Abstract
Background To our knowledge, Bverum acupuncture has never been directly compared with sham dacupuncture and guideline-based conventional therapy in patients with cchronic low back pain. Methods A patient- and observerblinded 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 ain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the backspecific 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 = 0.39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4 to 26.7%; P = 0.001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P = 0.001. 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.
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