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.
Highlights
Research of plant-derived products stands at the complex intersection of science, consumerism, industry, and federal regulation connecting stakeholders with differing and only partly overlapping interests and expectations
As exemplified by the turmeric clinical trial literature [9], even for diseases where botanical clinical efficacy is reported across a majority of clinical trials [13], definitive conclusions as to efficacy or informed clinical use by consumers are often limited since botanical clinical trials often test only a single dose, with the added complication of disparate products being tested across trials for a given clinical condition
Another element to be considered in the United States (US), even when testing an overthe-counter product, is the need to prepare, file and undergo an FDA review of an Investigational New Drug application (IND), following botanical specific guidelines [102], if disease outcomes are an endpoint, as well as consideration of whether clinical trial goals could be met with an alternative design [103]
Summary
Received: 25 September 2021 Accepted: 05 November 2021 Published: 03 December 2021. 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. 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.
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