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

Janet L. Funk, Claus Schneider

Research output: Contribution to journalReview articlepeer-review

Abstract

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.

Original languageEnglish (US)
Article number782912
JournalFrontiers in Nutrition
Volume8
DOIs
StatePublished - Dec 3 2021
Externally publishedYes

Keywords

  • botanical
  • clinical trial
  • curcumin
  • curcuminoids
  • dietary supplement
  • turmeric

ASJC Scopus subject areas

  • Food Science
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

Fingerprint

Dive into the research topics of 'Perspective on Improving the Relevance, Rigor, and Reproducibility of Botanical Clinical Trials: Lessons Learned From Turmeric Trials'. Together they form a unique fingerprint.

Cite this