Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

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Abstract

In the United States (US), the risk of hepatotoxicity linked to the widespread use of certain herbal products has gained increased attention among regulatory scientists. Based on current US law, all dietary supplements sold domestically, including botanical supplements, are regulated by the Food and Drug Administration (FDA) as a special category of foods. Under this designation, regulatory scientists do not routinely evaluate the efficacy of these products prior to their marketing, despite the content variability and phytochemical complexity that often characterizes them. Nonetheless, there has been notable progress in the development of advanced scientific methods to qualitatively and quantitatively measure ingredients and screen for contaminants and adulterants in botanical products when hepatotoxicity is recognized.

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Most cited references 194

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Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey.

D M Eisenberg, R B Davis, S L Ettner … (1998)

A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990. To document trends in alternative medicine use in the United States between 1990 and 1997. Nationally representative random household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997, respectively. A total of 1539 adults in 1991 and 2055 in 1997. Prevalence, estimated costs, and disclosure of alternative therapies to physicians. Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8% in 1990 to 42.1% in 1997 (P < or = .001). The therapies increasing the most included herbal medicine, massage, megavitamins, self-help groups, folk remedies, energy healing, and homeopathy. The probability of users visiting an alternative medicine practitioner increased from 36.3% to 46.3% (P = .002). In both surveys alternative therapies were used most frequently for chronic conditions, including back problems, anxiety, depression, and headaches. There was no significant change in disclosure rates between the 2 survey years; 39.8% of alternative therapies were disclosed to physicians in 1990 vs 38.5% in 1997. The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 (64.0%) and 1997 (58.3%) (P=.36). Extrapolations to the US population suggest a 47.3% increase in total visits to alternative medicine practitioners, from 427 million in 1990 to 629 million in 1997, thereby exceeding total visits to all US primary care physicians. An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and/or high-dose vitamins (18.4% of all prescription users). Estimated expenditures for alternative medicine professional services increased 45.2% between 1990 and 1997 and were conservatively estimated at $21.2 billion in 1997, with at least $12.2 billion paid out-of-pocket. This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations. Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $27.0 billion, which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services. Alternative medicine use and expenditures increased substantially between 1990 and 1997, attributable primarily to an increase in the proportion of the population seeking alternative therapies, rather than increased visits per patient.

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Unconventional medicine in the United States. Prevalence, costs, and patterns of use.

D M Eisenberg, R C Kessler, C. Foster … (1993)

Many people use unconventional therapies for health problems, but the extent of this use and the costs are not known. We conducted a national survey to determine the prevalence, costs, and patterns of use of unconventional therapies, such as acupuncture and chiropractic. We limited the therapies studied to 16 commonly used interventions neither taught widely in U.S. medical schools nor generally available in U.S. hospitals. We completed telephone interviews with 1539 adults (response rate, 67 percent) in a national sample of adults 18 years of age or older in 1990. We asked respondents to report any serious or bothersome medical conditions and details of their use of conventional medical services; we then inquired about their use of unconventional therapy. One in three respondents (34 percent) reported using at least one unconventional therapy in the past year, and a third of these saw providers for unconventional therapy. The latter group had made an average of 19 visits to such providers during the preceding year, with an average charge per visit of $27.60. The frequency of use of unconventional therapy varied somewhat among socio-demographic groups, with the highest use reported by nonblack persons from 25 to 49 years of age who had relatively more education and higher incomes. The majority used unconventional therapy for chronic, as opposed to life-threatening, medical conditions. Among those who used unconventional therapy for serious medical conditions, the vast majority (83 percent) also sought treatment for the same condition from a medical doctor; however, 72 percent of the respondents who used unconventional therapy did not inform their medical doctor that they had done so. Extrapolation to the U.S. population suggests that in 1990 Americans made an estimated 425 million visits to providers of unconventional therapy. This number exceeds the number of visits to all U.S. primary care physicians (388 million). Expenditures associated with use of unconventional therapy in 1990 amounted to approximately $13.7 billion, three quarters of which ($10.3 billion) was paid out of pocket. This figure is comparable to the $12.8 billion spent out of pocket annually for all hospitalizations in the United States. The frequency of use of unconventional therapy in the United States is far higher than previously reported. Medical doctors should ask about their patients' use of unconventional therapy whenever they obtain a medical history.

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Why US adults use dietary supplements.

Regan L. Bailey, Jaime J. Gahche, Paige E Miller … (2013)

Dietary supplements are used by more than half of adults, although to our knowledge, the reasons motivating use have not been previously examined in US adults using nationally representative data. The purpose of this analysis was to examine motivations for dietary supplement use, characterize the types of products used for the most commonly reported motivations, and to examine the role of physicians and health care practitioners in guiding choices about dietary supplements. Data from adults (≥20 years; n = 11 956) were examined in the 2007-2010 National Health and Nutrition Examination Survey, a nationally representative, cross-sectional, population-based survey. The most commonly reported reasons for using supplements were to "improve" (45%) or "maintain" (33%) overall health. Women used calcium products for "bone health" (36%), whereas men were more likely to report supplement use for "heart health or to lower cholesterol" (18%). Older adults (≥60 years) were more likely than younger individuals to report motivations related to site-specific reasons like heart, bone and joint, and eye health. Only 23% of products were used based on recommendations of a health care provider. Multivitamin-mineral products were the most frequently reported type of supplement taken, followed by calcium and ω-3 or fish oil supplements. Supplement users are more likely to report very good or excellent health, have health insurance, use alcohol moderately, eschew cigarette smoking, and exercise more frequently than nonusers. Supplement users reported motivations related to overall health more commonly than for supplementing nutrients from food intakes. Use of supplements was related to more favorable health and lifestyle choices. Less than a quarter of supplements used by adults were recommended by a physician or health care provider.

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Rolf Teschke: Role: Academic Editor

Journal

Journal ID (nlm-ta): Int J Mol Sci

Journal ID (iso-abbrev): Int J Mol Sci

Journal ID (publisher-id): ijms

Title: International Journal of Molecular Sciences

Publisher: MDPI

ISSN (Electronic): 1422-0067

Publication date (Electronic): 03 March 2016

Publication date Collection: March 2016

Volume: 17

Issue: 3

Electronic Location Identifier: 331

Affiliations

[1 ]Office of Pharmacovigilance and Epidemiology, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA; mark.avigan@ 123456fda.hhs.gov

[2 ]Office of Dietary Supplement Products, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740, USA; robert.mozersky@ 123456fda.hhs.gov

[3 ]6403 Hillmead Rd, Bethesda, MD 20817, USA

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[* ]Correspondence: mahler68@ 123456hotmail.com ; Tel.: +1-240-793-6177; Fax: +1-301-767-0392

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Publisher ID: ijms-17-00331

DOI: 10.3390/ijms17030331

PMC ID: 4813193

PubMed ID: 26950122

SO-VID: 01f4db93-31c8-465b-bf0c-4802f89133e4

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This article is an open access article distributed under the terms and conditions of the Creative Commons by Attribution (CC-BY) license ( http://creativecommons.org/licenses/by/4.0/).

Scientific and Regulatory Perspectives in Herbal and Dietary Supplement Associated Hepatotoxicity in the United States

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Abstract

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Higher order chromatin architecture

Most cited references 194

Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey.

Unconventional medicine in the United States. Prevalence, costs, and patterns of use.

Why US adults use dietary supplements.

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