Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) remain significant clinical problems, especially in the delayed phase (24-120 h after chemotherapy). Amisulpride is a dopamine D2/D3-receptor antagonist previously shown to be an effective intravenous antiemetic. We conducted a randomised, double-blind study to characterise the dose response of oral amisulpride in delayed phase CINV. METHODS: Chemotherapy-naïve patients receiving cisplatin ≥ 70 mg/m2 or an anthracycline-cyclophosphamide regimen for breast cancer received, on day 1, 20 mg amisulpride and 8-16 mg ondansetron intravenously followed, once daily on days 2-4, by 10, 20 or 40 mg oral amisulpride or placebo. A control group receiving standard three-drug prophylaxis was enrolled for assay sensitivity purposes. The primary endpoint was complete response (CR), defined as no emesis or rescue medication use, in the delayed phase. RESULTS: Three hundred eighteen subjects were evaluable per protocol. CR rate (24-120 h) was 20% with placebo and 46% with 10 mg amisulpride (p = 0.006 after multiplicity adjustment); in the three-drug control group, it was 59%. Emesis, nausea and 0-120-h CR rate were significantly improved with 10 mg amisulpride compared to placebo. Higher doses of amisulpride were not more effective than 10 mg. In patients with acute phase CR, delayed phase CR rate was 44% for placebo, 75% for 10 mg amisulpride (p = 0.022) and 70% for the 3-drug control. No significant differences were seen between groups in safety parameters. CONCLUSIONS: Amisulpride 10 mg orally is safe and superior to placebo at preventing delayed CINV caused by highly emetogenic chemotherapy. TRIAL REGISTRATION: NCT01857232.

Gender inequality and bio-social factors in nutritional status among under five children attending anganwadis in an urban slum of a town in Western Maharashtra, India.

Nutrition for under-5 children is of great importance as the foundation for life-time health, strength, and intellectual vitality is laid during this period. Globally, more than one-third of the child deaths are attributable to under-nutrition. The discriminatory attitudes against female children vary from being implicit to those that are quite explicit. So, the present cross-sectional study aims to assess the nutritional status (gender differences) of 146 under-5 children attending Anganwadis and also to study the bio-socio-demographic factors associated with malnutrition attending three Anganwadis of Adopted Urban slum area, involving anthropometric examination using standardized techniques and interview using predesigned semi-structured questionnaire for the mothers in September-October 2011. Nutritional status grading was done based on weight for age as per Indian Academy of Pediatrics (IAP) Classification and using height for age as per Vishveshwara Rao's Classification. 51.4% were males, majority in age group of 2-3 years. 63% children were malnourished, majority in Grade I malnutrition. Out of the total females, 72% were stunted and 43% were severely malnourished having mid arm circumference <12.5 cm. Birth order (P < 0.05), education status of the mother (P < 0.001), socio-economic status (P < 0.05) and type of family (P < 0.05) were found to be significantly associated with malnutrition.