Sex-controlled differences in sertraline and citalopram efficacies in major depressive disorder: a randomized, double-blind trial.

To investigate the response to antidepressants while controlling for sex, which has been controversial, 92 outpatient males and females with major depressive disorder were assigned to sertraline (100 mg/day) or citalopram (40 mg/day) in two strata and were assessed using Hamilton depression rating scale (HDRS) scores and brain-derived neurotrophic factor (BDNF), interleukin (IL)-6 and cortisol serum levels in this 8-week, randomized, parallel-group, double-blind clinical trial. Data of 40 sertraline and 40 citalopram recipients with equal representation of males and females assigned to each medication were analyzed, while their baseline characteristics were not statistically different (P > 0.05). There were no significant differences between sertraline and citalopram recipients in outcome changes (P > 0.05), all of which indicated improvement, but a significant time-treatment-sex interaction effect in BDNF levels was observed (P = 0.035). Regarding this, subgroup analyses illustrated a significantly greater increase in male BDNF levels following sertraline treatment (P = 0.020) with a moderate to large effect size (Cohen's d = 0.76 and ). Significant associations were observed between percentage changes in IL-6 levels and BDNF levels in sertraline recipients (P = 0.033) and HDRS scores in citalopram recipients (P < 0.001). Sex was an effect modifier in BDNF alterations following sertraline and citalopram administration. Further large-scale, high-quality, long-term studies are recommended.

Evaluation of safety and efficacy of purgative manna (billinaster drop) and glycerin suppository in icterus of healthy term newborns.

OBJECTIVE: The aim of the present study was to investigate safety and efficacy of billinaster drop and glycerin suppository in hyperbilirubinemia of healthy term newborns who had passage of first meconium. METHODS: In a randomized clinical trial, 90 neonates with total plasma bilirubin(TPB) level of 15-20mg/dL, were randomly assigned to be treated with alone phototherapy (control) or 5drop/kg of bilinaster drop every eight hours and phototherapy(B) or half of glycerin suppository every twelve hours and phototherapy(G). The primary outcomes were safety of drugs and efficacy in obtaining TPB of less than 14 mg/dL as measured at the beginning, 12, 24 and 48 hours after intervention. Secondary endpoint was hospitalization days. RESULTS: After 48 hours of intervention, achieving TPB of less than 14 mg/dL was seen in 50 %( N=15) in control group, 73.3 %( N=22) in B group and 86.7 %( N=26 neonates) in G group (P= 0.01). Watery stool was seen in two neonates of glycerin group and safety of the treatments was not significantly different. Mean of TPB 12 hours after beginning of phototherapy(mean±SD:14.38±2.27mg/dL in G, 15.97±1.96mg/dL in B and 16.67±1.77mg/dL in control), 24 hours after intervention(mean±SD:12.56 ±1.59mg/dL in G, 12.57±2.05mg/dL in B and 14.36±2.26mg/dL in control), 48 hours after intervention (mean±SD: 9.34 ± 1.6mg/dL in G, 9.96 ± 2.95mg/dL in B and 12.27 ± 2.4mg/dL in control) and mean of hospitalization days (mean± SD: 1.5 ± 0.4days in G, 1.7 ± 0.4days in B and 2.9 ± 1.1days in control) were significantly lower in glycerin and billinaster groups. CONCLUSION: Bilinaster drop and glycerin suppository can be used as hazardless, efficient and cost effective drugs in treatment of neonatal hyperbilirubinemia.