The Study of the Sham Acupuncture for Acupuncture Clinical Trials

침 임상시험 논문에 적용한 Sham Acupuncture에 대한 고찰

Objectives : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group or use another therapy for control group. So, we didn't say it was true acupuncture effect, though subjects in clinical study improved. Recently several sham needles for control group were developed and validated. This study aimed at summarizing the validation studies of these needles and evaluating the control group of the acupuncture clinical study. Methods : Computerized literature searches were performed using 'acupuncture' and 'placebo or sham' with a limitation of the results to RCTs in Pubmed, Sciencedirect, NDSL, KISS, RISS. Data were extracted regarding study design, sample size, acupuncture point, stimulation form, credibility testing. And We have examined 106 acupuncture clinical studies published by Pubmed from January 1, 2005 to April 30, 2008. Data were extracted author's country, subject of study, type of study groups, type of control groups, type of blinding, difference between the results in the control groups. Results : Streitberger's placebo needle, Fink's sham needle, Park sham needle, Kim sham needle were developed. They were validated at domestic and abroad. But the results were deviation depending on the each of the researcher. They has shown that sample, acupuncture points, experiences or knowledge of acupuncture dependent on the results. Recent three years, acupuncture clinical trial had different results. Significant differences between Study group and control group emerged from using other therapy or non-treatment for control group. Many study has no significant differences using sham acupuncture for control groups. Conclusions : Acupuncture clinical studies need to meet several requirements. First of all, they require the basics of randomized controlled clinical studies such as blinding and the accurate implementation and description of randomization. And also need to research the unique circumstances of these studies such as the development of sham acupuncture and blinding method which differs from other clinical trials.