Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: is the liver‐unspecific Naranjo scale precise enough to ascertain causality?

@article{Teschke2011SpontaneousRO,
  title={Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: is the liver‐unspecific Naranjo scale precise enough to ascertain causality?},
  author={Rolf Teschke and Wolfgang Schmidt-Taenzer and Albrecht Wolff},
  journal={Pharmacoepidemiology and Drug Safety},
  year={2011},
  volume={20}
}
Causality assessment of cases with herbal hepatotoxicity represents a major regulatory challenge and included, in the past, the application of a diagnostic algorithm consisting of causality evaluation methods with either liver‐specific or liver‐unspecific characteristics. To evaluate various causality assessing methods in cases with suspected herbal hepatotoxicity, two different scales were now used for reasons of comparison. 
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54 Citations
Background Citations
12
Methods Citations
8
Results Citations
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54 Citations

Citation Type

Citation Type

Suspected Herbal Hepatotoxicity
TLDR
The USP and other regulatory agencies should apply validated liver-specific causality assessment methods rather than liver unspecific and not validated assessment methods in suspected HILI cases.
Suspected herbal hepatotoxicity: requirements for appropriate causality assessment by the US Pharmacopeia.
TLDR
The USP and other regulatory agencies should apply validated liver-specific causality assessment methods rather than liver unspecific and not validated assessment methods in suspected HILI cases.
Herbal hepatotoxicity: a critical review.
TLDR
This review deals with herbal hepatotoxicity, identical to herb induced liver injury (HILI), and critically summarizes the pitfalls associated with the evaluation of assumed HILI cases and proposes steps for improvements with impact on future cases of liver injury by herbs, herbal drugs and herbal supplements.
Herbal hepatotoxicity: challenges and pitfalls of causality assessment methods.
TLDR
HILI causality assessment is challenging and is best achieved by the liver specific CIOMS scale, avoiding pitfalls commonly observed with other approaches.
Herb induced liver injury presumably caused by black cohosh: a survey of initially purported cases and herbal quality specifications.
Herbal hepatotoxicity and WHO global introspection method.
HERBS , HERBAL DRUGS , AND HERBAL SUPPLEMENTS
TLDR
In conclusion, causality of herbal hepatotoxicity is best assessed by the liver specific CIOMS scale validated for liverotoxicity rather than the obsolete WHO method that is liver unspecific and not validated for hepatot toxicity.
Herbal hepatotoxicity by Greater Celandine (Chelidonium majus): causality assessment of 22 spontaneous reports.
Clinical and causality assessment in herbal hepatotoxicity
TLDR
The authors call for substantial improvements in data quality of herbal products and case characteristics and strongly recommend using the CIOMS scale to assess causality in suspected herbal hepatotoxicity.
Suspected Greater Celandine hepatotoxicity: liver-specific causality evaluation of published case reports from Europe
TLDR
Confounding variables reduced causality levels for GC in reported cases of liver injury, but there is still striking evidence for herb-induced liver injury by GC with high causality gradings.
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References

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TLDR
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TLDR
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