Maternal-fetal safety evaluation of an aqueous extract of Casearia sylvestris leaves in rats.

BACKGROUND: This study evaluated the maternal, embryotoxic, and teratogenic effects of the aqueous extract of Casearia sylvestris (AECS), a species listed in the Unique Health System of Brazil, and widely used for treating several conditions, such as diarrhea, wounds, pain, and ulcers. METHODS: Pregnant rats were daily treated orally with 0, 175, 350, or 700 mg/kg/body weight of AECS, from gestational day (GD) 6 to 15 (organogenesis period). On GD 20, the pregnant rats were euthanized, and the litters submitted to an assessment of fetal development. RESULTS: No clinical signs of toxicity were observed in the dams during the treatment. In the embryo-fetal development study, a significant increase in the basal zone height of the placenta was observed in the intermediate dose group. Furthermore, there was a significant increase in the relative anogenital distance measurement of female fetuses in the lowest and intermediate dose groups. Although no visceral abnormalities were observed in the treated-fetuses, skeletal anomalies evidenced by changes in the ossification of the sternum and the presence of supernumerary ribs were found in the intermediate and high dose groups. CONCLUSION: In conclusion, the treatment with AECS during organogenesis at this dose level had detrimental effects on the normal development of fetuses.

Evaluation of the safety of ethanolic extract from Piper amalago L. (Piperaceae) leaves in vivo: Subacute toxicity and genotoxicity studies.

Piper amalago L. (Piperaceae) is traditionally used due to its anti-inflammatory, analgesic, diuretic, and antiparasitic properties. However, few studies have focused on its adverse effects, compromising its safe use. This study evaluated the toxicological safety of ethanolic extract from Piper amalago leaves (EEPA), through subacute toxicity and genotoxicity assays in rodents. In subacute toxicity, 100, 200 or 300 mg/kg of EEPA were tested in female Wistar rats, by gavage, for 28 days. For genotoxicity test, female Swiss mice were orally treated with 17.5, 175 or 1750 mg/kg of EEPA and the comet, micronucleus, and splenic phagocytic assays were evaluated. In subacute toxicity, the extract induced an increase in the food and water intakes, as well as in the liver absolute weight, and in the heart and kidney relative weights. EEPA also provoked alterations in histopathological analysis of liver and in hemato-biochemical parameters, evidenced by a decrease in hematocrit levels and albumin levels, and an increase in the number of platelets and in alkaline phosphatase and cholesterol levels. However, EEPA did not presented genotoxic nor mutagenic properties. EEPA showed hemato-biochemical toxicity profile in rats and should be used with caution, especially when for prolonged period.

Analysis of fertility clinic marketing of complementary therapy add-ons.

Complementary therapies are often used during in-vitro fertilization (IVF) treatment. The aim of this study was to determine how UK fertility clinic websites are advertising complementary therapy add-ons. The Human Fertilisation and Embryology Authority's (HFEA) 'Choose a Fertility Clinic' website was used to identify fertility clinics and their websites. Acupuncture, reflexology, nutritional advice and miscellaneous complementary therapies were examined to determine treatment provision and costs. Treatment claims for acupuncture and reflexology were analysed using an inductive coding approach, and categorized depending on whether they pertained to holistic benefits, physiological benefits or improvements to IVF treatment outcome. At least one complementary therapy was advertised by 17 of 66 (26%) websites. Acupuncture was the most commonly advertised complementary therapy (16/66 clinic websites, 24%), followed by nutritionist services (11/66, 17%), reflexology (10/66, 15%) and other miscellaneous complementary therapies (9/66, 14%). Treatment costs were found to range from less than £50 for individual appointments to hundreds of pounds for treatment packages. Treatments were not always offered in-house at the fertility clinic, but rather patients were referred to an affiliated practitioner. Analysing claims relating to the complementary therapies highlighted that there were differences in the extent to which clinics claimed that complementary therapies benefited IVF, and that information occasionally acknowledged scientific research evidence but did not always present resources in an unbiased manner. Fertility clinic websites should provide accurate information for patients for complementary therapy add-ons. HFEA should add acupuncture and reflexology to their traffic-light system with amber and red ratings, respectively.