Issues in Research Design for Complementary and

Alternative Medicine

Ronald Glick, MDMedical Director—CIMAssistant Professor of Psychiatry and PM&R

University of Pittsburgh School of Medicine

Clash of Cultures

• Gold standard of research is ___• 1 issue Double Standard• Many Western therapies don’t meet

thisArthroscopy for Knee OA Moseley JB et. al NEJM 2002 347(2): 81-8

3 groups: Debridement, Lavage, & ShamResults: 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 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

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

Difficulty in Finding Benefit > Placebo• GERAC trials—Multicenter trial

Acu/LBPHaake M et. al. Arch Internal Medicine 2007 167(17): 1892-8

340 practices in Germany & 1100 patientsSubjects randomized to TCM acupuncture, Sham acupuncture, or PT/MD contactTx 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.

Domains of CAM (NCCAM)

• Whole (Alternative) Systems• Biologically Based Tx• Manipulative & Body Based• Mind-Body• Energetic

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

Biologically Based Tx

• Easiest to study in a RCT model• Issues:

Standardization of plant extractIsolate out specific agent vs. extracte.g. with ginkgoidsPotential for impurities or contaminantsPick the right 1—Glucosamine/ChondroitinClegg DO et. al. NEJM 2006 354(8): 795-8081 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

• 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

Mind-Body Approaches

• Generally look at a comparison group—e.g. Enhanced Usual Care

• Some areas, e.g. Biofeedback for Migraines no longer “Alternative”

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

Future Directions

• Focus on Physiologic Effects of Interventions

Functional imaging in acupuncture studies

Heart Rate Variability in Mind-Body Interventions

• Qualitative research• Pragmatic design

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