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

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

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

Research Issues in CAM Studies Type 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

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

Difficulty in Finding Benefit > Placebo GERAC trials—Multicenter trial Acu/LBP GERAC trials—Multicenter trial Acu/LBP Haake M et. al. Arch Internal Medicine (17): 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 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):

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

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

Biologically Based Tx Easiest to study in a RCT model Easiest to study in a RCT model Issues: 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 (8): good reference on supplements, through HSL-on-line: Natural Medicines Comprehensive Database

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

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

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

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

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