Human carcinogenicity data

An outbreak of rapidly progressive renal fibrosis in Belgium involved at least 100 patients, mostly middle-aged women undergoing a weight-loss regimen that included use of a mixture of Chinese herbs containing Aristolochia species incorrectly labelled as Stephania tetrandra. Additional cases of rapidly progressive renal disease involving Chinese herbs have been reported from at least five other countries in Europe and Asia. This syndrome has been called 'Chinese herb nephropathy'.

Because of a few early cases of urothelial cancer among Belgian patients suffering from Chinese herb nephropathy, individuals with end-stage renal disease were offered prophylactic nephroureterectomy. This surgical procedure led to the identification of a high prevalence of pre-invasive and invasive neoplastic lesions of the renal pelvis, the ureter and the urinary bladder in patients with Chinese herb nephropathy. The number of malignancies detected (18 cancers in 39 women undergoing prophylactic nephroureter-ectomy) greatly exceeded the expected number of these uncommon tumours. There was a positive dose-response relationship between the consumption of the herbal mixture and the prevalence of the tumours. Some cases of clinically invasive disease have been described in the follow-up of end-stage Chinese herb nephropathy patients not undergoing prophylactic nephroureterectomy.

Subsequent phytochemical investigation led to the identification of aristolochic acids in the herbal mixture consumed by these patients. While there was batch-to-batch variation in the chemical composition of such mixtures employed in the weight-loss clinics in Belgium, specific aristolochic acid-DNA adducts were found in urothelial tissue specimens from all the urothelial cancer patients, providing conclusive evidence of exposure to plants of the genus Aristolochia.

One additional case of urothelial cancer following treatment for eczema with another herbal mixture that contained aristolochic acid has been reported.

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