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

Michael Haake, PhD, MD; Hans-Helge MŸller, PhD; Carmen Schade-Brittinger; Heinz D. Basler, PhD; Helmut SchŠfer, 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. Nausea is hard to live with and can make us very uncomfortable. It is our bodyÕs way of telling us something is wrong or a change is happening. During pregnancy, morning sickness is natural and up to 70% of women suffer from nausea during this time. The good news is that acupuncture is very safe, and has a long tradition of helping with these symptoms.

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, Ð3.7% 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 MŸller and SchŠfer) 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, DŸsseldorf, Germany (Dr Molsberger).