Approaches by the US National Institutes of Health to support rigorous scientific research on dietary supplements and natural products

Kuszak, Adam; Hopp, D. Craig; Williamson, John S.; Betz, Joseph M.; Sorkin, Barbara C.

doi:10.1002/dta.1931

Cited by 31 publications

(23 citation statements)

References 24 publications

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“…According to the most recent study, 52% of the US population were using DS from 1999 through 2012 (Kantor et al, 2016). Moreover, the number of DS in the US DS market has increased tremendously from 4,000 in 1994 to 55,000 in 2012 (Kuszak et al, 2016), with a USD32 billion sales in 2012 (Garcia-Cazarin et al, 2014). A similar trend of DS consumption has also been observed in the United Kingdom, European countries and Korea (Rautiainen et al, 2016a).…”

Section: Introductionmentioning

confidence: 71%

Factors affecting consumers’ decisions on the use of nutraceuticals: a systematic review

Teoh

Ngorsuraches

Lai

et al. 2019

International Journal of Food Sciences and Nutrition

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There is a high and increasing global prevalence of nutraceuticals use. This study aims to systematically review and critically appraise all available evidence to identify the factors affecting consumers' decisions in taking nutraceuticals. Questionnaire, interview or focus group studies which directly reported factors affecting consumers' decisions in using nutraceuticals were included. A thematic synthesis method was employed to synthesis the findings from the included studies. Out of the 76 studies included, the key factors identified as the most important factors motivating consumers to take nutraceuticals were the perceived health benefits and safety of nutraceuticals, as well as the advice from healthcare professionals, friends and family. The identified barriers to take nutraceuticals were a lack of belief in the health benefit of nutraceuticals, the high cost of nutraceuticals and consumers' lack of knowledge about nutraceuticals. As a chief course of recommendation for the use of nutraceuticals, healthcare professionals should strive to utilise reliable information from clinical evidence to help consumers in making an informed decision in using nutraceuticals. Future studies should explore the possible ways to improve channelling clinical evidence information of nutraceuticals to the public.

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Section: Introductionmentioning

confidence: 71%

Factors affecting consumers’ decisions on the use of nutraceuticals: a systematic review

Teoh

Ngorsuraches

Lai

et al. 2019

International Journal of Food Sciences and Nutrition

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“…However, given the open-ended nature of the responses to the questions regarding NHP recommendations and indications, it is worth asking if there is any credible evidence of significant clinical benefit from using the recommended NHPs to treat or address indications listed or identified in the study findings. Our limited review of the literature suggests that available evidence of clinical benefit from the recommended NHPs is generally low or of substandard quality, or based on studies plagued with issues of poor design, publication bias and limited participant enrolment [ 56 – 59 ]. Most of the NHPs included in this study have not been found to provide any clinical benefits in randomized, double-blind clinical studies.…”

Section: Discussionmentioning

confidence: 99%

Community Pharmacists’ Views and Practices Regarding Natural Health Products Sold in Community Pharmacies

Ogbogu

Necyk

2016

PLoS ONE

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BackgroundReports of regulatory and evidentiary gaps have raised concerns about the marketing and use of natural health products (NHPs). The majority of NHPs offered for sale are purchased at a community pharmacy and pharmacists are “front-line” health professionals involved in the marketing and provision of NHPs. To date, the involvement of pharmacists in pharmacy care involving NHPs and the degree to which concerns over the safety, efficacy, marketing and regulation of NHPs are addressed in pharmacy care in Canada have not been studied.MethodsUsing Qualtrics, a web-based data collection and analysis software, and a study instrument made up of fifteen (15) open-ended, closed and rating scale questions, we surveyed the attitudes and practices of 403 community pharmacists in the Canadian province of Alberta regarding NHPs offered for sale in community pharmacies.ResultsThe majority of pharmacists surveyed (276; 68%) recommend NHPs to clients sometimes to very often. Vitamin D, calcium, multivitamins, prenatal vitamins, probiotics and fish oil and omega-3 fatty acids were the most frequently recommended NHPs. The most common indications for which NHPs are recommended include bone and musculoskeletal disorders, maintenance of general health, gastrointestinal disorders and pregnancy. Review articles published in the Pharmacist’s Letter and Canadian Pharmacists Journal were the primary basis for recommending NHPs. The majority of pharmacists surveyed (339; 84%) recommend the use of NHPs concurrently with conventional drugs, while a significant number and proportion (125; 31%) recommend alternative use. Pharmacists in the study overwhelmingly reported providing counselling on NHPs to clients based on information obtained mainly from the Natural Medicines Comprehensive Database.ConclusionsThe study findings indicate a high prevalence of pharmacy care relating to NHPs among study participants. Although pharmacists’ practices around NHPs are consistent with the existing licensing framework, we found some involvement in problematic practices that necessitate further research and potential policy scrutiny. The study also uncovered patterns of recommendations, including sources relied on in recommending NHPs and in providing counselling to patients, that raise concerns about the quality and credibility of NHP-related care provided to pharmacy patrons.

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“…If not yet realized, clinical trials using PFSs should be supported by rigorous preclinical data on molecular mechanisms and better data on safety, pharmacokinetics, and metabolism in both healthy and, where appropriate, more application-relevant human populations. The mechanistic data should include strong evidence pinpointing the key bioactive components and the critical molecular targets in the organism [151]. Of course, the most critical element will be to define specific standards for PFSs to ensure consistency between studies.…”

Section: Efficacymentioning

confidence: 99%

Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework

Abdel‐Tawab

2017

Planta Med

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Given the expanding market of plant food supplements (PFSs) not undergoing any pre-marketing authorization, the overall quality, safety and efficacy of PFSs were subjected to a critical examination. Although many high-quality PFSs exist on the legal market, quality concerns are in general justified. Besides economic adulteration, active ingredients dramatically differing from label claims and among products were reported in several studies. In addition, PFSs sold via the Internet may be intentionally adulterated with undeclared prescription drugs. Compared to PFSs with only one single herb, PFSs containing herbal mixtures were more involved in moderate and severe clinical courses. Although prohibited by regulation, misleading labels on PFSs are common. Above all, only vague evidence for the efficacy of PFSs exists. Notwithstanding the unproven efficacy and insufficient safety assessment, PFSs represent a relevant source for consumers to get access to herbal preparations in the United States and meanwhile also in Europe, as launching of licensed/registered European herbal medicinal products (HMPs) has steadily decreased. However, being non-vitamin, non-mineral products, PFSs are neither food nor drugs. In terms of protecting public health and providing the consumer with high-quality, effective, and safe PFSs, possibilities are shown how to deal with the many challenges of PFSs. Last but not least, suggestions are made for assigning PFSs a separate regulatory category being less regulated compared to HMPs but more strictly regulated compared to food laws including implementation of good manufacturing practices and a scientific pre-marketing review process by an expert commission.

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Approaches by the US National Institutes of Health to support rigorous scientific research on dietary supplements and natural products

Cited by 31 publications

References 24 publications

Factors affecting consumers’ decisions on the use of nutraceuticals: a systematic review

Factors affecting consumers’ decisions on the use of nutraceuticals: a systematic review

Community Pharmacists’ Views and Practices Regarding Natural Health Products Sold in Community Pharmacies

Do We Need Plant Food Supplements? A Critical Examination of Quality, Safety, Efficacy, and Necessity for a New Regulatory Framework

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