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Background  Acupuncture has been widely used in the management of a variety of diseases for thousands of years, and many relevant randomized controlled trials have been published. In recent years, many randomized controlled trials have provided controversial or less-than-convincing evidence that supports the efficacy of acupuncture. The clinical effectiveness of acupuncture in Western countries remains controversial.    Discussion  Acupuncture is a complex intervention involving needling components, specific non-needling components, and generic components. Common problems that have contributed to the equivocal findings in acupuncture randomized controlled trials were imperfections regarding acupuncture treatment and inappropriate placebo/sham controls. In addition, some inherent limitations were also present in the design and implementation of current acupuncture randomized controlled trials such as weak external validity. The current designs of randomized controlled trials of acupuncture need to be further developed. In contrast to examining efficacy and adverse reaction in a “sterilized” environment in a narrowly defined population, real world research assesses the effectiveness and safety of an intervention in a much wider population in real world practice. For this reason, real world research might be a feasible and meaningful method for acupuncture assessment.    Summary  Randomized controlled trials are important in verifying the efficacy of acupuncture treatment, but the authors believe that real world research, if designed and conducted appropriately, can complement randomized controlled trials to establish the effectiveness of acupuncture. Furthermore, the integrative model that can incorporate randomized controlled trial and real world research which can complement each other and potentially provide more objective and persuasive evidence.

Real world research: a complementary method to establish the effectiveness of acupuncture