Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): Causality assessment of 22 spontaneous reports

Teschke, Rolf; Glass, Xaver; Schulze, Johannes

doi:10.1016/j.yrtph.2011.08.008

Cited by 66 publications

(106 citation statements)

References 44 publications

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“…The lower threshold of ALT > 2N will include multiple cases with nonspecific enzyme increases and requires more stringent exclusion of causes unrelated to drug(s) and herb(s) [24] . Also for low threshold N values, the inclusion rate of alternative diagnoses must be higher; false positive fulfilment of a hepatotoxicity definition results in high numbers of misattributed cases due to overdiagnosing and overreporting [8,12,17,24,[34][35][36][37][38][39][40][41][42][43][44][45][46][47][48] . This phenomenon is illustrated in a recent HILI study where initial ALT values were available in only 8/22 cases (36%), including 3 cases with a range of 50-69 U/L serum activity [36] .…”

Section: Hepatotoxicity Definitionmentioning

confidence: 99%

“…None withstanding, regulatory assessment attributed a possible causality for the incriminated herb to all 22 cases [36,42] . In other spontaneous case collections, initial ALT values were available in 5/24 cases (21%) [35] , 19/22 cases (86%) [37] , 12/15 cases (80%) [38] , and 7/13 cases (54%) [39] . The corresponding figures for ALT in published case reports of HILI were 16/16 cases (100%) [35] , 21/21 cases (100%) [32] , and 5/8 cases (63%) [33] .…”

Section: Hepatotoxicity Definitionmentioning

confidence: 99%

“…This limit is in line with the recommendations of NIH LiverTox equalling 1 drink to 10 g ethanol [44,45] . The impact of including alcohol as a risk factor on the overall CIOMS scoring was negligible as only 9/146 patients (6%) of a HILI study cohort were allotted an alcohol related scoring point (Table 5) [12,30,32,[36][37][38][39][46][47][48] . In these 9 patients, CIOMS causality grading was changed in only one case (patient 16) and unchanged in the other 8 cases (patients 2, 13, 14, 17, 20, 21, 22, 32) ( Table 6).…”

Section: Risk Factorsmentioning

confidence: 99%

See 2 more Smart Citations

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

Teschke

Wolff

Frenzel

et al. 2014

WJH

Self Cite

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: Hepatotoxicity Definitionmentioning

confidence: 99%

Section: Hepatotoxicity Definitionmentioning

confidence: 99%

Section: Risk Factorsmentioning

confidence: 99%

See 1 more Smart Citation

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

Teschke

Wolff

Frenzel

et al. 2014

WJH

Self Cite

109

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show abstract

“…Greater Celandine (Chelidonium majus L.) has been used in traditional Chinese medicine as weel as in the Western world for its numerous biological activities [6,7] . Teschke et al [8,9] reviewed several reports from Europe regarding Greater Celandine (Chelidonium majus) hepatotoxicity. The causality assessment of these reports provided evidence for the existence of Greater Celandine hepatotoxicity [8,9] .…”

Section: Introductionmentioning

confidence: 99%

“…Teschke et al [8,9] reviewed several reports from Europe regarding Greater Celandine (Chelidonium majus) hepatotoxicity. The causality assessment of these reports provided evidence for the existence of Greater Celandine hepatotoxicity [8,9] .…”

Section: Introductionmentioning

confidence: 99%