RESEARCH METHODOLOGY POSTER PRESENTATION ABSTRACTS
Please note: All posters will be displayed in
Salons 10-12.
FRIDAY, 5:45-6:30 PM
Cardini F, Wade C*.
Clinical research in Traditional Medicine: priorities
and methods.
University of Verona—Italy. Rosenthal Center,
Columbia University Ð USA. cardinif@internetstudio3.it
*Presenting author
PURPOSE: Migration patterns and consumer and
industry-driven market forces contribute to the distribution of traditional
treatments globally, but do not necessarily ensure their usefulness
or safety. WHO estimates that up to 80% of the world's population use
Traditional Systems of Medicine as primary healthcare. In consideration
of the wide spread use and potential for impact of Traditional Systems
of Medicine on global public health, the international scientific community
is obliged to evaluate the safety and efficacy of traditional medicine
(TM) treatments. Clinical evaluations of traditional treatments, however,
pose complex methodological and practical challenges.
METHODS: To address these challenges, we offer
consideration of a rationale schema based on the experience of conducting
several studies collaboratively with researchers in China.(1,2,3) We
extend and adapt a framework proposed by NCCAM in 2001 to identify and
prioritize research in complementary and alternative medicine (4) in
particular consideration of TM. Patient and clinician need(s) for knowledge
about treatments which already have extensive use and may be standard
of care, are proposed as the crucial organizing factor for study design.
CONCLUSION: A "rational sequence of phases of
clinical research and models for study of Traditional Medicine", can
serve as a strategy for evaluating treatments coming from complex and
widely used TM systems (for example: Traditional Chinese Medicine).
Evaluations of traditional treatments are best addressed first by collaborative,
international, pragmatic studies. Protocols for observational, prospective,
pragmatic studies should be designed collaboratively and executed simultaneously
in the originating healthcare culture and in new contexts. Such research
programs, in turn, could determine the usefulness and feasibility of
larger (Phase II and III) randomized clinical trials (RCTs). Explanatory
trials, with placebo controls, and clinical or basic science studies
of mechanism should be a secondary approach. In addition to evaluating
safety and efficacy, international multi-center pragmatic RCTs also
provide information on the transferability of a traditional treatment
across social and cultural contexts.
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