With the increase in the medical level, the improvement of adverse drug reaction(ADR) monitoring systems, and the enhancement of public awareness of safe medication, drug safety incidents have been frequently reported. Drug-induced liver injury(DILI), especially liver injury attributed to herbal and dietary supplements(HDS), has globally attracted high attention, bringing great threats and severe challenges to the people for drug safety management such as clinical medication and medical supervision. Consensus on drug-induced liver injury had been published by the Council for International Organizations of Medical Sciences(CIOMS) in 2020. In this consensus, liver injury attributed to HDS was included in a special chapter for the first time. The hot topics, including the definition of HDS-induced liver injury, epidemiological history, potential risk factors, collection of related risk signals, causality assessment, risk prevention, control and management were discussed from a global perspective. Based on the previous works, some experts from China were invited by CIOMS to undertake the compilation of this chapter. Meanwhile, a new causality assessment in DILI based on the integrated evidence chain(iEC) method was widely recognized by experts in China and abroad, and was recommended by this consensus. This paper briefly introduced the main contents, background, and characteristics of the Consensus on drug-induced liver injury. Significantly, a brief interpretation was illustrated to analyze the special highlights of Chapter 8, "Liver injury attributed to HDS", so as to provide practical references for the medical staff and the researchers who worked on either Chinese or Western medicine in China.
Humans ; Consensus ; Chemical and Drug Induced Liver Injury/etiology* ; Risk Factors ; Dietary Supplements/adverse effects*

Drug-induced liver injury (DILI) is an important adverse drug reaction that can lead to acute liver failure or even death in severe cases. Currently, the diagnosis of DILI still follows the strategy of exclusion. Therefore, a detailed history taking and a thorough and careful exclusion of other potential causes of liver injury is the key to correct diagnosis. This guideline was developed based on evidence-based medicine provided by the latest research advances and aims to provide professional guidance to clinicians on how to identify suspected DILI timely and standardize the diagnosis and management in clinical practice. Based on the clinical settings in China, the guideline also specifically focused on DILI in chronic liver disease, drug-induced viral hepatitis reactivation, common causing agents of DILI (herbal and dietary supplements, anti-tuberculosis drugs, anti-neoplastic drugs), and signal and assessment of DILI in clinical trials.
Humans ; Chemical and Drug Induced Liver Injury/therapy* ; Drug-Related Side Effects and Adverse Reactions ; Liver Failure, Acute ; Dietary Supplements/adverse effects* ; Risk Factors

Rising rates of obesity has increased the global use of herbal supplements intended to control weight. However, taking these preparations without appropriate medical supervision could increase the risk of manifestation of side effects, especially at the hepatic level. In literature, different cases of acute liver injury consequent to the use of food supplements containing Garcinia cambogia and hydroxycitric acid are reported. This letter aims to review the most recent literature that analysed the herb-induced liver disease due to the use of hydroxycitric acid, from the first alert coming from the European Food and Drug Administration in 2009, to the last recent European food alerts from 2020 to 2021. It is noteworthy that in some cases it demonstrated the relationship between hydroxycitric acid and hepatotoxicity. Therefore, there is a need to draw more attention to the relationship between a safe use and a more awareness in the intake of these supplements, to preserve the safety of the consumers who increasingly purchase food supplements, products that have only nutritive properties and are never curative.
Anti-Obesity Agents/pharmacology* ; Chemical and Drug Induced Liver Injury/etiology* ; Citrates ; Dietary Supplements/adverse effects* ; Humans ; Plant Extracts/pharmacology*

Objective: To understand the current status of taking nutrient supplements for residents aged 18 to 79 years old in Beijing and its related factors. Methods: Data were gathered from the 2017 Beijing Non-communicable and Chronic Disease Surveillance Program. Multiple classified cluster sampling method was used, and participants aged 18-79 were sampled from 16 districts. The questionnaire included chronic diseases and related risk factors, health knowledge, and oral nutritional supplements within 12 months. Multivariate logistic regression models were established to analyze associated factors that affect the intake of nutrient supplements. Results: The weighted prevalence of supplements use was 13.1% among 12 696 subjects within the past 12 months. The proportions of multivitamins (4.7%), B vitamins (4.5%), and folic acid (3.2%) were higher. The prevalence of supplement use of young people (18-39 years old) and the elderly (60-79 years old) was higher than middle-aged people (40-59 years old) (χ²=54.09, P<0.001). Except for the age group of 70-79 years old, the consumption rate of women was significantly higher than that of men (P<0.05). After adjusting age and sex, among patients with hypertension, diabetes, or dyslipidemia, the control rates of blood pressure, glucose and lipids of patients who take nutrient supplements were higher than those who do not (P<0.05). And participants who took nutrient supplements had a more heightened awareness rate of health knowledge, such as the hazards of smoking and second-hand smoke, and recommended amount of salt per day (P<0.001). The multi-factor logistic analysis found that nutrient supplement-related factors include women, old age, higher education level, living in urban, insufficient physical activity, sleeping problems, active physical examination, blood pressure control among patients, and health knowledge (P<0.05). Conclusions: The factors of nutrient supplements use were related to sex, age, education level, health status, and health literacy. We should pay attention to key populations and guide them to establish the correct concept of taking nutrient supplements.
Adolescent ; Adult ; Aged ; Beijing/epidemiology* ; Dietary Supplements ; Female ; Folic Acid ; Humans ; Male ; Middle Aged ; Smoking/adverse effects* ; Vitamin B Complex ; Young Adult

OBJECTIVES: To study the efficacy of intermittent iron supplementation in children with mild iron-deficiency anemia. METHODS: A total of 147 children with mild iron-deficiency anemia were enrolled in this prospective study. They were divided into an intermittent iron supplementation group (n=83) and a conventional iron supplementation group (n=64). The levels of hemoglobin were measured before treatment and after 1 and 3 months of treatment. The treat response rate and the incidence rate of adverse drug reactions were compared between the two groups. RESULTS: Both groups had a significant increase in the level of hemoglobin after iron supplementation (P<0.05). After 1 month of treatment, the conventional iron supplementation group had a significantly higher treatment response rate than the intermittent iron supplementation group (61% vs 42%, P<0.05). After 3 months of treatment, there was no significant difference in the treatment response between the two groups (86% vs 78%, P>0.05). The incidence rate of adverse drug reactions in the conventional iron supplementation group was significantly higher than that in the intermittent iron supplementation group (25% vs 8%, P<0.05). CONCLUSIONS For children with mild iron-deficiency anemia, although intermittent iron supplementation is inferior to conventional iron supplementation in the short-term efficacy, there is no significant difference in the long-term efficacy between the two methods, and compared with conventional iron supplementation, intermittent iron supplementation can reduce the incidence of adverse drug reactions, alleviate family financial burdens, and improve treatment compliance of children, thus holding promise for clinical application.
Anemia, Iron-Deficiency/epidemiology* ; Child ; Dietary Supplements/adverse effects* ; Hemoglobins/analysis* ; Humans ; Iron, Dietary/adverse effects* ; Prospective Studies

Objective: This research was performed to evaluate the effect of tebuconazole (TBZ) on reproductive organs of male rats and to assess the protective role of combined essential trace elements in alleviating the detrimental effect of TBZ on male reproductive function. Methods: For this purpose, 48 rats were exposed to 100 mg/kg TBZ, TBZ supplemented with zinc (Zn), selenium (Se), copper (Cu), and iron (Fe), TBZ + (Se + Zn); TBZ + Cu; or TBZ + Fe. The experiment was conducted for 30 consecutive days. Results: TBZ caused a significant perturbation in mineral levels and reduction in reproductive organs weights, plasma testosterone level, and testicular antioxidant enzyme activities. The TBZ-treated group also showed a significant increase in sperm abnormalities (count, motility, and viability percent), plasma follicle-stimulating hormone and luteinizing hormone concentrations, lipid peroxidation, protein oxidation, and severe DNA degradation in comparison with the controls. Histopathologically, TBZ caused testis impairments. Conversely, treatment with trace elements, in combination or alone, improved the reproductive organ weights, sperm characteristics, TBZ-induced toxicity, and histopathological modifications in testis. Conclusion TBZ exerts significant harmful effects on male reproductive system. The concurrent administration of trace elements reduces testis dysfunction, fertility, and toxicity induced by TBZ.
Animal Feed/analysis* ; Animals ; Antioxidants/metabolism* ; Diet ; Dietary Supplements/analysis* ; Fungicides, Industrial/adverse effects* ; Male ; Minerals/metabolism* ; Mutagenicity Tests ; Rats ; Rats, Wistar ; Spermatozoa/physiology* ; Testis/physiology* ; Trace Elements/metabolism* ; Triazoles/adverse effects*

In the market of botanical dietary supplements, Cimicifuga heracleifolia (CH) has always been considered as an adulterated species of Cimicifuga racemosa (CR), a conventional American herb with promising benefits to counteract troubles arising from the menopause. However, the detailed comparison of their therapeutic effects is lacking. In present study, the pharmacological and metabolomics studies were comparatively conducted between CH and CR in ovariectomized (OVX) female rats. Specifically, estrogen-like, anti-hyperlipidemia and anti-osteoporosis effects were evaluated through measuring serum biochemical parameters, histopathological examination and micro computed tomography (Micro-CT) scanning. At the same time, a gas chromatography-mass spectrometry (GC-MS)-based serum metabolomics method was employed to profile the metabolite compositional changes. As a result, both CR and CH displayed anti-osteoporosis and anti-hyperlipemia on menopause syndrome. Meanwhile, their potentials in improving the OVX-induced metabolic disorders were discovered. In conclusion, these results demonstrated that CH is therapeutically similar to CR in relieving menopausal symptoms and CH could be considered as a promising alternative to CR instead of an adulterant in the market of botanical dietary supplements.
Animals ; Cimicifuga ; chemistry ; classification ; Dietary Supplements ; analysis ; Drug Evaluation, Preclinical ; Female ; Humans ; Menopause ; blood ; drug effects ; Metabolomics ; Osteoporosis ; blood ; drug therapy ; Ovariectomy ; adverse effects ; Phytotherapy ; Plant Extracts ; administration & dosage ; blood ; Rats ; Rats, Sprague-Dawley

Adolescent ; Anticonvulsants ; adverse effects ; Bone and Bones ; drug effects ; metabolism ; Calcium ; blood ; Calcium, Dietary ; administration & dosage ; Child ; Child, Preschool ; Dietary Supplements ; Epilepsy ; drug therapy ; metabolism ; Female ; Humans ; Male ; Valproic Acid ; adverse effects ; Vitamin D ; administration & dosage

Drug-induced liver injury (DILI) remains a significant clinical challenge and is the leading cause of acute liver failure in most countries. An aging population that uses more medications, a constant influx of newly developed drugs and a growing risk from unfamiliar herbal and dietary supplements will make DILI an increasing part of clinical practice. Currently, the most effective strategy for disease management is rapid identification, withholding the inciting agents, supportive care and having a firm understanding of the expected natural history. There are resources available to aid the clinician, including a new online "textbook" as well as causality assessment tools, but a heightened awareness of risk and the disease's varying phenotypes and good history-taking remain cornerstones to diagnosis. Looking ahead, growing registries of cases, pharmacoepidemiology studies and translational research into the mechanisms of injury may produce better diagnostic tools, markers for risk and disease, and prevention and therapeutics.
Age Factors ; Anti-Infective Agents/adverse effects ; Anti-Inflammatory Agents, Non-Steroidal/adverse effects ; Anticonvulsants/adverse effects ; Biopsy ; Dietary Supplements/adverse effects ; Drug-Induced Liver Injury/*diagnosis/epidemiology ; Drugs, Chinese Herbal/adverse effects ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects ; Incidence ; Liver/pathology ; Liver Function Tests ; Risk Factors ; Tumor Necrosis Factor-alpha/antagonists & inhibitors

No abstract available.
Diet, High-Fat/*adverse effects ; *Dietary Supplements ; Dyspepsia/*prevention & control ; Female ; Humans ; Lipase/*administration & dosage ; Male ; Stomach/*drug effects