Role of ursodeoxycholic acid in neonates with indirect hyperbilirubinemia-an open labelled randomised control trial

Jafari, Shazia; Khan, Kabeer Ahmad; Bhatnagar, Saurabha; Srivastava, Geetika; Nanda, Chhavi; Chandra, Anu

doi:10.18203/2349-3291.ijcp20180530

Cited by 9 publications

(15 citation statements)

References 6 publications

(11 reference statements)

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“…The reductive effect of UDCA on unconjugated hyperbilirubinemia in neonates receiving phototherapy has been documented by Honar et al,15 Hassan et al16 and Jafari et al17 Unfortunately, none of these studies was conducted among newborn of African newborn who are more likely to be genetically different and varied in skin complexion. It has been shown that different skin colors manifest different traits to light exposure 18.…”

Section: Introductionmentioning

confidence: 98%

<p>Reductive effect of ursodeoxycholic acid on bilirubin levels in neonates on phototherapy</p>

Ughasoro

Adimorah

Chukwudi

et al. 2019

CEG

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Background Phototherapy is paramount in the management of high total serum bilirubin (TSB). Whether its effectiveness can be improved with ursodeoxycholic acid (UDCA) has not been evaluated among newborns of African descent. Methods A double-blind-controlled study was used to evaluate the effect of UDCA on the management of high TSB in neonates. Recruited neonates were categorized into the experimental group (given UDCA plus phototherapy) and the control group (phototherapy and plain syrup), and their TSB and conjugated bilirubin levels were measured. The data were analyzed using SPSS version 20. Statistical significance was set at a p -value of <0.05. Results The mean (SD) percentage reductions in TSB after 24 hrs were 40.73% (18.1) and 10.21% (7.1) in the experimental and control groups, respectively, and the difference was statistically significant ( p =0.001). The mean (SD) durations on therapy were 3.0 days (0.58) in the experimental group and 5.5 days (1.35) in the control group ( p =0.001). Conclusions Phototherapy is still effective in the management of neonatal hyperbilirubinemia, but inclusion of UDCA accentuates the reductive effect of phototherapy on the TSB in neonates, reducing the duration of treatment and in-patient care.

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Section: Introductionmentioning

confidence: 98%

<p>Reductive effect of ursodeoxycholic acid on bilirubin levels in neonates on phototherapy</p>

Ughasoro

Adimorah

Chukwudi

et al. 2019

CEG

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“…Three studies included neonates younger than 14 days old as the inclusion criteria [ 28 , 29 , 31 ], two studies reported their age range was 3–7 days old [ 21 , 26 ], two studies reported their mean age was 4.9–5.91 days [ 25 , 27 ], and one study did not report patient’s mean age [ 30 ]. All eight articles were randomized clinical trials done in various countries (four studies in Iran, two studies in India, one study in Egypt, and one study in Iraq).…”

Section: Resultsmentioning

confidence: 99%

“…Due to different reported outcomes, three studies were not included in the meta-analysis. The outcomes were: indirect bilirubin (not total serum bilirubin) [ 27 ], incomplete total serum bilirubin reported (not measured after reaching normal value) [ 29 ], and changes of direct bilirubin [ 31 ]. The summary of these three studies’ findings is presented in Table 4 .…”

Section: Resultsmentioning

confidence: 99%

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Role of ursodeoxycholic acid in neonatal indirect hyperbilirubinemia: a systematic review and meta-analysis of randomized controlled trials

et al. 2022

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Background Neonatal jaundice is a transitional phenomenon affecting three out of five full-term newborns globally. Ursodeoxycholic acid could be beneficial in neonatal jaundice needing phototherapy. Methods We searched PubMed, EBSCO, ProQuest, and Cochrane Library up to August 21st, 2021, for articles to be reviewed. Meta-analysis using random-effects model was performed. Results Eight studies involving 1116 neonates were chosen in this review; however, only five studies were included for meta-analysis. Phototherapy duration was significantly lower in the interventional group with high heterogeneities. Subgroup analysis of the phototherapy duration based on the risk of bias resulted in a shorter duration (mean difference (MD) = –17.82; 95% CI = –20.17 to –15.47; p = < 0.001) with low heterogeneity in the treatment group. Secondary outcome focusing on mean total serum bilirubin showed a lower mean total serum bilirubin in 48 h post-treatment (MD = –0.43; 95% CI = –0.64 to –0.22; p = < 0.0001) with low heterogeneities in Asian countries.” Conclusions Ursodeoxycholic acid might be considered as a novel adjuvant therapy in neonatal indirect hyperbilirubinemia to shorten the phototherapy duration and lower the mean total serum bilirubin.

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“…All participants received UDCA orally at 10 mg/kg/day divided every 12 hours except the paper by Shahramian et al 24 where the dose of UDCA was 15 mg/kg/day, and the paper by Jafari et al 19 where 20 mg/kg/day was administered along with PT. The PT was received according to charts of the American Academy of Pediatrics in two studies, 13,26 and others did not report on the chart used for the treatment of jaundice.…”

Section: Intervention and Reported Outcomesmentioning

confidence: 99%

Effect of Ursodeoxycholic Acid in Unconjugated Hyperbilirubinemia in the Term Neonates Treated with Phototherapy: A Systematic Review

Huseynova¹

2022

Newborn

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Background: Neonatal hyperbilirubinemia is a common clinical condition worldwide. Phototherapy (PT) is the standard intervention for hyperbilirubinemia; however, it may have side effects. It has been suggested that the implementation of adjuvant therapy including ursodeoxycholic acid (UDCA), for example, may decrease the duration of PT. Objectives: To determine the efficacy and safety of UDCA in addition to PT in term neonates with unconjugated hyperbilirubinemia (UH) vs PT alone. Methods: A systemic review was undertaken using the following databases: PubMed, Medline, Cochrane database, Scopus, Google Scholar, and ClinicalTrials.gov. Randomized controlled trials (RCTs) assessing the efficacy and safety of UDCA combined with PT on the total serum bilirubin (TSB) and duration of PT were included. The data quality assessment was carried out. Results: Low-moderate quality evidence from seven RCTs reported significantly lower TSB levels in the UDCA group compared to the control group after 12, 24, 48, and 72 hours of treatment with a mean difference (MD) of -2.23 mg/dL (95% CI: from −2.49 to −1.96); −1.59 mg/dL (95% CI: from −1.83 to −1.35); −1.03 mg/dL (95% CI: from −1.27 to −0.79); and −1.32 mg/dL (95% CI: from −1.63 to −1.01), respectively, with heterogeneity of studies I 2 = 92% (p < 0.00001). In addition, three studies observed that UDCA significantly decreased the duration of PT with MD −19.14 hours (95% CI: from −20.70 to −17.59) with heterogeneity I 2 = 91% (p < 0.00001). None of the studies reported any significant adverse effects of UDCA. Conclusion: Ursodeoxycholic acid combined with PT in the treatment of UH significantly reduces the TSB and duration of PT without significant risk of adverse events. However, limited and low-moderate quality evidence exists to support the routine use of UDCA in neonates. We discuss the limitations of the review results for clinical practice.

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Role of ursodeoxycholic acid in neonates with indirect hyperbilirubinemia-an open labelled randomised control trial

Cited by 9 publications

References 6 publications

<p>Reductive effect of ursodeoxycholic acid on bilirubin levels in neonates on phototherapy</p>

<p>Reductive effect of ursodeoxycholic acid on bilirubin levels in neonates on phototherapy</p>

Role of ursodeoxycholic acid in neonatal indirect hyperbilirubinemia: a systematic review and meta-analysis of randomized controlled trials

Effect of Ursodeoxycholic Acid in Unconjugated Hyperbilirubinemia in the Term Neonates Treated with Phototherapy: A Systematic Review

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