Abstract
Objective: To determine the relative safety and efficacy of ursodeoxycholic acid (UDCA) in children and neonates with parenteral nutrition–associated cholestasis (PNAC). Data Sources: A comprehensive search (up to May 29, 2006) of the following databases was conducted to identify relevant prospective, randomized, double-blind clinical trials and systematic reviews: Ovid–MEDLINE, PubMed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Controlled Trials Register, Database of Abstracts of Reviews of Effects, and the Centre for Reviews and Dissemination. In addition, reference lists from retrieved articles were searched to identify trials or systematic reviews not identified in the search of electronic databases. Also, the manufacturer of UDCA was contacted regarding access to any other unpublished trials that could be included in this review. Study Selection and Data Extraction: Prospective, double-blind, randomized, controlled trials of neonates (<36 wk gestational age) and/or children (0–18 y) who developed PNAC while receiving parenteral nutrition were included in the analysis. Articles were evaluated with specific focus placed on the following hierarchy of outcomes: mortality, nonfatal serious adverse events, liver failure, infection, sepsis, return of liver function test results to within normal ranges, and relief of pruritus. Data Synthesis: No prospective, double-blind, randomized, controlled trials assessing the efficacy and safety of UDCA for the treatment of PNAC in children and/or neonates were identified. Five retrospective chart reviews and/or case series were identified; however, the results of these studies were conflicting and do not provide sufficient evidence of the safety and efficacy of UDCA for the treatment of PNAC. Conclusions: There is no evidence from prospective, double-blind, randomized, controlled trials in neonates and/or children with PNAC regarding the relative safety and efficacy of UDCA therapy.
Published Version
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