Designing a Clinical Trial on Qigong Therapy: Hospital Rehabilitation of Cardiac Patients

A nationally representative random household survey by Eisenberg and colleagues in 1998 suggested that energy healing is among the fastest growing demands among consumers in the United States. This form of complementary or alternative medicine includes such approaches as Reiki, Qigong, polarity therapy, pranic therapy, and therapeutic healing touch, which are believed to involve transfusion of energy through a therapist to patients. Yet, until recently there have been few clinical trials with sound research design investigating its clinical efficacy, risks, and cost-effectiveness. 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. The key lesson is that all parties involved in such research need to be open to different ideas because the encounter between Western science and forms of CAM such as energy healing takes places across cross-cultural and epistemological barriers. 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. These include: research emphasis on outcome vs. mechanism, staff and practitioner bias/conflict of interest, ethics/information consent, patients' belief, selection/consent bias, intent-to-treat analysis, sample size/power analysis, and premise in outcome report. All solutions were based on the experience of an interdisciplinary team of researchers. In conclusion, difficulties of energy healing trials lie in the study of a paradigm based on alternative health belief that remarkably differs from that of allopathic medicine. Clinical evaluation of energy healing, therefore, should allow both modality flexibility and method soundness and may eventually enrich methodologies used in clinical research on other treatments.