6 months than usual care alone.
• Predictors of good response to acupuncture treatment are younger age and better baseline quality of life in randomized and nonrandomized patients with hip or knee OA.