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. |
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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. |
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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. |
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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. |