Abstract

In evidence-based medicine, randomized controlled trials (RCTs) are the preferred method for evaluating the efficacy of interventions. In regard to acupuncture RCTs, the most difficult issues are the design of the control group and implementation of the principle of “double-blinding.” We compared the advantages and limitations associated with different control group designs in acupuncture RCTs, to assist researchers in this field.

Highlights

  • In regard to acupuncture randomized controlled trials (RCTs), the most difficult issues are the design of the control group and implementation of the principle of “double-blinding.”

  • We compared the advantages and limitations associated with different control group designs in acupuncture RCTs, to assist researchers in this field

  • We list 11 different designs and four strategies associated with control group design in acupuncture RCTs

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Summary

Introduction

In 1979, the World Health Organization (WHO) issued its first report on traditional medicine and described 43 categories of symptoms treatable by acupuncture; in 1996, the list was expanded to 64 [2]. This fact alone shows the value of acupuncture worldwide. In 1995, the WHO “Guidelines for Clinical Research on Acupuncture” [3] stipulated three criteria for good acupuncture studies: validity, reliability, and statistical significance (P value). At every stage of research, from basic studies to clinical trials, these criteria are paramount in any attempt to explain the function and effect of acupuncture

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