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Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups

Michael Haake, PhD, MD; Hans-Helge Müller, PhD; Carmen Schade-Brittinger; Heinz D. Basler, PhD; Helmut Schäfer, PhD; Christoph Maier, PhD, MD; Heinz G. Endres, MD; Hans J. Trampisch, PhD; Albrecht Molsberger, PhD, MD

Arch Intern Med. 2007;167(17):1892-1898.

Background  To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain.

Methods  A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean ± SD age, 50 ± 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement.

Results  At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, –3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P < .001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P < .001.

Conclusions  Low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.

Author Affiliations: Orthopedic Department, University of Regensburg, Bad Abbach, Germany (Dr Haake); Institutes for Medical Biometry and Epidemiology (Drs Müller and Schäfer) and Medical Psychology (Dr Basler) and Centre for Clinical Trials (Ms Schade-Brittinger), Philipps-University Marburg, Marburg, Germany; Departments of Pain Management, BG-Kliniken Bergmannsheil (Dr Maier) and Medical Informatics, Statistics and Epidemiology, Ruhr-University Bochum, Bochum, Germany (Drs Endres and Trampisch); and Centre for Clinical Acupuncture and Research, Düsseldorf, Germany (Dr Molsberger).

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