P05.02
Purpose: A novel study methodology for complementary and alternative medicine's mind and body interventions (CAM-MABI) is presented here. CAM-MABI have been hindered not only by the inability to mask participants and their teachers to the study intervention but also by the major practical hurdles of long-term study of practices that can be lifelong. Two other important methodological problems are that study of newly trained practitioners cannot directly address long-term practice and that long-term practitioners likely self-select in ways that make finding appropriate controls (or a comparison group) challenging.
Methods: Temporary practice pause then resumption study design (TPPR) introduced here is a new tool that extends the withdrawal study design, established in the field of drug evaluation, to the CAM-MABI field. With the exception of the inability to mask, TPPR can address the other methodological problems noted above. In a randomized withdrawal trial, subjects receiving a test treatment for a specified time are randomly assigned to continued treatment with the test treatment or to withdrawal. Any difference that emerges between the group receiving continued treatment and the group randomized to placebo would demonstrate the effect of the active treatment. A critically important component of TPPR is studying the resumption of practice after the pause.
Results: The randomized withdrawal study design is included as a valid methodology by the U.S. FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. A real-world example is provided. Of great interest to investigators will likely be measures in practitioners of CAM-MABI that change with temporary pausing of CAM-MABI practice, followed by return of the measures to pre-pause levels with resumption of practice; this would suggest a link of the practice to measured changes.
Conclusion: Study findings using TPPR may enhance our insight into fundamental biological processes, leading to beneficial practical applications.
Contact: M. Miles Braun, miles.braun@yahoo.com
