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Discrepant incidence has been reported regarding the incidence of herb-induced liver injury (HILI). To address the growing worldwide concern of HILI, we evaluated the risk of HILI in a nationwide prospective study. Between April 2013 and January 2016, 1001 inpatients (360 males and 641 females) from 10 tertiary hospitals throughout South Korea were treated with herbal drugs and had their liver enzymes periodically measured. A total of six patients met the criteria for HILI with RUCAM scores ranging from 4 to 7. All these participants were women and developed the hepatocellular type of HILI. One HILI participant met the criteria for Hy’s law; however, none of six cases presented clinical symptoms related to liver injury. This is the first nationwide prospective study that estimated the extent of the incidence of HILI [total: 0.60%, 95% confidence interval (CI) 0.12–1.08; women: 0.95%, 95% CI 0.19–1.68] and described its features in hospitalized participants. Electronic supplementary material The online version of this article (doi:10.1007/s00204-017-2007-9) contains supplementary material, which is available to authorized users.

Background Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) has been emerging as a significant health issue worldwide. This study aimed to systemically assess the prevalence of CFS/ME in various aspects of analyses for precise assessment. Methods We systematically searched prevalence of CFS/ME from public databases from 1980 to December 2018. Data were extracted according to 7 categories for analysis: study participants, gender and age of the participants, case definition, diagnostic method, publication year, and country of the study conducted. Prevalence data were collected and counted individually for studies adopted various case definitions. We analyzed and estimated prevalence rates in various angles: average prevalence, pooled prevalence and meta-analysis of all studies. Results A total of 1291 articles were initially identified, and 45 articles (46 studies, 56 prevalence data) were selected for this study. Total 1085,976 participants were enrolled from community-based survey (540,901) and primary care sites (545,075). The total average prevalence was 1.40 ± 1.57%, pooled prevalence 0.39%, and meta-analysis 0.68% [95% CI 0.48–0.97]. The prevalence rates were varied by enrolled participants (gender, study participants, and population group), case definitions and diagnostic methods. For example, in the meta-analysis; women (1.36% [95% CI 0.48–0.97]) vs. men (0.86% [95% CI 0.48–0.97]), community-based samples (0.76% [95% CI 0.53–1.10]) vs. primary care sites (0.63% [95% CI 0.37–1.10]), adults ≥ 18 years (0.65% [95% CI 0.43–0.99]) vs. children and adolescents Conclusions This study comprehensively estimated the prevalence of CFS/ME; 0.89% according to the most commonly used case definition CDC-1994, with women approximately 1.5 to 2 folds higher than men in all categories. However, we observed the prevalence rates are widely varied particularly by case definitions and diagnostic methods. An objective diagnostic tool is urgently required for rigorous assessment of the prevalence of CFS/ME.

Aims We aimed to conduct a systematic review and a meta-analysis to estimate NAFLD prevalence and its change in Korea. Methods We searched the literature involving NAFLD prevalence in Korea in PubMed, RISS, and KMBASE from inception to June 2017. Studies with subjects with certain disorders, population limitations, or subjects who consume alcohol were excluded. Analysis was stratified by publication year, age, gender, severity, body mass index (BMI), and diagnostic technique. Random-effects models were used to provide point estimates (95% confidence interval) of prevalence with subgroup analysis to account for heterogeneity. Results A total of 61 studies (837,897 participants) were included. The overall NAFLD prevalence in Korea was 30.3% (men: 41.1%, women: 20.3%), with a slight increase from 29.0% to 31.0% over an approximately 10-year period. BMI significantly affected NAFLD prevalence (≤ or > 25 kg/m2, 12.3% vs. 41.7%, p Conclusion The current study is the first systematic analysis on NAFLD prevalence in Korea and found a change in NAFLD prevalence during the recent decade.

Sasang constitutional medicine is a component of traditional Korean medicine that classifies individuals into four Sasang constitutional types (SCTs) by their physical and psychological traits. Each SCT is known to show different susceptibilities to disorders. This systematic review investigated the effect of SCT as a risk factor for various disorders.A systematic literature survey was conducted by searching seven databases for all articles on the prevalence rates of disorders according to SCT and sex.From 14,272 relevant articles, 15 studies (13 disorders) were ultimately identified to verify different prevalence rates by SCT. Of the 13 disorders, 6 (prehypertension, general obesity, abdominal obesity, metabolic syndrome, diabetes mellitus, and irritable bowel syndrome [IBS]) had a significantly different prevalence by SCT. Metabolic syndrome and its associated disorders showed the highest prevalence in Taeumin-type individuals, whereas IBS was most prevalent in Soeumin-type individuals. In general, these findings were consistent with the results obtained in an analysis of male and female participants.This study revealed that susceptibility to disorders was affected by SCT to some extent. Further studies are needed to determine the concrete features of SCT-related susceptibility, which may be helpful in preventive medicine with Sasang constitutional practice.

Background: Chunggan extract (CGX) is an herbal formula used for the treatment of chronic liver disease in traditional Korean medicine. Many preclinical studies have suggested its therapeutic or preventive effects on liver fibrosis. To evaluate the efficacy and safety of CGX, we conducted a randomized controlled clinical trial of CGX in patients with liver fibrosis diagnosed by Fibroscan. Methods: We enrolled 67 subjects at two hospitals with chronic liver disorders with a 5.5 ≤ liver stiffness measurement (LSM) score ≤ 16 kPa. Subjects were randomly assigned at a 1:1:1 ratio with stratification (with/without concomitant use of antivirals) and orally administered CGX (1 g or 2 g) or placebo twice daily for 24 weeks. The end point was the change in instantaneous elasticity of the liver assessed by Fibroscan before and after treatment. Results: LSM scores were significantly decreased in both the CGX1 g (2.5 ± 1.7 kPa, p < 0.01) and CGX2 g (1.9 ± 2.0 kPa, p < 0.05) groups compared to the placebo (0.6 ± 1.6 kPa) group. The change was also significant in 35 subjects without concomitant use of antiviral agents in the CGX1 g group (placebo 0.1 ± 1.4 kPa vs. 2.7 ± 1.6 kPa, p < 0.01) but not in those with concomitant antiviral use (p > 0.05). No notable adverse events were present. Conclusion: CGX appeared to have a pharmacological effect against liver fibrosis. Further studies to confirm the results are needed in the future using a larger sample size.

Among sex hormones, estrogen is particularly well known to act as neuroprotective agent. Unlike estrogen, testosterone has not been well investigated in regard to its effects on the brain, especially under psychological stress. To investigate the role of testosterone in oxidative brain injuries under psychological stress, we adapted an orchiectomy and restraint stress model. BALB/c mice were subjected to either an orchiectomy or sham operation. After allowing 15 days for recovery, mice were re-divided into four groups according to exposure of restraint stress: sham, sham plus stress, orchiectomy, and orchiectomy plus stress. Serum testosterone was undetectable in orchiectomized groups and restraint-induced stress significantly reduced testosterone levels in sham plus stress group. The serum levels of corticosterone and adrenaline were notably elevated by restraint stress, and these elevated hormones were markedly augmented by orchiectomy. Two oxidative stressors and biomarkers for lipid and protein peroxidation were significantly increased in the cerebral cortex and hippocampus by restraint stress, while the reverse pattern was observed in antioxidant enzymes. These results were supported by histopathological findings, with 4-hydroxynonenal staining for oxidative injury and Fluoro-Jade B staining showing the degenerating neurons. The aforementioned patterns of oxidative injury were accelerated by orchiectomy. These findings strongly suggest the conclusion that testosterone exerts a protective effect against oxidative brain damage, especially under stressed conditions. Unlike estrogen, the effects of testosterone on the brain have not been thoroughly investigated. In order to investigate the role of testosterone in oxidative brain injuries under psychological stress, we adapted an orchiectomy and restraint stress model. Orchiectomy markedly augmented the restraint stress-induced elevation of serum corticosterone and adrenaline levels as well as oxidative alterations in brain tissues, especially in the hippocampus. These findings are the first evidence that testosterone depletion makes the brain prone to oxidative injury.

Ethnopharmacological relevance The Pinus densiflora leaf has been traditionally used to treat mental health disorders as a traditional Chinese medicine. Here we examined the ethnopharmacological relevance of pine needle on memory impairment caused by stress. Aim of the study To elucidate the possible modulatory actions of 30% ethanolic pine needle extract (PNE) on stress-induced hippocampal excitotoxicity, we adopted an acute restraint stress mouse model. Materials and methods Mice were orally administered with PNE (25, 50, or 100 mg/kg) or ascorbic acid (100 mg/kg) for 9 days, and were then subjected to restraint stress (6 h/day) for 3 days (from experimental day 7–9). To evaluate spatial cognitive and memory function, the Morris water maze was performed during experimental days 5–9. Results Restraint stress induced the memory impairment (the prolonged escape latency and cumulative path-length, and reduced time spent in the target quadrant), and these effects were significantly prevented by PNE treatment. The levels of corticosterone and its receptor in the sera/hippocampus were increased by restraint stress, which was normalized by PNE treatment. Restraint stress elicited the hippocampal excitotoxicity, the inflammatory response and oxidative injury as demonstrated by the increased glutamate levels, altered levels of tumor necrosis factor (TNF)-α and imbalanced oxidant-antioxidant balance biomarkers. Two immunohistochemistry activities against glial fibrillary acidic protein (GFAP)-positive astrocytes and neuronal nuclei (NeuN)-positive neurons supported the finding of excitotoxicity especially in the cornu ammonis (CA)3 region of the hippocampus. Those alterations were notably attenuated by administration of PNE. Conclusions The above findings showed that PNE has pharmacological properties that modulate the hippocampal excitotoxicity-derived memory impairment under severe stress conditions.

We evaluated the pharmacological effects of Myelophil, a 30% ethanol extract of a mix of Astragali Radix and Salviae Radix, on oxidative stress-induced brain damage in mice caused by restraint stress. C57BL/6 male mice (eight weeks old) underwent daily oral administration of distilled water, Myelophil (25, 50, or 100 mg/kg), or ascorbic acid (100 mg/kg) 1 h before induction of restraint stress, which involved 3 h of immobilization per day for 21 days. Nitric oxide levels, lipid peroxidation, activities of antioxidant enzymes (superoxide dismutase, catalase, and glutathione redox system enzymes), and concentrations of adrenaline, corticosterone, and interferon-γ, were measured in brain tissues and/or sera. Restraint stress-induced increases in nitric oxide levels (serum and brain tissues) and lipid peroxidation (brain tissues) were significantly attenuated by Myelophil treatment. Restraint stress moderately lowered total antioxidant capacity, catalase activity, glutathione content, and the activities of glutathione reductase, glutathione peroxidase, and glutathione S -transferase; all these responses were reversed by Myelophil. Myelophil significantly attenuated the elevated serum concentrations of adrenaline and corticosterone and restored serum and brain interferon-γ levels. Moreover, Myelophil normalized expression of the genes encoding monoamine oxidase A, catechol- O -methyltransferase, and phenylethanolamine N -methyltransferase, which was up-regulated by restraint stress in brain tissues. These results suggest that Myelophil has pharmacological properties protects brain tissues against stress-associated oxidative stress damage, perhaps in part through regulation of stress hormones.

Herbal drugs have become a popular form of healthcare, raising concerns about their safety. This study aimed to characterize the adverse effects of herbal drugs through a systematic review of results reported in randomized controlled trials (RCTs). Using eight electronic databases including PubMed, the Cochrane library and six Korean medical databases, the frequency of reported toxicity was recorded based on drug composition and indication. Among 4957 potentially relevant articles, 242 papers comprised of 244 studies met our inclusion criteria; these included 111 studies of a single herb and 133 of multiple herbs. These studies accounted for a total 15 441 participants (male = 5590; female = 9851; 7383 for single and 8058 for multiple herb studies). There were 480 cases (3.1%) of adverse events (344 for single, 136 for multiple herb studies; p 0.01). A total of 259 cases reported blood test abnormalities, including five cases of abnormality in hepatic functional enzymes. The most frequently reported adverse event was digestive symptoms (44.3%), followed by nervous system symptoms (17.3%) and behaviors such as loss of appetite (16.3%). This is the first systematic review of adverse effects of herbal drugs among clinical studies, and the results indicate that herbal drugs are relatively safe. Copyright © 2016 John WileySons, Ltd.

Background: Functional dyspepsia (FD), which is a very common disorder worldwide, is known to be caused by multiple factors including environmental and genetic factors. Sasang constitutional medicine (SCM) is a component of traditional Korean medicine that emphasizes inherited characteristics of the physical and psychological patterns of a patient. This study investigated whether the prevalence of FD differs depending on Sasang classification. Methods: A total 517 subjects (190 males and 327 females) were recruited, and interviewed for the presence of FD using a Rome III-based questionnaire. The Sasang constitution of all subjects were diagnosed using a Sasang constitutional analytical tool (SCAT). A Chi-square test was performed to compare prevalence of DF among different Sasang constitutional types. Results: Of the 517 subjects, 115 (22.2 %) met the diagnostic criteria for FD, and the prevalence was significantly higher in females (26.9 %) than males (14.2 %, p < 0.01). The Sasang-constitution-based prevalence among all subjects was 27.5 % for Taeumin, 23.1 % for Soumin, and 16.4 % for Soyangin (p = 0.055). When compared by sex, the prevalence of FD among Sasang types showed significantly different patterns between males and females (p < 0.05); in females with FD, Taeumin predominated (32.5 % compared with 29.5 % and 18.8 % for Soumin and Soyangin, respectively; p < 0.05), whereas males with FD displayed a higher prevalence of Soumin (17.3 % compared with 9.1 % and 11.3 % for Taeumin and Soyangin, respectively; p > 0.05). Conclusions: This study identified significant differences in FD prevalence depending on Sasang constitution and sex. Our findings provide data to guide future research on the prevention and management of FD.

Dear editor: Functional supplements are intended not only to provide nutrients, but also to increase the physical and mental well-being of their consumer. Based on increasing demand to reduce health risks and improve health quality, the functional supplement market has expanded; it was estimated to be worth over US$80 billion worldwide in 2008 (Vergari et al., 2010). Given the abundant use of supplements, doubts regarding their benefits and risks represent a public health concern (Pascal, 2009). It is therefore important to identify the national status of functional supplement usage. In this study, we surveyed the current prevalence and types of functional supplements including herbal medicines among middle- and high-school students using questionnaires. A total of 4,709 students (2,458 males and 2,251 females, aged 13–19 years), including 2,254 middle-school (650 males and 1,604 females) and 2,455 high-school students (1,808 males and 647 females), from four schools in Daejeon, South Korea, were included as subjects. The comparisons of the frequency and choice of functional supplements were analysed using Chi-square test with SPSS (SPSSs 18.0K for Windows; SPSS, Inc., Chicago, IL, USA). As shown in table 1, 35.8% of the students consumed at least one type of functional supplement or herbal products. The average prevalence of functional supplement use was higher among high-school students (40.7% total, 40.6% males and 40.8% females) than middle-school students (30.5% total, 29.5% males and 30.9% females). The statistical analysis showed significant difference between male and female students (p < 0.01) as well as middle-and high-school students (p < 0.01). We also surveyed the type of functional supplements which the students were consuming. The students consumed primarily multivitamins (19.5%), ginseng products (9.0%), mineral supplements (5.9%), herbal medicines (4.5%), and others (2.7%) as multiple-choice. Significant difference of choice for functional supplements was observed between male and female (p < 0.01), as well as middle- and high-school students (p < 0.01) respectively. Table 1 Prevalence of functional supplement use and types in Korean adolescents

UNLABELLED: The present study investigated the antifatigue effects of Panax ginseng C.A. Meyer in 90 subjects (21 men and 69 women) with idiopathic chronic fatigue (ICF) in a randomised, double-blind, placebo-controlled and parallel designed trial. A bespoke 20% ethanol extract of P. ginseng (1 g or 2 g day(-1)) or a placebo was administered to each group for 4 weeks, and then fatigue severity was monitored using a self-rating numeric scale (NRS) and a visual analogue scale (VAS) as a primary endpoint. Serum levels of reactive oxygen species (ROS), malondialdehyde (MDA), total glutathione (GSH) contents and glutathione reductase (GSH-Rd) activity were determined. After 4-week, P. ginseng administration decreased the total NRS score, but they were not statistically significant compared with placebo (P>0.05). Mental NRS score was significantly improved by P. ginseng administrations as 20.4 ± 5.0 to 15.1 ± 6.5 [95% CI 2.3 ~ 8.2] for 1 g and 20.7 ± 6.3 to 13.8 ± 6.2 [95% CI -0.1 ~ 4.2] for 2 g compared with placebo 20.9 ± 4.5 to 18.8 ± 2.9 [95% CI 4.1 ~ 9.9, P

Ethnopharmacological relevance Along with increase of herbal medicine use worldwide, the safety of traditional herbal medicines frequently becomes a medical issue. Aim of the study This study aimed to investigate the incidence of herbal medicine-induced adverse effects on liver functions. Subjects and methods A prospective study was performed with 313 inpatients (87 male and 226 female) receiving herbal prescriptions during hospitalization. The patients were classified into two groups based on their treatments: one group received herbal medicines only (57 patients), and another received herbal and conventional medicines concurrently (256 patients). All patients were given liver and renal function tests at the start of hospitalization (baseline) and at approximately 2-week intervals thereafter, until discharge. Results Six of the 313 patients showed abnormal liver function without related clinical symptoms (1.9%, 95% CI 0.38–3.41); none of the patients in the herbal group had abnormal result in liver function tests (0% of 57 patients) while all six had received a combination of herbal and conventional medicines (2.3% of 256 patients, 95% CI 0.46–4.14). Conclusion Our findings indicate that herbal drugs used alone are relatively safe, but the risk for adverse reactions may increase when herbal and conventional drugs are taken concurrently.

Objective To investigated the characteristics of patients with functional dyspepsia (FD) in terms of Sasang constitutional medicine. Methods A total of 116 patients with FD were recruited based on diagnosis by gastroscopy and symptomatic measurements. The distributions of Sasang constitutions and six syndromes in terms of TKM theory in the patients was compared with those from 1423 healthy subjects. Results The distribution of Sasang constitutions for the patients with FD significantly differed from that for healthy subjects, especially among women; 36.7% vs 45.6% for Taeumin, 28.9% vs 33.9% for Soumin, and 34.4% vs 20.4% for Soyangin. Our results assumed a high prevalence in Soyangin women (around 1.7 folds), and Soumin (45.2%), in particular, had a high prevalence of “deficiency and coldness of spleen and stomach” compared with Taeumin (14.9%) and Soyangin types (15.7%). Conclusion This study identified a trend for the frequency of FD and the Sasang constitutions. The findings may provide new ideas for the study of prevention and management of FD.

Objective To examine the efficacy of Korean red ginseng for improving blood flow in healthy people. Methods Participants were randomized and treated with 1500 mg of Korean red ginseng extract or placebo for 8 weeks. The effect of Korean red ginseng was evaluated by digital infrared thermal images, and Doppler sonography, and blood test. Results Forty subjects completed the protocol. Imbalance in local thermal distribution was significantly decreased in the Korean red ginseng group confirmed by digital infrared thermal images. Doppler sonography showed no significant change in maximum and average rates of blood circulation in single or complex areas. Blood analyses for coagulation and lipid metabolism factors revealed no significant changes. No abnormal reactions to the Korean red ginseng were observed. Conclusion Digital infrared thermal imaging showed that the temperature deviation in the whole body decreased safely in the Korean red ginseng group, which mitigated the body-temperature imbalance. This result suggests that the Korean red ginseng improves blood circulation in the human body.