Recently the use of herbal preparations as remedies for various medical conditions, has been rapidly increasing in Korea. In our previous study, 38.9% of patients with chronic liver disease were found to use some sorts of herbal preparations. They believe herbal preparations are safe although the ingredients has never been rigorously substantiated. Toxicities of certain herbal preparations are caused by their contaminants and adulterated ingredients or concurrently used conventional drugs rather than specific components of the herbal preparations. Furthermore, in most instances, multiple herbal ingredients are used by the prescribers of oriental medicine. All of these conditions frequently impose diagnostic difficulties. There are myriads of plant-derived hepatotoxic substances which may or may not cause liver injury in individuals. The severity of liver injury depends largely on the toxicity of the substance, the amount of exposure and the individual's susceptibility. These toxic substances cause liver injury not only through the mechanism of intrinsic hepatotoxicity but also through the idiosyncrasy as in conventional drug-induced injury. Therefore, theoretically, it is possible to apply pre-existing CAMs (Causality Assessment Methods) to the assessment of causality in cases with diagnostic difficulties.
English Abstract ; Humans ; Liver Diseases/*chemically induced ; Phytotherapy/*adverse effects ; Plant Preparations/*adverse effects

Drug-induced liver injury (DILI) is an increasingly common cause of acute hepatitis. We examined clinical features and types of liver injury of 65 affected patients who underwent liver biopsy according DILI etiology. The major causes of DILI were the use of herbal medications (43.2%), prescribed medications (21.6%), and traditional therapeutic preparations and dietary supplements (35%). DILI from herbal medications, traditional therapeutic preparations, and dietary supplements was associated with higher elevations in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels than was DILI from prescription medications. The types of liver injury based on the R ratio were hepatocellular (67.7%), mixed (10.8%), and cholestatic (21.5%). Herbal medications and traditional therapeutic preparations were more commonly associated with hepatocellular liver injury than were prescription medications (P = 0.002). Herbal medications and traditional therapeutic preparations induce more hepatocellular DILI and increased elevations in AST and ALT than prescribed medications.
Adult ; Alanine Transaminase/blood ; Aspartate Aminotransferases/blood ; Dietary Supplements/adverse effects ; Drug-Induced Liver Injury/enzymology/*etiology/pathology ; Female ; Humans ; Male ; Middle Aged ; Phytotherapy/adverse effects ; Plant Preparations/adverse effects ; Prescription Drugs/adverse effects ; Republic of Korea ; Retrospective Studies

Animals ; Coronary Disease ; prevention & control ; Dibutyl Phthalate ; adverse effects ; Dioxins ; adverse effects ; Environmental Pollutants ; adverse effects ; Estrogens, Non-Steroidal ; pharmacology ; Humans ; Isoflavones ; pharmacology ; Phytoestrogens ; Plant Preparations ; pharmacology ; Zearalenone ; adverse effects

OBJECTIVETo evaluate rates on the adverse side effect and discontinuation of second-line drugs frequently used in the treatment of rheumatoid arthritis (RA).

METHODEight hundred and sixty-four RA patients were studied in a retrospective program.

RESULTSUpper abdominal discomfort was most commonly seen when using second-line drugs. Rash was often associated with D-penicillamine (20.6%) and Sinomenium therapy (13.7%). Methotrexate (MTX) was uniquely characterized by substantial upper GI toxicity (32.2%) and Tripterygium wilfordii Hook. f. (TWH) (14.4%) by menstrual abnormality. Sulfasalazine users reported adverse events including upper abdominal trouble (39.0%), nausea (7.3%) and anorexia (7.3%) while the risk of GI malaise was greater. Patients taking hydroxychloroquine complained of blurred vision (19.6%) but no one went blind. Toxic side effects seemed to be the most common reasons for stoppages, and the patients taking MTX had the lowest discontinuation rate. Combination of D-penicillamine and Methotrexate did not increase the incidence of adverse events.

CONCLUSIONSKnowledge on these different patterns of toxicity provided choices in the selection of second line agents for particular RA patients. However, long-term monitor are required when drugs are being used.

Adult ; Anorexia ; chemically induced ; Antirheumatic Agents ; adverse effects ; therapeutic use ; Arthritis, Rheumatoid ; drug therapy ; Exanthema ; chemically induced ; Female ; Gastrointestinal Diseases ; chemically induced ; Humans ; Hydroxychloroquine ; adverse effects ; therapeutic use ; Male ; Methotrexate ; adverse effects ; therapeutic use ; Middle Aged ; Nausea ; chemically induced ; Penicillamine ; adverse effects ; therapeutic use ; Phytotherapy ; Plant Preparations ; adverse effects ; therapeutic use ; Retrospective Studies ; Sinomenium ; Sulfasalazine ; adverse effects ; therapeutic use

OBJECTIVETo report the results of curative and adverse effects of compound huangdai tablet (CHDT) as induction therapy for 193 patients with acute promyelocytic leukemia (APL).

METHODSCHDT was administered 1.25 g orally three times a day after meal for three days, then the dosage was gradually increased to 7.5 g/d.

RESULTSOne hundred and ninety-three patients achieved complete remission (CR), 78.8% of whom in 30 to 60 days with an average time of 44.3 d. No serious infection, bleeding or DIC occurred during the treatment course. The major adverse effects were gastrointestinal symptoms. There was no change in lanine transaminase, urea, creatinine or electrocardiographic QTc interval in 110 APL patients observed before and after the treatment.

CONCLUSIONCHDT therapy is a modality of higher CR rate, good safety and tolerance without bone marrow suppression for APL patients.

Adolescent ; Adult ; Aged ; Child ; Child, Preschool ; Female ; Follow-Up Studies ; Humans ; Leukemia, Promyelocytic, Acute ; drug therapy ; Male ; Middle Aged ; Phytotherapy ; adverse effects ; Plant Preparations ; adverse effects ; therapeutic use ; Treatment Outcome ; Young Adult

OBJECTIVETo analyze hepatotoxicity of Polygonum multiflorum and clinical character- istics of drug-induced liver injury (DILI) caused by Polygonum multiflorum and its preparations.

METHODSA retrospective study was performed in 158 patients treated at 302 Military Hospital between January 2009 and January 2014. All of them had used Polygonum multiflorum and its preparations before the onset of DILI, and their clinical characteristics and prognoses were analyzed.

RESULTSOf the 158 DILI patients who used Polygonum multiflorum or its preparations, 92 (58.2%) combined with Western medicine or Chinese herbal preparations without Polygonum multiflorum; 66 patients (41.8%) used Polygonum mult florum and its preparations alone. In 66 DILI patients induced by Polygonum multiflorum or its preparations alone, 51 cases (77.3%) were induced by Polygonum multiflorum compounds and 22.7% by single Po- lygonum multiflorum; 4 cases (6.1%) were caused by crude Polygonum multiflorum and 62 (93.9%) by processed Polygonum multiflorum and its preparations. Clinical injury patterns were hepatocellular 92.4% (61 cases), cholestatic 1.5% (1 case), and mixed 6.1% (4 cases). Pathological examination was per- formed by liver biopsy in 32 cases (48.15%), manifested as hepatocellular degeneration and necrosis, fibroplasia, Kupffer cells with pigment granule, and a large number of eosinophil infiltration, were ob- served. Four patients were developed into liver failure, 4 into cirrhosis, and 1 died.

CONCLUSIONPolygo- num multiflorum and its preparations could induce DILI, but clinical diagnosis of Polygonum multiflorum induced hepatotoxicity should be cautious.

Asian Continental Ancestry Group ; Chemical and Drug Induced Liver Injury ; diagnosis ; Cholestasis ; Drugs, Chinese Herbal ; adverse effects ; Fallopia multiflora ; Humans ; Liver Cirrhosis ; Liver Failure ; Plant Preparations ; adverse effects ; Polygonum ; Retrospective Studies

AIMto investigate the effects of crude garlic on adult male rat reproductive functions.

METHODSThirty male rats were divided into five groups: group 1 (untreated) and groups 2, 3, 4 and 5 were fed for 30 days with 5%, 10%, 15% and 30% crude garlic, respectively. Testes and accessory organs were weighed and some markers were assessed. Light and electron microscopy observations were also performed.

RESULTSA significant decrease was observed in the body weight of groups 4 (14%; P < 0.01) and 5 (20%; P < 0.01); of the prostate weight in group 5 (29.1%; P < 0.05) and of seminal vesicle weight in groups 3 (14.4%; P < 0.01), 4 (18.3%; P < 0.01) and 5 (27.3%; P < 0.01). In contrast, testis and epididymis weights were unchanged. In epididymis tissue, the alpha glucosidase activity and the spermatozoa density were unchanged. The treatment resulted in a significant decrease in testosterone serum levels in groups 3 (77.3%; P < 0.01), 4 (77.3%; P < 0.01) and 5 (90.9%; P < 0.01), associated with a significant increase in LH serum levels (P < 0.01). Testicular histology showed a dose-dependent increase in the percentage of empty seminiferous tubules. Moreover, testicular function was affected; a significant decrease in phosphatase acid activity (P < 0.01) and testosterone (P < 0.05) contents were observed.

CONCLUSIONCrude garlic consumption during 1 month reduced testosterone secretion and altered spermatogenesis at 10%, 15% and 30% doses.

Animals ; Dose-Response Relationship, Drug ; Epididymis ; drug effects ; physiology ; Garlic ; adverse effects ; Leydig Cells ; drug effects ; physiology ; Luteinizing Hormone ; blood ; Male ; Plant Preparations ; pharmacology ; Prostate ; drug effects ; physiology ; Rats ; Rats, Wistar ; Reproduction ; drug effects ; physiology ; Seminal Vesicles ; drug effects ; physiology ; Sertoli Cells ; drug effects ; physiology ; Sperm Count ; Spermatogenesis ; drug effects ; physiology ; Testis ; cytology ; drug effects ; metabolism ; Testosterone ; blood

Local healthcare providers often question the possible steroidal activity of traditional Chinese medicine (TCM) herbs or herbal products and implicate them as a cause for adrenal insufficiency or Cushing's syndrome in patients with a history of TCM intake. We conducted a comprehensive database search for evidence of potential glucocorticoid, mineralocorticoid, androgenic or oestrogenic activity of herbs or herbal products. Overall, there are not many herbs whose steroidal activity is well established; among these, most cases were based on preclinical studies. Liquorice root may cause pseudoaldosteronism through interference with the steroidogenesis pathway. Although ginseng and cordyceps have some in vitro glucocorticoid activities, the corroborating clinical data is lacking. Deer musk and deer antler contain androgenic steroids, while epimedium has oestrogenic activity. On the other hand, adulteration of herbal products with exogenous glucocorticoids is a recurrent problem encountered locally in illegal products masquerading as TCM. Healthcare providers should stay vigilant and report any suspicion to the relevant authorities for further investigations.
Androgens ; analysis ; Animals ; Cordyceps ; Databases, Factual ; Deer ; Drugs, Chinese Herbal ; adverse effects ; analysis ; Epimedium ; Estrogens ; analysis ; Fatty Acids, Monounsaturated ; Glucocorticoids ; analysis ; Glycyrrhiza uralensis ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Mineralocorticoids ; analysis ; Panax ; Plant Preparations ; analysis ; Risk ; Singapore ; Steroids ; adverse effects ; analysis ; Tissue Extracts

OBJECTIVETo evaluate the clinical efficacy of Ganxian recipe (GXR) and lamivudine (LVD) in a two-year treatment of chronic hepatitis B (CHB).

METHODSOne hundred and twenty patients with CHB were randomly divided into the combinedly treated group (combined group) of 40 CHB patients who were treated with GXR combined with LVD. Another 40 CHB patients were treated with LVD alone (WM group), and still another 40 CHB patients were treated with GXR alone (TCM group). All these cases were randomly controlled and observed for two years.

RESULTSComprehensive efficacy: Total effective rate of the combined group (complete response and partial response) was 92.5%, while that of the WM group was 67.5% and TCM group 57.5%, respectively, with the difference between them was significant (P < 0.01); after treatment, the hepatic functions (AST, ALT, SB) of the three groups were all reduced, and the reduction in the combined group was particularly significant in comparison with the WM group or TCM group, P < 0.05 or P < 0.01 respectively, suggesting that the effect in the combined group was better than that in the other two groups; the rate of tyrosine-methionine-aspartate-aspartate (YMDD) virus mutation: it was 7.5% in the combined group, 40.0% in the WM group, and 5.0% in the TCM group; liver fibrosis improvement parameter: after treatment, the results in the combined group got better than those in the other two groups.

CONCLUSIONGXR could inhibit the appearance of YMDD after long-term application of LVD, and combined use has marked synergism.

Adolescent ; Adult ; Female ; Gene Frequency ; Genes, Viral ; Hepatitis B Antibodies ; blood ; Hepatitis B e Antigens ; blood ; immunology ; Hepatitis B virus ; genetics ; Hepatitis B, Chronic ; complications ; physiopathology ; therapy ; virology ; Humans ; Lamivudine ; adverse effects ; therapeutic use ; Liver ; physiopathology ; Liver Cirrhosis ; pathology ; virology ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Mutation ; Phytotherapy ; adverse effects ; Plant Preparations ; adverse effects ; therapeutic use ; Reverse Transcriptase Inhibitors ; adverse effects ; therapeutic use ; Treatment Outcome

OBJECTIVETo observe the clinical effect of Shengxueling (SXL) on idiopathic thrombocytopenic purpura (ITP), and study the possible mechanism.

METHODSEighty-six cases of ITP were randomly divided into two groups. The SXL group, 56 patients treated with SXL, a traditinal Chinese medicine and 30 patients administered with prednisone were taken as control. Each group took drugs for 3 months and was under follow-up observation.

RESULTSIn the SXL group, the total effective rate was 85.71%, similar to prednisone 83.33% (P > 0.05) for 3 months, but the total effective rate of SXL (91.07%) were obviously better than that of the control group (53.33%) (P < 0.01) for 6 months and had no obvious adverse reaction. The patients bleeding was alleviated or stopped, the general condition was improved. At the same time, blood platelet count (PLT) was increased, platelet associated immunoglobulin (PAIg) and interleukin-4 (IL-4) were markedly dropped, the level of natural killers cells activity (NKa) increased, the rate of T lymphocyte subsets gradually returned to normal level. Megakaryocyte tended to maturation on bone marrow smear after treatment. All differences above were statistically significant.

CONCLUSIONSXL is an effective and safe medicine for ITP. Its mechanism could regulate cytoimmune, inhibit platelet antibody to reduce the destruction of platelet, increase the number of platelet, promote the division and maturation of megakaryocyte, facilitate the production and release of platelet, lower the fragility of capillary, prevent and cure hemorrhagic tendency.

Adolescent ; Adult ; Blood Platelets ; metabolism ; Bone Marrow ; pathology ; Female ; Glucocorticoids ; therapeutic use ; Hemorrhage ; etiology ; physiopathology ; Humans ; Immunoglobulins ; blood ; Interleukin-4 ; blood ; Killer Cells, Natural ; pathology ; Lymphocyte Count ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; adverse effects ; Plant Preparations ; adverse effects ; therapeutic use ; Platelet Count ; Prednisone ; therapeutic use ; Purpura, Thrombocytopenic, Idiopathic ; blood ; complications ; pathology ; therapy ; T-Lymphocyte Subsets ; pathology ; Treatment Outcome