Experiences of acupuncturists in a placebo-controlled, randomized clinical trial.
BACKGROUND
This paper describes the experiences of 8 licensed acupuncturists in a placebo-controlled randomized clinical trial (RCT). This information is important to the design and conduct of high-quality trials.


METHODS
We conducted a RCT (N=135) with a 2-week placebo run-in followed by 4 weeks of twice-weekly treatments comparing genuine to sham acupuncture (using the Streitberger placebo needle) in the treatment of arm pain caused by repetitive use. At the end of this study, we conducted written structured interviews with 8 participating acupuncturists. The acupuncturists were not aware of the study's results at the time of these interviews. The questions focused on their experiences in the study, adherence to study protocols, their thoughts about the technical and ethical issues involved in using a sham needling device, and their expectations of trial outcomes. The questions were motivated by expressions of concerns the acupuncturists raised in feedback groups during the course of the study, and our desire to improve further trials.


RESULTS
The acupuncturists differed widely in their comfort levels with the research methods used, their adherence to the study protocol, and their expectations of trial outcomes.


CONCLUSIONS
We conclude that careful monitoring of acupuncturists, including observation of treatments and frequent meetings to support them throughout the trial, is necessary to maintain a high degree of quality control.
McManus
Claire A
CA
Osher Institute, Harvard Medical School, Boston, MA 02115, USA. mcmanusacupuncture@mac.com
Kaptchuk
Ted J
TJ
Schnyer
Rosa N
RN
Goldman
Rose
R
Kerr
Catherine E
CE
Nguyen
Long T
LT
Stason
William B
WB
D026881:Acupuncture / Q000592:standards*; D015670:Acupuncture Therapy / Q000379:methods / Q000592:standards*; D000328:Adult; D001132:Arm; D001291:Attitude of Health Personnel; D002983:Clinical Competence; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059408:Pain Management; D018802:Patient-Centered Care / Q000592:standards; D010818:Practice Patterns, Physicians'; D011795:Surveys and Questionnaires