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Reply to: Suspected black cohosh hepatotoxicity-Causality assessment versus safety signal. Quality versus quantity

2009; Elsevier BV; Volume: 64; Issue: 2 Linguagem: Inglês

10.1016/j.maturitas.2009.08.006

1873-4111

Rolf Teschke, Ruediger Bahre, A Genthner, Johannes Fuchs, Wolfgang Schmidt‐Taenzer, Albrecht Wolff,

Genomics, phytochemicals, and oxidative stress

We appreciate the efforts of Mahady et al. [ [1] Mahady G. Low Dog T. Sarma D.N. Giancaspro G. Suspected black cohosh hepatotoxiciy-causality assessment versus safety signal, quality versus quantity. Maturitas. 2009; 64: 139-140 Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar ] to extent the discussion regarding assumed hepatotoxicity in connection with the use of black cohosh (BC) by presenting 13 additional cases with suspected BC hepatotoxicity. We have previously shown that there is little, if any, supportive evidence for a substantial hepatotoxic potency of BC in 69 analyzed cases [ 2 Teschke R. Schwarzenboeck A. Suspected hepatotoxicity by Cimicifugae racemosae rhizome (black cohosh, root): critical analysis and structured causality assessment. Phytomedicine. 2009; 16: 72-84 Abstract Full Text Full Text PDF PubMed Scopus (47) Google Scholar , 3 Teschke R. Bahre R. Fuchs J. et al. Black cohosh hepatotoxicity: qantitative causality evaluation in nine suspected cases. Menopause. 2009; 16: 956-965 Crossref PubMed Scopus (35) Google Scholar , 4 Teschke R. Bahre R. Genthner A. et al. Suspected black cohosh hepatotoxicity—challenges and pitfalls of causality assessment. Maturitas. 2009; 63: 302-314 Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar ]. One of the now presented 13 cases (TGA 220336) [ [1] Mahady G. Low Dog T. Sarma D.N. Giancaspro G. Suspected black cohosh hepatotoxiciy-causality assessment versus safety signal, quality versus quantity. Maturitas. 2009; 64: 139-140 Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar ] corresponds, however, to the case of Chow et al. discussed by us already in detail before [ 3 Teschke R. Bahre R. Fuchs J. et al. Black cohosh hepatotoxicity: qantitative causality evaluation in nine suspected cases. Menopause. 2009; 16: 956-965 Crossref PubMed Scopus (35) Google Scholar , 4 Teschke R. Bahre R. Genthner A. et al. Suspected black cohosh hepatotoxicity—challenges and pitfalls of causality assessment. Maturitas. 2009; 63: 302-314 Abstract Full Text Full Text PDF PubMed Scopus (55) Google Scholar ]. The other reports of three cases [ 5 Vannacci A. Lapi F. Gallo E. et al. A case of hepatitis associated with long-term use of Cimicifuga racemosa. Altern Ther Health Med. 2009; 15: 62-63 PubMed Google Scholar , 6 Pierard S. Coche J.S. Lanthier P. et al. Severe hepatitis associated with the use of black cohosh: a report of two cases and an advice for caution. Eur J Gastroenterol Hepatol. 2009; 21: 941-945 Crossref PubMed Scopus (22) Google Scholar ] shortly appeared after our paper was accepted for publication. Tieraona Low Dog, one of the authors of the present letter to the editor, has already analyzed and criticized the case report of Vannacci et al. [ [5] Vannacci A. Lapi F. Gallo E. et al. A case of hepatitis associated with long-term use of Cimicifuga racemosa. Altern Ther Health Med. 2009; 15: 62-63 PubMed Google Scholar ] within the frame of the same publication. She argued that "we have no way of knowing whether the hepatitis was due to BC". Indeed, the patient admitted that she had been taking an herbal formula that she believed it contained BC. The herbal formula was not sent for analysis, so there is no data about the constituent ingredients or any potential contamination. Interestingly, ALT values strikingly dropped despite continued herbal use. Regarding the two other cases reported by Pierard et al. [ [6] Pierard S. Coche J.S. Lanthier P. et al. Severe hepatitis associated with the use of black cohosh: a report of two cases and an advice for caution. Eur J Gastroenterol Hepatol. 2009; 21: 941-945 Crossref PubMed Scopus (22) Google Scholar ], the analysis of the first case is complicated by the use of an herbal mixture including soy, trifolium pratense, dioscorea villosa, pueraria lobata, angelica polymorpha, hypericum perforatum and calcium phosphate, and by other confounding variables such as high BC dosage (240 mg/d), long dechallenge period over several years, and unexplained increase of liver values upon treatment with methyl-prednisolone and azathioprine. The latter condition may suggest some form of underlying virus hepatitis such as herpetic hepatitis. The second case was confounded by co-medication including irbesartan, simvastatin and levothyroxine. Nine of the remaining 12 cases were spontaneous reports, lacking further information and structured, hepatotoxicity specific causality assessment. Thus, the claims of Mahady et al. [ [1] Mahady G. Low Dog T. Sarma D.N. Giancaspro G. Suspected black cohosh hepatotoxiciy-causality assessment versus safety signal, quality versus quantity. Maturitas. 2009; 64: 139-140 Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar ] are not really substantiated, awaiting further documentation and analysis.