TY - JOUR
T1 - Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials
T2 - Lessons Learned From Turmeric Trials
AU - Funk, Janet L.
AU - Schneider, Claus
N1 - Funding Information:
Work on botanicals including curcumin in the authors’ laboratories has been funded by the National Center for Complementary and Integrative Health (NCCIH) and the Office of Dietary Supplements (ODS) (R01AT006896, R34AT007837, R21AT003614, R21AT004182, R21AT005145, P50AT000474, F31AT004875, F31AT007287, and F31AT009938), the National Cancer Institute (R01CA174926 and R03CA159382), and the National Institute of Arthritis and Musculoskeletal and Skin Diseases (R21AR078424) at the National Institutes of Health (NIH).
Publisher Copyright:
Copyright © 2021 Funk and Schneider.
PY - 2021/12/3
Y1 - 2021/12/3
N2 - Plant-derived compounds, without doubt, can have significant medicinal effects since many notable drugs in use today, such as morphine or taxol, were first isolated from botanical sources. When an isolated and purified phytochemical is developed as a pharmaceutical, the uniformity and appropriate use of the product are well defined. Less clear are the benefits and best use of plant-based dietary supplements or other formulations since these products, unlike traditional drugs, are chemically complex and variable in composition, even if derived from a single plant source. This perspective will summarize key points–including the premise of ethnobotanical and preclinical evidence, pharmacokinetics, metabolism, and safety–inherent and unique to the study of botanical dietary supplements to be considered when planning or evaluating botanical clinical trials. Market forces and regulatory frameworks also affect clinical trial design since in the United States, for example, botanical dietary supplements cannot be marketed for disease treatment and submission of information on safety or efficacy is not required. Specific challenges are thus readily apparent both for consumers comparing available products for purchase, as well as for commercially sponsored vs. independent researchers planning clinical trials to evaluate medicinal effects of botanicals. Turmeric dietary supplements, a top selling botanical in the United States and focus of over 400 clinical trials to date, will be used throughout to illustrate both the promise and pitfalls associated with the clinical evaluation of botanicals.
AB - Plant-derived compounds, without doubt, can have significant medicinal effects since many notable drugs in use today, such as morphine or taxol, were first isolated from botanical sources. When an isolated and purified phytochemical is developed as a pharmaceutical, the uniformity and appropriate use of the product are well defined. Less clear are the benefits and best use of plant-based dietary supplements or other formulations since these products, unlike traditional drugs, are chemically complex and variable in composition, even if derived from a single plant source. This perspective will summarize key points–including the premise of ethnobotanical and preclinical evidence, pharmacokinetics, metabolism, and safety–inherent and unique to the study of botanical dietary supplements to be considered when planning or evaluating botanical clinical trials. Market forces and regulatory frameworks also affect clinical trial design since in the United States, for example, botanical dietary supplements cannot be marketed for disease treatment and submission of information on safety or efficacy is not required. Specific challenges are thus readily apparent both for consumers comparing available products for purchase, as well as for commercially sponsored vs. independent researchers planning clinical trials to evaluate medicinal effects of botanicals. Turmeric dietary supplements, a top selling botanical in the United States and focus of over 400 clinical trials to date, will be used throughout to illustrate both the promise and pitfalls associated with the clinical evaluation of botanicals.
KW - botanical
KW - clinical trial
KW - curcumin
KW - curcuminoids
KW - dietary supplement
KW - turmeric
UR - http://www.scopus.com/inward/record.url?scp=85121368130&partnerID=8YFLogxK
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U2 - 10.3389/fnut.2021.782912
DO - 10.3389/fnut.2021.782912
M3 - Review article
AN - SCOPUS:85121368130
SN - 2296-861X
VL - 8
JO - Frontiers in Nutrition
JF - Frontiers in Nutrition
M1 - 782912
ER -