ABSTRACT
OBJECTIVE: The possible toxicity of drugs in pregnancy should be tested before their use in pregnant patients. In the present study, we aimed to evaluate the safety of phytovagex, a pessary formulation of Nigella sativa (N. sativa), which is already in clinical use for vaginal fungal infection. MATERIALS AND METHODS: The pregnant rats were treated intravaginal with physiological saline (vehicle) or phytovagex pessary in the first half of their pregnancy (days 1 to 10 of gestation). Duration of pregnancy and health parameters of the newborns were recorded after parturition. Also, cytotoxicity of N. sativa hydroalcoholic extract was tested against ovary Cho cells. RESULTS: The phytovagex had no significant effect on the duration of pregnancy, number of newborns, weight of neonates, and percent of stillbirth. No deformity or general behavioral abnormality was observed in neonates monitored for 30 days after birth. N. sativa extract had no significant effect on the viability of ovary cells at the concentrations of 12.5-200 µg/mL. CONCLUSION: Results of this animal study showed that phytovagex has no overall effect on the duration of pregnancy and health parameters of the newborns. Also, its active agent, N. sativa, does not induce any cytotoxic effect on ovary cells.
ABSTRACT
To date, there is no report on safety of Artemisia Kopetdaghensis. This study aimed to determine the possible undesirable effects of A. Kopetdaghensis on reproduction of female rats. The pregnant rats were treated (i.p.) with vehicle or 200 and 400 mg/kg of A. Kopetdaghensis hydroalcoholic extract from the 2nd to 8th day of pregnancy. Then, number and weight of neonates, duration of pregnancy, and percent of dead fetuses were determined. Also, cytotoxicity of this plant was tested using fibroblast (L929) and ovary (Cho) cell lines. The A. Kopetdaghensis had no significant effect on duration of pregnancy, average number of neonates, and weight of neonates. However, administration of 200 and 400 mg/kg of the extract led to 30 and 44% abortion in animals, respectively. The extract at concentrations ≥200 µg/mL significantly (P < 0.001) inhibited the proliferation of L929 fibroblast cells. Regarding the Cho cells, the extract induced toxicity only at concentration of 800 µg/mL (P < 0.01). Our results showed that continuous consumption of A. Kopetdaghensis in pregnancy may increase the risk of abortion and also may have toxic effect on some cells.
