Riikonen 2000.

Methods	Randomised controlled trial.
Participants	39 women randomised. Setting: Helsinki, Finland. Inclusion criteria: women with a singleton pregnancy referred due to an elevated serum bile acid concentration (> 5 mol/L) and/or presence of typical pruritus of ICP, with no concomitant chronic disease. The participants had to be on treatment for at least 10 days to be included in the analysis. Exclusion criteria: dermatological cause of pruritus; viral hepatitis (hepatitis B and C), primary liver and gallbladder diseases. 1 woman was entered into the study despite the absence of symptoms and biochemical abnormality. She had developed ICP in 3 previous pregnancies and later developed ICP.
Interventions	Guar gum (n = 19). 5‐15 g day, orally; the dose was increased from 5 to 15 g/day at 3 day intervals, until birth. Placebo (wheat flour) (n = 20). Participants were seen in the outpatient clinic up to 37 weeks' gestation and were admitted to hospital at 37 weeks. Fetus was monitored by CTG at every clinic visit and daily at the ward. The intensity of pruritus was estimated by 1 investigator and participant simultaneously. The investigator used the following score: 0 = no pruritus; 1 = mild pruritus; 2 = moderate pruritus disturbing sleep but not requiring antihistamine medication; 3 = severe pruritus requiring continuous antihistamine medication. The participants used a 10 cm long VAS. Fasting blood samples were collected for the assessment of LFTs and total bile acids from 1‐3 days before birth. If pruritus was severe, women were given prometazine hydrochloride 10‐30 mg/day.
Outcomes	Maternal: status of pruritus (assessed by both clinician and woman); assays of liver function and bile acids; CS for abnormal CTG; adverse effects. Fetal/neonatal: gestation at birth; birthweight.
Notes	This study had an additional non‐randomised control group of 20 women (additional to the 39 participating in the randomised trial) to provide a comparison group for the serum values.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"In‐house built computer programme validated according to company standard operating procedures."
Allocation concealment (selection bias)	Unclear risk	Allocation concealment method not described.
Blinding (performance bias and detection bias) All outcomes	Low risk	The investigators and the participants were blinded to the drug used.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	9/39 (23%) women (5 guar gum, 4 placebo) were excluded from "the intervention analyses" to birth within 10 days of treatment. Not clear which analyses these were e.g. n's not given for Table II (liver function results).
Selective reporting (reporting bias)	High risk	Outcomes such as perinatal death, fetal distress and spontaneous birth < 37 weeks were not reported.
Other bias	Low risk	No other additional bias noted.