National Center for Complementary and Integrative Health Perspectives on Clinical Research Involving Natural Products

Abstract

The sales of dietary supplements continue to increase year after year. Despite their use by a large percentage of Americans, there is little evidence for the vast majority of products regarding their safety or efficacy. National Center for Complementary and Integrative Health supports a broad range of research on dietary supplements, including clinical trials. Our experience with these trials has shaped our current policies and priorities for clinical research. This perspective outlines those policies and priorities that are shaping our investments going forward. SIGNIFICANCE STATEMENT The sales of dietary supplements continue to increase year after year. Despite their use by a large percentage of Americans, there is little evidence for the vast majority of products regarding their safety or efficacy. National Center for Complementary and Integrative Health supports a broad range of research on dietary supplements, including clinical trials. Our experience with these trials has shaped our current policies and priorities for clinical research. This perspective outlines those policies and priorities that are shaping our investments going forward.

Natural Products: Experimental Approaches to Elucidate Disposition Mechanisms and Predict Pharmacokinetic Drug Interactions

“…However, obvious disadvantages, notably cost and time, preclude routine testing. In addition, clinical testing of natural products adds complexities that typically are not encountered with NCEs, particularly with respect to product integrity (Kellogg et al, 2019;Weber and Hopp, 2020). Nevertheless, when warranted based on the collective in vitro, preclinical, and safety data, clinical studies involving natural products are feasible.…”

“…The NCCIH is a major federal funder of natural products research in the United States (https://www.nccih.nih.gov/), supporting a broad portfolio that includes clinical trials. The commentary by Weber and Hopp (2020) describes an overview of key aspects covering product integrity and clinical research design considerations, as well as NCCIH's current investments and funding opportunities.…”

“…Dissemination of scientific data to the research community and other stakeholders beyond journal publications and presentations at professional and scientific meetings has come to the forefront due in part to the information being readily accessible via internet sources, including social media. As noted by Weber and Hopp (2020), the NCCIH is supporting a repository that houses data generated by the Center of Excellence for Natural Product Drug Interaction Research (NaPDI Center), whose mission is to provide leadership and guidance on the optimal design and conduct of pharmacokinetic natural product-drug interaction studies . Birer-Williams et al (2020) describe this new user-friendly online repository, which is accessible through a public access portal.…”

Developing a Rational, Optimized Product of Centella asiatica for Examination in Clinical Trials: Real World Challenges

“…While there is a significant body of literature on preclinical studies performed on botanicals, relatively few of these materials have been evaluated in formal, rigorous clinical trials. Additionally, several recent large-scale trials have failed to demonstrate a clinical effect of the botanical product under study (3). Recent articles led by authors at the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and National Center for Complementary and Integrative Health (NCCIH) have highlighted the particular challenges involved in the clinical evaluation of botanical supplements (3)(4)(5).…”

“…Additionally, several recent large-scale trials have failed to demonstrate a clinical effect of the botanical product under study (3). Recent articles led by authors at the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and National Center for Complementary and Integrative Health (NCCIH) have highlighted the particular challenges involved in the clinical evaluation of botanical supplements (3)(4)(5). Significant factors include the natural variation in plant materials and the multiplicity of available products of a given botanical.…”