Is It Necessary to Perform the Pharmacological Interventions for Intrahepatic Cholestasis of Pregnancy? A Bayesian Network Meta-Analysis.


Journal

Clinical drug investigation
ISSN: 1179-1918
Titre abrégé: Clin Drug Investig
Pays: New Zealand
ID NLM: 9504817

Informations de publication

Date de publication:
Jan 2019
Historique:
pubmed: 26 10 2018
medline: 19 3 2019
entrez: 26 10 2018
Statut: ppublish

Résumé

Although many meta-analyses have evaluated the pharmacotherapy of intrahepatic cholestasis of pregnancy (ICP) and recommended ursodeoxycholic acid (UDCA) as an effective treatment, the defect of the pair-wise analyses and the mixture of the control group made the outcome uncertain and unclear. We aimed to employ Bayesian network meta-analysis (NMA) to compare the maternal and fetal outcomes after UDCA, S-adenosylmethionine (SAMe) mono-therapy or the combination treatment of these two drugs for ICP patients. Multiple electronic database searches were conducted for articles published up to 1 September 2018. The relevant information was extracted from the published reports with a predefined data extraction sheet, and the risk of bias was assessed with the Cochrane risk-of-bias tool. Poisson Bayesian network meta-analysis was employed to identify the synthesized evidence from the relevant trials, with reporting hazard risks (HRs) and 95% credible intervals (CrIs). The pooled outcomes of the 13 randomized controlled trials (RCTs) with 625 participants indicated that none of the three regimens can significantly improve maternal and fetal outcomes. This NMA of the RCTs clarified that the current intervention has no favorable effect on pruritus and other symptoms in ICP patients.

Sections du résumé

BACKGROUND AND OBJECTIVE OBJECTIVE
Although many meta-analyses have evaluated the pharmacotherapy of intrahepatic cholestasis of pregnancy (ICP) and recommended ursodeoxycholic acid (UDCA) as an effective treatment, the defect of the pair-wise analyses and the mixture of the control group made the outcome uncertain and unclear. We aimed to employ Bayesian network meta-analysis (NMA) to compare the maternal and fetal outcomes after UDCA, S-adenosylmethionine (SAMe) mono-therapy or the combination treatment of these two drugs for ICP patients.
METHODS METHODS
Multiple electronic database searches were conducted for articles published up to 1 September 2018. The relevant information was extracted from the published reports with a predefined data extraction sheet, and the risk of bias was assessed with the Cochrane risk-of-bias tool. Poisson Bayesian network meta-analysis was employed to identify the synthesized evidence from the relevant trials, with reporting hazard risks (HRs) and 95% credible intervals (CrIs).
RESULTS RESULTS
The pooled outcomes of the 13 randomized controlled trials (RCTs) with 625 participants indicated that none of the three regimens can significantly improve maternal and fetal outcomes.
CONCLUSION CONCLUSIONS
This NMA of the RCTs clarified that the current intervention has no favorable effect on pruritus and other symptoms in ICP patients.

Identifiants

pubmed: 30357607
doi: 10.1007/s40261-018-0717-2
pii: 10.1007/s40261-018-0717-2
doi:

Substances chimiques

Ursodeoxycholic Acid 724L30Y2QR

Types de publication

Journal Article Meta-Analysis Systematic Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

15-26

Subventions

Organisme : Jiangsu Provincial Department of Science and Technology
ID : BE2015655
Organisme : National Natural Science Foundation of China
ID : 81370520
Organisme : The Nantong Municipal Bureau of Science and Technology
ID : HS2016002
Organisme : The Postgraduate Research & Practice Innovation Program of Jiangsu Province
ID : KYCX17-1941

Références

Hay JE. Liver disease in pregnancy. Med Clin North Am. 2008;73(3):1067.
Bacq Y, Besco ML, Lecuyer AI, Gendrot C, Potin J, Andres CR, et al. Ursodeoxycholic acid therapy in intrahepatic cholestasis of pregnancy: results in real-world conditions and factors predictive of response to treatment. Digest Liver Dis. 2017;49(1):63–9.
doi: 10.1016/j.dld.2016.10.006
Lee NM, Brady CW. Liver disease in pregnancy. World J Gastroenterol. 2009;1(8):608.
Williamson C, Geenes V. Intrahepatic cholestasis of pregnancy. Obstet Gynecol. 2014;124(1):120–33.
doi: 10.1097/AOG.0000000000000346 pubmed: 24901263
Williamson C, Nelson-Piercy C. Liver disease in pregnancy. Br J Hosp Med. 2011;58(5):213–6.
Ozkan S, Ceylan Y, Ozkan OV, Yildirim S. Review of a challenging clinical issue: Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2015;21(23):7134.
doi: 10.3748/wjg.v21.i23.7134 pubmed: 26109799 pmcid: 4476874
Lammert F, Marschall HU, Glantz A, Matern S. Intrahepatic cholestasis of pregnancy: molecular pathogenesis, diagnosis and management. J Hepatol. 2000;33(6):1012–21.
doi: 10.1016/S0168-8278(00)80139-7 pubmed: 11131439
Zhuang X, Cui AM, Wang Q, et al. Liver dysfunction during pregnancy and its association of with preterm birth in China: a prospective cohort study. EBioMedicine. 2017;26:152–6.
doi: 10.1016/j.ebiom.2017.11.014 pubmed: 29174520 pmcid: 5832609
Fisk NM, Bye WB, Storey GN. Maternal features of obstetric cholestasis: 20 years experience at King George V Hospital. Aust N Z J Obstet Gynaecol. 1988;28(3):172–6.
doi: 10.1111/j.1479-828X.1988.tb01657.x pubmed: 3233079
Alsulyman OM, Ouzounian JG, Amescastro M, Goodwin TM. Intrahepatic cholestasis of pregnancy: perinatal outcome associated with expectant management. Am J Obstet Gynecol. 1996;175(4):957–60.
doi: 10.1016/S0002-9378(96)80031-7 pubmed: 8885754
Glantz A, Marschall HU, Mattsson LÅ. Intrahepatic cholestasis of pregnancy: Relationships between bile acid levels and fetal complication rates. Hepatology. 2004;40(2):467–74.
doi: 10.1002/hep.20336 pubmed: 15368452
Jain R, Suri V, Chopra S, Chawla YK, Kohli KK. Obstetric cholestasis: outcome with active management. J Obstetr Gynaecol Res. 2013;39(5):953–9.
doi: 10.1111/jog.12005
Geenes V, Williamson C. Intrahepatic cholestasis of pregnancy. World J Gastroenterol. 2009;19(17):46–57.
Lorente S, Montoro MA. Cholestasis of pregnancy. Gastroenterol Hepatol. 2007;30(9):541.
doi: 10.1157/13111695 pubmed: 17980133
Zhang L, Liu XH, Qi HB, Li Z, Fu XD, Chen L, et al. Ursodeoxycholic acid and S-adenosylmethionine in the treatment of intrahepatic cholestasis of pregnancy: a multi-centered randomized controlled trial. Eur Rev Med Pharmacol Sci. 2015;19(19):3770.
pubmed: 26502869
Gurung V, Middleton P, Milan SJ, Hague W, Thornton JG. Interventions for treating cholestasis in pregnancy. Cochrane Database Syst Rev. 2013;6(6):CD000493.
Zhou F, Gao B, Wang X, Li J. Meta-analysis of ursodeoxycholic acid and S-adenosylmethionine for improving the outcomes of intrahepatic cholestasis of pregnancy. Chin J Hepatol. 2014;22(4):299–304.
Bacq Y, Sentilhes L, Reyes HB, Glantz A, Kondrackiene J, Binder T, et al. Efficacy of ursodeoxycholic acid in treating intrahepatic cholestasis of pregnancy: a meta-analysis. Gastroenterology. 2012;143(6):1492–501.
doi: 10.1053/j.gastro.2012.08.004 pubmed: 22892336
Grand’Maison S, Durand M, Mahone M. The effects of ursodeoxycholic acid treatment for intrahepatic cholestasis of pregnancy on maternal and fetal outcomes: a meta-analysis including non-randomized studies. J Obstetr Gynaecol Canada. 2014;36(7):632.
doi: 10.1016/S1701-2163(15)30544-2
Zhang Y, Lu L, Victor DW, Xin Y, Xuan S. Ursodeoxycholic acid and s-adenosylmethionine for the treatment of intrahepatic cholestasis of pregnancy: a meta-analysis. Hepat Month. 2016;16(8):e38558.
Singh S, Khera R, Allen AM, Murad MH, Loomba R. Comparative effectiveness of pharmacological interventions for nonalcoholic steatohepatitis: a systematic review and network meta-analysis. Hepatology. 2015;149(4):958–70.
Cipriani A, Barbui C, Salanti G, Rendell J, Brown R, Stockton S, et al. Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis. Lancet. 2011;378(9799):1306–15.
doi: 10.1016/S0140-6736(11)60873-8 pubmed: 21851976
Song F, Altman DG, Glenny AM, Deeks JJ. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ. 2003;326(7387):472.
doi: 10.1136/bmj.326.7387.472 pubmed: 12609941 pmcid: 150178
Sutton A, Ades AE, Cooper N, Abrams K. Use of indirect and mixed treatment comparisons for technology assessment. Pharmacoeconomics. 2008;26(9):753–67.
doi: 10.2165/00019053-200826090-00006 pubmed: 18767896
Cipriani A, Higgins JPT, Geddes JR, Salanti G. Conceptual and technical challenges in network meta-analysis. Ann Intern Med. 2013;159(2):130–7.
doi: 10.7326/0003-4819-159-2-201307160-00008 pubmed: 23856683
Mills EJ, Ioannidis JP, Thorlund K, Schünemann HJ, Puhan MA, Guyatt GH. How to use an article reporting a multiple treatment comparison meta-analysis. JAMA. 2012;308(12):1246–53.
doi: 10.1001/2012.jama.11228 pubmed: 23011714
Cortese S. Guidance on conducting systematic reviews/meta-analyses of pharmacoepidemiological studies of safety outcomes: the gap is now filled. Epidemiol Psychiatr Sci. 2016;1(5):1.
Moher D, Liberati A, Tetzlaff J, Altman DG, Group TP. Preferred reporting items for systematic reviews and meta-analyses: the prisma statement. Revista Española De Nutrición Humana Y Dietética. 2009;18(3):e123.
Hutton B, Salanti G, Chaimani A, Caldwell DM, Schmid C, Thorlund K, et al. The Quality of reporting methods and results in network meta-analyses: an overview of reviews and suggestions for improvement. PLoS One. 2014;9(3):e92508.
doi: 10.1371/journal.pone.0092508 pubmed: 24671099 pmcid: 3966807
Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ Br Med J. 2011;343(7829):889–93.
Dias S, Sutton AJ, Ades AE, Welton NJ. Evidence synthesis for decision making 2: a generalized linear modeling framework for pairwise and network meta-analysis of randomized controlled trials. Med Decis Making. 2013;33(5):607–17.
doi: 10.1177/0272989X12458724 pubmed: 23104435 pmcid: 3704203
Dias S, Sutton AJ, Welton NJ, Ades AE. Evidence synthesis for decision making 3: heterogeneity–subgroups, meta-regression, bias, and bias-adjustment. Med Decis Making. 2013;33(5):618–40.
doi: 10.1177/0272989X13485157 pubmed: 23804507 pmcid: 3704206
Dias S, Welton NJ, Sutton AJ, Caldwell DM, Guobing L, Ades AE. Evidence synthesis for decision making 4: inconsistency in networks of evidence based on randomized controlled trials. Med Decis Making. 2013;33(5):641–56.
doi: 10.1177/0272989X12455847 pubmed: 23804508 pmcid: 3704208
Böhning D, Mylona K, Kimber A. Meta-analysis of clinical trials with rare events. Biom J. 2015;57(4):633–48.
doi: 10.1002/bimj.201400184 pubmed: 25914347
Cai T, Parast L, Ryan L. Meta-analysis for rare events. Stat Med. 2010;29(20):2078.
doi: 10.1002/sim.3964 pubmed: 20623822 pmcid: 2932857
Lunn D, Spiegelhalter D, Thomas A, Best N. The BUGS project: evolution, critique and future directions. Stat Med. 2009;28(25):3049–67.
doi: 10.1002/sim.3680 pubmed: 19630097
Lambert PC, Sutton AJ, Burton PR, Abrams KR, Jones DR. How vague is vague? A simulation study of the impact of the use of vague prior distributions in MCMC using WinBUGS. Stat Med. 2005;24(15):2401–28.
doi: 10.1002/sim.2112 pubmed: 16015676
Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple-treatment meta-analysis: an overview and tutorial. J Clin Epidemiol. 2011;64(2):163–71.
doi: 10.1016/j.jclinepi.2010.03.016 pubmed: 20688472
Held U, Brunner F, Steurer J, Wertli MM. Bayesian meta-analysis of test accuracy in the absence of a perfect reference test applied to bone scintigraphy for the diagnosis of complex regional pain syndrome. Biom J. 2015;57(6):1020–37.
doi: 10.1002/bimj.201400155 pubmed: 26479506
Turner RM, Davey J, Clarke MJ, Thompson SG, Higgins JP. Predicting the extent of heterogeneity in meta-analysis, using empirical data from the Cochrane Database of Systematic Reviews. Int J Epidemiol. 2012;41(3):818–27.
doi: 10.1093/ije/dys041 pubmed: 22461129 pmcid: 3396310
Frezza M, Surrenti C, Manzillo G, Fiaccadori F, Bortolini M, Di PC. Oral S-adenosylmethionine in the symptomatic treatment of intrahepatic cholestasis. A double-blind, placebo-controlled study. Gastroenterology. 1990;99(1):211.
Ribalta J, Reyes H, Gonzalez MC, Iglesias J, Arrese M, Poniachik J, et al. S-Adenosyl-L-methionine in the treatment of patients with intrahepatic cholestasis of pregnancy: A randomized, double-blind, placebo-controlled study with negative results. Hepatology. 1991;13(6):1084–9.
pubmed: 2050326
Diaferia A, Nicastri PL, Tartagni M, Loizzi P, Iacovizzi C, Di LA. Ursodeoxycholic acid therapy in pregnant women with cholestasis. Int J Gynecol Obstetr. 1996;52(2):133–40.
doi: 10.1016/0020-7292(95)02528-6
Floreani A, Paternoster D, Melis A, Grella PV. S-adenosylmethionine versus ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: preliminary results of a controlled trial. Eur J Obstetr Gynecol Reprod Biol. 1996;67(2):109.
doi: 10.1016/0301-2115(96)02442-6
Palma J, Reyes H, Ribalta J, Hernández I, Sandoval L, Almuna R, et al. Ursodeoxycholic acid in the treatment of cholestasis of pregnancy: a randomized, double-blind study controlled with placebo. J Hepatol. 1997;27(6):1022.
doi: 10.1016/S0168-8278(97)80146-8 pubmed: 9453428
Nicastri PL, Diaferia A, Tartagni M, Loizzi P, Fanelli M. A randomised placebo-controlled trial of ursodeoxycholic acid and S-adenosylmethionine in the treatment of intrahepatic cholestasis of pregnancy. Br J Obstet Gynaecol. 1998;105(11):1205.
doi: 10.1111/j.1471-0528.1998.tb09976.x pubmed: 9853771
Roncaglia N, Locatelli A, Arreghini A, Assi F, Cameroni I, Pezzullo JC, et al. A randomised controlled trial of ursodeoxycholic acid and S-adenosyl-l-methionine in the treatment of gestational cholestasis. BJOG Int J Obstetr Gynaecol. 2004;111(1):17–21.
doi: 10.1046/j.1471-0528.2003.00029.x
Glantz A, Marschall HU, Lammert F, Mattsson LA. Intrahepatic cholestasis of pregnancy: a randomized controlled trial comparing dexamethasone and ursodeoxycholic acid. Hepatology. 2005;42(6):1399–405.
doi: 10.1002/hep.20952 pubmed: 16317669
Binder T, Salaj P, Zima T, Vítek L. Randomized prospective comparative study of ursodeoxycholic acid and S-adenosyl-L-methionine in the treatment of intrahepatic cholestasis of pregnancy. J Perinat Med. 2006;34(5):383–91.
doi: 10.1515/JPM.2006.077 pubmed: 16965225
Liu Y, Qiao F, Liu H, Liu D. Ursodeoxycholic acid in the treatment of intraheptic cholestasis of pregnancy. J Huazhong Univ Sci Technol (Med Sci). 2006;26(3):350.
doi: 10.1007/BF02829573
Chappell LC, Gurung V, Seed PT, Chambers J, Williamson C, Thornton JG. Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semifactorial randomised clinical trial. BMJ. 2012;13(344):e3799.
doi: 10.1136/bmj.e3799
Joutsiniemi T, Timonen S, Leino R, Palo P, Ekblad U. Ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy: a randomized controlled trial. Arch Gynecol Obstet. 2014;289(3):541.
doi: 10.1007/s00404-013-2995-5 pubmed: 23978872
Obstetriciansgynecologists ACO. ACOG committee opinion no. 560: Medically indicated late-preterm and early-term deliveries. Obstetr Gynecol. 2013;121(4):908–10.
Henderson CE, Shah RR, Gottimukkala S, Ferreira KK, Hamaoui A, Mercado R. Primum non nocere: how active management became modus operandi for intrahepatic cholestasis of pregnancy. Am J Obstet Gynecol. 2014;211(3):189–96.
doi: 10.1016/j.ajog.2014.03.058 pubmed: 24704063
Ofliver EAF. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009;51(4):237–67.
Kong X, Kong Y, Zhang F, Wang T, Yan J. Evaluating the effectiveness and safety of ursodeoxycholic acid in treatment of intrahepatic cholestasis of pregnancy: a meta-analysis (a prisma-compliant study). Medicine. 2016;95(40):e4949.
doi: 10.1097/MD.0000000000004949 pubmed: 27749550 pmcid: 5059052
Chappell LC, Chambers J, Thornton JG, Williamson C. Does ursodeoxycholic acid improve perinatal outcomes in women with intrahepatic cholestasis of pregnancy? BMJ. 2018;360:k104.
doi: 10.1136/bmj.k104 pubmed: 29419378
Arthur C, Mahomed K. Intrahepatic cholestasis of pregnancy: diagnosis and management; a survey of Royal Australian and New Zealand College of Obstetrics and Gynaecology fellows. Aust N Z J Obstet Gynaecol. 2014;54(3):263.
doi: 10.1111/ajo.12178 pubmed: 24506294
Azzaroli F, Turco L, Lisotti A, Calvanese C, Mazzella G. The pharmacological management of intrahepatic cholestasis of pregnancy. Curr Clin Pharmacol. 2011;6(1):12.
doi: 10.2174/157488411794941313 pubmed: 21352094
Almasio P, Bortolini M, Pagliaro L, Coltorti M. Role of S-adenosyl-L-methionine in the treatment of intrahepatic cholestasis. Drugs. 1990;40(3):111–23.
doi: 10.2165/00003495-199000403-00011 pubmed: 2081476
Crowther MJ, Riley RD, Staessen JA, Wang J, Francois G, Lambert PC. Individual patient data meta-analysis of survival data using Poisson regression models. BMC Med Res Methodol. 2012;12(1):34.
doi: 10.1186/1471-2288-12-34 pubmed: 22443286 pmcid: 3398853
Pjetursson BE, Thoma D, Jung R, Zwahlen M, Zembic A. A systematic review of the survival and complication rates of implant-supported fixed dental prostheses (FDPs) after a mean observation period of at least 5 years. Clin Oral Implants Res. 2012;23(Suppl 6):22–38.
doi: 10.1111/j.1600-0501.2012.02546.x pubmed: 23062125
Friede T, Röver C, Wandel S, Neuenschwander B. Meta-analysis of few small studies in orphan diseases. Res Synthesis Methods. 2016;8(1):79–91.
doi: 10.1002/jrsm.1217
Golder S, Loke YK, Bland M. Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: methodological overview. Plos Med. 2011;8(5):e1001026.
doi: 10.1371/journal.pmed.1001026 pubmed: 21559325 pmcid: 3086872
Schünemann HJ, Tugwell P, Reeves BC, Akl EA, Santesso N, Spencer FA, et al. Non-randomized studies as a source of complementary, sequential or replacement evidence for randomized controlled trials in systematic reviews on the effects of interventions. Res Synth Methods. 2013;4(1):49–62.
doi: 10.1002/jrsm.1078 pubmed: 26053539

Auteurs

Yi Shen (Y)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Jie Zhou (J)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Sheng Zhang (S)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Xu-Lin Wang (XL)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Yu-Long Jia (YL)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Shu He (S)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Yuan-Yuan Wang (YY)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Wen-Chao Li (WC)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Jian-Guo Shao (JG)

Center for Liver Diseases, Nantong Third People's Hospital, Nantong University, 60 Mid-Youth Road, Nantong, 226006, Jiangsu, China.

Xun Zhuang (X)

Department of Epidemiology and Medical Statistics, School of Public Health, Nantong University, Nantong, China.

Yuan-Lin Liu (YL)

Department of Obstetrics and Gynecology, Affiliated Hospital of Nantong University, Nantong, China.

Gang Qin (G)

Center for Liver Diseases, Nantong Third People's Hospital, Nantong University, 60 Mid-Youth Road, Nantong, 226006, Jiangsu, China. tonygqin@ntu.edu.cn.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH