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

Huang 2004.

Methods Randomised controlled trial.
Participants 60 women randomised.
Recruitment: July ‐ October 2002.
Inclusion criteria: primigravidae, singleton pregnancies, pruritus in the second half of pregnancy, raised serum CG (> 10 UNL) and ALT.
Exclusion criteria: PIH; gestational diabetes; anaemia; other liver (hepatitis A, B, C, D) and gallbladder diseases.
Interventions YCHD (n = 35).
BD orally for 3 weeks.
SAMe (n = 25).
IV infusion of 2 x 500 mg daily for 3 weeks.
Pruritus, serum bile acids and LFTs were assessed after 3 weeks treatment.
Outcomes Maternal: improvement in pruritus; serum CG; ALT; bilirubin; length of gestation; delivery by CS.
Fetal/neonatal: mortality; Apgar score < 7; meconium‐stained liquor; preterm birth at < 37 weeks; birthweight; asphyxial events; umbilical cord artery pH, PO2, PCO2.
Notes Full article in Chinese, abstract published in English.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table.
Allocation concealment (selection bias) Unclear risk Not stated.
Blinding (performance bias and detection bias) 
 All outcomes High risk Not mentioned. Unlikely to be blinded because these 2 drugs have different modes of administration.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses to follow‐up.
Selective reporting (reporting bias) Low risk All the pre‐specified outcomes reported.
Other bias High risk Imbalance in numbers randomised to each group (35 versus 25) which may indicate a failure of proper randomisation.