German Acupuncture Trials (Gerac) For Chronic Low Back Pain<subtitle>Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups</subtitle>

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 Ͻ .001);and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P Ͻ.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.