Designing clinical trials on energy healing: ancient art encounters medical science

Demand for energy healing is growing rapidly in the United States. Until recently, however, few clinical trials have been conducted to investigate its clinical efficacy, risks, and cost-effectiveness. This article discusses principles underlying the research design of clinical trials on energy healing, based on the experience of an interdisciplinary team conducting a large-sample clinical study on qigong funded by the National Institutes of Health. The first part overviews the background and contemporary practice of qigong therapy. The second addresses some difficulties and unique issues to be considered in designing a clinical trial on energy healing. These issues include research emphasis on outcome versus mechanism, randomization, control, expectations/placebo effects, staff and practitioner bias/conflict of interest, patients' belief, selection bias, intent-to-treat analysis, ethics, informed consent, sample size, and outcome report. The ultimate goal is to promote more scholarly and clinical discussion on the evaluation of energy healing.