Issues in Research Design for Complementary and Alternative Medicine

1. Issues in Research Design for Complementary and Alternative Medicine Ronald Glick, MD Medical Director—CIM Assistant Professor of Psychiatry and PM&R University of Pittsburgh School of Medicine

2. Clash of Cultures • Gold standard of research is ___ • 1 issue Double Standard • Many Western therapies don’t meet this Arthroscopy for Knee OA Moseley JB et. al NEJM 2002 347(2): 81-8 3 groups: Debridement, Lavage, & Sham Results: No differences in pain or fxn

3. Research Issues in CAM Studies Type 1 Error • Greatest concern is not having a believable control • Cultural factors—eg expectation effect of an acupuncture study will likely be high in China

4. Research Issues in CAM StudiesType 2 Errors • Placebo is ___ & ___ • Having an “ert” placebo • Acupuncture—common control superficial needling of non-acu points—DNIC • Watering down a therapy so that it’s standardized—eg cook-book acupuncture points for IBS rather than an individualized protocol based on pulse & tongue dx • Non-specific effects of support of being in a study

5. Western-Designed StudyAcupuncture for IBS • Look at acupuncture only—no herbs • No individual TCM Diagnosis • Diarrhea vs Constipation predominant may have correlate in TCM • Pick standardized points for everyone • No flexibility to modify approach, unless built into the protocol that specific points can be added, e.g. for nausea or TCM Dx

6. Difficulty in Finding Benefit > Placebo • GERAC trials—Multicenter trial Acu/LBP Haake M et. al. Arch Internal Medicine 2007 167(17): 1892-8 340 practices in Germany & 1100 patients Subjects randomized to TCM acupuncture, Sham acupuncture, or PT/MD contact Tx response at 6 months 48%, 44%, & 27 • More recent meta-analysis-4 groups statisitcal but not clinical difference acupuncture vs. control Vickers AJ, Cronin AM, Maschino AC, et al. Acupuncture for Chronic Pain: Individual Patient Data Meta-analysis. Arch Intern Med. 2012;172(19):1444-1453.

7. Domains of CAM (NCCAM) • Whole (Alternative) Systems • Biologically Based Tx • Manipulative & Body Based • Mind-Body • Energetic

8. Whole Systems • Each have an understanding of health & disease, pathophysiology, & pathogenesis • When you draw the Venn Diagram, there may be some overlap with Western Medicine • Since Dx (eg in TCM) may not concur with Western Dx, difficult to study in Western model • Often too many variables for Western study

9. Biologically Based Tx • Easiest to study in a RCT model • Issues: Standardization of plant extract Isolate out specific agent vs. extract e.g. with ginkgoids Potential for impurities or contaminants Pick the right 1—Glucosamine/Chondroitin Clegg DO et. al. NEJM 2006 354(8): 795-808 1 good reference on supplements, through HSL-on-line: Natural Medicines Comprehensive Database

10. Manipulative & Body Based Tx • Similar issue to acupuncture in finding an inert & believable placebo • Hard to find people naïve to chiropractic • If you position a person like you would for DC manipulation—mobilization without impulse • Activator is a consideration, which can be rigged to not deliver any force • Most of the studies look at other comparison group

11. Mind-Body Approaches • Generally look at a comparison group—e.g. Enhanced Usual Care • Some areas, e.g. Biofeedback for Migraines no longer “Alternative”

12. Energetic Therapies • Energetic fields/healing, e.g. Therapeutic Touch/Reiki • External magnetic fields, e.g. static magnets in a lumbar support • Most difficult to study with a plausible inert control

13. Future Directions • Focus on Physiologic Effects of Interventions • Functional imaging in acupuncture studies • Heart Rate Variability in Mind-Body Interventions • Qualitative research • Pragmatic design

15. Design Your Own Study • Pick a condition you’d like to treat • What commonalities do these have • Pick a modality to study • What leads you to choose that approach • Benefits & shortcomings with this approach