Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs
Abstract
:1. Introduction
2. Data Sources and Searches
2.1. Search Terms
2.2. Data Extraction
3. Herbal Traditional Chinese Medicine, Its History, Philosophy and Challenges
3.1. History
3.2. Philosophical Background
3.3. Herbal TCM Use and Current Issues
3.4. Integration of Herbal TCM into Western Medicine
3.5. New TCM Drugs and Approaches of Research and Development
3.6. Therapeutic Efficacy
3.7. Safety
3.8. Nomenclature
4. TCM Herbs with Published Claims of Hepatotoxic Potential
4.1. Compilation of TCM Herbal Products with Reported Claims of Liver Injury
4.2. Worldwide Reports
5. Narratives of TCM HILI Cases
5.1. An Shu Ling
5.2. Ba Jiao Lian
5.3. Bai Fang
5.4. Bai Xian Pi
5.5. Ban Tu Wan
5.6. Bo He
5.7. Bofu Tsu Sho San
5.8. Boh Gol Zhee
5.9. Bupleurum
5.10. Camellia Sinensis
5.11. Chai Hu
5.12. Chaso
5.13. Chi R Yun
5.14. Chinese Herbal Mixtures
5.15. Chinese Skullcap
5.16. Chuan Lian Zi
5.17. Ci Wu Jia
5.18. Da Chai Hu Tang
5.19. Da Huang
5.20. Dai Saiko To
5.21. Dan Zhi Xiao Yao San
5.22. Dictamnus Dasycarpus
5.23. Gan Cao
5.24. Ge Gen
5.25. Glycyrrhiza Uralensis
5.26. Ho Shou Wu
5.27. Huang Qin
5.28. Hwang Geun Cho
5.29. Ji Gu Cao
5.30. Ji Xue Cao
5.31. Jia Wei Xiao Yao San
5.32. Jiguja
5.33. Jin Bu Huan
5.34. Jing Tian San Qi
5.35. Ju San Qi
5.36. Jue Ming Zi
5.37. Kamishoyosan
5.38. Kudzu
5.39. Liquorice
5.40. Long Dan Xie Gan Tang
5.41. Long Dan Xie Gan Wan
5.42. Lu Cha
5.43. Ma Huang
5.44. Mao Guo Tian Jie Cai
5.45. Onshido
5.46. Phyllanthus Urinaria
5.47. Polygonum Multiflorum
5.48. Qibao Meiran Wan
5.49. Rhen Shen
5.50. Sairei To
5.51. Shan Chi
5.52. Shen Min
5.53. Shi Can
5.54. Shou Wu Pian
5.55. Syo Saiko To
5.56. TJ-8
5.57. TJ-9
5.58. TJ-24
5.59. White Flood
5.60. Xiao Chai Hu Tang
5.61. Yin Chen Hao
5.62. Zexie
5.63. Zhen Chu Cao
5.64. Zhi Gan Cao
6. Pathogenetic Aspects of Liver Injury from Herbal TCM
6.1. Abundance of Herbs Used as TCM
6.2. TCM Herbs and Their Molecules
6.3. Idiosyncratic and Intrinsic Liver Injury from Herbal TCM
6.3.1. Idiosyncratic Type of Liver Injury
6.3.2. Intrinsic Type of Liver Injury
6.3.3. Tentative Toxic Components or Intermediates
7. Key Clinical Features of Liver Injury Due to TCM Herbs
7.1. Duration of Herbal Use and Time to Onset
7.2. Symptoms and Clinical Features
7.3. Laboratory Results
7.4. Severity of Liver Disease and Hy’s Law
7.4.1. Liver Adaptation
7.4.2. Severe Liver Injury and Acute Liver Failure
7.4.3. Natural Course and Outcome
8. Biomarkers: Microsomal Epoxide Hydrolase, Pyrrole-Protein Adducts, HLA, MicroRNA, and Metabolomics
8.1. Diagnostic Biomarkers
8.1.1. Established Diagnostic Biomarkers
8.1.1.1. Microsomal Epoxide Hydrolase
8.1.1.2. Pyrrole-Protein Adducts
8.1.1.3. Metabolomics
8.2. Progress in Developing Valid Diagnostic Biomarkers
8.2.1. Human Leucocyte Antigen (HLA)
8.2.2. MicroRNA
9. Diagnostic Challenges
9.1. Minimum Quality Requirements of Herbal TCM Products
9.2. Variability of Herbal TCM Product Names, Quality, Misidentifications, Adulterants, and Impurities
9.3. Case Data Quality
10. Hepatotoxicity Criteria and Liver Injury Pattern
11. RUCAM as the Preferred Method to Assess Causality in Liver Injury Caused by TCM Herbs
12. Reexposure
13. TCM Herbs with Established, Questionable, or Lacking Liver Injury and Listing Compilation
14. Chronic Courses and Injury Risk from TCM Herbs for Preexisting Liver Disease
15. Comparison with Drug Induced Liver Injury
16. Outbreaks of Liver Injury from TCM Herbs
17. Conclusions
Conflicts of Interest
References
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Issues | Details of Issues and Proposed Solutions | First Author |
---|---|---|
| Therapeutic efficacy is rarely provided for most TCM herbs. Randomized controlled trials (RCTs) are urgently needed, based on criteria of evidence based medicine (EBM). | Manheimer, 2009 [9] |
Teschke, 2015 [10] | ||
Ernst, 2006 [41] | ||
Wang, 2007 [42] | ||
Tang, 1999, 2008 [43,44] | ||
| Most TCM herbs are well tolerated by the majority of users, but few are not. RCTs should evaluate the individual benefit-risk profile for each herbal TCM product. It is important to define product quality specifications and adherence to the principles of cGAPs and cGMPs. | Ekor, 2014 [3] |
Liu, 2015 [8] | ||
Melchart, 2016 [13] | ||
Northier, 2000, 2002 [45,46] | ||
Vanherweghem, 1998 [47] | ||
Wagner, 2013 [48] | ||
WHO, 2016 [49] | ||
Frenzel, 2016 [50] | ||
| Causality assessment is often missing, must be verified by RUCAM for each spontaneous and clinical trial report submitted to regulatory agencies and for each case report submitted to a scientific journal for consideration of publication. | Frenzel, 2016 [50] |
Danan, 2016 [51] | ||
| Less strict regulatory surveillance is risky for consumers, calling for substantial improvement. Regulatory definitions of indications and use are mandatory. Herbal TCM products for medicinal use should be approved by regulatory agencies and registered as herbal drugs, provided efficacy is validly established and their benefit-risk balance is favorable. | Liu, 2015 [8] |
Zhang, 2012 [12] | ||
Frenzel, 2016 [50] | ||
| Variable nomenclature of herbal TCM products causes confusion, requiring CMM international name standards. Unlike Latin scientific names, CMM names, be they Chinese, pin yin, English, or according to pharmacopoeia, have not been standardized and their use, spelling and occasionally even the plant species to which they refer vary from publication to publication. | Chan, 2012 [52] |
Reported Side Effects | Patients (n) | Patients (%) |
---|---|---|
Liver adaptation | 3 | 0.3 |
Liver injury | 3 | 0.3 |
Diarrhea | 46 | 4.6 |
Nausea | 11 | 1.1 |
Vomiting | 4 | 0.4 |
Other gastrointestinal symptoms | 103 | 13.4 |
Neuro-vegetative symptoms | 61 | 6.1 |
Aggravation of pain | 36 | 3.6 |
Chinese Name | Botanical Names, Main Ingredients |
---|---|
| Artemisia argyi. |
| Lycopodium serratum or rarely, Corydalis species, Panax ginseng, Pseudo ginseng, or two species of Stephania. |
| Angelica sinensis, Cyperus rotundus, Ginseng, Ligusticumwallichii, Paeonia alba, Rehmannia glutinosa. |
| Atractylis, Carthamus tinctorius, Dalbergia odorifera, Dioscorea bulbifera, Glycyrrhiza, Lithospermum erythrorhizon, Paeonia suffruticosa, Polygonum multiflorum, Psoralea corylifolia, Salvia miltiorrhiza; Endoconcha sepiae, Ganoderma lucidum (mushroom). |
| Rhicinus communis, Chaenomeles, Codonopsis pilosula, Notopterygium, Polygonum multiflorum, Rehmannia, Schisandra. |
| Mentha haplocalyx. |
| Tinospora crispa. |
| Angelica, Atractylis, Cnidium, Gardenia, Ephedra, Forsythia, Glycyrrhhiza, Gypsum fibrosum, Ledebouriella, Mentha, Paeonia, Platycodon, Rheum, Schizonepeta, Scutellaria, Zingiber ; Kadinum (talcum powder), sodium sulfuricum. |
| Psoralea corylifolia. |
| Xanthium sibiricum. |
| Dichora febrifuga Lour. |
| Bupleurum falcatum. |
| Camellia sinensis, Cassia tora (syn. Senna), Crataegus, N-nitroso-fenfluramine. |
| Breynia officinalis. |
| Dictamnus dasycarpus, Gentiana scabra, Hedyotis diffusa, Paeonia suffructicosa, Paris polyphylla, Rehmannia glutinosa, Smilax glabra, Sophora subprostrata; Angelica sinensis, Bupleurum chinese, Dictamnus dasycarpus, Paeonia suffructiosa, Philodendron chinese, Saposhnikovia divaricata, Shisandra chinesis, Shizonepeta tenuifolia, Tribulus terrestris; Cocculus trilobus, Dictamnus dasycarpus, Eurysolen gracilis, Glycyrrhiza, Lophatherum, Paeonia, Potentilla, Rehmannia glutinosa; Alisma plantago aquatica, Artemisia capillaris, Gardenia jasminoidis, Gentiana scabra, Glycyrrhiza, Magnolia, Paeonia, Plantago asiatica, Saussurea Lappa. |
| Melia toosendan. |
| Acanthopanax senticosus. |
| Bupleurum falcatum, Ginseng, Glycyrrhiza glabra, Pinellia, Scutellaria, Zingiber officinale, Zizyphus jujuba. |
| Rheum palmatum. |
| Angelica archangelica. |
| Angelica dahurica, Isatis indigotica (Indigo naturalis), Massa medicata fermentata (yeast), Salvia milthiorrhiza, Smilax glabra. |
| Glycyrrhiza uralensis, syn. Liquorice. |
| Pueraria lobata, syn. Arrowroot. |
| Albizia julibrissin. |
| Polygonum multiflorum, syn. He Shou Wu. |
| Mentha pulegium, syn. Pennyroyal oil. |
| Polygonum cuspidatum. |
| Scutellaria baicalensis. |
| Dioscorea bulbifera. |
| Corydalis speciosa. |
| Abrus cantoniensis. |
| Chloranthus serratus. |
| Centella asiatica, syn. Gotu Kola. |
| Hovenia dulcis. |
| Lycopodium serratum or rarely, Corydalis species, Panax ginseng, Pseudo ginseng, or two species of Stephania. |
| Cassia obtusifolia, syn. Senna. |
| Angelica sinensis, Atractylodes racea, Bupleurum falcatum, Gardenia, Glycyrrhiza glabra, Mentha haplocalyx, Moutan, Paeonia alba, Sclerotium Poriae Cocos, Zingiber officinale. |
| Pueraria thunbergiana. |
| Melia azedarach. |
| Tripterygium wilfordii Hook. |
| Aloe vera. |
| Acebia, Alisma, Angelica sinensis, Bupleurum, Gardenia, Gentiana, Glycyrrhiza, Plantago, Rehmannia, Scutellaria. |
| Camellia sinensis, syn. Chinese green tea. |
| Ephedra sinica. |
| Heliotropium lasiocarpum. |
| Aloe, Camellia sinensis, Crataegus, Gynostemma pentaphyllum makino, Raphanus; N-nitroso-fenfluramine. |
| Senecio scandens. |
| Polygonum multiflorum, Angelica sinensis, fructus psoraleae (Yan Shuizhi), wolfberry fruit, Cuscuta species, poria cocos, achyranthes bidentata. |
| Panax ginseng. |
| Alisma, Atractylis, Bupleurum, Cinnamomum, Ginseng, Glycyrrhiza, Pinellia, Polyporus, Poria, Scutellaria, Zingiber, Zizyphus. |
| Gynura segetum. |
| Phytolacca acinosa. |
| Black cohosh, Burdock, Cayenne pepper, Ginkgo biloba, Horse chestnut, Piper nigrum, Polygonum multiflorum, uva ursi; biotin, collagen (hydrolyzed), niacin, pantothenic acid, silica (from plant sources), soy isoflavones, vitamin A, vitamin B6. |
| Teucrium chamaedrys, syn. Germander. |
| Pericarpium granati. |
| Achyranthes bidentata, Cuscuta chinensis, Eclipta prostrata, Ligustrum lucidum, Lonicera japonica, Morus alba, Polygonum multiflorum, Psoralea corylifolia, Rehmannia glutinosa, Rosa aevigat, Sesemum indicum, Siegesbeckia orientalis. |
| Trichosanthes kirilowii. |
| Qian Ceng Ta (Huperzia serrata), Wu Zhu Yu Evodia rutaecarpa); beet root, caffein, cocoa bean, vinpocetine (from Vinca plant); acesulfame potassium, calcium silicate, carnitine tartrate, Carno-Syn® beta-alanine, citrulline, cryptoxanthin, folic acid, gamma-aminobutyric acid (GABA), glucuronolactone, selenium, L-norvaline, L-tyrosine, lutein, malic acid, ornithine, potassium gluconate, sucralose, sugar cane, water melon flavor, zeaxanthin. |
| Galla chinensis. |
| Camptotheca acuminate. |
| Abrus Precatorius. |
| Bupleurum falcatum, Ginseng, Glycyrrhiza glabra, Pinellia tuber, Scutellaria baicalensis, Zingiber officinale, Zizyphus jujuba. |
| Artemisia capillaris. |
| Alisma orientalis. |
| Phyllanthus urinaria. |
Country/Area | Cases (n) | References with First Author |
---|---|---|
| 3 | Jorge, 2005 [112] |
| 1 | Park, 2001 [156] |
| 1 | Divinsky, 2002 [116] |
| 1 | Cárdenas, 2006 [151] |
| 7 | Larrey, 1992 [168] |
26 | Castot, 1992 [169] | |
1 | Mostefa-Kara, 1992 [170] | |
1 | Diaz, 1992 [171] | |
1 | Ben Yahia, 1993 [172] | |
1 | Dao, 1993 [173] | |
1 | Mattéi, 1999 [175] | |
1 | Peyrin-Biroulet, 2004 [133] | |
| 1 | Starakis, 2006 [176] |
| 2 | Dai, 2006 [124] |
1 | Chen, 2007 [128] | |
41 | Wu, 2008 [119] | |
1 | Li, 2010 [129] | |
116 | Gao, 2012 [122] | |
146 | Zhou, 2013 [184] | |
1 | Li, 2015 [165] | |
40 | Wang, 2015 [164] | |
15 | Zhu, 2015 [189] | |
563 | Zhu, 2016 [188] | |
| 4 | Kumana, 1983, 1985 [125,126] |
1 | But, 1996 [155] | |
7 | Yuen, 2006 [82] | |
3 | Cheung, 2009 [88] | |
52 | Lin, 2011 [120] | |
| 1 | Picciotti, 1998 [117] |
1 | Mazzanti, 2004 [157] | |
36 | Mazzanti, 2009 [138] | |
1 | Valente, 2010 [154] | |
19 | Mazzanti, 2015 [141] | |
| 4 | Itoh, 1995 [178] |
1 | Kamiyama, 1997 [91] | |
12 | Adachi, 2003 [93] | |
1 | Aiba, 2007 [166] | |
1 | Motoyama, 2008 [83] | |
21 | Gono, 2010 [106] | |
1 | Furukawa, 2010 [159] | |
1 | Tsuda, 2010 [167] | |
1 | Inoue, 2011 [92] | |
| 1 | Hwang, 2001 [86] |
1 | Nam, 2005 [87] | |
4 | Jang, 2008 [75] | |
120 | Kang, 2008 [79] | |
24 | Sohn, 2008 [80] | |
1 | Kang, 2009 [111] | |
2 | Kim, 2009 [104] | |
1 | Bae, 2010 [105] | |
25 | Jung, 2011 [153] | |
1 | Yang, 2012 [108] | |
3 | Kim, 2012 [113] | |
| 1 | Huseini, 2016 [142] |
| 1 | Panis, 2005 [152] |
| 1 | Banarova, 2012 [160] |
| 1 | Garcia-Moran, 2004 [132] |
1 | Jimenez-Saenz, 2006 [134] | |
8 | Garcia-Cortés, 2008 [136] | |
| 61 | Lee, 2011 [90] |
2 | Lin, 2002 [97] | |
19 | Lin, 2003 [98] | |
1 | Hsu, 2006 [179] | |
| 1 | Davies, 1990 [100] |
1 | Graham-Brown, 1992 [76] | |
1 | Sanders, 1995 [101] | |
3 | Kane, 1995 [77] | |
1 | Vautier, 1995 [78] | |
1 | Skoulidis, 2005 [148] | |
| 7 | Woolf, 1994 [114] |
1 | Nadir, 1996 [145] | |
6 | Horowitz, 1996 [115] | |
1 | Borum, 2001 [147] | |
2 | Haller, 2002 [70] | |
7 | Estes, 2003 [74] | |
1 | Bonkovsky, 2006 [135] | |
1 | Laird, 2008 [158] | |
34 | Sarma, 2008 [137] | |
1 | Linnebur, 2010, [107] | |
1 | Cohen, 2012 [177] | |
1 | Cortez, 2012 [81] | |
1 | Yang, 2012 [108] | |
1 | Dhanasekaran, 2013 [109] | |
47 | Navarro, 2013 [139] | |
1 | Papafragkakis, 2016 [110] |
Chinese Name | Scientific Name | Tentative Hepatotoxic Components |
---|---|---|
Ai Ye | Artemisia argyi | Volatile oil |
Bi Ma Zi | Rhicinus communis | Ricin, toxic proteins |
Cang Shan | Xanthium | Glycosides (kaurene), diterpenoids |
Chang Shan | Dichor febrifuga Lour | Alkaloids (dichroine) |
He Huan Pi | Albizia julibrissin | Glycosides (saponine) |
He Shou Wu | Polygonum multiflorum | Anthraquinones |
Huang Yao Zi | Discorea bulbifera L | Glycosides (steroids, diosgenin), diterpenoids-lactones |
Ku Lian Zi | Melia azedarach | Glycosides (tetranortriterpenoids) |
Lei Gong Teng | Tripterygium wilfordii hook F | Glycosides (tripterygium), diterpenoid-lactones |
Qian Li Guang | Senecio scandens | Pyrrolizidine alkaloids |
Shan Lu | Phytolacca acinosa Roxb. | Alkaloids (phytolaccine) |
Xiang Si Zi | Abrus Precatorius | Abrin |
Conditions | Results |
---|---|
| n = 116 |
| Males 57 |
Females 56 | |
(NA 3) | |
| 17–76 years |
| 115/116 cases |
| 104/113 cases |
| 95/113 cases |
| 47/60 cases |
(NA 56 cases) | |
| 50/58 cases |
(NA 58 cases) | |
| Recovery 75 cases |
Chronicity 27 cases | |
Death 11 cases | |
(NA 3 cases) |
TCM Product/TCM Herb | Fatality (n) | LTX (n) | Selected References with First Author |
---|---|---|---|
| 2 | Sohn, 2008 [80] | |
| 2 | Sohn, 2008 [80] | |
| 1 | Sohn, 2008 [80] | |
| 4 | Mazzanti, 2015 [141] | |
| 2 | Estes, 2003 [74] | |
1 | Skoulidis, 2005 [148] | ||
| 3 | Sohn, 2008 [80] | |
1 | Jung, 2011 [153] | ||
1 | 1 | Wang, 2015 [164] | |
| 1 | Gao, 2012 [122] | |
| 11 | 1 | Sohn, 2008 [80] |
| 1 | Sohn, 2008 [80] | |
| 3 | 3 | Lee, 2015 [238] |
|
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Differential Diagnosis | Diagnostic Parameters | Diagnostic Exclusion Done for Patient’s Causality Assessment | ||
---|---|---|---|---|
Yes | No | Partial | ||
| Anti-HAV-IgM | □ | □ | □ |
| HBV-DNA, anti-HBc-IgM | □ | □ | □ |
| HCV-RNA, anti-HCV | □ | □ | □ |
| HEV-RNA , titer change for anti-HEV-IgM/anti-HEV-IgG | □ | □ | □ |
| CMV-PCR, titer change for anti-CMV-IgM/anti-CMV-IgG | □ | □ | □ |
| EBV-PCR, titer change for anti-EBV-IgM/anti-EBV-IgG | □ | □ | □ |
| HSV-PCR, titer change for anti-HSV-IgM/anti-HSV-IgG | □ | □ | □ |
| VZV-PCR, titer change for anti-VZV-IgM/anti-VZV-IgG | □ | □ | □ |
| Specific serology of Adenovirus, Coxsackie-B-Virus, Echovirus, Measles virus, Rubella virus, Flavivirus, Arenavirus, Filovirus, Parvovirus, HIV, and others | □ | □ | □ |
| Specific assessment of bacteria, fungi, parasites, worms, and others | □ | □ | □ |
| Gamma globulins, ANA, SMA, AAA, SLA/LP, Anti-LSP, Anti-ASGPR | □ | □ | □ |
| Gamma globulins, Anti-LKM-1 (CYP 2D6), Anti-LKM-2 (CYP 2C9), Anti-LKM-3 | □ | □ | □ |
| AMA, Anti PDH-E2 | □ | □ | □ |
| p-ANCA, MRC | □ | □ | □ |
| ANA, SMA | □ | □ | □ |
| See AIH, PBC, PSC, and AIC | □ | □ | □ |
| BMI, insulin resistance, hepatomegaly, echogenicity of the liver | □ | □ | □ |
| Patient’s history, clinical and laboratory assessment, other alcoholic disease(s) | □ | □ | □ |
| Patient’s history, clinical and laboratory assessment, sonography, use of the updated RUCAM | □ | □ | □ |
| Toxin screening | □ | □ | □ |
| Toxin screening for household and occupational toxins | □ | □ | □ |
| Serum ferritin, total iron-binding capacity, genotyping for C2824 and H63D mutation, hepatic iron content | □ | □ | □ |
| Copper excretion (24 h urine), ceruloplasmin in serum, free copper in serum, Coombs-negative hemolytic anemia, hepatic copper content, Kayser-Fleischer-ring, neurologic-psychiatric work-up, genotyping | □ | □ | □ |
| Porphobilinogen in urine, total porphyrines in urine | □ | □ | □ |
| α1—Antitrypsin in serum | □ | □ | □ |
| Clinical and laboratory assessment, hepatobiliary sonography, MRC | □ | □ | □ |
| Clinical and laboratory assessment, sonography, CT, MRT | □ | □ | □ |
| TTG antibodies, endomysium antibodies, duodenal biopsy | □ | □ | □ |
| Clinical context | □ | □ | □ |
| Clinical context | □ | □ | □ |
| Cardiopulmonary assessment of congestive heart disease, myocardial infarction, cardiomyopathy, cardiac valvular dysfunction, pulmonary embolism, pericardial diseases, arrhythmia, hemorrhagic shock, and various other conditions | □ | □ | □ |
| Plasma cortisol | □ | □ | □ |
| TSH basal, T4, T3 | □ | □ | □ |
| Clinical context of epileptic seizure (duration > 30 min) | □ | □ | □ |
| Shock, hyperthermia | □ | □ | □ |
| Shock, liver injury | □ | □ | □ |
| Specific assessment of sarcoidosis, amyloidosis, metastatic tumor, sepsis, and others | □ | □ | □ |
| Clinical context | □ | □ | □ |
Items | RUCAM | MV | DILIN | Naranjo | WHO | AD HOC |
---|---|---|---|---|---|---|
| + | + | 0 | 0 | 0 | 0 |
| + | + | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | 0 | 0 | + | 0 | 0 |
| + | 0 | 0 | 0 | 0 | |
| + | + | 0 | 0 | 0 | 0 |
| + | + | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | + | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | + | 0 | + | 0 | 0 |
| + | + | 0 | + | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
| + | + | + | 0 | 0 | 0 |
| + | + | + | 0 | 0 | 0 |
| + | + | + | 0 | 0 | 0 |
| + | + | 0 | 0 | 0 | 0 |
| + | + | 0 | 0 | 0 | 0 |
| + | 0 | 0 | 0 | 0 | 0 |
Cases | Products | Country/Region | Year | First Author |
---|---|---|---|---|
HILI | Ji Xue Cao | Argentina/South America | 2005 | Jorge [112] |
HILI | Lu Cha (Green tea , Camellia sinensis) | France/Europe | 2005 | Gloro [278] |
HILI | Bo He, Chuan Lian Zi, and various other herbal TCM | Korea/Asia | 2006 | Yuen [82] |
HILI | Lu Cha | Spain/Europe | 2006 | Jimenez-Saenz [134] |
HILI | Polygonum multiflorum | Columbia/South America | 2006 | Cárdenas [151] |
HILI | Bai Xian Pi, Kudzu, Lu Cha, Yin Chen Hao | Korea/Asia | 2008 | Kang [111] |
HILI | Bai Xian Pi, Ci Wu Jia, Shou Wu Pian, Yin Chen Hao | Korea/Asia | 2008 | Sohn [80] |
HIL | Polygonum multiflorum | China/Asia | 2009 | Zhang [161] |
HILI | Lu Cha | Italy/Europe | 2009 | Mazzanti [138] |
HILI | Corydalis speciosa | Korea/Asia | 2009 | Kang [111] |
HILI | Ge Gen | Korea/Asia | 2009 | Kim [104] |
HILI | Ho Shou Wu | Korea/Asia | 2010 | Bae [105] |
HILI | Aloe | Korea/Asia | 2010 | Yang [279] |
HIL | Polygonum multiflorum | Korea/Asia | 2011 | Jung [153] |
HILI | Gynura segetum | Hong Kong/Asia | 2011 | Lin [120] |
HILI | Juguju | Korea/Asia | 2012 | Kim [113] |
HILI | Gynura segetum | Hong Kong/Asia | 2012 | Gao [122] |
HILI DILI | Multiple herbs synthetic drugs and | Korea/Asia | 2012 | Suk [182] |
DILI HILI | Multiple TCM herbs and synthetic drugs | China/Asia | 2014 | Hao [186] |
HILI | Polygonum multiflorum | China/Asia | 2014 | Dong [162] |
HILI | Lu Cha | Italy/Europe | 2015 | Mazzanti [221] |
HILI | Polygonum multiflorum | China/Asia | 2015 | Lei [163] |
HILI | Polygonum multiflorum | China/Asia | 2015 | Wang [164] |
HILI | Polygonum multiforme | China/Asia | 2015 | Zhu [187] |
HILI | Single TCM herbs | Germany/Europe | 2016 | Douros [183] |
HILI DILI | Multiple TCM herbs, synthetic drugs | Korea/Asia | 2016 | Woo [280] |
HILI | Chinese skullcap, black catechu | USA | 2016 | Papafragkakis [110] |
HILI | Various TCM herbs | Germany/Europe | 2016 | Melchart [14] |
Cases | Suspected Products | Country/Region | Year | First Author of the Group/Agency |
---|---|---|---|---|
HILI DILI | Various herbal TCM, synthetic drugs | Singapore/Asia | 2006 | Wai [283], National University of Singapore |
HILI | Lu Cha | Sweden/Europe | 2007 | Björnsson [284], Swedish Adverse Drug Reactions Advisory Committee |
HILI | Lu Cha, other TCM herbs | Spain/Europe | 2008 | García-Cortés [136], Spanish Liver Toxicity Registry |
HILI DILI | Few TCM herbs, multiple drugs | Spain/Europe | 2008 | García-Cortés [285], Spanish Group for the Study of Drug-induced Liver Disease |
HILI | Various TCM herbs | Hong Kong | 2011 | Chau [286], Hong Kong Herb-Induced Liver Injury Network (HK-HILIN), Hong Kong |
HILI | Polygonum multiflorum | Korea/Asia | 2011 | Jung [153], School of Medicine, Changwon Gyeongsang National University School of Medicine, Jinju/Sungkyunkwan University |
Reexposure Test Result | Hepatocellular Injury | Cholestatic or Mixed Liver Injury | ||
---|---|---|---|---|
ALTb | ALTr | ALPb | ALPr | |
| <5 N | ≥2 ALTb | <2 N | ≥2 ALPb |
| <5 N | <2 ALTb | <2 N | <2 ALPb |
| ≥5 N | ≥2 ALTb | ≥2 N | ≥2 ALPb |
| ≥5 N | <2 ALTb | ≥2 N | <2 ALPb |
| <5 N | n.a. | <2 N | n.a. |
| n.a. | ≥2 ALTb | n.a. | ≥2 ALPb |
| n.a. | n.a. | n.a. | n.a. |
Herbal TCM | RUCAM Based Causality | Reexposure Based Causality |
---|---|---|
| + | − |
| + | − |
| + | − |
| + | − |
| + | − |
| + | − |
| + | − |
| + | − |
| + | − |
| + | − |
| + | − |
| − | − |
| − | + |
| − | + |
| − | − |
| + | + |
| + | − |
| + | − |
| − | − |
| + | − |
| + | + |
| − | + |
| + | + |
| + | − |
| + | − |
| + | − |
| + | + |
| + | − |
| + | − |
| + | + |
| − | + |
| + | − |
| + | − |
© 2016 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC-BY) license (http://creativecommons.org/licenses/by/4.0/).
Share and Cite
Teschke, R.; Larrey, D.; Melchart, D.; Danan, G. Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs. Medicines 2016, 3, 18. https://doi.org/10.3390/medicines3030018
Teschke R, Larrey D, Melchart D, Danan G. Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs. Medicines. 2016; 3(3):18. https://doi.org/10.3390/medicines3030018
Chicago/Turabian StyleTeschke, Rolf, Dominique Larrey, Dieter Melchart, and Gaby Danan. 2016. "Traditional Chinese Medicine (TCM) and Herbal Hepatotoxicity: RUCAM and the Role of Novel Diagnostic Biomarkers Such as MicroRNAs" Medicines 3, no. 3: 18. https://doi.org/10.3390/medicines3030018