Published September 18, 1986; Replaced August 29, 1992.
List of German Commission E Monographs (Phytotherapy)
Rubiae tinctorum radix, madder root.
Madder root consists of the dried root of Rubia tinctorum L. [Fam. Rubiaceae], as well as preparations thereof in effective dosage. The herb contains lucidin.
In rats, oral intake of fresh madder root (10 percent of the food) decreased stone formation in bladder and kidney induced by 3 percent CaCO3. In rabbits, oral intake of madder root extract (150 - 200 mg/kg) caused decreased calcium oxalate crystallization in the kidney.
An increase in death rate was observed with feeding experiments of rats. Furthermore, feeding experiments with rabbits showed hepatotoxic effects. Genotoxic effects were observed in bacterial as well as in mammalian cell test systems.
Application as a result of evaluation:
None Claimed uses with negative evaluation:
kidney stones and disintegration of kidney stones. Because of the risks and the insufficiently documented effectiveness, the risk/benefit evaluation is negative.
Madder root contains lucidin. Lucidin is positive in various bacterial strains using the Ames test. The substance induces concentration-dependent gene mutations and DNA strand cleavage in V79 cells, causes transformation in the C3H/M2 cell transformation test, and is positive in the DNA-repair-test on rat hepatocytes. In vivo, a clear covalent bonding of lucidin to rat liver DNA has been observed. Therefore, there exists a strong indication that lucidin is mutagenic and carcinogenic.
Based on the genotoxic risk, combined with the fact that the claimed applications may involve an extended therapy and the insufficiently documented effectiveness, a therapy with madder root is not justified.
Note: After intake of madder root, occasional cases of red coloration of the urine, saliva, perspiration, and milk have been observed.