Issues in Research Design for
Complementary and
Alternative Medicine
Medical Director—CIM
Assistant 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 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

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
• 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/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.

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 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

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