Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials

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 us...

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Autores principales:	Janet L. Funk, Claus Schneider
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	botanical clinical trial curcumin turmeric curcuminoids dietary supplement Nutrition. Foods and food supply TX341-641
Acceso en línea:	https://doaj.org/article/0e20daa6dd10458c8392798f587fea8c
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spelling	oai:doaj.org-article:0e20daa6dd10458c8392798f587fea8c2021-12-03T08:44:33ZPerspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials2296-861X10.3389/fnut.2021.782912https://doaj.org/article/0e20daa6dd10458c8392798f587fea8c2021-12-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fnut.2021.782912/fullhttps://doaj.org/toc/2296-861XPlant-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.Janet L. FunkClaus SchneiderFrontiers Media S.A.articlebotanicalclinical trialcurcuminturmericcurcuminoidsdietary supplementNutrition. Foods and food supplyTX341-641ENFrontiers in Nutrition, Vol 8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	botanical clinical trial curcumin turmeric curcuminoids dietary supplement Nutrition. Foods and food supply TX341-641
spellingShingle	botanical clinical trial curcumin turmeric curcuminoids dietary supplement Nutrition. Foods and food supply TX341-641 Janet L. Funk Claus Schneider Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials
description	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.
format	article
author	Janet L. Funk Claus Schneider
author_facet	Janet L. Funk Claus Schneider
author_sort	Janet L. Funk
title	Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials
title_short	Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials
title_full	Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials
title_fullStr	Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials
title_full_unstemmed	Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials
title_sort	perspective on improving the relevance, rigor, and reproducibility of botanical clinical trials: lessons learned from turmeric trials
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/0e20daa6dd10458c8392798f587fea8c
work_keys_str_mv	AT janetlfunk perspectiveonimprovingtherelevancerigorandreproducibilityofbotanicalclinicaltrialslessonslearnedfromturmerictrials AT clausschneider perspectiveonimprovingtherelevancerigorandreproducibilityofbotanicalclinicaltrialslessonslearnedfromturmerictrials
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Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials

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