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![Page 1: Issues in Research Design for Complementary and Alternative Medicine Ronald Glick, MD Medical Director—CIM Assistant Professor of Psychiatry and PM&R University.](https://reader036.fdocuments.in/reader036/viewer/2022082709/56649da25503460f94a8fb29/html5/thumbnails/1.jpg)
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
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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
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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
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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
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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
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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.
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Domains of CAM (NCCAM)
• Whole (Alternative) Systems• Biologically Based Tx• Manipulative & Body Based• Mind-Body• Energetic
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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
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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
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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
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Mind-Body Approaches
• Generally look at a comparison group—e.g. Enhanced Usual Care
• Some areas, e.g. Biofeedback for Migraines no longer “Alternative”
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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
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Future Directions
• Focus on Physiologic Effects of Interventions
Functional imaging in acupuncture studies
Heart Rate Variability in Mind-Body Interventions
• Qualitative research• Pragmatic design
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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