Millions of Americans Use Potentially Hepatotoxic Botanical Products

An estimated 15.6 million adults in the U.S. reported use of at least one potentially hepatotoxic botanical supplement within the past 30 days, according to a survey study using nationally representative data.

In the cohort of over 9,600 participants in the National Health and Nutrition Examination Survey (NHANES), the overall prevalence of herbal and dietary supplement use was 57.6%, and the prevalence of using six potentially hepatotoxic botanicals of interest was 4.7%, reported Alisa Likhitsup, MD, MPH, of the University of Michigan in Ann Arbor, and colleagues in JAMA Network Open.

The six potentially hepatotoxic botanicals in question were turmeric/curcumin (n=236), green tea extract (n=92), ashwagandha (n=28), Garcinia cambogia (n=20), red yeast rice (n=20), and black cohosh (n=19).

The estimate of 15.6 million is comparable to the estimated numbers of U.S. patients who are prescribed the potentially hepatotoxic medications simvastatin and nonsteroidal anti-inflammatory drugs, Likhitsup and team noted.

However, “the safety and efficacy of herbal and dietary supplements are not well established due to the lack of regulatory requirements by the [FDA] for human pharmacokinetic or prospective clinical trials prior to marketing,” they added.

They pointed out that the number of cases of liver injuries due to herbal and dietary supplements jumped from 7% in 2004-2005 to 20% in 2013-2014, according to the Drug-Induced Liver Injury Network, a multicenter, observational program that collects data from U.S. patients with hepatotoxic effects attributed to various drugs and herbal and dietary supplements. A similar increase in liver injuries due to herbal and dietary supplements was observed by the Acute Liver Failure Study Group: 12.4% in 1998-2007 to 21.1% in 2007-2015.

“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,” Likhitsup and colleagues concluded.

Of note, the most common reasons for using the botanicals among the survey respondents were to “improve or maintain health or to prevent health problems or boost immunity.”

Maya Balakrishnan, MD, MPH, of Baylor College of Medicine in Houston, told MedPage Today that “most people are using the products intentionally to treat or to prevent a specific medical condition, most commonly osteoarthritis, fatigue, or hot flashes associated with menopause.”

“I was also struck that most users are learning about and making the decision to take these botanicals on their own, without input from their physicians,” noted Balakrishnan, who was not involved in the study.

“It is important for the public to know that most botanicals taken as supplements are packaged at much higher concentrations than found in their natural forms,” she said, adding that clinicians should discuss botanical products and engage in conversations about their pros and cons with patients.

“This means inquiring about herbal, botanical, and supplement use, just as we review all other medications,” she said.

For this study, Likhitsup and team used nationally representative data from NHANES, a national cross-sectional survey of the U.S. population, from January 2017 to March 2020. They also used information from the 2020 U.S. Census for population estimates.

Of the 9,685 adults enrolled in this cohort, mean age was 47.5, 51.8% were women, 62.2% were white, 11.5% were Black, and 16.3% were Mexican or non-Mexican Hispanic.

Those who used the six herbal and dietary supplements were significantly older (adjusted OR 2.36, 95% CI 1.06-5.25, P=0.04 for ages 40-59 and aOR 3.96, 95% CI 1.93-8.11, P=0.001 for ages ≥60), had a higher educational level (aOR 4.78, 95% CI 2.62-8.75, P<0.001), and were more likely to have arthritis (aOR 2.27, 95% CI 1.62-3.29, P<0.001) compared with those who did not use them.

Of the turmeric users, 26.8% said they consumed these products for joint health or arthritis, and 27.2% of green tea users said they were trying to improve their energy level. Seventy percent of Garcinia cambogia users reported that they were trying to lose weight, while 84.2% of black cohosh users said they were taking these products to treat hot flashes. The most commonly stated reason to consume red yeast rice was for heart health (90%).

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