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International Journal of Surgery... Jun 2015Laparoscopic cholecystectomy (LC) has become a popular alternative to open cholecystectomy (OC) in the treatment of acute cholecystitis (AC). Laparoscopic... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Laparoscopic cholecystectomy (LC) has become a popular alternative to open cholecystectomy (OC) in the treatment of acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is now considered the gold standard of therapy for symptomatic cholelithiasis and chronic cholecystitis. However no definitive data on its use in AC has been published. CIAO and CIAOW studies demonstrated 48.7% of AC were still operated with the open technique. The aim of the present meta-analysis is to compare OC and LC in AC.
MATERIAL AND METHODS
A systematic-review with meta-analysis and meta-regression of trials comparing open vs. laparoscopic cholecystectomy in patients with AC was performed. Electronic searches were performed using Medline, Embase, PubMed, Cochrane Central Register of Controlled Trials (CCTR), Cochrane Database of Systematic Reviews (CDSR) and CINAHL.
RESULTS
Ten trials have been included with a total of 1248 patients: 677 in the LC and 697 into the OC groups. The post-operative morbidity rate was half with LC (OR = 0.46). The post-operative wound infection and pneumonia rates were reduced by LC (OR 0.54 and 0.51 respectively). The post-operative mortality rate was reduced by LC (OR = 0.2). The mean postoperative hospital stay was significantly shortened in the LC group (MD = -4.74 days). There were no significant differences in the bile leakage rate, intraoperative blood loss and operative times.
CONCLUSIONS
In acute cholecystitis, post-operative morbidity, mortality and hospital stay were reduced by laparoscopic cholecystectomy. Moreover pneumonia and wound infection rate were reduced by LC. Severe hemorrhage and bile leakage rates were not influenced by the technique. Cholecystectomy in acute cholecystitis should be attempted laparoscopically first.
Topics: Blood Loss, Surgical; Cholecystectomy; Cholecystitis, Acute; Humans; Laparoscopy; Length of Stay; Operative Time; Postoperative Complications
PubMed: 25958296
DOI: 10.1016/j.ijsu.2015.04.083 -
The Journal of Trauma and Acute Care... Nov 2022Timely management is critical for treating symptomatic common bile duct (CBD) stones; however, a single optimal management strategy has yet to be defined in the acute... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Timely management is critical for treating symptomatic common bile duct (CBD) stones; however, a single optimal management strategy has yet to be defined in the acute care setting. Consequently, this systematic review and network meta-analysis, comparing one-stage (CBD exploration or intraoperative endoscopic retrograde cholangiopancreatography [ERCP] with simultaneous cholecystectomy) and two-stage (precholecystectomy or postcholecystectomy ERCP) procedures, was undertaken with the main outcomes of interest being postprocedural complications and hospital length of stay (LOS).
METHODS
PubMed, SCOPUS, MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were methodically queried for articles from 2010 to 2021. The search terms were a combination of medical subject headings terms and the subsequent terms: gallstone; common bile duct (stone); choledocholithiasis; cholecystitis; endoscopic retrograde cholangiography/ERCP; common bile duct exploration; intraoperative, preoperative, perioperative, and postoperative endoscopic retrograde cholangiography; stone extraction; and one-stage and two-stage procedure. Studies that compared two procedures or more were included, whereas studies not recording complications (bile leak, hemorrhage, pancreatitis, perforation, intra-abdominal infections, and other infections) or LOS were excluded. A network meta-analysis was conducted to compare the four different approaches for managing CBD stones.
RESULTS
A total of 16 studies (8,644 participants) addressing the LOS and 41 studies (19,756 participants) addressing postprocedural complications were included in the analysis. The one-stage approaches were associated with a decrease in LOS compared with the two-stage approaches. Common bile duct exploration demonstrated a lower overall risk of complications compared with preoperative ERCP, but there were no differences in the overall risk of complications in the remaining comparisons. However, differences in specific postprocedural complications were detected between the four different approaches managing CBD stones.
CONCLUSION
This network meta-analysis suggests that both laparoscopic CBD exploration and intraoperative ERCP have equally good outcomes and provide a preferable single-anesthesia patient pathway with a shorter overall length of hospital stay compared with the two-stage approaches.
LEVEL OF EVIDENCE
Systematic Review/Meta Analysis; Level III.
Topics: Humans; Gallstones; Sphincterotomy, Endoscopic; Cholecystectomy, Laparoscopic; Network Meta-Analysis; Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde; Common Bile Duct
PubMed: 35939370
DOI: 10.1097/TA.0000000000003755 -
Clinics and Research in Hepatology and... Feb 2019Progressive familial intrahepatic cholestasis (PFIC) is a heterogeneous group of rare genetic disorders associated with bile acid secretion or transport defects. This is...
BACKGROUND AND AIMS
Progressive familial intrahepatic cholestasis (PFIC) is a heterogeneous group of rare genetic disorders associated with bile acid secretion or transport defects. This is the first systematic review of the epidemiology, natural history and burden of PFIC.
METHODS
MEDLINE and Embase were searched for publications on PFIC prevalence, incidence or natural history, and the economic burden or health-related quality of life (HRQoL) of patients with PFIC. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed.
RESULTS
Of 1269 records screened, 20 were eligible (epidemiology, 17; humanistic burden, 5; both, 2). Incidence of intrahepatic cholestasis, including but not limited to PFIC, was 1/18 000 live births in one study that did not use genetic testing. In two studies of infants and children (2-18 years) with cholestasis, 12-13% had genetically diagnosed PFIC. Of the three main PFIC subtypes, PFIC2 was the most common (21-91% of patients). Common symptoms (e.g. pruritus, jaundice, hepatomegaly, splenomegaly) generally appeared at about 3 months of age and tended to emerge earliest in patients with PFIC2. Patients reported that pruritus was often severe and led to dermal damage and reduced HRQoL. Disease progression led to complications including liver failure and hepatocellular carcinoma, with 20-83% of patients requiring liver transplantation. Mortality was 0-87% across 10 studies (treatment varied among studies), with a median age at death of ~4 years in one study.
CONCLUSIONS
Patients with PFIC face debilitating symptoms and poor prognosis. Further research is needed to inform patient management and clinical trial design. Published data on the epidemiology and socioeconomic burden of PFIC is limited.
Topics: Cholestasis, Intrahepatic; Humans
PubMed: 30236549
DOI: 10.1016/j.clinre.2018.07.010 -
Biomedicine & Pharmacotherapy =... Jan 2021Metabolic diseases such as obesity, type 2 diabetes mellitus, and hyperlipidemia are associated with the dysfunction of gut microbiota. Traditional Chinese medicines...
Metabolic diseases such as obesity, type 2 diabetes mellitus, and hyperlipidemia are associated with the dysfunction of gut microbiota. Traditional Chinese medicines (TCMs) have shown considerable effects in the treatment of metabolic disorders by regulating the gut microbiota. However, the underlying mechanisms are unclear. Studies have shown that TCMs significantly affect glucose and lipid metabolism by modulating the gut microbiota, particularly mucin-degrading bacteria, bacteria with anti-inflammatory properties, lipopolysaccharide- and short-chain fatty acid (SCFA)-producing bacteria, and bacteria with bile-salt hydrolase activity. In this review, we explored potential mechanisms by which TCM improved metabolic disorders via regulating gut microbiota composition and functional structure. In particular, we focused on the protection of the intestinal barrier function, modulation of metabolic endotoxemia and inflammatory responses, regulation of the effects of SCFAs, modulation of the gut-brain axis, and regulation of bile acid metabolism and tryptophan metabolism as therapeutic mechanisms of TCMs in metabolic diseases.
Topics: Animals; Bacteria; Blood Glucose; Drugs, Chinese Herbal; Dysbiosis; Energy Metabolism; Gastrointestinal Microbiome; Humans; Intestines; Lipid Metabolism; Medicine, Chinese Traditional; Metabolic Diseases; Treatment Outcome
PubMed: 33197760
DOI: 10.1016/j.biopha.2020.110857 -
Nutrients May 2023Breast milk is tailored for optimal growth in all infants; however, in some infants, it is related to a unique phenomenon referred to as breast milk jaundice (BMJ). BMJ... (Review)
Review
Breast milk is tailored for optimal growth in all infants; however, in some infants, it is related to a unique phenomenon referred to as breast milk jaundice (BMJ). BMJ is a type of prolonged unconjugated hyperbilirubinemia that is often late onset in otherwise healthy-appearing newborns, and its occurrence might be related to breast milk itself. This review aims to systematically evaluate evidence regarding breast milk composition and the development of BMJ in healthy neonates. PubMed, Scopus and Embase were searched up to 13 February 2023 with key search terms, including neonates, hyperbilirubinemia, and breastfeeding. A total of 678 unique studies were identified and 12 were ultimately included in the systematic review with narrative synthesis. These included studies covered both nutritional compositions (e.g., fats and proteins) and bioactive factors (e.g., enzymes and growth factors) of breast milk and formally assessed the difference in the concentration (or presence) of various endogenous components of breast milk collected from mothers of BMJ infants and healthy infants. The results were inconsistent and inconclusive for most of the substances of interest, and there was only a single study available (e.g., total energy and mineral content, bile salts and cytokines); conflicting or even contradictory results arose when there were two or more studies on the subject matter (e.g., fats and free fatty acids contents and epidermal growth factor). The etiology of BMJ is likely multifactorial, and no single constituent of breast milk could explain all the BMJ cases observed. Further well-designed studies are warranted to investigate the complex interaction between maternal physiology, the breast milk system and infant physiology before this field could be progressed to uncover the etiology of BMJ.
Topics: Infant; Female; Humans; Infant, Newborn; Milk, Human; Bilirubin; Jaundice, Neonatal; Breast Feeding; Hyperbilirubinemia; Jaundice
PubMed: 37242142
DOI: 10.3390/nu15102261 -
HPB : the Official Journal of the... Oct 2022Compare outcomes of early laparoscopic cholecystectomy (ELC) and percutaneous trans-hepatic drainage of gallbladder (PTGBD) as an initial intervention for AC and to... (Meta-Analysis)
Meta-Analysis Review
Outcome of early cholecystectomy compared to percutaneous drainage of gallbladder and delayed cholecystectomy for patients with acute cholecystitis: systematic review and meta-analysis.
BACKGROUND
Compare outcomes of early laparoscopic cholecystectomy (ELC) and percutaneous trans-hepatic drainage of gallbladder (PTGBD) as an initial intervention for AC and to compare operative outcomes of ELC and delayed laparoscopic cholecystectomy (DLC).
METHODS
English-language studies published until December 2020 were searched. Randomised controlled trials (RCTs) and observational studies compared EC and PTGBD with delayed cholecystectomy for patients presented with acute cholecystitis were considered. Main outcomes were mortality, conversion to open, complications and length of hospital stay.
RESULTS
Out of 1347 records, 14 studies were included. 205,361 (94.7%) patients had EC and 11,565 (5.3%) patients had PTGBD as an initial intervention for AC. Mortality was higher in PTGBD; HR, 95% CI: [3.68 (2.13, 6.38)]. In contrast, complication rate was significantly higher in EC group (47%) vs PTGBD group (8.7%) in patients admitted to ICU; P-value = 0.011. Patients who had ELC were at higher risk of post-operative complications compared to DLC; RR [95% CI]: 2.88 [1.78, 4.65]. Risk of bile duct injury was six folds more in ELC; RR [95% CI]: 6.07 [1.67, 21.99].
CONCLUSION
ELC may be a preferred treatment option over PTGBD in AC. However, patient and disease specific factors should be considered to avoid unfavourable outcomes with ELC.
Topics: Humans; Gallbladder; Time Factors; Cholecystitis, Acute; Cholecystectomy; Cholecystectomy, Laparoscopic; Drainage; Treatment Outcome; Retrospective Studies
PubMed: 35597717
DOI: 10.1016/j.hpb.2022.04.010 -
HPB : the Official Journal of the... Sep 2018Consistent measurement and reporting of outcomes, including adequately defined complications, is important for the evaluation of surgical care and the appraisal of new...
BACKGROUND
Consistent measurement and reporting of outcomes, including adequately defined complications, is important for the evaluation of surgical care and the appraisal of new surgical techniques. The range of complications reported after LC has not been evaluated. This study aimed to identify the range of complications currently reported for laparoscopic cholecystectomy (LC), and the adequacy of their definitions.
METHODS
MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were searched for prospective studies reporting clinical outcomes of LC, between 2013 and 2016.
RESULTS
In total 233 studies were included, reporting 967 complications, of which 204 (21%) were defined. One hundred and twenty-two studies (52%) did not provide definitions for any of the complications reported. Conversion to open cholecystectomy was the most commonly reported complication, reported in 135 (58%) studies, followed by bile leak in 89 (38%) and bile duct injury in 75 (32%). Mortality was reported in 89 studies (38%).
CONCLUSION
Considerable variation was identified between studies in the choice of measures used to evaluate the complications of LC, and in their definitions. A standardised set of core outcomes of LC should be developed for use in clinical trials and in evaluating the performance of surgical units.
Topics: Anastomotic Leak; Bile Ducts; Cholecystectomy, Laparoscopic; Conversion to Open Surgery; Humans; Postoperative Complications; Risk Factors; Treatment Outcome; Wounds and Injuries
PubMed: 29650299
DOI: 10.1016/j.hpb.2018.03.004 -
Lancet (London, England) Mar 2019Intrahepatic cholestasis of pregnancy is associated with adverse perinatal outcomes, but the association with the concentration of specific biochemical markers is... (Meta-Analysis)
Meta-Analysis
Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses.
BACKGROUND
Intrahepatic cholestasis of pregnancy is associated with adverse perinatal outcomes, but the association with the concentration of specific biochemical markers is unclear. We aimed to quantify the adverse perinatal effects of intrahepatic cholestasis of pregnancy in women with increased serum bile acid concentrations and determine whether elevated bile acid concentrations were associated with the risk of stillbirth and preterm birth.
METHODS
We did a systematic review by searching PubMed, Web of Science, and Embase databases for studies published from database inception to June 1, 2018, reporting perinatal outcomes for women with intrahepatic cholestasis of pregnancy when serum bile acid concentrations were available. Inclusion criteria were studies defining intrahepatic cholestasis of pregnancy based upon pruritus and elevated serum bile acid concentrations, with or without raised liver aminotransferase concentrations. Eligible studies were case-control, cohort, and population-based studies, and randomised controlled trials, with at least 30 participants, and that reported bile acid concentrations and perinatal outcomes. Studies at potential higher risk of reporter bias were excluded, including case reports, studies not comprising cohorts, or successive cases seen in a unit; we also excluded studies with high risk of bias from groups selected (eg, a subgroup of babies with poor outcomes were explicitly excluded), conference abstracts, and Letters to the Editor without clear peer review. We also included unpublished data from two UK hospitals. We did a random effects meta-analysis to determine risk of adverse perinatal outcomes. Aggregate data for maternal and perinatal outcomes were extracted from case-control studies, and individual patient data (IPD) were requested from study authors for all types of study (as no control group was required for the IPD analysis) to assess associations between biochemical markers and adverse outcomes using logistic and stepwise logistic regression. This study is registered with PROSPERO, number CRD42017069134.
FINDINGS
We assessed 109 full-text articles, of which 23 studies were eligible for the aggregate data meta-analysis (5557 intrahepatic cholestasis of pregnancy cases and 165 136 controls), and 27 provided IPD (5269 intrahepatic cholestasis of pregnancy cases). Stillbirth occurred in 45 (0·83%) of 4936 intrahepatic cholestasis of pregnancy cases and 519 (0·32%) of 163 947 control pregnancies (odds ratio [OR] 1·46 [95% CI 0·73-2·89]; I=59·8%). In singleton pregnancies, stillbirth was associated with maximum total bile acid concentration (area under the receiver operating characteristic curve [ROC AUC]) 0·83 [95% CI 0·74-0·92]), but not alanine aminotransferase (ROC AUC 0·46 [0·35-0·57]). For singleton pregnancies, the prevalence of stillbirth was three (0·13%; 95% CI 0·02-0·38) of 2310 intrahepatic cholestasis of pregnancy cases in women with serum total bile acids of less than 40 μmol/L versus four (0·28%; 0·08-0·72) of 1412 cases with total bile acids of 40-99 μmol/L (hazard ratio [HR] 2·35 [95% CI 0·52-10·50]; p=0·26), and versus 18 (3·44%; 2·05-5·37) of 524 cases for bile acids of 100 μmol/L or more (HR 30·50 [8·83-105·30]; p<0·0001).
INTERPRETATION
The risk of stillbirth is increased in women with intrahepatic cholestasis of pregnancy and singleton pregnancies when serum bile acids concentrations are of 100 μmol/L or more. Because most women with intrahepatic cholestasis of pregnancy have bile acids below this concentration, they can probably be reassured that the risk of stillbirth is similar to that of pregnant women in the general population, provided repeat bile acid testing is done until delivery.
FUNDING
Tommy's, ICP Support, UK National Institute of Health Research, Wellcome Trust, and Genesis Research Trust.
Topics: Alanine Transaminase; Aspartate Aminotransferases; Bile Acids and Salts; Bilirubin; Biomarkers; Case-Control Studies; Cholestasis, Intrahepatic; Cohort Studies; Female; Humans; Infant, Newborn; Perinatal Death; Pregnancy; Pregnancy Complications; Premature Birth; ROC Curve; Randomized Controlled Trials as Topic; Risk Factors; Stillbirth
PubMed: 30773280
DOI: 10.1016/S0140-6736(18)31877-4 -
The Cochrane Database of Systematic... Jul 2020Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder that can develop in pregnancy. It occurs when there is a build-up of bile acids in the maternal blood. It... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder that can develop in pregnancy. It occurs when there is a build-up of bile acids in the maternal blood. It has been linked to adverse maternal and fetal/neonatal outcomes. As the pathophysiology is poorly understood, therapies have been largely empiric. As ICP is an uncommon condition (incidence less than 2% a year), many trials have been small. Synthesis, including recent larger trials, will provide more evidence to guide clinical practice. This review is an update of a review first published in 2001 and last updated in 2013.
OBJECTIVES
To assess the effects of pharmacological interventions to treat women with intrahepatic cholestasis of pregnancy, on maternal, fetal and neonatal outcomes.
SEARCH METHODS
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (13 December 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials, including cluster-randomised trials and trials published in abstract form only, that compared any drug with placebo or no treatment, or two drug intervention strategies, for women with a clinical diagnosis of intrahepatic cholestasis of pregnancy.
DATA COLLECTION AND ANALYSIS
The review authors independently assessed trials for eligibility and risks of bias. We independently extracted data and checked these for accuracy. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 26 trials involving 2007 women. They were mostly at unclear to high risk of bias. They assessed nine different pharmacological interventions, resulting in 14 different comparisons. We judged two placebo-controlled trials of ursodeoxycholic acid (UDCA) in 715 women to be at low risk of bias. The ten different pharmacological interventions were: agents believed to detoxify bile acids (UCDA) and S-adenosylmethionine (SAMe); agents used to bind bile acids in the intestine (activated charcoal, guar gum, cholestyramine); Chinese herbal medicines (yinchenghao decoction (YCHD), salvia, Yiganling and Danxioling pill (DXLP)), and agents aimed to reduce bile acid production (dexamethasone) Compared with placebo, UDCA probably results in a small improvement in pruritus score measured on a 100 mm visual analogue scale (VAS) (mean difference (MD) -7.64 points, 95% confidence interval (CI) -9.69 to -5.60 points; 2 trials, 715 women; GRADE moderate certainty), where a score of zero indicates no itch and a score of 100 indicates severe itching. The evidence for fetal distress and stillbirth were uncertain, due to serious limitations in study design and imprecision (risk ratio (RR) 0.70, 95% CI 0.35 to 1.40; 6 trials, 944 women; RR 0.33, 95% CI 0.08 to 1.37; 6 trials, 955 women; GRADE very low certainty). We found very few differences for the other comparisons included in this review. There is insufficient evidence to indicate if SAMe, guar gum, activated charcoal, dexamethasone, cholestyramine, Salvia, Yinchenghao decoction, Danxioling and Yiganling, or Yiganling alone or in combination are effective in treating women with intrahepatic cholestasis of pregnancy.
AUTHORS' CONCLUSIONS
When compared with placebo, UDCA administered to women with ICP probably shows a reduction in pruritus. However the size of the effect is small and for most pregnant women and clinicians, the reduction may fall below the minimum clinically worthwhile effect. The evidence was unclear for other adverse fetal outcomes, due to very low-certainty evidence. There is insufficient evidence to indicate that SAMe, guar gum, activated charcoal, dexamethasone, cholestyramine, YCHD, DXLP, Salvia, Yiganling alone or in combination are effective in treating women with cholestasis of pregnancy. There are no trials of the efficacy of topical emollients. Further high-quality trials of other interventions are needed in order to identify effective treatments for maternal itching and preventing adverse perinatal outcomes. It would also be helpful to identify those women who are mostly likely to respond to UDCA (for example, whether bile acid concentrations affect how women with ICP respond to treatment with UDCA).
Topics: Charcoal; Cholagogues and Choleretics; Cholestasis; Cholestyramine Resin; Dexamethasone; Drugs, Chinese Herbal; Female; Fetal Distress; Galactans; Glucocorticoids; Humans; Mannans; Plant Gums; Pregnancy; Pregnancy Complications; Pruritus; Randomized Controlled Trials as Topic; S-Adenosylmethionine; Stillbirth; Ursodeoxycholic Acid
PubMed: 32716060
DOI: 10.1002/14651858.CD000493.pub3 -
The Lancet. Gastroenterology &... Jul 2021Ursodeoxycholic acid is commonly used to treat intrahepatic cholestasis of pregnancy, yet its largest trial detected minimal benefit for a composite outcome (stillbirth,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Ursodeoxycholic acid is commonly used to treat intrahepatic cholestasis of pregnancy, yet its largest trial detected minimal benefit for a composite outcome (stillbirth, preterm birth, and neonatal unit admission). We aimed to examine whether ursodeoxycholic acid affects specific adverse perinatal outcomes.
METHODS
In this systematic review and individual participant data meta-analysis, we searched PubMed, Web of Science, Embase, MEDLINE, CINAHL, Global Health, MIDIRS, and Cochrane without language restrictions for relevant articles published between database inception, and Jan 1, 2020, using search terms referencing intrahepatic cholestasis of pregnancy, ursodeoxycholic acid, and perinatal outcomes. Eligible studies had 30 or more study participants and reported on at least one individual with intrahepatic cholestasis of pregnancy and bile acid concentrations of 40 μmol/L or more. We also included two unpublished cohort studies. Individual participant data were collected from the authors of selected studies. The primary outcome was the prevalence of stillbirth, for which we anticipated there would be insufficient data to achieve statistical power. Therefore, we included a composite of stillbirth and preterm birth as a main secondary outcome. A mixed-effects meta-analysis was done using multi-level modelling and adjusting for bile acid concentration, parity, and multifetal pregnancy. Individual participant data analyses were done for all studies and in different subgroups, which were produced by limiting analyses to randomised controlled trials only, singleton pregnancies only, or two-arm studies only. This study is registered with PROSPERO, CRD42019131495.
FINDINGS
The authors of the 85 studies fulfilling our inclusion criteria were contacted. Individual participant data from 6974 women in 34 studies were included in the meta-analysis, of whom 4726 (67·8%) took ursodeoxycholic acid. Stillbirth occurred in 35 (0·7%) of 5097 fetuses among women with intrahepatic cholestasis of pregnancy treated with ursodeoxycholic acid and in 12 (0·6%) of 2038 fetuses among women with intrahepatic cholestasis of pregnancy not treated with ursodeoxycholic acid (adjusted odds ratio [aOR] 1·04, 95% CI 0·35-3·07; p=0·95). Ursodeoxycholic acid treatment also had no effect on the prevalence of stillbirth when considering only randomised controlled trials (aOR 0·29, 95% CI 0·04-2·42; p=0·25). Ursodeoxycholic acid treatment had no effect on the prevalence of the composite outcome in all studies (aOR 1·28, 95% CI 0·86-1·91; p=0·22), but was associated with a reduced composite outcome when considering only randomised controlled trials (0·60, 0·39-0·91; p=0·016).
INTERPRETATION
Ursodeoxycholic acid treatment had no significant effect on the prevalence of stillbirth in women with intrahepatic cholestasis of pregnancy, but our analysis was probably limited by the low overall event rate. However, when considering only randomised controlled trials, ursodeoxycholic acid was associated with a reduction in stillbirth in combination with preterm birth, providing evidence for the clinical benefit of antenatal ursodeoxycholic acid treatment.
FUNDING
Tommy's, the Wellcome Trust, ICP Support, and the National Institute for Health Research.
Topics: Cholagogues and Choleretics; Cholestasis, Intrahepatic; Female; Humans; Pregnancy; Pregnancy Complications; Ursodeoxycholic Acid
PubMed: 33915090
DOI: 10.1016/S2468-1253(21)00074-1