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.