Evaluating the effect of ursodeoxycholic acid on total bilirubin of neonates with glucose‐6‐phosphate dehydrogenase deficiency complicated by indirect hyperbilirubinaemia

Abstract

Aim This study aimed to investigate the effect of adding ursodeoxycholic acid (UDCA) to phototherapy in neonates with glucose‐6‐phosphate dehydrogenase (G6PD) deficiency and hyperbilirubinaemia. G6PD deficiency is a common cause of severe hyperbilirubinaemia in neonates. Methods This study was a triple blind, clinical trial study of 40 neonates with G6PD deficiency and hyperbilirubinaemia who admitted for phototherapy in hospitals affiliated to the University of Medical Sciences. The treatment group (n = 20) received UDCA 10 mg/kg (2 cc/kg) daily divided into 2 doses every 12 h. The control group (n = 20) received the same volume of placebo syrup. The drug and placebo treatments were continued until the bilirubin level dropped below 171 μmol/L. Both the control and treatment group received continuous phototherapy. Independent sample t‐test, survival analysis and logrank test were used to statistically analyse the results. Results The mean total bilirubin level was 231.9 ± 18.8 μmol/L and 184.3 ± 18.6 μmol/L in the control and intervention group respectively, 24 h after drug administration and 209.7 ± 19.3 μmol/L and 157.4 ± 16.4 μmol/L, respectively, 48 h after intervention (P < 0.05). The median length of hospitalisation in the treatment group was approximately 1 day lower than the control group (logrank test P value: <0.001). Conclusion The study showed that the addition of UDCA to phototherapy accelerates the reduction of total bilirubin level in neonates with G6PD deficiency and can reduce the duration of hospitalisation.

Ursodeoxycholic acid use in lactating female patients is associated with clinically negligible concentrations of this bile acid in breast milk

“…Finally, as we reported in our previous experimental studies on hyperbilirubinemic Gunn rats, UDCA in clinically relevant doses substantially increased turnover of unconjugated bilirubin, with a drop of bilirubin concentrations in the vascular bed comparable to that of phototherapy 32,33 ; establishing a rationale for the use of UDCA in the treatment of severe neonatal jaundice. Indeed, this hypobilirubinemic effect of UDCA has recently been proven in several clinical studies on human neonates suffering from serious unconjugated hyperbilirubinemia, with no apparent adverse reactions attributable to administration of UDCA [34][35][36][37][38] .…”

Ursodeoxycholic acid as adjuvant treatment to phototherapy for neonatal hyperbilirubinemia: a systematic review and meta-analysis

“…The initial search yielded 376 studies, of which 17 were further assessed in the full text phase. Six RCTs were found, and of these, two were excluded: in the study by Ughasoro et al, randomization was not stratified, and children with ABO immunizations and septic newborns were included [ 23 ]; Rezaie et al included only neonates with G6PD deficiency [ 24 ]. Four RCTs were included from the initial search [ 18 , 20 – 22 ], and two additional RCTs were found from the references of included articles and included in the systematic review and meta-analysis [ 17 , 19 ] (Fig.…”

“…Potential pharmacological therapies for unconjugated hyperbilirubinemia have gained interest, both to reduce lengths of hospital stays and to avoid more intensive therapies and their harmful side effects, such as those seen with exchange transfusions. A few studies have evaluated whether ursodeoxycholic acid (UDCA) would be effective as an adjuvant therapy [ 17 – 24 ]. UDCA is a bile acid, and it has been hypothesized to work by preventing the reabsorption of bilirubin from the intestines and thus occupying enterohepatic circulation [ 25 , 26 ].…”

“…UDCA is generally well tolerated [ 27 ]. UDCA was reported to be effective in reducing the duration of phototherapy in healthy term neonates [ 17 – 21 ], in sick neonates [ 23 ] and among neonates with G6PD deficiency [ 24 ]. One previous study found no additional value of combining UDCA with standard phototherapy [ 22 ].…”

Effects of Two Different Doses of Ursodeoxycholic Acid on Indirect Hyperbilirubinemia in Neonates with Glucose-6-phosphate Dehydrogenase Deficiency Treated with Phototherapy: A Randomized Controlled Trial

“…However, the limitations of this study were the small sample size, and the authors recommended further studies with large sample sizes and different doses of UDCA. 27 To the best of our knowledge, our study is the second one that exclusively investigated the effect of UDCA on the reduction of bilirubin in neonates with unconjugated hyperbilirubinemia who at the same time were G6PD deficient. Our study was performed on a larger sample size and we also evaluated 2 different doses.…”