ORIGINAL INVESTIGATION German Acupuncture Trials (GERAC) for.pdfVIP

ORIGINAL INVESTIGATION German Acupuncture Trials (GERAC) for Chronic Low Back Pain Randomized, Multicenter, Blinded, Parallel-Group Trial With 3 Groups Michael Haake, PhD, MD; Hans-Helge Mu¨ller, PhD; Carmen Schade-Brittinger; Heinz D. Basler, PhD; Helmut Scha¨fer, PhD; Christoph Maier, PhD, MD; Heinz G. Endres, MD; Hans J. Trampisch, PhD; Albrecht Molsberger, PhD, MD Background: To our knowledge, verum acupuncture better on the back-specific Hanover Functional Ability has never been directly compared with sham acupunc- Questionnaire. Patients who were unblinded or had re- ture and guideline-based conventional therapy in pa- course to other than permitted concomitant therapies dur- tients with chronic low back pain. ing follow-up were classified as nonresponders regard- less of symptom improvement. Methods: A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 out- Results: At 6 months, response rate was 47.6% in the patient practices, including 1162 patients aged 18 to verum acupuncture group, 44.2% in the sham acupunc- 86 years (mean±SD age, 50±15 years) with a history of ture group, and 27.4% in the conventional therapy group. chronic low back pain for a mean of 8 years. Patients un- Differences among groups were as follows: verum vs sham, derwent ten 30-minute sessions, generally 2 sessions per 3.4% (95% confidence interval, −3.7% to 10.3%; P =.39); week, of verum acupuncture (n=387) according to prin- verum vs conventional therapy, 20.2% (95% confidence ciples of traditional Chinese medicine; sham acupunc- interval, 13.4% to 26.7%; P .001); and sham vs con- ture (n=387) consistin