Until recently there have been few clinical trials with sound research design investigating the clinical efficacy, risks, and cost-effectiveness of Qigong, a type of energy healing. This presentation addresses the research design of a clinical trial on energy healing - the National Center for Complementary and Alternative Medicine (NC-CAM) funded, large sample (360 cases), randomized controlled trial on External Qigong Therapy and hospital rehabilitation of mid-life and older patients following cardiac surgery. The first part briefly overviews the general concept and background of Qigong and the history of the successfully funded grant proposal of this project. Based on the historical lesson of Franz Anton Mesmer in 18th century Europe and the rationale drawn from trials on contemporary psychotherapy, the second part of the presentation focuses on the unique role of expectations/placebo in energy healing trials in comparison with its presumably ineffective counterpart in conventional drug trials. This argument leads to methodological strategies for testing the placebo effect in its own right as a part of potential healing effects and of employing so-called sham or “mimic” therapy in a three-arm research design. Several specific problems in designing and implementing this “mimic” therapy are detailed. Finally, the third part discusses other issues that are uniquely raised in designing a clinical trial on energy healing and our resolutions of them.
Learning Objectives: Innovation of using RCT to evaluate alternative medicine demonstrated in a desig of a large sample trial funded by the NCCAM (patients following cardiac surgery)
Keywords: Clinical Trails, Alternative Medicine/Therapies
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: None
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.