Large study adds evidence that acupuncture is effective in OA

Janis Kelly

January 26, 2006

January 26, 2006

Munich, Germany - A "real-world" observational study of 736 osteoarthritis (OA) patients treated with acupuncture as part of routine clinical care by German doctors found statistically and clinically significant improvements in pain, disability, and quality of life both immediately after treatment and six months later. Dr Klaus Linde (Centre for Complementary Medicine at the Technical University of Munich, Germany) and colleagues report the study in the February 2006 issue of Rheumatology [ 1 ].

"The prior randomized controlled trials [ 3 , 4 ] and our study in routine care suggest that acupuncture is a useful adjunctive tool [in the treatment of OA]," Linde tells rheuma wire .


Observational study meant to determine insurance issues

The prior randomized controlled trials and our study in routine care suggest that acupuncture is a useful adjunctive tool [in the treatment of OA].

This analysis was based on data from a large observational study the German Federal Committee of Physicians and Statutory Sickness Funds will use to evaluate the efficacy of acupuncture in chronic osteoarthritis pain, chronic low back pain, and chronic headaches, with the goal of determining whether the statutory sickness funds should continue to pay for acupuncture treatments. The group of German statutory sickness funds participating in the study covers about one quarter of the German population, about 20 million people. Linde says that about half a million patients and 10,000 physicians participated in the study and that more than 61,000 of the patients (12.4%) had OA pain as the primary diagnosis.

Physicians were asked to screen the first six patients born in a specific month who presented with headache, chronic low back pain, or OA for inclusion in the observational study. Inclusion criteria included radiographically confirmed polyarthritis, primary hip OA, dysplastic hip OA, posttraumatic hip OA, other secondary hip OA, primary knee OA, posttraumatic knee OA, other secondary knee OA, thumb OA, and primary, posttraumatic, or other secondary OA of other joints. Inclusion criteria also included pain in the relevant joint for at least six months. Exclusion criteria included inflammatory polyarthritis and infectious arthropathy.

Patients completed modified versions of the Pain Questionnaire of the German Society for the Study of Pain (DGSS) before the first acupuncture session, after the last session, and six months after the first session. This included the Pain Disability Index (PDI), a scale for assessing sensory and affective aspects of pain, a depression scale, and the Short Form 36 (SF-36) to assess health-related quality of life. It also included rating scales for pain intensity and frequency. Patients with hip or knee OA also filled in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

The main outcome measures were average pain during the last four weeks on a numerical rating scale, the PDI, the physical-component scale from the SF-36, and the WOMAC sum score.

Of the 1443 identified OA patients, 1167 met the inclusion criteria, but only 736 patients (treated by 602 different physicians) had completed questionnaires at all three time points and were included in the analysis.

Patients received a mean of 8.7 acupuncture treatments, with a median treatment cycle duration of 43 days.


Patients report significant and durable improvement in OA pain

"After treatment and six months after inclusion, patients reported less pain, medication use, and disability; better physical health and mental health; better scores for sensory and affective aspects of pain; and lower depression scores. All changes were statistically highly significant (p<0.001) in all subgroups except for mental health in patients with hip osteoarthritis," the authors write.

When the last-value-carried-forward method was used to replace missing values to investigate the impact of the large loss to follow-up, the effect size changed somewhat but still remained statistically significant.

The observational study, which is notable for its size, adds to a growing body of evidence suggesting that acupuncture is associated with clinical improvements in OA patients. Both Linde and Dr Edzard Ernst (Peninsula Medical School, Exeter, UK), who wrote an accompanying editorial [ 2 ], strongly emphasize that these data do not prove that acupuncture causes the improvements. Ernst points out that the positive outcome could be due to either a placebo effect or a Hawthorne effect (the subject improves because he or she knows that improvement is expected by the investigator).

Linde also points out that, unlike the situation in many other countries, all of the patients in this study were treated by physicians with at least 140 hours of acupuncture training. In the US, by contrast, an OA patient seeking acupuncture is more likely to be treated by a practitioner who is not a physician but who may have a much higher level of training in acupuncture.

In the editorial, Ernst says, "Participating doctors as well as patients knew that the results of these evaluations would determine whether or not acupuncture would be refunded in future. It is, I think, unlikely that their judgments regarding the effects of acupuncture were not influenced by this knowledge."

However, Linde tells rheuma wire that this was not the situation. "Most patients were not aware of the framework situation," Linde says. "And for physicians, the situation was problematic: on one hand, they have an interest in showing that their work is effective, but, on the other, most do not want acupuncture to become a part of routine reimbursement, because the fee would decrease considerably."

 

Sources

1. Linde K, Weidenhammer W, Streng A, et al. Acupuncture for osteoarthritis pain: an observational study in routine care. Rheumatology 2006; 45:222-227.

2. Ernst E. Testing acupuncture for osteoarthritis: pragmatic trials or efficacy studies? Rheumatology 2006; 45:125.

3. Berman BM, Lao L, Langenberg P, et al. Effectiveness of acupuncture as adjunctive therapy in osteoarthritis of the knee. A randomized controlled trial. Ann Intern Med 2004; 141:901-910.

4. Ezzo J, Hadhazy V, Birch S, et al. Acupuncture for osteoarthritis of the knee. A systematic review. Arthritis Rheum 2001; 44:819-825.


 

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