Frezza 1990.

Methods	Randomised placebo‐controlled trial‐ using a pre‐established code, single‐blinded.
Participants	30 women randomised. Setting: Milan, Italy. Inclusion criteria: pruritus, with or without jaundice, and elevated levels of serum bile acids, bilirubin, ALT and AST during the last trimester of pregnancy. Exclusion criteria: acute hepatitis A, hepatitis B, dermatological conditions.
Interventions	SAMe (n = 15). Daily IV dose of 800 mg of SAMe diluted in 500 mL of 5% dextrose. Half of the dosage was infused in the morning, and half in the afternoon. It was administered up to the day of birth and was withdrawn 12 hours after birth. Placebo (n = 15). Daily IV dose of 500 mL of 5% dextrose. Half of the dosage was infused in the morning, and half in the afternoon. It was administered up to the day of birth and was withdrawn 12 hours after birth. Pruritus was a scored on a 10 cm analogue scale every 3 days up to 24 hours after birth. LFTs were measured before randomisation and 24 hours after birth.
Outcomes	Maternal: status of pruritus; assays of liver function and bile acid; adverse effects. Fetal/neonatal: preterm birth at < 37 weeks; birthweight < 2500 g.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote ‐ "According to pre‐established code, consecutive patients were randomised to receive either SAMe or placebo". It is unclear how this code was generated.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Single‐blind. Participants were blinded. The medical staff were not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	There were no losses to follow‐up.
Selective reporting (reporting bias)	High risk	Fetal mortality (stillbirth and neonatal deaths), mean length of gestation, mode of birth and blood loss at birth were not reported. Some outcomes were only presented as graphs.
Other bias	Low risk	No other bias apparent.