 |
The 130th Annual Meeting of APHA |
|
The 130th Annual Meeting of APHA |
Sara Warber, MD1, Brenda Gillespie, PhD2, Amy L. Ai, PhD3, Elena Gillespie1, Christopher Peterson, PhD4, and Steven F. Bolling, MD5. (1) Complementary and Alternative Medicine Research Center, University of Michigan, 715 E. Huron St. Suite 1W, Ann Arbor, MI 48104, (2) Center for Statistical Consultation and Research, University of Michigan, 3514 Rackham Building, Ann Arbor, MI 48109-1070, 734 647 4609, swarber@umich.edu, (3) Health Sceince System, University of Washington & University of Michgan CAM Research Center, 4101 15th Ave. NE, Seattle, WA 98105-6299, (4) Dept. of Psychology, University of Michgin, East Hall, E. University, Ann Arbor, MI 48109-1106, (5) Dept. of Surgery, Department of Surgery, 2120B Taubman Center, Medical Center Ave, U of Michigan Medical Center, Ann Arbor, MI 48109
In complementary and alternative medicine, biofield energy therapies such as Therapeutic Touch, Reiki, and Qigong are potential treatments for anxiety, wound healing, and pain. Testing these modalities in randomized clinical trials (RCTs) requires appropriate placebo control for everything other than the active ingredient of the therapy: the therapist's intention to heal the patient and manipulation of energy to achieve this end. Other elements of the therapist/patient interaction include the presence of a human in the room, the effect of movements or touch, the relationship between the therapist and patient, and the patient's expectation of healing. We have designed two RCTs in energy therapy, each with placebo controls. One trial involves Reiki therapy for diabetic neuropathy patients, with 16 weekly 30-minute sessions. All "therapists" wear headphones. Placebo therapists, actors trained in the body movements of Reiki, hear instructional tapes that focus their attention away from the subject. The other trial involves Qigong therapy for cardiac surgery patients, with 4 daily one-hour sessions post surgery. The Qigong therapists screened the placebo therapists to verify their inability to transmit Qi energy, and instructed them in hand movements. No headsets were used because no matter what the intentionality, these therapists have no skill in energy transmission. To control for patient expectation, all subjects were told that they would receive one of two forms of the energy therapy. We conclude that careful attention to placebo design for RCTs of biofield energy therapies provides data from which valid inferences can be drawn about efficacy.
Learning Objectives:
Keywords: Clinical Trails, Diabetes
Presenting author's disclosure statement:
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.