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Project Concept Review
Project Title: Complex Botanical Interactions
Office Submitting: National Center for Complementary and Alternative Medicine
Project Officer:
Shan Wong, Ph.D.
Phone: 301-496-7498
E-mail: shanw@mail.nih.gov
This project concept document describes proposed research. Project concepts are presented for review and comment to the National Advisory Council for Complementary and Alternative Medicine during its open session meeting. Therefore, this is a public document. It is not a solicitation for applications. Depending on the Council's recommendations and other considerations, a solicitation may or may not result. Any solicitation that does result may be different from the proposed research described in this document. The NCCAM project officer is not at liberty to discuss the solicitation until after it is released.
Background
Complementary and alternative systems of medicine involve, and the American public routinely uses, complex botanical products and combinations of plant species for health maintenance, disease prevention, and as treatments. There is an underlying system of belief, yet a relatively small amount of supportive evidence based on biomedical research, that the polypharmacy of complex botanicals provides distinct advantages over single-ingredient drugs. One underlying, theoretical paradigm is that primary active ingredients in complex botanicals act synergistically with secondary compounds. A second paradigm is that secondary compounds mitigate the undesirable side effects caused by the predominant active ingredients. Another possibility is that multiple ingredients act through multiple discrete pathways to therapeutically impact the host, and that lower concentrations of each of the botanicals can therefore be more efficacious when used together than they would be individually. If true, these theories could explain and justify complex botanical actions in single and multiple species usages, and thus studies are needed to demonstrate the mechanisms of action and veracity of these therapeutic usages of complex mixtures.
Purpose of Proposed Initiative
The proposed initiative is expected to stimulate investigator-initiated biomedical research on complex botanical interactions in vitro, in animal models, and in Phase I/II clinical studies. The patient-based studies are expected to examine the uptake, bioavailability, pharmacodynamics, pharmacokinetics, and efficacy (Phase II only) of the complex botanical(s) compared to these parameters when the single product or ingredient is administered alone. Given the widespread use of so many complex botanical products, the findings from a series of prospective studies would help to provide the public and health professionals with the information necessary to make appropriate treatment choices.
These studies will help to elucidate
- Whether complex botanical preparations from an individual species have advantages over single ingredient (purified) products derived from the same species.
- Whether the therapeutic application of combinations of complex products derived from different botanical species has a rational basis.
Objectives
This initiative is designed to stimulate investigator-initiated basic (mechanistic) and/or clinical studies to better understand the scientific bases for the therapeutic use of complex botanicals by increasing the amount and quality of biomedical research in this field. The initiative will include studies on the rationales for the use of complex products from a single plant species and studies to evaluate the mechanisms of action and to help establish the rational bases for the belief in the therapeutic efficacy of using multiple plant species simultaneously.
Significance
The widespread use of complex botanical products and combinations of complex botanicals by the public and the emphasis on complex botanical use in traditional systems of medicine have historically been based on pragmatic observation versus systematic evaluation. This initiative is designed to help provide insights into the mechanisms of action of complex botanicals and to help determine which combinations are truly likely to be efficacious.
Proposed Funding Mechanisms
An RFA for R21 (Exploratory/Developmental) and R01 (Research Project) Grants is proposed.
Proposed Funding
$4.3M total costs in the first year.
