S09: Real World Studies of Complementary and Alternative Medicine:  Rigorous Study Designs that Increase Generalizability

Wendy Weber1, Peter Wayne2, William Elder3, Leanna Standish4

1National Center for Complementary and Alternative Medicine, National Institutes of Health, USA; 2Osher Center for Integrative Medicine, Division of Preventive Medicine Brigham and Women's Hospital and Harvard Medical School, USA;3University of Kentucky Chandler Medical Center, USA; 4Bastyr University Research Institute, USA


Complementary and alternative medicine practices are widely utilized by the American public, with approximately 38% of Americans reporting the use of a CAM therapy in the last 12 months.  Attempts to study CAM therapies in randomized controlled studies may require aspects of the intervention to be modified in order to facilitate blinding or simplify a particular intervention.  Because of this, many CAM practitioners have difficulty relating the results of tightly controlled efficacy studies to their clinical practice.  This workshop will begin with an introduction from the Division of Extramural Research at the National Center for Complementary Medicine, describing how natural experiments of CAM use can be leveraged to provide scientific data and how real world studies of CAM interventions can be can be designed to minimize bias in outcomes studies.  This introduction will be followed by presentations from three NCCAM funded investigators that will provide examples of rigorous research study designs allowing the testing of real worldCAM therapies. Dr. Peter Wayne will summarize his experience establishing and utilizing a network of Boston-based Tai Chi schools for a pragmatic randomized trial evaluating Tai Chi for post-menopausal osteopenic women.   Dr. Wayne will discuss the rationale, successes, challenges, and lessons learned in utilizing a pragmatic vs. protocol-specific interventions.  Dr. William Elder will describe his experience using the University of Kentucky practice based research network (PBRN) to study referral patterns and outcomes of mind-body and clinical massage therapy interventions for chronic low back pain. Dr. Elder will describe his research design and methods, which employ techniques specific to ambulatory practices; the research questions that can be answered from this design; and successes and challenges encountered during the study.  Finally, Dr. Leanna Standish will present the challenges experienced and solutions developed in conducting a matched controlled outcomes studies to evaluate the impact of integrated oncology care in patients with breast cancer.   She will describe the benefits and challenges of using a patient registry as a source of matched controls.  Presentations will be followed by ample time for discussion with the audience about the research design options to study real world CAM practice and utilization.