Designing an acupuncture study: II. The nationwide, randomized, controlled German acupuncture trials on low-back pain and gonarthrosis.
BACKGROUND
In the nationwide German Acupuncture Trials (GERAC), verum acupuncture, mirroring the Traditional Chinese Medicine (TCM) acupuncture style, was tested against sham acupuncture and guideline standard therapy for the entities classified in the West as chronic low back pain (LBP) and gonarthrosis (GON).


OBJECTIVE
The objective was to develop broadly consensual acupuncture and control protocols for the treatment of LBP and GON in the GERAC trials.


METHODS
Extensive literature study and consultation with acupuncture experts were consulted. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used as well.


RESULTS
Broadly consensual acupuncture protocols for LBP and GON for verum and invasive sham acupuncture were developed. They included semistandardized point combinations with clearly described point selection rules based on TCM acupuncture diagnosis. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial.


CONCLUSIONS
With 1162 randomized patients for LBP and 1039 patients for GON, the GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of LBP and GON.
Molsberger
Albrecht F
AF
Acupuncture Research Group, Duesseldorf, Germany. a.molsberger@facm.de
Streitberger
Konrad
K
Kraemer
Juergen
J
Brittinger
Carmen Schade
CS
Witte
Steffen
S
Boewing
Gabriele
G
Haake
Michael
M
D015669:Acupuncture Points; D015670:Acupuncture Therapy / Q000592:standards*; D019091:Critical Pathways / Q000458:organization & administration*; D019317:Evidence-Based Medicine / Q000592:standards; D005260:Female; D005858:Germany; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D015337:Multicenter Studies as Topic / Q000592:standards; D020370:Osteoarthritis, Knee / Q000628:therapy*; D017410:Practice Guidelines as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D016896:Treatment Outcome