Kava—the Unfolding Story: Report on a Work-in-Progress

Denham, Alison; McIntyre, Michael J.; Whitehouse, Julie

doi:10.1089/10755530260127943

Cited by 74 publications

(83 citation statements)

References 38 publications

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“…The TTK scale is widely used in Japan [74] , as recently reviewed [75] . In other countries, this scale is not or rarely [59] Kava 20 Teschke et al [60] Kava 36 Stickel et al [61] Kava 80 Schmidt et al [62] Greater Celandine 23 BfArM [63] Black cohosh 31 EMA [54] Herbalife products 12 Elinav et al [64] Herbalife products 12 Schoepfer et al [65] Kava 26 Teschke et al [12] Black cohosh 30 Mahady et al [42] Green tea 34 Sarma et al [43] Black cohosh 4 Teschke et al [47] Black cohosh 9 Teschke et al [48] Kava 31 Teschke [34] Hydroxycut 17 Fong et al [66] Black cohosh 22 Teschke et al [36] Greater Celandine 22 Teschke et al [37] Herbalife products 20 Manso et al [67] Various herbs 45 Chau et al [57] Greater Celandine 21 Teschke et al [32] Pelargonium sidoides 15 Teschke et al [38] Pelargonium sidoides 13 Teschke et al [39] Sum ( The data are derived from a study evaluating alternative causes in suspected HILI cases (n = 573) comprising the study cohort [5] . For the 275 CIOMS cases, causality assessment was performed with the updated CIOMS scale the original CIOMS scale, or both.…”

Section: Other Liver Specific Methodsmentioning

confidence: 99%

“…Among various causality assessment methods, the original and updated CIOMS scales were the preferred tools in cases of DILI [28] and HILI (Table 8) [5] , seen for 573 cases from 23 HILI reports evaluating alternative causes [12,32,34,[36][37][38][39]42,43,47,48,54,[57][58][59][60][61][62][63][64][65][66][67] . Transparency CIOMS based assessments should be reported or published as an original data set suitable for subsequent and independent assessments, rather than as final scores and corresponding causality levels, to improve data transparency.…”

Section: Usage Frequencymentioning

confidence: 99%

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Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

Teschke

Wolff

Frenzel

et al. 2014

WJH

109

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Causality assessment of suspected drug induced liver injury (�ILI) and herb induced liver injury (HILI) is hampered by the lack of a standardized approach to be used by attending physicians and at various subsequent evaluating levels. The aim of this review was to analyze the suitability of the liver specific Council for International Organizations of �edical Sciences (CIO�S) scale as a standard tool for causality assessment in �ILI and HILI cases. �ub�ed database was searched for the following terms: drug induced liver injury; herb induced liver injury; �ILI causality assessment; and HILI causality assessment. The strength of the CIO�S lies in its potential as a standardized scale for �ILI and HILI causality assessment. Other advantages include its liver specificity and its validation for hepatotoxicity with excellent sensitivity, specificity and predictive validity, based on cases with a positive reexposure test. This scale allows prospective collection of all relevant data required for a valid causality assessment. It does not require expert knowledge in hepatotoxicity and its results may subsequently be refined. Weaknesses of the CIO�S scale include the limited exclusion of alternative causes and qualitatively graded risk factors. In conclusion, CIO�S appears to be suitable as a standard scale for attending physicians, regulatory agencies, expert panels and other scientists to provide a standardized, reproducible causality assessment in suspected �ILI and HILI cases, applicable primarily at all assessing levels involved.© 2014 Baishideng �ublishing Group Co., Limited. All rights reserved.Key words: �rug induced liver injury; �rug hepatotoxicity; Herb induced liver injury; Herbal hepatotoxicity; Causality assessment Core tip: We propose that the attending physicians caring for patients with assumed drug induced liver injury and herb induced liver injury should use the Council for International Organizations of �edical Sciences (CIO�S) scale for causality assessment. This approach includes the option of subsequent refinement of the CIO�S based results by expert panels and regulatory agencies. The use of the CIO�S scale as an identical

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Section: Other Liver Specific Methodsmentioning

confidence: 99%

Section: Usage Frequencymentioning

confidence: 99%

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

Teschke

Wolff

Frenzel

et al. 2014

WJH

109

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“…Total score and resulting causality grad- ity assessment in hepatotoxicity cases [1][2][3][4]13,14,17,[21][22][23][24][25][26][34][35][36][37][38][39][59][60][61][62][63][64] . HILI case series reported in 23 publications with 573 HILI cases used various causality assessment methods [12][13][14]23,25,[34][35][36]38,39,53,54,[65][66][67][68][69][70][71][72][73][74][75] . These can be classified into prospective and retrospective analyses (Table 3).…”

Section: Methods Categoriesmentioning

confidence: 99%

“…Analyzing 23 publications of initially assumed causality but not necessarily confirmed later on [12][13][14]23,25,[34][35][36]38,39,53,54,[65][66][67][68][69][70][71][72][73][74][75] with HILI cases by BC, Greater Celandine, Green Tea extracts, some Herbalife products, Hydroxycut, kava, Pelargonium sidoides, and various herbs, the CIOMS scale was applied in 52.2%, the WHO method in 17.4%, the ad hoc approach in 13.1%, the Naranjo scale in 8.7%, and the KL and DILIN method each in 4.3% of these publications [82] . Similar results were obtained when analyzing the frequency for the 573 cases: the CIOMS scale was used in 275 cases (48.0%), the WHO method in 134 cases (23.4%), the Naranjo scale in 64 cases (11.2%), the ad hoc approach in 63 cases (11.0%), the KL method in 20 cases (3.5%), and the DILIN method in 20 cases (3.0%) [82] .…”

Section: Usage Frequencymentioning

confidence: 99%

“…Similar results were obtained when analyzing the frequency for the 573 cases: the CIOMS scale was used in 275 cases (48.0%), the WHO method in 134 cases (23.4%), the Naranjo scale in 64 cases (11.2%), the ad hoc approach in 63 cases (11.0%), the KL method in 20 cases (3.5%), and the DILIN method in 20 cases (3.0%) [82] . For instance, the CIOMS scale was applied for Kava [13,14,67] , BC [25,34,71,72] , Greater Celandine [35,36] , Pelargonium sidoides [38,39] , and various herbs [75] , the WHO method for Kava [65,68] and Herbalife products [53,54] , the ad hoc approach for Kava [12,66] and Greater Celandine [69] , the Naranjo scale for BC [23] and Green Tea extracts [70] , the KL method for Herbalife products [74] , and the DILIN method for Hydroxycut ® [73] . A systematic analysis of causality methods is also available for DILI cases [83] .…”

Section: Usage Frequencymentioning

confidence: 99%

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Herbal hepatotoxicity: Challenges and pitfalls of causality assessment methods

Teschke¹,

Frenzel²,

Schulze³

et al. 2013

WJG

156

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totoxicity cases, compared to numerous other causality assessment methods, which are inferior on various grounds. Among these disputed methods are the Maria and Victorino scale, an insufficiently qualified, shortened version of the CIOMS scale, as well as various liver unspecific methods such as the ad hoc causality approach, the Naranjo scale, the World Health Organization (WHO) method, and the Karch and Lasagna method. An expert panel is required for the Drug Induced Liver Injury Network method, the WHO method, and other approaches based on expert opinion, which provide retrospective analyses with a long delay and thereby prevent a timely assessment of the illness in question by the physician. In conclusion, HILI causality assessment is challenging and is best achieved by the liver specific CIOMS scale, avoiding pitfalls commonly observed with other approaches.© 2013 Baishideng. All rights reserved.Key words: Herbal hepatotoxicity; Herb induced liver injury; Herbs; Drug hepatotoxicity; Drug induced liver injury; Causality assessment Core tip: This review focuses on diagnostic causality assessment algorithms that have been used so far in herb induced liver injury (HILI) cases. Detailed information of the various methods with their strengths and weaknesses is provided including their challenges and pitfalls that emerged during the assessing course. For the physician caring for a patient with suspected HILI, the Council for International Organizations of Medical Sciences (CIOMS) scale is the preferred tool for assessing causality compared to numerous other causality assessment methods, which are inferior on various grounds. CIOMS based assessment should start at the day HILI is suspected to ensure completeness of clinical data. AbstractThe diagnosis of herbal hepatotoxicity or herb induced liver injury (HILI) represents a particular clinical and regulatory challenge with major pitfalls for the causality evaluation. At the day HILI is suspected in a patient, physicians should start assessing the quality of the used herbal product, optimizing the clinical data for completeness, and applying the Council for International Organizations of Medical Sciences (CIOMS) scale for initial causality assessment. This scale is structured, quantitative, liver specific, and validated for hepatotoxicity cases. Its items provide individual scores, which together yield causality levels of highly probable, probable, possible, unlikely, and excluded. After completion by additional information including raw data, this scale with all items should be reported to regulatory agencies and manufacturers for further evaluation. The CIOMS scale is preferred as tool for assessing causality in hepa-

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Abnormal Liver Function Tests Due to Hepatotoxic Herbs

Dasgupta¹,

Hammett‐Stabler

2010

Herbal Supplements

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Kava—the Unfolding Story: Report on a Work-in-Progress

Cited by 74 publications

References 38 publications

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

Drug and herb induced liver injury: Council for International Organizations of Medical Sciences scale for causality assessment

Herbal hepatotoxicity: Challenges and pitfalls of causality assessment methods

Abnormal Liver Function Tests Due to Hepatotoxic Herbs

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