Nearly 15.6 million Americans using botanical supplements may be at risk for liver injury
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Key takeaways:
- Of 9,685 U.S. adults surveyed, 4.7% used at least one of six potentially hepatotoxic botanicals.
- By extrapolating this data, researchers estimated that more than 15.6 million Americans consume these products.
Researchers estimated that nearly 15.6 million Americans consumed at least one potentially hepatotoxic botanical product in the past 30 days, similar to usage reports for simvastatin and NSAIDS.
“Chemical analyses of [herbal and dietary supplement (HDS)] products associated with confirmed liver toxic effects show frequent discrepancies between product labels and detected ingredients,” Alisa Likhitsup MD, MPH, a clinical assistant professor in the division of gastroenterology and hepatology at Michigan Medicine, and colleagues wrote in JAMA Network Open. “The safety and efficacy of HDSs are not well-established due to the lack of regulatory requirements by the U.S. FDA for human pharmacokinetic or prospective clinical trials prior to marketing.”
To determine the prevalence and clinical characteristics of consumers of six potentially hepatoxic botanical supplements — turmeric or curcumin, green tea, ashwagandha, black cohosh, Garcinia cambogia and red yeast rice — the researchers analyzed data from adults who participated in the National Health and Nutrition Examination Survey from January 2017 to March 2020. They also used U.S. Census data from 2020 to determine population-level estimates.
In addition to analyzing supplement use in the past 30 days, Likhitsup and colleagues examined the use of other potentially hepatotoxic drugs, which included NSAIDS, sertraline and simvastatin.
Of 9,685 adults (mean age, 47.5 years; 51.8% women; 62.2% non-Hispanic white) included in the analysis, 57.6% (95% CI, 55.9-59.4) used at least one herbal and dietary supplement in the past 30 days, 7.5% used a botanical-containing product and 4.7% (95% CI, 3.9-5.7) used one of the six botanicals of interest. The most commonly used products contained turmeric or curcumin (n = 236), followed by green tea (n = 92), ashwagandha (n = 28), Garcinia cambogia (n = 20), red yeast rice (n = 20) and black cohosh (n = 19).
According to multivariable analysis, adults who consumed these six botanicals were “significantly older” than nonusers ( 60 years: adjusted OR = 3.96; 95% CI, 1.93-8.11 vs. 40-59 years: aOR = 2.36; 95% CI, 1.06-5.25), and also more likely to have a higher educational level (aOR = 4.78; 95% CI, 2.62-8.75) and arthritis (aOR = 2.27; 95% CI, 1.62-3.29). Among those most likely to consume botanicals, the median number of products used was four and was highest among consumers of red yeast rice and ashwagandha.
By extrapolating survey data, the researchers estimated that 15,584,599 (95% CI, 13,047,571-18,648,801) U.S. adults used at least one of the six botanical products within the past 30 days, similar to the number of adults using NSAIDs (n = 14,793,837; 95% CI, 13,014,623-16,671,897) and simvastatin (n = 14,036,024; 95% CI, 11,202,460-17,594,452). Sertraline use was lower at about 7.6 million adults.
“This survey study found that in the NHANES 2017 to March 2020 study, over 7% of U.S. adults used a botanical-containing herbal and dietary supplement product within the last 30 days and that the six products most commonly implicated in liver injury in the U.S. are popular among U.S. adults and used as frequently as common hypolipidemic drugs, NSAIDs and antidepressants,” Likhitsup and colleagues wrote.
“In light of the lack of regulatory oversight on the manufacturing and testing of botanical products, it is recommended that clinicians obtain a full medication and herbal and dietary supplement use history when evaluating patients with unexplained symptoms or liver test abnormalities.”
Perspective
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William Carey, MD, MACG, FAASLD
The appetite for herbal and dietary supplements in the U.S. and around the world is enormous and growing. Despite lack of evidence of benefit beyond a placebo effect, herbal supplements continue to compete successfully in the marketplace.
The research by Likhitsup and colleagues provides a needed caution. Building on prior evidence of a threefold rise in proportion of drug-induced liver injury cases attributed to herbal and dietary supplements over 9 years, they asked: How many consumers are using products containing known hepatotoxins? They found that just under 5% of their sample of nearly 10,000 extrapolates into millions across the country.
What can we do with this information? When my patients ask if it is OK to take over-the-counter herbal supplements, I respond that it is the Wild West out there. No one knows what is really in these lightly regulated products or how much, as the labeling is often incorrect and several contain liver toxic compounds.
Since the evidence of proven benefit is lacking, I suggest patients not use these products. What you don’t know can hurt you.
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