The objective of the review is to evaluate the effectiveness and safety of therapeutic interventions in women with a clinical diagnosis of
cholestasis of pregnancy (CIP) SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register, the Cochrane Controlled Trials Register, MEDLINE and PREMEDLINE, EMBASE, CINAHL and Current Contents. Date of last search: March 2001.
SELECTION CRITERIA: Reviewers assessed identified trials for 1) eligibility and 2) methodological quality. Attempts were made to contact authors for missing data.
MAIN RESULTS: Nine RCTs involving 227 women were included but adequate data for appropriate comparisons in
pruritus,
bile acids or liver
enzymes were not consistently reported.
S-adenosylmethionine (SAMe) versus placebo (four trials, 82 women): only one trial showed significantly greater improvements in
pruritus,
bile salts and liver
enzymes with SAMe.
Ursodeoxycholic acid (UDCA) versus placebo (three trials, 56 women): in two trials a significant difference in
pruritus relief was not detected. One trial observed greater reductions in
bile salts and liver
enzymes with UDCA.
Preterm births were fewer with UDCA in one study while two studies reported no difference in
fetal distress incidence.
Guar gum versus placebo (one trial, 48 patients): no differences in
pruritus,
bile salts, or fetal/neonatal outcomes were observed.
Activated charcoal versus no treatment (one trial, 20 patients): the reduction in
bile salts was greater with
charcoal, but no difference in
pruritus relief: relative risk (RR) 9.0 95% confidence interval (CI) 0.6 - 148 or fetal/neonatal outcomes. UDCA versus SAMe (two trials, 36 patients):
pruritus relief was better with UDCA in one study and with SAMe in the other. UDCA was better in reducing
bile acids but not liver
enzymes in one trial. UDCA + SAMe versus placebo, UDCA or SAMe (one study, eight patients/arm): UDCA + SAMe versus placebo or UDCA resulted in greater improvements in
pruritus,
bile salts and selected liver function assays; UDCA + SAMe versus SAMe resulted in greater improvements in
bile salts and ALP only. No treatments were found to be unsafe.
REVIEWER'S CONCLUSIONS: There is insufficient evidence to recommend
guar gum,
activated charcoal, SAMe and UDCA alone or in combination in treating women with CIP. Inconsistent and inadequate reporting of results precluded pooling the results of small studies.