Evaluation of Safety and Efficacy of Purgative Manna (Billinaster Drop) and Glycerin Suppository in Icterus of Healthy Term Newborns

Abstract

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. 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. 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. Bilinaster drop and glycerin suppository can be used as hazardless, efficient and cost effective drugs in treatment of neonatal hyperbilirubinemia.