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. 2013 Jun 24;2013(6):CD000493. doi: 10.1002/14651858.CD000493.pub2

Luo 2008.

Methods Randomised controlled trial.
Participants 64 women randomised.
Setting: Affiliated Hospital of Hanzhou Normal University, Hanzhou, China.
Recruitment: June 2002‐July 2007.
Inclusion criteria: neonatal jaundice and/or maternal? itching, rise in the levels of serum transaminase and CG.
Exclusion criteria: any skin infection, prolonged liver disease, any other illnesses, high blood pressure, received other forms of treatment for ICP.
Interventions Transmetil + UDCA (n = 34).
Transmetil (1 g + 5% Glucose 250 mL IV OD) + UDCA (250 mg Oral pill BD) for 10 days.
UDCA (n = 30).
UDCA 250 mg BD for 10 days. Patients took dexamethasone (10 mg OD) for 3 days before the treatment in both groups.
Outcomes Maternal: scale of itchiness (0‐4 Ribalta scale); levels of ALT, AST, total bile acids, amount of haemoglobin, CS rate.
Fetal/neonatal: preterm birth, clearness of amniotic fluid (i.e. number of cases where the fluid was not clear), Apgar score, birthweight.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomly assigned" ‐ no further details reported.
Allocation concealment (selection bias) Unclear risk "randomly assigned" ‐ no further details reported.
Blinding (performance bias and detection bias) 
 All outcomes High risk The route of administration of interventions in the 2 groups were different and therefore blinding would not have been possible.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses to follow‐up or withdrawal in either group.
Selective reporting (reporting bias) Unclear risk Not all expected outcomes reported.
Other bias Low risk According to the translation, “Their traits and characteristics were not significantly different from each other".