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The Safety of Viscum album l. in a Murine Model: A Reproductive Toxicity Study

Ricardo Ghelman, Mirlene Cecília Soares Pinho Cernach, Marcia Marcelino de Souza Ishigai, Jorge Kioshi Hosomi, Manuel de Jesus Simões, Luiz Kulay Junior, João Vitor da Costa Batista, Catharina Delebinski, Georg Seifert, Mary Uchiyama Nakamura

Background: The use of antineoplastic drugs in pregnancy poses a huge safety challenge because of the risk of teratogenicity, mutagenicity and carcinogenicity. The rational use of the herbal medicine Viscum Album (VA) has shown promising results in several tumor lines as part of the strategy of immunotherapy and anti-angiogenesis in integrative oncology. The safety of intrauterine fetal exposure to VA is however unknown and can be further evidence for therapeutic doses in pregnant cancer patients.

Methods: 47 pregnant Wistar rats and 399 foetuses bred following exposure to VA were investigated. The rats were randomized into five groups. Control Group (CG) received no treatment and the Stress Group (SG) received daily vehicle subcutaneous injections alone in the same volume as the treatment groups from day zero until the twentieth day of pregnancy. There were three treatments groups: Therapeutic Dose Group (TG) received the Usual Therapeutic Dose (UTD) of 0.013 mg/kg BW; High Dose Group (HG) received 12.5 mg/kg BW and Very High dose Group (VHG) received 25 mg/kg BW, daily.

Keyword: Viscum album; Mistletoe; Reproductive toxicology; Cancer; integrative medicine; Phytotherapy; Traditional and complementary medicine; Safety; Pregnancy

Results: Weight gain was greater in the rats, placentas and fetuses in the TG and HG compared to SG. Histology of the placentas showed a greater inflammatory process in HG and VHG.

Conclusion: Since no cases of abortion, embryo toxicity, natimortality or teratogenicity were found in the fetuses and histology detected no lesions in the tissues evaluated, it is reasonable to conclude that this drug is safe for use in pregnant rats.