Non-clinical safety evaluation of Mangeum-tang

Abstract

In South Korea, the traditional use of Korean medicine is recognized by the government, with efforts being made to expand its inclusion in health insurance. However, unlike pharmaceutical drugs, traditional medicines are used in clinical practice without proper non-clinical and clinical trial validation, raising criticism and concerns. Mangeum-tang is commonly used for treating sequelae from stroke and neuralgia. The rhizome of Cnidium officinale MAKINO, included in Mangeum-tang, is known to reduce embryonic growth and development in rats and induce mild limb malformations, raising safety concerns. The causes of malformations are diverse, often linked to genotoxicity, prompting toxicity investigations. In vitro, Mangeum-tang did not induce genetic mutations or chromosomal aberration, and in vivo, it did not cause micronucleus formation or acute toxicity in hematopoietic cells. Therefore, Mangeum-tang does not appear to induce acute toxicity or genotoxicity. However, the studies conducted were short-term, and toxicity from repeated administration has not been confirmed. To ensure the safety of Mangeum-tang, further studies, including repeated-dose toxicity tests, carcinogenicity tests, reproductive toxicity tests, and additional research on the genotoxicity of Cnidium officinale MAKINO, are necessary.