Pharmacological interventions for primary biliary cholangitis: an attempted network meta-analysis
- PMID: 28350426
- PMCID: PMC6464661
- DOI: 10.1002/14651858.CD011648.pub2
Pharmacological interventions for primary biliary cholangitis: an attempted network meta-analysis
Abstract
Background: Primary biliary cholangitis (previously primary biliary cirrhosis) is a chronic liver disease caused by the destruction of small intra-hepatic bile ducts resulting in stasis of bile (cholestasis), liver fibrosis, and liver cirrhosis. The optimal pharmacological treatment of primary biliary cholangitis remains uncertain.
Objectives: To assess the comparative benefits and harms of different pharmacological interventions in the treatment of primary biliary cholangitis through a network meta-analysis and to generate rankings of the available pharmacological interventions according to their safety and efficacy. However, it was not possible to assess whether the potential effect modifiers were similar across different comparisons. Therefore, we did not perform the network meta-analysis, and instead, assessed the comparative benefits and harms of different interventions using standard Cochrane methodology.
Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 2), MEDLINE, Embase, Science Citation Index Expanded, World Health Organization International Clinical Trials Registry Platform, and randomised controlled trials registers to February 2017 to identify randomised clinical trials on pharmacological interventions for primary biliary cholangitis.
Selection criteria: We included only randomised clinical trials (irrespective of language, blinding, or publication status) in participants with primary biliary cholangitis. We excluded trials which included participants who had previously undergone liver transplantation. We considered any of the various pharmacological interventions compared with each other or with placebo or no intervention.
Data collection and analysis: We used standard methodological procedures expected by Cochrane. We calculated the odds ratio (OR) and rate ratio with 95% confidence intervals (CI) using both fixed-effect and random-effects models based on available-participant analysis with Review Manager 5. We assessed risk of bias according to Cochrane, controlled risk of random errors with Trial Sequential Analysis, and assessed the quality of the evidence using GRADE.
Main results: We identified 74 trials including 5902 participants that met the inclusion criteria of this review. A total of 46 trials (4274 participants) provided information for one or more outcomes. All the trials were at high risk of bias in one or more domains. Overall, all the evidence was low or very low quality. The proportion of participants with symptoms varied from 19.9% to 100% in the trials that reported this information. The proportion of participants who were antimitochondrial antibody (AMA) positive ranged from 80.8% to 100% in the trials that reported this information. It appeared that most trials included participants who had not received previous treatments or included participants regardless of the previous treatments received. The follow-up in the trials ranged from 1 to 96 months.The proportion of people with mortality (maximal follow-up) was higher in the methotrexate group versus the no intervention group (OR 8.83, 95% CI 1.01 to 76.96; 60 participants; 1 trial; low quality evidence). The proportion of people with mortality (maximal follow-up) was lower in the azathioprine group versus the no intervention group (OR 0.56, 95% CI 0.32 to 0.98; 224 participants; 2 trials; I2 = 0%; low quality evidence). However, it has to be noted that a large proportion of participants (25%) was excluded from the trial that contributed most participants to this analysis and the results were not reliable. There was no evidence of a difference in any of the remaining comparisons. The proportion of people with serious adverse events was higher in the D-penicillamine versus no intervention group (OR 28.77, 95% CI 1.57 to 526.67; 52 participants; 1 trial; low quality evidence). The proportion of people with serious adverse events was higher in the obeticholic acid plus ursodeoxycholic acid (UDCA) group versus the UDCA group (OR 3.58, 95% CI 1.02 to 12.51; 216 participants; 1 trial; low quality evidence). There was no evidence of a difference in any of the remaining comparisons for serious adverse events (proportion) or serious adverse events (number of events). None of the trials reported health-related quality of life at any time point.
Funding: nine trials had no special funding or were funded by hospital or charities; 31 trials were funded by pharmaceutical companies; and 34 trials provided no information on source of funding.
Authors' conclusions: Based on very low quality evidence, there is currently no evidence that any intervention is beneficial for primary biliary cholangitis. However, the follow-up periods in the trials were short and there is significant uncertainty in this issue. Further well-designed randomised clinical trials are necessary. Future randomised clinical trials ought to be adequately powered; performed in people who are generally seen in the clinic rather than in highly selected participants; employ blinding; avoid post-randomisation dropouts or planned cross-overs; should have sufficient follow-up period (e.g. five or 10 years or more); and use clinically important outcomes such as mortality, health-related quality of life, cirrhosis, decompensated cirrhosis, and liver transplantation. Alternatively, very large groups of participants should be randomised to facilitate shorter trial duration.
Conflict of interest statement
This report is independent research funded by the National Institute for Health Research (NIHR Cochrane Programme Grants, 13/89/03 ‐ Evidence‐based diagnosis and management of upper digestive, hepato‐biliary, and pancreatic disorders). The views expressed in this publication are those of the review authors and not necessarily those of the National Health System (NHS), the NIHR, or the Department of Health.
FS has no financial disclosures. KG has no financial disclosures. LHE has no financial disclosures. ET has participated in advisory boards for Astra Zeneca and ViiV healthcare. BD has no financial disclosures. DT was funded by Astellas for his attendance at the International Liver Transplantation Society meeting in 2014. He received GBP 25,000 from Boston Scientific to fund a clinical research fellow in 2013.
Figures
Update of
- doi: 10.1002/14651858.CD011648
References
References to studies included in this review
Almasio 2000 {published data only}
-
- Almasio P, Provenzano G, Battezzati PM, Podda M, Todros L, Rosina F, et al. The Italian multi‐centre randomized controlled trial of UDCA vs colchicine plus UDCA in symptomatic primary biliary cholangitis. Hepatology 1994;20(4 (Pt 2)):73.
-
- Almasio PL, Floreani A, Chiaramonte M, Provenzano G, Battezzati P, Crosignani A, et al. Multicentre randomized placebo‐controlled trial of UDCA with or without colchicine in symptomatic primary biliary cholangitis. Alimentary Pharmacology & Therapeutics 2000;14(12):1645‐52. - PubMed
-
- Battezzati PM, Zuin M, Crosignani A, Allocca M, Invernizzi P, Selmi C, et al. Ten‐year combination treatment with colchicine and UDCA for primary biliary cholangitis: a double‐blind, placebo‐controlled trial on symptomatic patients. Alimentary Pharmacology & Therapeutics 2001;15(9):1427‐34. - PubMed
-
- Podda M, Almasio P, Battezzati PM, Crosignani A. Long‐term effect of the administration of UDCA alone or with colchicine in patients with primary biliary cholangitis: a double‐blind multicentre study. 68th Falk Symposium; 1992 Oct 12‐14; Basel, Switzerland. 1993:310‐5.
Angulo 1999a {published data only}
-
- Angulo P, Dickson ER, Therneau TM, Jorgensen RA, Smith C, DeSotel CK, et al. Comparison of three doses of UDCA in the treatment of primary biliary cholangitis: a randomized trial. Journal of Hepatology 1999;30(5):830‐5. - PubMed
Arora 1990 {published data only}
-
- Arora R, Batta AK, Salen G, O'Brien C, Senior JR. Effect of ursodiol on bile acid conjugation in patients with primary biliary cholangitis. Hepatology 1990;12(4 (Pt 2)):994.
-
- Batta AK, Arora R, Salen G, Katz S. UDCA improves liver function and reduces serum and urinary endogenous bile acids in primary biliary cholangitis. Hepatology 1988;8(5):1221.
-
- Batta AK, Arora R, Salen G, O'Brien C, Senior JR. Effect or ursodiol on biliary bile acid composition and conjugation in patients with primary biliary cholangitis. Gastroenterology 1990;98(2 (Pt 2)):A567.
Askari 2010 {published data only}
-
- Askari F, Innis D, Dick RB, Hou GQ, Marrero J, Greenson J, et al. Treatment of primary biliary cholangitis with tetrathiomolybdate: results of a double‐blind trial. Translational Research 2010;155(3):123‐30. - PubMed
Battezzati 1993 {published data only}
-
- Anonymous. UDCA (UDCA) for symptomatic primary biliary cholangitis (PBC): a double‐blind multicenter trial. Journal of Hepatology 1989;9(Suppl 1):S44.
-
- Battezzati PM, Podda M, Bianchi FB, Naccarato R, Orlandi F, Surrenti C, et al. UDCA for symptomatic primary biliary cholangitis. Preliminary analysis of a double‐blind multicenter trial. Italian multicenter group for the study of UDCA in PBC. Journal of Hepatology 1993;17(3):332‐8. - PubMed
-
- Podda M, Battezzati PM, Crosignani A, Bianchi FB, Fusconi M, Chiaramonte M, et al. UDCA (UDCA) for symptomatic primary biliary cholangitis (PBC): a double‐blind multicenter trial. Hepatology 1989;10(4):639.
Bobadilla 1994 {published data only}
-
- Bobadilla J, Vargas F, Dehesa M, Zapata L, Kaplan M, Nava R, et al. Colchicine and ursodiol in the treatment of primary biliary cholangitis. Hepatology 1994;20(4 (Pt 2)):332a.
Bodenheimer 1988 {published data only}
-
- Bodenheimer H Jr, Schaffner F, Pezzullo J. Evaluation of colchicine therapy in primary biliary cholangitis. Gastroenterology 1988;95(1):124‐9. - PubMed
-
- Bodenheimer H, Schaffner F, Pezzullo J. A randomized double‐blind controlled trial of colchicine in primary biliary cholangitis. Hepatology 1985;5(5):968.
-
- Bodenheimer H, Schaffner F, Pezzullo J. Colchicine therapy in primary biliary cholangitis. Hepatology 1986;6(5):1172.
-
- Zifroni A, Schaffner F. Long‐term follow‐up of patients with primary biliary cholangitis on colchicine therapy. Hepatology 1991;14(6):990‐3. - PubMed
Bowlus 2014 {published data only}
-
- Bowlus CL, Pockros PJ, Drenth J, Floreani A, Vincent C, Luketic VA, et al. Obeticholic acid in PBC patients: the utility of titration based on therapeutic response and tolerability. Hepatology 2014;60:353a.
Cash 2013 {published data only}
-
- Cash WJ, O'Neill S, O'Donnell ME, McCance DR, Young IS, McEneny J, et al. Randomized controlled trial assessing the effect of simvastatin in primary biliary cholangitis. Liver International 2013;33(8):1166‐74. - PubMed
Christensen 1985 {published data only}
-
- Christensen E, Neuberger J, Crowe J. Beneficial effect of azathioprine and prediction of prognosis in primary biliary cholangitis. Final results of an international trial. Gastroenterology 1985;89(5):1084‐91. - PubMed
-
- Christensen E, Neuberger J, Crowe J, Popper H, Portmann B, Deniach D, et al. Azathioprine in primary biliary cholangitis: late results of an international trial. Liver 1984;4(1):81.
-
- Christensen E, Neuberger J, Crowe J, Popper H, Portmann B, Doniach D, et al. Azathioprine in primary biliary cholangitis: late results of an international trial. Gut 1983;24(10):A995‐6.
-
- Crowe J, Christensen E, Smith M. Azathioprine in primary biliary cholangitis: a preliminary report of an international trial. Gastroenterology 1980;78(5 I):1005‐10. - PubMed
Combes 1995a {published data only}
-
- Combes B, Carithers RL Jr, Maddrey WC, Lin D, McDonald MF, Wheeler DE, et al. A randomized, double‐blind, placebo‐controlled trial of UDCA in primary biliary cholangitis. Hepatology 1995;22(3):759‐66. - PubMed
-
- Combes B, Carithers RL Jr, McDonald MF, Maddrey WC, Munoz SJ, Boyer JL, et al. UDCA therapy in patients with primary biliary cholangitis. Hepatology 1991;14(4 (Pt 2)):91a.
-
- Combes B, Carithers RL, Maddrey WC, Munoz SJ, McDonald MF, Garcia‐Tsao G. A randomized, double‐blind, placebo‐controlled trial of UDCA in primary biliary cholangitis. 68th Falk Symposium; 1992 Oct 12‐14; Basel, Switzerland. 1993:289‐91.
Combes 2005 {published data only}
-
- Combes B, Emerson SS, Flye NL. The primary biliary cholangitis (PBC) ursodiol (UDCA) plus methotrexate (MTX) or its placebo study (PUMPS) ‐ a multicenter randomized trial. Hepatology 2003;38(4):210A‐1A.
-
- Combes B, Emerson SS, Flye NL, Munoz SJ, Luketic VA, Mayo MJ, et al. Methotrexate (MTX) plus UDCA (UDCA) in the treatment of primary biliary cholangitis. Hepatology 2005;42(5):1184‐93. - PubMed
-
- Munoz S, Carithers R, Emerson SS, Flye N, Kowdley K, Combes B. Absence of pulmonary toxicity in primary biliary cholangitis (PBC) treated with methotrexate and ursodiol. Hepatology 1998;28(Suppl 4):392a.
-
- NCT00004784. Phase III randomized study of ursodiol with vs without methotrexate for primary biliary cholangitis. clinicaltrials.gov/ct2/show/NCT00004784 (date first received: 24 February 2000).
Dickson 1985 {published data only}
-
- Deering TB, Dickson ER, Fleming CR. Effect of D penicillamine on copper retention in patients with primary biliary cholangitis. Gastroenterology 1977;72(6):1208‐12. - PubMed
-
- Dickson ER. The syndrome of primary biliary cholangitis. Journal of Rheumatology ‐ Supplement 1981;7:121‐3. - PubMed
-
- Dickson ER, Fleming CR, Geall MG. A double blind controlled study using D‐penicillamine in chronic cholangiolitic hepatitis (primary biliary cholangitis). Gastroenterology 1977;72(5 II):A‐26.
-
- Dickson ER, Fleming TR, Wiesner RH. Trial of penicillamine in advanced primary biliary cholangitis. New England Journal of Medicine 1985;312(16):1011‐5. - PubMed
-
- Dickson ER, Wiesner RH, Baldus WP, Fleming CR, Ludwig JL. D‐penicillamine improves survival and retards histologic progression in primary biliary‐cirrhosis. Gastroenterology 1982;82(5 Part 2):1225.
Epstein 1979 {published data only}
-
- Epstein G, Williers D, Jain S, Potter BJ, Thomas HC, Sherlock S. Effect of penicillamine on immune complexes and immunoglobulins in primary biliary cholangitis (PBC). Gut 1978;19(Suppl 3):A994.
-
- Epstein O, Cook D, Jain S, Sherlick S. D‐Penicillamine in primary biliary cholangitis (PBC) ‐ an untested (and untestable?) treatment. Gut 1984;25:A1134.
-
- Epstein O, Cook DG, Jain S, McIntyre N, Sherlock S. D‐Penicillamine and clinical‐trials in PBC. Hepatology 1984;4(5):1032.
-
- Epstein O, Cook DG, Jain S, Sherlock S. D‐Penicillamine in PBC ‐ an untested (and untestable?) treatment. Journal of Hepatology 1985;1(Suppl 1):S49.
-
- Epstein O, Villiers D, Jain S. Reduction of immune complexes and immunoglobulins induced by D‐penicillamine in primary biliary cholangitis. New England Journal of Medicine 1979;300(6):274‐8. - PubMed
Eriksson 1997 {published data only}
-
- Eriksson LS, Olsson R, Glauman H, Prytz H, Befrits H, Lindgren S, et al. UDCA (UDCA) in patients with primary biliary cholangitis (PBC): results of a two‐year randomized placebo‐controlled study (abstract). Scandinavian Journal of Gastroenterology 1995;30(Suppl 209):35.
-
- Eriksson LS, Olsson R, Glauman H, Prytz H, Befrits R, Ryden BO, et al. UDCA treatment in patients with primary biliary cholangitis. A Swedish multicentre, double‐blind, randomized controlled study. Scandinavian Journal of Gastroenterology 1997;32(2):179‐86. - PubMed
Ferri 1993 {published data only}
-
- Ferri F, Bernocchi P, Fedeli S. [Taurodeoxycholic acid in the treatment of primary biliary cholangitis. A controlled study in comparison to UDCA]. Clinica Terapeutica 1993;143(4):321‐6. - PubMed
Gao 2012 {published data only}
-
- Gao LX, Zhang FC, Wang L, Zhang X, Liu B. The clinical observation of different therapeutic strategies in combined primary biliary cholangitis and Sjogren syndrome. Chung‐Hua Nei Ko Tsa Chih 2012;51(11):851‐4. - PubMed
Goddard 1994 {published data only}
-
- Goddard C, Smith A, Hunt L, Halder T, Hillier V, Rowan B, et al. Surrogate markers of response in a trial of UDCA (UDCA) and colchicine in primary biliary cholangitis (PBC). Gut 1995;36(Suppl 1):A30.
-
- Goddard CJR, Hunt L, Smith A, Followfield G, Rowan B, Warnes TW. A trial of UDCA (UDCA) and colchicine in primary biliary cholangitis (PBC). Hepatology 1994;20(4 (Pt 2)):151a.
Gonzalezkoch 1997 {published data only}
-
- Gonzalezkoch A, Brahm J, Antezana C, Smok G, Cumsille MA. The combination of UDCA and methotrexate for primary biliary cholangitis is not better than UDCA alone. Journal of Hepatology 1997;27(1):143‐9. - PubMed
Heathcote 1976 {published data only}
-
- Heathcote J, Ross A, Sherlock S. A prospective controlled trial of azathioprine in primary biliary cholangitis. Gastroenterology 1976;70(5 PT.1):656‐60. - PubMed
-
- Ross A, Sherlock S. A controlled trial of azathioprine in primary biliary cholangitis. Gut 1971;12(2):770.
-
- Ross A, Sherlock S. A trial of azathioprine in primary biliary cholangitis. Gut 1970;11(12):1058. - PubMed
Heathcote 1994 {published data only}
-
- Heathcote EJ, Cauch‐Dudek K, Walker V, Bailey RJ, Blendis LM, Ghent CN, et al. The Canadian multicenter double‐blind randomized controlled trial of UDCA in primary biliary cholangitis. Hepatology 1994;19(5):1149‐56. - PubMed
-
- Heathcote EJL, Cauch K, Walker V, Bailey RJ, Blendis LM, Ghent CN, et al. The Canadian multicenter double‐blind randomized controlled trial of UDCA in primary biliary‐cirrhosis. Hepatology 1992;16(4):A91. - PubMed
-
- Heathcote EJL, Cauch K, Walker V, Blendis LM, Pappas SC, Wanless IR. A double‐blind randomized controlled multicentre trial of UDCA in primary biliary cholangitis: results from a 1991 interim analysis. 68th Falk Symposium; 1992 Oct 12‐14; Basel, Switzerland. 1993:294‐8.
-
- Neuman MG, Cameron RG, Haber JA, Katz GG, Blendis LM. An electron microscopic and morphometric study of ursodeoxycholic effect in primary biliary cholangitis. Liver 2002;22(3):235‐44. - PubMed
-
- Neuman MG, Cameron RG, Shear NH, Blendis LM. Electron microscopic study on antifibrotic effects of ursodeoxycholate treatment in primary biliary cholangitis. Bile Acids and Cholestasis 1999;108:254‐69.
Hendrickse 1999 {published data only}
-
- Giaffer MH, Hendrickse M, Soomoro I, Triger DR, Underwood JCE, Gleeson D. Low‐dose methotrexate in treatment of primary biliary cholangitis. Gut 1995;36(Suppl 1):A30.
-
- Hendrickse M, Rigney E, Giaffer MH, Soomoro I, Triger DR, Underwood JC, et al. Low‐dose methotrexate in primary biliary cholangitis: long‐term results of a placebo‐controlled trial. Hepatology 1997;26(4):479. - PubMed
-
- Hendrickse MT, Rigney E, Giaffer MH, Soomro I, Triger DR, Underwood JC, et al. Low‐dose methotrexate is ineffective in primary biliary cholangitis: long‐term results of a placebo‐controlled trial. Gastroenterology 1999;117(2):400‐7. - PubMed
Hirschfield 2015 {published data only}
-
- Hirschfield G, Kowdley K, Mason A, Luketic V, Gordon S, Vincent C, et al. Long‐term (LT) therapy of a farnesoid X receptor (FXR) agonist obeticholic acid (OCA) maintains biochemical response in primary biliary cholangitis (PBC). Journal of Hepatology 2012;56:S372.
-
- Hirschfield GM, Mason A, Luketic V, Lindor K, Gordon SC, Mayo M, et al. Efficacy of obeticholic acid in patients with primary biliary cholangitis and inadequate response to UDCA. Gastroenterology 2015;148(4):751‐61.e8. - PubMed
-
- Luketic V, Gordon SG, Vincent C, Chapman R, Mayo M, Kowdley K, et al. The FXR agonist obeticholic acid improves a transplant free survival‐proven biochemical response criterion in placebo controlled primary biliary cholangitis studies. Journal of Hepatology 2014;60(1 (Suppl 1)):S193‐4.
-
- Luketic VA, Invernizzi P, Trauner M, Regula J, Mazzella G, Strasser SI, et al. Efficacy of obeticholic acid in primary biliary cholangitis as assessed by response criteria associated with clinical outcome: a poise analysis. Hepatology 2014;60:355a‐6a.
-
- Marschall H, Luketic VA, Mason AL, Lindor KD, Hirschfield GM, Gordon SC, et al. The farnesoid X receptor (FXR) agonist obeticholic acid (INT‐747, 6α‐ethyl chenodeoxycholic acid) in combination with UDCA (UDCA) increases plasma FGF‐19 concentrations but not bile acid concentration or profile in primary biliary cholangitis (PBC). Hepatology 2010;52(Suppl S1):355a.
Hoofnagle 1986 {published data only}
-
- Hoofnagle JH, Davis GL, Schafer DF, Peters M, Avigan MI, Pappas SC, et al. Randomized trial of chlorambucil for primary biliary cholangitis. Gastroenterology 1986;91(6):1327‐34. - PubMed
-
- Hoofnagle JH, Davis GL, Schafer DF, Peters MG, Avigan MI, Hanson RG, et al. Randomized trial of chlorambucil for primary biliary‐cirrhosis. Hepatology 1984;4(5):1062. - PubMed
Hosonuma 2015 {published data only}
-
- Hosonuma K, Sato K, Yamazaki Y, Yanagisawa M, Hashizume H, Horiguchi N, et al. A prospective randomized controlled study of long‐term combination therapy using UDCA and bezafibrate in patients with primary biliary cholangitis and dyslipidaemia. American Journal of Gastroenterology 2015;110(3):423‐31. - PubMed
-
- Sato K, Hosonuma K, Yamazaki Y, Yanagisawa M, Hashizume H, Horiguchi N, et al. Long‐term prognosis of combination therapy with UDCA and bezafibrate for primary biliary cholangitis: a prospective, multicenter, randomized controlled study. Hepatology International 2014;8(1 (Suppl 1)):S15.
Ikeda 1996 {published data only}
-
- Ikeda T, Tozuka S, Noguchi O, Kobayashi F, Sakamoto S, Marumo F, et al. Effects of additional administration of colchicine in UDCA‐treated patients with primary biliary cholangitis: a prospective randomized study. Journal of Hepatology 1996;24(1):88‐94. - PubMed
Iwasaki 2008a {published data only}
-
- Iwasaki S, Ohira H, Nishiguchi S, Zeniya M, Kaneko S, Onji M, et al. The efficacy of UDCA and bezafibrate combination therapy for primary biliary cholangitis: a prospective, multicenter study. Hepatology Research 2008;38(6):557‐64. - PubMed
Iwasaki 2008b {published data only}
-
- Iwasaki S, Ohira H, Nishiguchi S, Zeniya M, Kaneko S, Onji M, et al. The efficacy of UDCA and bezafibrate combination therapy for primary biliary cholangitis: a prospective, multicenter study. Hepatology Research 2008;38(6):557‐64. - PubMed
Kanda 2003 {published data only}
-
- Kanda T, Yokosuka O, Imazeki F, Saisho H. Bezafibrate treatment: a new medical approach for PBC patients?. Journal of Gastroenterology 2003;38(6):573‐8. - PubMed
Kaplan 1986 {published data only}
-
- Johnston DE, Kaplan MM, Miller KB, Connors CM, Milford EL. Histocompatibility antigens in primary biliary cholangitis. American Journal of Gastroenterology 1987;82(11):1127‐9. - PubMed
-
- Kaplan MM, Alling DW, Wolfe HJ, Zimmerman HJ. Colchicine is effective in the treatment of primary biliary cholangitis. Hepatology 1985;5(5):967.
-
- Kaplan MM, Alling DW, Zimmerman HJ, Wolfe HJ, Sepersky RA, Hirsch GE, et al. A prospective trial of colchicine for primary biliary cholangitis. (abstract). Acta Gastroenterologica Belgica 1987;50(3):382.
-
- Kaplan MM, Alling DW, Zimmerman HJ, Wolfe HJ, Sepersky RA, Hirsch GS, et al. A prospective trial of colchicine for primary biliary cholangitis. New England Journal of Medicine 1986;315(23):1448‐54. - PubMed
-
- Miller LC, Kaplan MM. Serum interleukin‐2 and tumor necrosis factor‐alpha in primary biliary cholangitis: decrease by colchicine and relationship to HLA‐DR4. American Journal of Gastroenterology 1992;87(4):465‐70. - PubMed
Kaplan 1999 {published data only}
-
- Kaplan M, Schmid C, McKusick A, Provenzale D, Sharma A, Sepe T. Double blind trial of methotrexate (MTX) versus colchicine (COLCH) in primary biliary cholangitis (PBC). Hepatology 1993;18(4 (Pt 2)):176a.
-
- Kaplan MM, Dickstein G, Schmid C. Methotrexate (MTX) improves histology in primary biliary cholangitis (PBC). Hepatology 1994;20(4 (Pt 2)):152a.
-
- Kaplan MM, Schmid C, Provenzale D, Sharma A, Dickstein G, McKusick A. A prospective trial of colchicine and methotrexate in the treatment of primary biliary cholangitis. Gastroenterology 1999;117(5):1173‐80. - PubMed
-
- Miller LC, Sharma A, McKusick AF, Tassoni JP, Dinarello CA, Kaplan MM. Synthesis of interleukin‐1 beta in primary biliary cholangitis: relationship to treatment with methotrexate or colchicine and disease progression. Hepatology 1995;22(2):518‐24. - PubMed
-
- NCT00004748. Phase III randomized, double‐blind, placebo‐controlled study of low‐dose oral methotrexate vs colchicine for primary biliary cholangitis. www.clinicaltrials.gov/ct2/show/NCT00004748 Date first received: 24 February 2000.
Kowdley 2011 {published data only}
-
- Kowdley K, Jones D, Luketic V, Chapman R, Burroughs A, Hirschfield G, et al. An international study evaluating the farnesoid X receptor agonist obeticholic acid as monotherapy in PBC. Journal of Hepatology 2011;54:S13.
Kurihara 2000 {published data only}
-
- Kurihara T, Niimi A, Maeda A, Shigemoto M, Yamashita K. Bezafibrate in the treatment of primary biliary cholangitis: comparison with UDCA. American Journal of Gastroenterology 2000;95(10):2990‐2. - PubMed
Leuschner 1989 {published data only}
-
- Guldutuna S, Leuschner U, Imhof M, Zimmer G. Treatment of chronic active hepatitis and primary biliary cholangitis with UDCA. Zeitschrift Fur Gastroenterologie 1992;30 Suppl 1:49‐54. - PubMed
-
- Leuschner U, Fischer H, Guldutuna S, Kurtz W, Gatzen M, Hellstern A. Does UDCA (UDCA) influence cell membrane architecture in patients with primary biliary cholangitis (PBC)?. Gastroenterology 1989;96(5 (Pt 2)):A621. - PubMed
-
- Leuschner U, Fischer H, Hubner K. [UDCA in the treatment of primary biliary cholangitis: results of a controlled study]. Zeitschrift fur Gastroenterologie ‐ Verhandlungsband 1989;24:133. - PubMed
-
- Leuschner U, Fischer H, Kurtz W, Guldutuna S, Hubner K, Hellstern A, et al. UDCA in primary biliary cholangitis: results of a controlled double‐blind trial. Gastroenterology 1989;97(5):1268‐74. - PubMed
-
- Leuschner U, Fisher H, Hübner K, Güldütuna S, Gatzen M, Hellstern A. UDCA (UDCA) treatment of primary biliary cholangitis: clinical and histological results of a controlled study. 52nd Falk Symposium; 1988 Jun 9‐11; Freiburg, Germany 1989;41:355‐8.
Leuschner 1999 {published data only}
-
- Leuschner M, Maier KP, Schlichting J, Strahl R, Herrmann G, Dahm HH, et al. Combination of UDCA (UDCA) with budesonide (BUD) is superior to UDCA‐mono‐therapy in primary biliary cholangitis (PBC). Journal of Hepatology 1999;30(Suppl 1):57.
-
- Leuschner M, Maier KP, Schlichting J, Strahl R, Herrmann G, Dahm HH, et al. UDCA (UDCA) and budesonide (BUD) in the treatment of primary biliary cholangitis (PBC): a prospective double‐blind trial. Hepatology 1999;30(4):471a. - PubMed
-
- Leuschner M, Maier KP, Schlichting J, Strahl R, Herrmann G, Dahm HH, et al. [UDCA (UDCA)‐placebo versus UDCA‐budesonide by primary biliary cholangitis (PBC). A double‐blind study]. Zeitschrift fur Gastroenterologie 1999;37(9):897.
-
- Leuschner M, Maier KP, Schlichting J, Strahl S, Herrmann G, Dahm HH, et al. Oral budesonide and UDCA for treatment of primary biliary cholangitis: results of a prospective double‐blind trial. Gastroenterology 1999;117(4):918‐25. - PubMed
Liberopoulos 2010 {published data only}
Lim 1994 {published data only}
-
- Lim AG, Jazrawi RP, Maxwell JD, Northfield TC. UDCA (UDCA) improves hepatic excretion in primary biliary cholangitis (PBC). Gut 1994;35(S5):S11.
-
- Lim AG, Jazrawi RP, Petroni ML, Pereira S, Maxwell JD, Northfield TC. T‐lymphocyte activation in primary biliary cholangitis: effects of UDCA. Falk Symposium XIII International Bile Acid Meeting 1994;80:147.
Lindor 1994 {published data only}
-
- Balan V, Dickson ER, Jorgensen RA, Lindor KD. Effect of UDCA on serum lipids of patients with primary biliary cholangitis. Mayo Clinic Proceedings 1994;69(10):923‐9. - PubMed
-
- Batts KP, Jorgensen RA, Dickson ER, Hofmann AF, Rossi SS, Ludwig J, et al. The effects of UDCA on hepatic inflammation and histologic stage in patients with primary biliary cholangitis. Hepatology 1993;18(4 (Pt 2)):175a.
-
- Batts KP, Jorgensen RA, Dickson ER, Lindor KD. Effects of UDCA on hepatic inflammation and histological stage in patients with primary biliary cholangitis. American Journal of Gastroenterology 1996;91(11):2314‐7. - PubMed
-
- Dickson ER, Lindor KD, Baldus WP, Jorgensen RA, Ludwig J, Murtaugh PA. Ursodiol is effective therapy for patients with primary biliary cholangitis. 68th Falk Symposium; 1992 Oct 12‐14; Basel, Switzerland. 1993:292‐3.
Lindor 1997 {published data only}
-
- Lindor KD, Jorgensen R, Therneau TM, Smith C, Mahoney DW, Dickson ER. Comparison of three different doses of UDCA in the treatment of primary biliary cholangitis: a randomized trial. Hepatology 1997;26(4):1240.
Lombard 1993 {published data only}
-
- Guanabens N, Pares A, Navasa M, Martinez de Osaba MJ, Hernandez ME, Munoz J, et al. Cyclosporin a increases the biochemical markers of bone remodeling in primary biliary cholangitis. Journal of Hepatology 1994;21(1):24‐8. - PubMed
-
- Guañabens N, Parés A, Navasa M, Rivera F, Muñoz J, Rodés J. Influence of cyclosporin a in bone metabolism in primary biliary cholangitis. Revista Española de Reumatología 1990;17(Suppl 1):14‐5.
-
- Lombard M, Portmann B, Neuberger J, Williams R, Tygstrup N, Ranek L, et al. Cyclosporin a treatment in primary biliary cholangitis: results of a long‐term placebo controlled trial. Gastroenterology 1993;104(2):519‐26. - PubMed
-
- Lombard M, Portmann BP, Tygstrup N, Ranek L, Larsen HR, Trepo C, et al. Cyclosporin a in primary biliary cholangitis: results of a long‐term placebo controlled trial and effect on survival. Hepatology 1990;12(4 (Pt 2)):872.
Ma 2016 {published data only}
Macklon 1982 {published data only}
-
- Bassendine M, Macklon A, Mulcahy R, James O. Controlled trial of high and low dose D‐penicillamine (DP) in primary biliary cholangitis (PBC): results at three years. Gut 1982;23:A909.
-
- Macklon AF, Bassendine MF, James OFW. Controlled trial of D‐penicillamine in primary biliary cholangitis: incidence of side effects and relation to dose. Hepatology 1982;2(1):166.
Manzillo 1993a {published data only}
-
- Manzillo G, Piccinino F, Surrenti C, Frezza M, Grazie C. Double‐blind, placebo‐controlled study with parenteral and oral S‐adenosyl‐L‐methionine (SAMe) in primary biliary cholangitis. II United European Gastroenterology Week 1993:A337.
Manzillo 1993b {published data only}
-
- Manzillo G, Piccinino F, Surrenti C, Frezza M, Grazie C. Double‐blind, placebo‐controlled study with parenteral and oral S‐adenosyl‐L‐methionine (SAMe) in primary biliary cholangitis. II United European Gastroenterology Week 1993:A337.
Mason 2008 {published data only}
-
- Mason A, Luketic V, Lindor K, Hirschfield G, Gordon S, Mayo M. Farnesoid‐x receptor agonists: a new class of drugs for the treatment of PBC? An international study evaluating the addition of INT‐747 to UDCA. Journal of Hepatology 2010;52(Suppl 1):S1‐S2.
-
- Mason AL, Lindor KD, Bacon BR, Vincent C, Neuberger JM, Vvasilenko ST. Clinical trial: randomized controlled study of zidovudine and lamivudine for patients with primary biliary cholangitis stabilized on ursodiol. Alimentary Pharmacology & Therapeutics 2008;28(7):886‐94. - PubMed
Matloff 1982 {published data only}
-
- Matloff D, Resnick R, Alpert E, Kaplan M. D‐Penicillamine does not alter the course of primary biliary cholangitis. Clinical Research 1979;27:579A.
-
- Matloff DS, Alpert E, Resnick RH, Kaplan MM. A prospective trial of D‐penicillamine in primary biliary cholangitis. New England Journal of Medicine 1982;306(6):319‐26. - PubMed
Mayo 2015 {published data only}
-
- Mayo MJ, Wigg AJ, Roberts SK, Arnold H, Hassanein TI, Leggett BA, et al. NGM282, a novel variant of FGF‐19, demonstrates biologic activity in primary biliary cholangitis patients with an incomplete response to UDCA: results of a phase 2 multicenter, randomized, double blinded, placebo controlled trial. Hepatology 2015;62:263A‐4A.
Mazzarella 2002 {published data only}
-
- Enrico R, Federica B, Andrea L, Patrizia S, Roda A, Mazzella G. Treatment of early (I‐II stage) primary biliary cholangitis (PBC): high versus standard UDCA doses after 15 years follow‐up. A randomized open controlled trial. Hepatology 2011;54(4 (Suppl)):1209a.
-
- Mazzarella G, Azzolini F, Casanova S, Giovanelli S, Ferrara F, Liva S, et al. Standard vs high dose UDCA in PBC: efficacy on liver function tests and histology after six years of treatment in a randomised controlled trial. Gastroenterology 2002;123(1):66.
McCormick 1994 {published data only}
-
- McCormick PA, Scott F, Epstein O, Burroughs AK, Scheuer PJ, McIntyre N. Thalidomide as therapy for primary biliary cholangitis: a double‐blind placebo controlled pilot study. Journal of Hepatology 1994;21(4):496‐9. - PubMed
Minuk 1988 {published data only}
-
- Hanley DA, Ayer LM, Gundberg CM, Minuk GY. Parameters of calcium metabolism during a pilot study of cyclosporin a in patients with symptomatic primary biliary cholangitis. Clinical & Investigative Medicine ‐ Medecine Clinique et Experimentale 1991;14(4):282‐7. - PubMed
-
- Minuk G, Bohme C, Burgess E, Hershfield N, Kelly J, Shaffer E, et al. A prospective, double‐blind, randomized, controlled trial of cyclosporine a in primary biliary‐cirrhosis. Hepatology 1987;7(5):1119.
-
- Minuk G, Bohme C, Burgess E, Hershfield N, Kelly J, Shaffer E, et al. A prospective, randomized, placebo‐controlled study of cyclosporine a in primary biliary‐cirrhosis. Clinical and Investigative Medicine ‐ Medecine Clinique et Experimentale 1987;10(4):B131.
-
- Minuk GY, Bohme CE, Burgess E, Hershfield NB, Kelly JK, Shaffer EA, et al. Pilot study of cyclosporin a in patients with symptomatic primary biliary cholangitis. Gastroenterology 1988;95(5):1356‐63. - PubMed
-
- Parsons HG, Thirsk JE, Frohlich J, Dias V, Minuk GY. Effect of cyclosporin a on serum lipids in primary biliary cholangitis patients. Clinical & Investigative Medicine ‐ Medecine Clinique et Experimentale 1989;12(6):386‐91. - PubMed
Mitchison 1989 {published data only}
-
- Mitchison HC, Bassendine MF, Malcolm AJ, Watson AJ, Record CO, James OF. A pilot, double‐blind, controlled 1‐year trial of prednisolone treatment in primary biliary cholangitis: hepatic improvement but greater bone loss. Hepatology 1989;10(4):420‐9. - PubMed
-
- Mitchison HC, Bassendine MF, Watson AJ, Record CO, James OFW. Double blind placebo‐controlled trial of prednisolone treatment in primary biliary cholangitis (PBC): a 3 year update. Journal of Hepatology 1989;9(1):P4.
-
- Mitchison HC, Palmer JM, Bassendine MF, Watson AJ, Record CO, James OF. A controlled trial of prednisolone treatment in primary biliary cholangitis. Three‐year results. Journal of Hepatology 1992;15(3):336‐44. - PubMed
-
- Mitchison HC, Watson AJ, Bassendine MF, Record CO, James OFW. A pilot double blind controlled trial of prednisolone treatment in primary biliary cholangitis (PBC). Journal of Hepatology 1986;3(Suppl 1):S28. - PubMed
Mitchison 1993 {published data only}
-
- Buuren HR, Schalm SW. Beneficial effect of malotilate on primary biliary cholangitis (PBC): results of a multicentre controlled trial. Journal of Hepatology 1989;9(Suppl 1):S28.
-
- Mitchison HC, Mutimer DJ, James OFW, Triger DR, Moller B, Hopf U, et al. The results of a randomized double blind controlled trial evaluating malotilate in primary biliary cholangitis. Journal of Hepatology 1993;17(2):227‐35. - PubMed
Nakai 2000 {published data only}
-
- Nakai S, Masaki T, Kurokohchi K, Deguchi A, Nishioka M. Combination therapy of bezafibrate and UDCA in primary biliary cholangitis: a preliminary study. American Journal of Gastroenterology 2000;95(1):326‐7. - PubMed
-
- Nakai S, Masaki T, Morita T, Deguchi A, Nishioka M. The effect of bezafibrate in patients with primary biliary cholangitis. Hepatology 1999;30(4 Suppl):566a.
Neuberger 1985 {published data only}
-
- Neuberger J, Christensen E, Popper H, Portmann B, Caballeri J, Rodes J, et al. D‐Penicillamine in primary biliary cholangitis: preliminary results of an international trial. Gut 1983;24(10):A968.
-
- Neuberger J, Christensen E, Popper H, Portmann B, Caballeri J, Rodes J, et al. D‐Penicillamine in primary biliary cholangitis: preliminary results of an international trial. Liver 1984;4(1):74.
Nevens 2016 {published data only}
-
- Andreone P, Mazzella G, Invernizzi P, Floreani A, Picaro LA, Adorini L. Efficacy and safety of obeticholic acid in patients with primary biliary cirrhosis: an analysis of the Italian patients from a phase 3, randomized, placebo controlled study. Digestive and Liver Disease 2016;48:e81.
-
- Andreone P, Mazzella G, Strasser SI, Bowlus CL, Invernizzi P, Drenth J, et al. The FXR agonist obeticholic acid (OCA) improves liver biochemistry parameters correlated with clinical benefit across a range of patient characteristics. Hepatology 2014;60:360a.
-
- Hirschfield GM, Floreani A, Trivedi PJ, Pencek R, Liberman A, Marmon T, et al. Long‐term effect of obeticholic acid on transient elastography and AST to platelet ratio index in patients with PBC. Hepatology 2017;64(1 Suppl S1):110A‐1A.
-
- Mayo M, Kremer AE, Beuers U, Marmon T, Hooshmand‐Rad R, Pencek R, et al. Mitigation of pruritus during obeticholic acid treatment in patients with primary biliary cirrhosis: strategies and successes. Gastroenterology 2016;150(4 Suppl):S1072.
-
- Nevens F, Andreone P, Mazzella G, Strasser S, Bowlus C, Invernizzi P, et al. The first primary biliary cholangitis (PBC) phase 3 trial in two decades‐an international study of the FXR agonist obeticholic acid in PBC patients. Journal of Hepatology 2014;60(1 Suppl 1):S525‐6.
Oka 1990 {published data only}
-
- Oka H, Toda G, Ikeda Y, Hashimoto N, Hasumura Y, Kamimura T, et al. A multi‐center double‐blind controlled trial of UDCA for primary biliary cholangitis. Gastroenterologia Japonica 1990;25(6):774‐80. - PubMed
-
- Toda G, Oka H, Hasumura Y, Kamimura T, Ohat Y, Tsuji T, et al. A multicenter double‐blind controlled trial of UDCA for primary biliary cholangitis in Japan. XI International Bile Acid Meeting Bile Acids as Therapeutic Agents ‐ From Basic Science to Clinical Practice 1990:76.
Papatheodoridis 2002 {published data only}
-
- Hadziyannis S. Long‐term treatment of primary biliary cholangitis with UDCA: the third year of a controlled trial. XI International Bile Acid Meeting Bile Acids as Therapeutic Agents ‐ From Basic Science to Clinical Practice 1990:57‐8.
-
- Hadziyannis S, Hadziyannis E. A randomised controlled trial of UDCA (UDCA) in primary biliary cholangitis (PBC). Hepatology 1988;8(5):1421.
-
- Hadziyannis S, Hadziyannis E, Lianidou E, Makris A. Long‐term treatment of primary biliary cholangitis with UDCA: the third year of a controlled trial. Bile Acids as Therapeutic Agents From Basic Science to Clinical Practice Falk Symposium 58 1990:287‐96.
-
- Hadziyannis SJ, Hadziyannis ES, Makris A. A randomized controlled trial of UDCA (UDCA) in primary biliary cholangitis (PBC). European Journal of Clinical Investigation 1989;19(Pt 2):A15.
-
- Hadziyannis SJ, Hadziyannis ES, Makris A. A randomized controlled trial of UDCA (UDCA) in primary biliary cholangitis (PBC). Hepatology 1989;10(4):580.
Pares 2000 {published data only}
-
- Pares A. Long‐term treatment of primary biliary cholangitis with UDCA: results of a randomized, double‐blind, placebo‐controlled trial. Journal of Hepatology 1997;26(Suppl 1):S166.
-
- Pares A, Caballeria L, Bruguera M, Rodes J. Factors influencing historical progression of early primary biliary cholangitis effect of UDCA (abstract). Journal of Hepatology 2001;34(1):189‐90.
-
- Pares A, Caballeria L, Rodes J. Long‐term UDCA treatment delays progression of mild primary biliary cholangitis (abstract). Journal of Hepatology 2001;34(1):187‐8.
-
- Pares A, Caballeria L, Rodes J, Bruguera M, Rodrigo L, Garcia‐Plaza A, et al. Long‐term effects of UDCA in primary biliary cholangitis: results of a double‐blind controlled multicentric trial. UDCA‐cooperative group from the Spanish Association for the Study of the Liver. Journal of Hepatology 2000;32(4):561‐6. - PubMed
Poupon 1991a {published data only}
-
- Calmus Y, Poupon R. UDCA (UDCA) in the treatment of chronic cholestatic diseases. Biochimie 1991;73(10):1335‐8. - PubMed
-
- Huet PM, Huet J, Hotte S. Long term effect of UDCA (UDCA) on hepatic function and portal hypertension in primary biliary cholangitis (PBC). Hepatology 1994;20(4 (Pt 2)):202a.
-
- Huet PM, Willems B, Huet J, Poupon R. Effects of UDCA (UDCA) on hepatic function and portal hypertension in primary biliary cholangitis (PBC). Hepatology 1990;12(4 (Pt 2)):907.
-
- Poupon R, Chazouilleres O, Balkau B, Poupon RE. Clinical and biochemical expression of the histopathological lesions of primary biliary cholangitis. UDCA‐PBC Group. Journal of Hepatology 1999;30(3):408‐12. - PubMed
-
- Poupon RE, Balkau B, Eschwege E, Poupon R. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cholangitis. New England Journal of Medicine 1991;324(22):1548‐54. - PubMed
Poupon 1996 {published data only}
-
- Huet P, Willems B, Huet J, Poupon R. Effects of UDCA (UDCA) on hepatic function and portal hypertension in primary biliary cholangitis (PBC). XII International Bile Acid Meeting Bile Acids and the Hepatobiliary System from Basic Science to Clinical Practice Falk Symposium No 68 1992:118.
-
- Huet PM, Huet J, Deslauriers J. Long‐term UDCA (UDCA) and colchicine (C) treatment in primary biliary cholangitis (PBC): effect on hepatic function and portal hypertension. Canadian Journal of Gastroenterology 1996;10(Suppl A):S47.
-
- Huet PM, Huet J, Poupon RE, Deslauriers J. The combination of UDCA (UDCA) and colchicine (C) for patients with primary biliary cholangitis (PBC): effect on hepatic function and portal hypertension. Hepatology 1996;23(1):I‐49.
-
- Poupon RE, Huet PM, Poupon R, Bonnand AM, Nhieu JT, Zafrani ES. A randomized trial comparing colchicine and UDCA combination to UDCA in primary biliary cholangitis. UDCA‐PBC Study Group. Hepatology 1996;24(5):1098‐103. - PubMed
-
- Poupon RE, Niard AM, Huet PM, Miguet JP, Mathieuchandelier C, Doffoel M, et al. A randomized trial comparing the combination UDCA (UDCA) and colchicine to UDCA alone in primary biliary‐cirrhosis. Hepatology 1994;20(4):A151.
Raedsch 1993 {published data only}
-
- Raedsch R, Stiehl A, Walker S, Rudi J, Schlenker T, Gerteis C. Controlled study on the effects of a combined colchicine plus UDCA treatment in primary biliary cholangitis. 68th Falk Symposium; 1992 Oct 12‐14; Basel, Switzerland. 1993:303‐9.
-
- Raedsch R, Stiehl A, Walker S, Scherrmann JM, Kommerell B. [Combined colchicine plus UDCA‐treatment of primary biliary cholangitis: results of a placebo‐controlled double‐blind study]. Zeitschrift Fur Gastroenterologie 1992;30(Suppl 1):55‐7. - PubMed
-
- Raedsch R, Stiehl A, Walker S, Theilmann L, Kommerell B. Effects of UDCA and colchicine plus UDCA in primary biliary cholangitis: a double‐blind pilot study. Bile Acids as Therapeutic Agents From Basic Science to Clinical Practice Falk Symposium 58 1991, (36):301‐4.
-
- Raedsch R, Stiehl A, Walker S, Theilmann L, Kommerell B. Influence of UDCA and URSO plus colchicine on primary biliary cholangitis: a double‐blind controlled pilot study. Klinische Wochenschrift 1991;69(Suppl 23):84.
Rautiainen 2005 {published data only}
-
- Rautiainen H, Farkkila M, Neuvonen M, Sane T, Karvonen AL, Nurm H, et al. Pharmacokinetics and bone effects of budesonide in primary biliary cholangitis. Alimentary Pharmacology & Therapeutics 2006;24(11‐12):1545‐52. - PubMed
-
- Rautiainen H, Karkkainen P, Karvonen AL, Nurmi H, Pikkarainen P, Nuutinen H, et al. Budesonide combined with UDCA to improve liver histology in primary biliary cholangitis: a three‐year randomized trial. Hepatology 2005;41(4):747‐52. - PubMed
Senior 1991 {published data only}
-
- O'Brien CB, Senior JR, Sternlieb JM, Sample M, Saul SM, Arora R. Ursodiol treatment of primary biliary cholangitis. Gastroenterology 1990;98(2 (Pt 2)):A617.
-
- Senior JR, O'Brien C. Mortality risk indices as outcome measures of the effectiveness of UDCA treatment of cholestatic liver diseases. Bile Acids as Therapeutic Agents From Basic Science to Clinical Practice Falk Symposium 58 1991:273‐85.
-
- Senior JR, O'Brien CB, Dickson ER. Effect of oral ursodiol treatment on the predicted probability of mortality in primary biliary cholangitis. Hepatology 1990;12(2):438.
Smart 1990 {published data only}
-
- Smart HL, Cann PA, Thuluvath PJ, Triger DR. A double blind placebo controlled study of antioxidants in primary biliary cholangitis (PBC). Gut 1990;31(10):A1184.
Steenbergen 1994 {published data only}
-
- Steenbergen W, Sciot R, Eycken P, Desmet V, Fevery J. Combined treatment with methotrexate and UDCA in primary biliary cholangitis (PBC). Journal of Hepatology 1994;21(Suppl 1):S89.
-
- Steenbergen W, Sciot R, Eyken P, Desmet V, Fevery J. Methotrexate alone or in combination with UDCA as possible treatment in primary biliary cholangitis. Cholestatic Liver diseases: New Strategies for Prevention and Treatment of Hepatobiliary and Cholestatic Liver Diseases Falk Symposium 75 1994:246‐54.
-
- Steenbergen W, Sciot R, Eyken P, Desmet V, Fevery J. Combined treatment with methotrexate and UDCA in non‐cirrhotic primary biliary cholangitis. Acta Clinica Belgica 1996;51(1):8‐18. - PubMed
Taal 1983 {published data only}
-
- Taal BG, Schalm SW. Prednisone plus D‐penicillamine, D‐penicillamine and placebo compared in primary biliary‐cirrhosis syndrome. Gastroenterology 1981;80(5 Part 2):1351.
-
- Taal BG, Schalm SW, Kate FWJ. Double‐blind controlled study of penicillamine in primary biliary cholangitis: dose‐dependent effects. Nederlands Tijdschrift voor Geneeskunde 1982;126(12):547.
-
- Taal BG, Schalm SW, Kate FW, Berge Henegouwen GP, Brandt KH. Low therapeutic value of D‐penicillamine in a short‐term prospective trial in primary biliary cholangitis. Liver 1983;3(6):345‐52. - PubMed
Triger 1980 {published data only}
-
- Triger DR, Manifold IH, Cloke P, Underwood JCE. D‐Penicillamine in primary biliary cholangitis: two year results of a single centre, doubled‐blind controlled trial. Gut 1980;21(10):A919‐20.
Turner 1994 {published data only}
-
- Myszor M, Turner I, Mitshison H, Bennett M, Burt AD, James OFW. No symptomatic or histological benefit from UDCA treatment in PBC after 1 year controlled pilot study. Hepatology 1990;12(2):415.
-
- Turner IB, Myszor M, Mitchison HC, Bennett MK, Burt AD, James OF. A two year controlled trial examining the effectiveness of UDCA in primary biliary cholangitis. Journal of Gastroenterology & Hepatology 1994;9(2):162‐8. - PubMed
Ueno 2005 {published data only}
-
- Ueno Y, Moritoki Y, Kanno N, Fukushima K, Yamagiwa Y, Kogure T, et al. Randomized double blind control trial of reverse transcriptase inhibitor for the treatment of UDCA‐resistant PBC. Gastroenterology 2005;128(4):A775‐A.
Van Hoogstraten 1998 {published data only}
-
- Hoogstraten HJF, Smet MBM, Renooij W, Hop WCJ, Berge‐Henegouwen GP, Schalm SW. A randomized controlled trial evaluating therapy with UDCA in daily doses of 10 mg/kg versus 20 mg/kg in primary biliary cholangitis. European Journal of Gastroenterology & Hepatology 1998;10(12):A7.
-
- Hoogstraten HJF, Smet MBM, Renooij W, Breed JGS, Engels L, Ouden‐Muller JW, et al. A randomized trial in primary biliary cholangitis comparing UDCA in daily doses of either 10 mg/kg or 20 mg/kg. Alimentary Pharmacology & Therapeutics 1998;12(10):965‐71. - PubMed
-
- Hoogstraten HJF, Smet MBM, Renooij W, Hop WCJ, Buuren HR, VanBerge‐Henegouwen GP. A randomized controlled trial evaluating therapy with UDCA in daily doses of 10 mg/kg versus 20 mg/kg in primary biliary cholangitis. Gastroenterology 1998;114(4):A1358‐A.
Warnes 1987 {published data only}
-
- Warnes T, Babbs C, Smith A, Lee F, Haboubi NY, Johnson PJ, et al. A controlled trial of colchicine in primary biliary cholangitis (PBC). Journal of Hepatology 1985;1(Suppl 2):S348. - PubMed
-
- Warnes TW, Goddard CJR, Smith A, Rowan BP, Hunt L. Liver function and prognosis in primary biliary cholangitis: 'sharp' and 'blunt' tests and the influence of colchicine treatment on survival. Hepatology 1996;23(1):I‐82.
-
- Warnes TW, Smith A, Lee F, Haboubi NY, Johnson PJ, Hunt L. A controlled trial of colchicine in primary biliary cholangitis. Hepatology 1984;4(5):1022. - PubMed
-
- Warnes TW, Smith A, Lee FI, Haboubi NY, Johnson PJ, Hunt L. A controlled trial of colchicine in primary biliary cholangitis. Trial design and preliminary report. Journal of Hepatology 1987;5(1):1‐7. - PubMed
Wiesner 1990 {published data only}
-
- Wiesner RH, Dickson ER, Lindor KD, Jørgensen R, LaRusso NF, Baldus W. A controlled clinical trial evaluating cyclosporin in the treatment of primary biliary cholangitis: a preliminary report. Hepatology 1987;7(5):1025.
-
- Wiesner RH, Ludwig J, Lindor KD, Jorgensen RA, Baldus WP, Homburger HA, et al. A controlled trial of cyclosporine in the treatment of primary biliary cholangitis. New England Journal of Medicine 1990;322(20):1419‐24. - PubMed
Wolfhagen 1998 {published data only}
-
- Hoogstraten H, Wolfhagen FHJ, Berge Henegouwen GP, Schalm SW, Kate FJW, Hop WCJ, et al. Combined bile acid‐immunosuppressive therapy for primary biliary cholangitis. Results of a 1‐year multi centre, placebo controlled trial. European Journal of Gastroenterology & Hepatology 1996;8(Suppl 12):A 41.
-
- Lim AG, Wolfhagen FH, Verma A, Buuren HR, Jazrawi RP, Levy JH, et al. Soluble intercellular adhesion molecule‐1 in primary biliary cholangitis: effect of UDCA and immunosuppressive therapy. European Journal of Gastroenterology & Hepatology 1997;9(2):155‐61. - PubMed
-
- Lim AG, Wolfhagen FHJ, Verma A, Buuren HR, Jazrawi RP, Levy JH, et al. Soluble intercellular adhesion molecule 1 in primary biliary cholangitis: effect of UDCA and immunosuppressive therapy. Hepatology 1995;22(4 (Pt 2)):124a.
-
- Lim AG, Wolfhagen FHJ, Verma A, Buuren HR, Jazrawi RP, Northfield TC. Soluble intercellular adhesion molecule‐1 in primary biliary cholangitis: effect of UDCA, prednisone and azathioprine. Falk Symposium Bile Acids and Immunology 1995;86:9.
-
- Lim AG, Wolfhagen FHJ, Verma A, Jazrawi RP, Bururen HR, Levy JH, et al. Combination UDCA and immunosuppressive therapy for the treatment of primary biliary cholangitis. Gut 1995;37(Suppl 2):A27.
Yokomori 2001 {published data only}
-
- Yokomori H, Oda M, Ishii H. Effects of UDCA and colestilan versus UDCA alone on serum bile acids and pruritus: a randomized, open‐label study. Current Therapeutic Research ‐ Clinical and Experimental 2001;62(3):221‐9.
References to studies excluded from this review
Angulo 1999b {published data only}
-
- Angulo P, Batts KP, Therneau TM, Jorgensen RA, Dickson ER, Lindor KD. Long‐term UDCA delays histological progression in primary biliary cholangitis. Hepatology 1999;29(3):644‐7. - PubMed
Angulo 1999c {published data only}
-
- Angulo P, Lindor KD, Therneau TM, Jorgensen RA, Malinchoc M, Kamath PS, et al. Utilization of the Mayo risk score in patients with primary biliary cholangitis receiving UDCA. Liver 1999;19(2):115‐21. - PubMed
Angulo 2002 {published data only}
-
- Angulo P, Petz JL, Jorgensen RA, Lindor KD. A randomized, cross‐over study evaluating single‐ and multiple‐daily dosage schedules of UDCA in primary biliary cholangitis. Gastroenterology 2002;122(4):A629.
Attili 1994 {published data only}
-
- Attili AF, Rusticali A, Varriale M, Carli L, Repice AM, Callea F. Effect of UDCA on serum enzymes and liver histology in patients with chronic active hepatitis ‐ a 12 month double‐blind, placebo‐controlled trial. Journal of Hepatology 1994;20(3):315‐20. - PubMed
Avezov 2004a {published data only}
-
- Avezov SA, Mansurova F. [Efficacy of combined use of UDCA and heptral in the treatment of primary biliary cholangitis]. Klinicheskaia Meditsina 2004;82(2):46‐9. - PubMed
Avezov 2004b {published data only}
-
- Avezov SA, Mansurov F. [Efficacy of combined administration of UDCA and hepthral in the treatment of primary biliary cholangitis]. Klinicheskaia Meditsina 2004;82(3):55‐8. - PubMed
Bach 2003 {published data only}
-
- Bach N, Bodian C, Bodenheimer H, Croen E, Berk PD, Thung SN, et al. Methotrexate therapy for primary biliary cholangitis. American Journal of Gastroenterology 2003;98(1):187‐93. - PubMed
Batta 1989 {published data only}
-
- Batta AK, Salen G, Arora R, Shefer S, Tint GS, Abroon J, et al. Effect of UDCA on bile acid metabolism in primary biliary cholangitis. Hepatology 1989;10(4):414‐9. - PubMed
Beukers 1988 {published data only}
-
- Beukers R, Schalm SW. Effect of cyclosporine and cyclosporine plus prednisone in primary biliary cholangitis. Transplantation Proceedings 1988;20(3 Suppl 4):340‐3. - PubMed
Blanche 1994 {published data only}
-
- Blanche P, Sicard D. Methotrexate for polymyositis associated with primary biliary cholangitis. Clinical & Experimental Rheumatology 1994;12(6):694. - PubMed
Bonis 2006 {published data only}
-
- Bonis PA, Kaplan M. Methotrexate for treatment of primary biliary cholangitis. Hepatology 2006;43(3):632; author reply 633. - PubMed
Borum 1990 {published data only}
-
- Borum M, Fromm H. UDCA in the treatment of primary biliary cholangitis: first controlled data. Hepatology 1990;12(1):172‐3. - PubMed
Bray 1991 {published data only}
-
- Bray GP, Padova C, Tredger JM, Williams R. A comparison of S‐adenosylmethionine (SAMe), rifampicin (R) and UDCA (UDCA) in primary biliary cholangitis (PBC): interim results. Journal of Hepatology 1991;13(Suppl 2):S101.
Carbone 2016 {published data only}
-
- Carbone M, Jones D, Mells GF, Pencek R, Marmon T, Shapiro D. Predicted risk of end stage liver disease with continued standard of care and subsequent addition of obeticholic acid in patients with PBC. Hepatology 2016;63 (1 Suppl 1):184A‐5A.
Chazouilleres 1995 {published data only}
-
- Chazouilleres O, Legendre C, StMaur P, Ismail PR, Poupon R. Histological course of primary biliary cholangitis (PBC) treated with UDCA (UDCA). Hepatology 1995;22(4 (Pt 2)):125a.
Christensen 1986 {published data only}
-
- Christensen E, Neuberger J, Crowe J, Portmann B, Williams R, Altman DG, et al. Azathioprine and prognosis in primary biliary cholangitis. Gastroenterology 1986;90(2):508‐9. - PubMed
Combes 1989 {published data only}
-
- Combes B. Prednisolone for primary biliary cholangitis ‐ good news, bad news. Hepatology 1989;10(4):511‐3. - PubMed
Combes 2004 {published data only}
Combes 2005b {published data only}
-
- Combes B. Reflections on therapeutic trials in primary biliary cholangitis. Hepatology 2005;42(5):1009. - PubMed
Copaci 2001 {published data only}
-
- Copaci I, Micu L, Cojocaru L. UDCA and methotrexate for primary biliary cholangitis. Journal of Hepatology 2001;34(1):59.
Corpechot 2000 {published data only}
-
- Corpechot C, Carrat F, Bonnand AM, Poupon RE, Poupon R. The effect of UDCA therapy on liver fibrosis progression in primary biliary cholangitis. Hepatology 2000;32(6):1196‐9. - PubMed
Corpechot 2001 {published data only}
-
- Corpechot C, Carrat F, Bonnand AM, Poupon RE, Poupon R. The effect of UDCA therapy on liver fibrosis progression in primary biliary cholangitis. European Journal of Gastroenterology & Hepatology 2001;13(1):90.
Crosignani 1996a {published data only}
-
- Crosignani A, Larghi A, Invernizzi P, Battezzati PM, DeValle G, Zuin M, et al. Tauroursodeoxycholic and UDCAs for the treatment of primary biliary cholangitis: a crossover study. Hepatology 1996;23(1):P111.
Crosignani 1996b {published data only}
-
- Crosignani A, Battezzati PM, Setchell KDR, Invernizzi P, Covini G, Zuin M, et al. TauroUDCA for treatment of primary biliary cholangitis ‐ a dose‐response study. Digestive Diseases and Sciences 1996;41(4):809‐15. - PubMed
Degott 1999 {published data only}
-
- Degott C, Zafrani ES, Callard P, Balkau B, Poupon RE, Poupon R. Histopathological study of primary biliary cholangitis and the effect of UDCA treatment on histology progression. Hepatology 1999;29(4):1007‐12. - PubMed
De la Mora 1994 {published data only}
-
- Mora G, Bobadilla J, Romero P, Rodríguez‐Leal G, Morán S, Kershenobich D, et al. Does treatment with UDCA (UDCA) really diminish cholesterol serum levels in primary biliary cholangitis (PBC)?. Hepatology 1994;19:571.
Dickson 1991 {published data only}
-
- Dickson ER, Lindor KD. Beneficial effects of UDCA in an open trial of patients with primary biliary cholangitis. Bile Acids as Therapeutic Agents From Basic Science to Clinical Practice Falk Symposium 58 1991, (32):271‐2.
Emond 1996 {published data only}
-
- Emond M, Carithers RL, Luketic VA, Peters M, Zetterman RK, Garcia‐Tsao G. Does UDCA improve survival in patients with primary biliary cholangitis? Comparison of outcome in the US multicenter trial to expected survival using the Mayo Clinic prognostic model. Hepatology 1996;24(4 (Pt 2)):168a.
Fischer 1967 {published data only}
-
- Fischer JA, Schmid M. Treatment of primary biliary cholangitis with azathioprine. Lancet 1967;1(7487):421‐4. - PubMed
Golovanova 2010 {published data only}
-
- Golovanova EV, Khomeriki SG, Petrakov AV, Serova TI. Budesonide in treatment of patients with cross primary biliary cholangitis and autoimmune hepatitis. Eksperimental'Naia i Klinicheskaia Gastroenterologiia 2010, (8):113‐7. - PubMed
Heathcote 1993 {published data only}
-
- Heathcote EJL, Cauch K, Walker V, Blendism LM, Ghent CN, Pappas SC. A four‐year follow‐up study of UDCA therapy for primary biliary cholangitis. Gastroenterology 1993;104(4 (Pt 2)):A914.
Heathcote 1995 {published data only}
-
- Heathcote EJ, Lindor KD, Poupon R, Cauchdudek K, Dickson ER, Trout R, et al. Combined analysis of French, American and Canadian randomized controlled trials of UDCA therapy in primary biliary cholangitis. Gastroenterology 1995;108(4 Suppl 3):A1082.
Hirschfield 2011 {published data only}
-
- Hirschfield GM, Mason AL, Gordon SC, Luketic VA, Mayo M, Vincent C, et al. A long term safety extension trial of the farnesoid x receptor (FXR) agonist obeticholic acid (OCA) and UDCA in primary biliary cholangitis (PBC). Hepatology 2011;54(S1):429a.
Hishon 1982 {published data only}
Howat 1966 {published data only}
-
- Howat HT, Ralston AJ, Varley H, Wilson JA. The late results of long‐term treatment of primary biliary cholangitis by corticosteroids. Revue Internationale d' Hepatologie 1966;16(2):227‐38. - PubMed
Hwang 1993 {published data only}
-
- Hwang SJ, Chan CY, Lee SD, Wu JC, Tsay SH, Lo KJ. UDCA in the treatment of primary biliary cholangitis: a short‐term, randomized, double‐blind controlled, cross‐over study with long‐term follow up. Journal of Gastroenterology & Hepatology 1993;8(3):217‐23. - PubMed
Invernizzi 1996 {published data only}
-
- Invernizzi A, Setchell DDR, Crosignani A, Larghi A, Battezzatti PM, O'Connell N, et al. Comparison between tauroursodeoxycholic and UDCAs in patients with primary biliary cholangitis: a cross over study. Hepatology 1996;24(4 (Pt 2)):168a.
Invernizzi 2015 {published data only}
-
- Invernizzi P, Pencek R, Marmon T, MacConell L, Shapiro D. Integrated efficacy summary for obeticholic acid in subjects with primary biliary cholangitis. Journal of Hepatology 2015;62:S778.
Itakura 2004 {published data only}
-
- Itakura J, Izumi N, Nishimura Y, Inoue K, Ueda K, Nakanishi H, et al. Prospective randomized crossover trial of combination therapy with bezafibrate and UDCA for primary biliary cholangitis. Hepatology Research 2004;29(4):216‐22. - PubMed
Jazrawi 1999 {published data only}
-
- Jazrawi RP, Verma A, Ahmed HA, Northfield TC. Effect of UDCA on cholestatic features and complications of primary biliary cholangitis. Bile Acids and Cholestasis 1999;108:231‐46.
Jones 2006 {published data only}
-
- Jones DE, Bhala N, Newton JL. Reflections on therapeutic trials in primary biliary cholangitis: a quality of life oriented counter‐view. Hepatology 2006;43(3):633; Author reply 634. - PubMed
Jorgensen 2002 {published data only}
-
- Jorgensen R, Angulo P, Dickson ER, Lindor KD. Results of long‐term ursodiol treatment for patients with primary biliary cholangitis. American Journal of Gastroenterology 2002;97(10):2647‐50. - PubMed
Joshi 2002 {published data only}
-
- Joshi S, Cauch‐Dudek K, Wanless IR, Lindor KD, Jorgensen R, Batts K, et al. Primary biliary cholangitis with additional features of autoimmune hepatitis: response to therapy with UDCA. Hepatology 2002;35(2):409‐13. - PubMed
Kaplan 1993 {published data only}
-
- Kaplan MM. New strategies needed for treatment of primary biliary cholangitis?. Gastroenterology 1993;104(2):651‐3. - PubMed
Kaplan 1998 {published data only}
-
- Kaplan M. Primary biliary cholangitis. Lancet 1998;351(9097):216. - PubMed
Kaplan 2004 {published data only}
-
- Kaplan MM, Cheng S, Price LL, Bonis PA. A randomized controlled trial of colchicine plus ursodiol versus methotrexate plus ursodiol in primary biliary cholangitis: ten‐year results. Hepatology 2004;39(4):915‐23. - PubMed
Kaplan 2009 {published data only}
-
- Kaplan MM, Poupon R. Treatment with immunosuppressives in patients with primary biliary cholangitis who fail to respond to ursodiol. Hepatology 2009;50(2):652. - PubMed
Kisand 1996 {published data only}
-
- Kisand KE, Karvonen AL, Vuoristo M, Farkkila M, Lehtola J, Inkovaara J, et al. UDCA treatment lowers the serum level of antibodies against pyruvate dehydrogenase and influences their inhibitory capacity for the enzyme complex in patients with primary biliary cholangitis. Journal of Molecular Medicine 1996;74(5):269‐72. - PubMed
Kisand 1998 {published data only}
-
- Kisand KE, Kisand KV, Karvonen AL, Vuoristo M, Mattila J, Makinen J, et al. Antibodies to pyruvate dehydrogenase in primary biliary cholangitis: correlation with histology. APMIS 1998;106(9):884‐92. - PubMed
Kowdley 2014a {published data only}
-
- Kowdley K, Hirschfield G, Chapman R, Vincent C, Jones D, Pares A, et al. Long‐term treatment of primary biliary cholangitis with the FXR agonist obeticholic acid shows durable efficacy. Journal of Hepatology 2014;60(1 Suppl 1):S192‐3.
Kowdley 2014b {published data only}
-
- Kowdley KV, Pencek R, Marmon T, Shapiro D, Hooshmand‐Rad R. FXR agonist obeticholic acid: sustained improvement in markers of cholestasis and long‐term safety in patients with primary biliary cholangitis through 4 years. Hepatology 2014;60:361a.
Kowdley 2015 {published data only}
-
- Kowdley KV, Shah H, Mason A, Luketic VA, Pencek R, Marmon T, et al. Long‐term safety and efficacy of obeticholic acid treatment in primary biliary cirrhosis after more than 4 years of treatment. Hepatology 2015;62:521a‐2a.
Kugler 1991 {published data only}
-
- Kugler CF, Fleig WE. [Placebo‐controlled double‐blind study of cyclosporin a in primary biliary cholangitis]. Zeitschrift Fur Gastroenterologie 1991;29(12):663‐4. - PubMed
Kurihara 2002 {published data only}
-
- Kurihara T, Maeda A, Shigemoto M, Yamashita K, Hashimoto E. Investigation into the efficacy of bezafibrate against primary biliary cholangitis, with histological references from cases receiving long term monotherapy. American Journal of Gastroenterology 2002;97(1):212‐4. - PubMed
Lampe 1972 {published data only}
-
- Lampe K, Hudepohl M, Schopen RD. [Immunosuppressive therapy of chronic aggressive hepatitis and primary biliary cholangitis]. Medizinische Klinik 1972;67(15):527‐34. - PubMed
Larghi 1997 {published data only}
-
- Larghi A, Crosignani A, Battezzati PM, Valle G, Allocca M, Invernizzi P, et al. Ursodeoxycholic and tauro‐UDCAs for the treatment of primary biliary cholangitis: a pilot crossover study. Alimentary Pharmacology & Therapeutics 1997;11(2):409‐14. - PubMed
Lee 2003 {published data only}
-
- Lee YM, Kaplan MM. Efficacy of colchicine in patients with primary biliary cholangitis poorly responsive to ursodiol and methotrexate. American Journal of Gastroenterology 2003;98(1):205‐8. - PubMed
Leung 2010 {published data only}
-
- Leung J, Bonder A, Sasson M, Bonis P, Kaplan M. 19‐year follow‐up of patients in a double‐blind trial of colchicine plus ursodiol versus methotrexate plus ursodiol in the treatment of primary biliary cholangitis. Gastroenterology 2010;1:S218.
Leung 2011 {published data only}
-
- Leung J, Bonis PA, Kaplan MM. Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cholangitis. Clinical Gastroenterology & Hepatology 2011;9(9):776‐80. - PubMed
Leuschner 1990 {published data only}
-
- Leuschner U, Güldütuna S, Fischer H, Hellstern A, Hübner K. UDCA in the treatment of primary biliary cholangitis: the Frankfurt experience. Strategies for the treatment of hepatobiliary diseases Falk symposium 53 1990, (9):83‐90.
Leuschner 1993a {published data only}
-
- Leuschner M, Güldütuna S, Imhof M, Bhati S, You T, Leuschner U. UDCA therapy in primary biliary cholangitis. 68th Falk Symposium; 1992 Oct 12‐14; Basel, Switzerland 1993:299‐302.
Leuschner 1993b {published data only}
-
- Leuschner M, Guldutuna S, Benjaminov A, Hubner K, Leuschner U. Interim evaluation of a prospective double‐blind trial of UDCA (UDCA) versus UDCA plus prednisolone in primary biliary cholangitis (PBC). Gastroenterology 1993;104(4):A938.
Leuschner 1996a {published data only}
-
- Leuschner M, Guldutuna S, You T, Hubner K, Bhatti S, Leuschner U. UDCA and prednisolone versus UDCA and placebo in the treatment of early stages of primary biliary cholangitis. Journal of Hepatology 1996;25(1):49‐57. - PubMed
Leuschner 1996b {published data only}
-
- Leuschner M, Guldutuna S, Hubner K, You T, Leuschner U. UDCA (UDCA) and prednisolone in the treatment of primary biliary cholangitis (PBC). Results of a controlled double‐blind trial. Gastroenterology 1996;110(4):A1250.
Leuschner 1997 {published data only}
-
- Leuschner U, Maier KP, Guldutuna S, Parte‐Peterhans S, Leuschner M. UDCA in combination with prednisolone or budesonide in the therapy of primary biliary cholangitis. Bile Acids in Hepatobiliary Diseases: Basic Research and Clinical Application 1997;93:299‐302.
Leuschner 1998 {published data only}
-
- Leuschner U, Maier P, Schitling J, Strahl R, Herrmann G, Leuschner M. UDCA and budesonide in the treatment of primary biliary cholangitis. XV International Bile Acid Meeting Bile Acids and Cholestasis Vol 1998;Falk Symposium 108:60‐1.
Levy 2004 {published data only}
-
- Levy C, Angulo P. UDCA and long‐term survival in primary biliary cholangitis. American Journal of Gastroenterology 2004;99(2):269‐70. - PubMed
Licinio 2015 {published data only}
-
- Licinio R, Facciorusso A, Castellaneta NM, Leo A. Combination therapy of UDCA and bezafibrate in patients with primary biliary cholangitis: the end of the steroid era in autoimmune liver diseases?. American Journal of Gastroenterology 2015;110(7):1086. - PubMed
Lim 2000 {published data only}
-
- Lim AG, Jazrawi RP, Ahmed HA, Northfield TC. UDCA ‐ an immunomodulator in primary biliary cholangitis?. Bile Acids in Hepatobiliary Disease 2000;110B:30‐5.
Lindor 1994a {published data only}
-
- Lindor KD, Jorgensen RA, Anderson ML, Gores GJ, Baldus WP, Dickson ER. The combination of UDCA (UDCA) and methotrexate (MTX) for patients with primary biliary cholangitis (PBC): the results of a pilot study. Hepatology 1994;20(4 (Pt 2)):202. - PubMed
Lindor 1995a {published data only}
-
- Lindor KD, Therneau TM, Jorgensen RA, Malinochoc M, Dickson ER. Effects of UDCA (UDCA) on survival in patients with primary biliary‐cirrhosis (PBC). Gastroenterology 1995;108(4 Suppl 3):A1111. - PubMed
Lindor 1995b {published data only}
-
- Lindor KD, Dickson ER, Jorgensen RA, Anderson ML, Wiesner RH, Gores GJ, et al. The combination of UDCA and methotrexate for patients with primary biliary cholangitis: the results of a pilot study. Hepatology 1995;22(4 I):1158‐62. - PubMed
Lindor 1995c {published data only}
-
- Lindor K. Long‐term experience with UDCA for patients with primary biliary cholangitis and primary sclerosing cholangitis. International Falk Workshop Bile Acids in Liver Diseases 1995:141‐5.
Lindor 1996 {published data only}
-
- Lindor KD, Therneau TM, Jorgensen RA, Malinchoc M, Dickson ER. Effects of UDCA on survival in patients with primary biliary cholangitis. Gastroenterology 1996;110(5):1515‐8. - PubMed
Lindor 2000 {published data only}
-
- Lindor KD, Poupon R, Poupon R, Heathcote EJ, Therneau T. UDCA for primary biliary cholangitis. Lancet 2000;355(9204):657‐8. - PubMed
Lindor 2005 {published data only}
-
- Lindor KD. Dose effect of UDCA used in the treatment of primary biliary cholangitis and primary sclerosing cholangitis. Bile Acid Biology and Its Therapeutic Implications 2005;141:225‐9.
Lindor 2007 {published data only}
-
- Lindor K. UDCA for the treatment of primary biliary cholangitis. New England Journal of Medicine 2007;357(15):1524‐9. - PubMed
Lytvyak 2015 {published data only}
-
- Lytvyak E, Montano‐Loza AJ, Saxinger L, Mason A. Combination anti‐retroviral therapy provides reduction in human betaretrovirus load and durable biochemical responses in patients with primary biliary cholangitis. Hepatology 2015;62:528A.
Lytvyak 2016 {published data only}
Miettinen 1993 {published data only}
-
- Miettinen TA, Farkkila M, Vuoristo M, Karvonen AL, Leino R, Lehtola J. Improvement of serum noncholesterol sterols may indicate retarded progression of primary biliary cholangitis (PBC) in a randomized placebo controlled two‐year trial with colchicine and UDCA. Gastroenterology 1993;104(4 (Pt 2)):A954.
Miettinen 1995 {published data only}
-
- Miettinen TA, Farkkila M, Vuoristo M, Karvonen AL, Leino R, Lehtola J, et al. Serum cholestanol, cholesterol precursors, and plant sterols during placebo‐controlled treatment of primary biliary cholangitis with UDCA or colchicine. Hepatology 1995;21(5):1261‐8. - PubMed
Muntoni 2010 {published data only}
Nikolaidis 2006 {published data only}
-
- Nikolaidis N, Kountouras J, Giouleme O, Tzarou V, Chatzizisi O, Patsiaoura K, et al. Colchicine treatment of liver fibrosis. Hepato‐Gastroenterology 2006;53(68):281‐5. - PubMed
Ohmoto 2001 {published data only}
-
- Ohmoto K, Mitsui Y, Yamamoto S. Effect of bezafibrate in primary biliary cholangitis: a pilot study. Liver 2001;21(3):223‐4. - PubMed
Ohmoto 2006 {published data only}
-
- Ohmoto K, Yoshioka N, Yamamoto S. Long‐term effect of bezafibrate on parameters of hepatic fibrosis in primary biliary cholangitis. Journal of Gastroenterology 2006;41(5):502‐3. - PubMed
Pan 2013 {published data only}
-
- Pan XL, Zhao L, Li L, Li AH, Ye J, Yang L, et al. Efficacy and safety of TUDCA in the treatment of liver cirrhosis: a double‐blind randomized controlled trial. Journal of Huazhong University of Science and Technology‐Medical Sciences 2013;33(2):189‐94. - PubMed
Pares 2009 {published data only}
-
- Pares A. Excellent long‐term survival in patients with primary biliary cholangitis treated with UDCA. Bile Acid Biology and Therapeutic Actions 2009;165:259‐69.
Podda 1989 {published data only}
-
- Podda M, Ghezzi C, Battezzati PM, Bertolini E, Crosignani A, Petroni ML, et al. Effect of different doses of UDCA in chronic liver disease. Digestive Diseases & Sciences 1989;34(12 Suppl):59S‐65S. - PubMed
Poupon 1989 {published data only}
-
- Poupon R, Poupon R, the UDCA‐PBCG. UDCA for primary biliary cholangitis. International Lugano Symposium on Biliary Physiology and Diseases: Strategies for the Treatment of Hepatobiliary Diseases Falk Symposium No 53 1989, issue 22.
Poupon 1990 {published data only}
-
- Poupon R, Poupon R, The UDCA‐PBCG. UDCA in the treatment of primary biliary cholangitis. Strategies for the treatment of hepatobiliary diseases. Falk Symposium 53 1990:79‐81.
Poupon 1991b {published data only}
-
- Poupon RE, Balkau B, Eschwege E, Poupon R, Kaplan MM. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cholangitis. Annals of Internal Medicine 1991;115(6 Suppl 2):48. - PubMed
Poupon 1994 {published data only}
-
- Poupon RE, Poupon R, Balkau B. Ursodiol for the long‐term treatment of primary biliary cholangitis. The UDCA‐PBC study group. New England Journal of Medicine 1994;330(19):1342‐7. - PubMed
Poupon 1997 {published data only}
-
- Poupon RE, Lindor KD, CauchDudek K, Dickson ER, Poupon R, Heathcote EJ. Combined analysis of randomized controlled trials of UDCA in primary biliary cholangitis. Gastroenterology 1997;113(3):884‐90. - PubMed
Poupon 1999 {published data only}
-
- Poupon RE, Bonnand AM, Chretien Y, Poupon R. Ten‐year survival in UDCA‐treated patients with primary biliary cholangitis. The UDCA‐PBC study group. Hepatology 1999;29(6):1668‐71. - PubMed
Poupon 2003 {published data only}
-
- Poupon RE, Lindor KD, Pares A, Chazouilleres O, Poupon R, Heathcote EJ. Combined analysis of the effect of treatment with UDCA on histologic progression in primary biliary cholangitis. Journal of Hepatology 2003;39(1):12‐6. - PubMed
Raedsch 1989 {published data only}
-
- Raedsch R, Stiehl A, Hopf U, Moller B. [Effect of UDCA treatment on primary biliary cholangitis]. Zeitschrift fur Gastroenterologie ‐ Verhandlungsband 1989;24:125‐7. - PubMed
Reed 1982 {published data only}
-
- Reed M. Penicillamine therapy 'encouraging' in primary biliary cholangitis study. JAMA 1982;248(1):11‐2. - PubMed
Robson 1994 {published data only}
-
- Robson SC, Neuberger JM, Williams R. The influence of cyclosporine a therapy on sex hormone levels in pre‐ and post‐menopausal women with primary biliary cholangitis. Journal of Hepatology 1994;21(3):412‐6. - PubMed
Roda 2002 {published data only}
-
- Roda E, Azzaroli F, Nigro G, Piazza F, Jaboli F, Ferrara F, et al. Improved liver tests and greater biliary enrichment with high dose UDCA in early stage primary biliary cholangitis. Digestive & Liver Disease 2002;34(7):523‐7. - PubMed
Savolainen 1983 {published data only}
Schaffner 1982 {published data only}
-
- Schaffner F, Sternlieb I, Sachs H. A 2 dose level randomized double‐blind controlled trial of penicillamine in primary biliary cholangitis ‐ the 1st 2 years. Hepatology 1982;2(5):714.
Setchell 1994 {published data only}
-
- Setchell KDR, Rodrigues C, Podda M, Crosignani A. TauroUDCA (TUDCA) appears more effective than UDCA at displacing hydrophobic bile acids from the bile acid pool of patients with primary biliary cholangitis (PBC). Hepatology 1994;20(4 (Pt 2)):150a.
Setchell 1996 {published data only}
Stellaard 1979 {published data only}
-
- Stellaard F, Bolt MG, Boyer JL, Klein PD. Phenobarbital treatment in primary biliary cholangitis. Differences in bile acid composition between responders and nonresponders. Journal of Laboratory & Clinical Medicine 1979;94(6):853‐61. - PubMed
Taal 1985 {published data only}
-
- Taal BG, Schalm SW. Cryoglobulins in primary biliary cholangitis: prevalence and modulation by immunosuppressive therapy. Zeitschrift Fur Gastroenterologie 1985;23(5):228‐34. - PubMed
Tang 2008 {published data only}
-
- Tang HH, Chen YJ, Tong GD, Zhou DQ, He JS, Zhou XZ, et al. [Efficacy of UDCA combined with Tongdan Decoction in treatment of patients with primary biliary cholangitis]. World Chinese Journal of Digestology 2008;16(13):1417‐24.
Tong 2012 {published data only}
-
- Tong GD, Tang HH, Wei CS, Chen YJ, He JS, Zhou XZ, et al. Efficacy of UDCA combined with Tongdan Decoction on immunological indices and histopathological changes in primary biliary cholangitis patients. Chinese Journal of Integrative Medicine 2012;18(1):16‐22. - PubMed
Verma 1999 {published data only}
-
- Verma A, Jazrawi RP, Ahmed HA, Davis T, Bland JM, Benson M, et al. Optimum dose of UDCA in primary biliary cholangitis. European Journal of Gastroenterology & Hepatology 1999;11(10):1069‐76. - PubMed
Verma 2000 {published data only}
-
- Verma A, Jazrawi RP, Ahmed HA, Northfield TC. The optimum dose of UDCA in primary biliary cholangitis. Bile Acids in Hepatobiliary Disease 2000;110B:25‐9.
Vogel 1988 {published data only}
-
- Vogel W, Kathrein H, Judmaier G, Braunsteiner H. Deterioration of primary biliary cholangitis during treatment with UDCA. Lancet 1988;1(8595):1163. - PubMed
Vuoristo 1995 {published data only}
-
- Vuoristo M, Farkkila M, Karvonen AL, Leino R, Lehtola J, Makinen J, et al. A placebo‐controlled trial of primary biliary cholangitis treatment with colchicine and UDCA. Gastroenterology 1995;108(5):1470‐8. - PubMed
Vuoristo 1997 {published data only}
-
- Vuoristo M, Farkkila M, Gylling H, Karvonen AL, Leino R, Lehtola J, et al. Expression and therapeutic response related to apolipoprotein e polymorphism in primary biliary cholangitis. Journal of Hepatology 1997;27(1):136‐42. - PubMed
Wiesner 1994 {published data only}
-
- Wiesner RH. Progression of primary biliary cholangitis on UDCA. Gastroenterology 1994;106(2):555. - PubMed
Wolfhagen 1995 {published data only}
-
- Wolfhagen FH, Buuren HR, Schalm SW, Kate FJ, Hattum J, Eskens FA, et al. Can UDCA induce disease remission in primary biliary cholangitis? The Dutch Multicentre PBC Study Group. Journal of Hepatology 1995;22(3):381. - PubMed
Yan 2007 {published data only}
-
- Yan G, Erik C, Gluud C. The long‐term beneficial effects of UDCA in primary biliary cholangitis are highly questionable. American Journal of Gastroenterology 2007;102(2):464‐5. - PubMed
Yano 2002 {published data only}
-
- Yano K, Kato H, Morita S, Takahara O, Ishibashi H, Furukawa R. Is bezafibrate histologically effective for primary biliary cholangitis?. American Journal of Gastroenterology 2002;97(4):1075‐7. - PubMed
Zuin 1991 {published data only}
-
- Zuin M, Grandinetti G, Camisasca M, Boga E, Ravizza L, Molteni P. A comparison of cholestyramine and diethylaminoethyl‐dextran for the treatment of hyperlipidemia and pruritus of primary biliary cholangitis. Current Therapeutic Research, Clinical and Experimental 1991;49(4):659‐65.
References to studies awaiting assessment
O'Brian 1990 {published data only}
-
- O'Brian C, Senior J, Sternlieb J, Saul S. Caution: not all patients with primary biliary cholangitis may successfully be treated by ursodiol. Second International Meeting on Pathochemistry, Pathophysiology and Pathomechanisms of the Biliary System and New Strategies for the Treatment of Hepato‐biliary Diseases 1990:208.
Zaman 2006 {published data only}
-
- Zaman A. Methotrexate in combination with UDCA is ineffective in the treatment of primary biliary cholangitis: commentary. Evidence‐Based Gastroenterology 2006;7(1):21‐2.
References to ongoing studies
ChiCTR‐IPR‐16008935 {unpublished data only}
-
- Biochemical Response of PBC‐AIH Overlap Syndrome Induced by Ursodeoxycholic Acid Only or Combination Therapy of Immunosuppressive Agents. Ongoing study Not stated..
EUCTR2015‐002698‐39‐GB {unpublished data only}
-
- A 12‐Week, Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Study to Evaluate the Effects of Two Doses of MBX‐8025 in Subjects with Primary Biliary Cirrhosis (PBC) and an Inadequate Response to Ursodeoxycholic Acid (UDCA).. Ongoing study Not stated..
NCT02308111 {published and unpublished data}
-
- Lindor K, Hansen B, Pencek R, Hooshmand‐Rad R, Marmon T, MacConell L, et al. A phase 3b, double blind, placebo controlled study evaluating the effect of obeticholic acid on clinical outcomes in subjects with primary biliary cholangitis at elevated risk of progression to liver transplant or death. Journal of Hepatology 2015;62:S850‐1.
NCT02701166 {unpublished data only}
-
- The Effect of Bezafibrate on Cholestatic Itch. Ongoing study February 2016..
NCT02823353 {unpublished data only}
-
- Fenofibrate in Combination with Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study. Ongoing study January 2016..
NCT02823366 {unpublished data only}
-
- Fenofibrate for Patients with Primary Biliary Cirrhosis who had an Inadequate Response to Ursodeoxycholic Acid. Ongoing study January 2016..
NCT02937012 {unpublished data only}
-
- Efficacy and Security of Bezafibrate in Patients with Primary Biliary Cirrhosis without Biochemical Response to Ursodeoxycholic Acid: a Randomized, Double‐blind, Placebo‐controlled Trial. Ongoing study October 2016..
NCT02943447 {unpublished data only}
-
- A Phase 2, Randomized, Double‐Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS‐9674 in Subjects with Primary Biliary Cholangitis without Cirrhosis. Ongoing study December 2016..
NCT02965911 {unpublished data only}
-
- A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined with Ursodeoxycholic Acid in PBC Patients with an Incomplete Biochemical Response to UDCA. Ongoing study January 2016..
Additional references
Baldursdottir 2012
-
- Baldursdottir TR, Bergmann OM, Jonasson JG, Ludviksson BR, Axelsson TA, Bjornsson ES. The epidemiology and natural history of primary biliary cholangitis: a nationwide population‐based study. European Journal of Gastroenterology and Hepatology 2012;24(7):824‐30. - PubMed
Bergasa 2000
-
- Bergasa NV, Mehlman JK, Jones EA. Pruritus and fatigue in primary biliary cholangitis. Bailliere's Best Practice & Research: Clinical Gastroenterology 2000;14(4):643‐55. - PubMed
Boberg 1998
-
- Boberg KM, Aadland E, Jahnsen J, Raknerud N, Stiris M, Bell H. Incidence and prevalence of primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis in a Norwegian population. Scandinavian Journal of Gastroenterology 1998;33(1):99‐103. - PubMed
Boonstra 2014
-
- Boonstra K, Kunst AE, Stadhouders PH, Tuynman HA, Poen AC, Nieuwkerk KM, et al. Rising incidence and prevalence of primary biliary cholangitis: a large population‐based study. Liver International 2014;34(6):e31‐8. - PubMed
Chaimani 2012
-
- Chaimani A, Salanti G. Using network meta‐analysis to evaluate the existence of small‐study effects in a network of interventions. Research Synthesis Methods 2012;3(2):161‐76. - PubMed
Chaimani 2013
Chan 2013
Del Re 2013
DeMets 1987
-
- DeMets DL. Methods for combining randomized clinical trials: strengths and limitations. Statistics in Medicine 1987;6(3):341‐50. - PubMed
DerSimonian 1986
-
- DerSimonian R, Laird N. Meta‐analysis in clinical trials. Controlled Clinical Trials 1986;7(3):177‐88. - PubMed
Dias 2010
-
- Dias S, Welton NJ, Caldwell DM, Ades AE. Checking consistency in mixed treatment comparison meta‐analysis. Statistics in Medicine 2010;29(7‐8):932‐44. - PubMed
Dias 2012a
-
- Dias S, Sutton AJ, Welton NJ, Ades AE. NICE DSU Technical Support Document 3: heterogeneity: subgroups, meta‐regression, bias and bias‐adjustment, September 2011 (last updated April 2012). www.nicedsu.org.uk/TSD3%20Heterogeneity.final%20report.08.05.12.pdf (accessed 27 March 2014).
Dias 2012b
-
- Dias S, Welton NJ, Sutton AJ, Ades AE. NICE DSU Technical Support Document 1: introduction to evidence synthesis for decision making, April 2011 (last updated April 2012). www.nicedsu.org.uk/TSD1%20Introduction.final.08.05.12.pdf (accessed 27 March 2014).
Dias 2014a
-
- Dias S, Welton NJ, Sutton AJ, Ades AE. NICE DSU Technical Support Document 2: a generalised linear modelling framework for pairwise and network meta‐analysis of randomised controlled trials, August 2011 (last updated April 2014). www.nicedsu.org.uk/TSD2%20General%20meta%20analysis%20corrected%2015Apri... (accessed 8 October 2014). - PubMed
Dias 2014b
-
- Dias S, Welton NJ, Sutton AJ, Caldwell DM, Lu G, Ades AE. NICE DSU Technical Support Document 4: inconsistency in networks of evidence based on randomised controlled trials, May 2011 (last updated April 2014). www.nicedsu.org.uk/TSD4%20Inconsistency.final.15April2014.pdf (accessed 8 October 2014). - PubMed
Dronamraju 2010
EASL 2009
-
- European Association for the Study of the Liver. EASL clinical practice guidelines: management of cholestatic liver diseases. Journal of Hepatology 2009;51(2):237‐67. - PubMed
Egger 1997
EuroQol 2014
-
- EuroQol. About EQ‐5D, 2014. www.euroqol.org/about‐eq‐5d.html (accessed 8 October 2014).
Floreani 2011
-
- Floreani A, Caroli D, Variola A, Rizzotto ER, Antoniazzi S, Chiaramonte M, et al. A 35‐year follow‐up of a large cohort of patients with primary biliary cholangitis seen at a single centre. Liver International 2011;31(3):361‐8. - PubMed
Gershwin 2005
Giljaca 2010
Gluud 2007
-
- Gluud C, Brok J, Gong Y, Koretz RL. Hepatology may have problems with putative surrogate outcome measures. Journal of hepatology 2007;46(4):734‐42. [PUBMED: 17316871] - PubMed
Gluud 2017
-
- Gluud C, Nikolova D, Klingenberg SL. Cochrane Hepato‐Biliary Group. About The Cochrane Collaboration (Cochrane Review Groups (CRGs)) 2017, Issue 2. Art. No.: LIVER.
Gong 2004a
Gong 2004b
Gong 2007a
Gong 2007b
Guanabens 2013
-
- Guanabens N, Monegal A, Cerda D, Muxi A, Gifre L, Peris P, et al. Randomized trial comparing monthly ibandronate and weekly alendronate for osteoporosis in patients with primary biliary cholangitis. Hepatology 2013;58(6):2070‐8. - PubMed
Guyatt 2011
-
- Guyatt G, Oxman AD, Akl EA, Kunz R, Vist G, Brozek J, et al. GRADE guidelines: 1. Introduction ‐ GRADE evidence profiles and summary of findings tables. Journal of Clinical Epidemiology 2011;64(4):383‐94. - PubMed
Higgins 2011
-
- Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from handbook.cochrane.org.
Higgins 2012
ICH‐GCP 1997
-
- International Conference on Harmonisation Expert Working Group. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH harmonised tripartite guideline. Guideline for good clinical practice CFR & ICH Guidelines. Vol. 1, Pennsylvania: Barnett International/PAREXEL, 1997.
Jakobsen 2014
Jones 1999
-
- Jones EA, Kate FJ, Ter Borg F, Houben M, Reesink HW, Chamuleau RA. Combination therapy with mycophenolate mofetil and UDCA for primary biliary cholangitis. European Journal of Gastroenterology & Hepatology 1999;11(10):1165‐9. - PubMed
Kim 2000
-
- Kim WR, Lindor KD, Locke GR 3rd, Therneau TM, Homburger HA, Batts KP, et al. Epidemiology and natural history of primary biliary cholangitis in a US community. Gastroenterology 2000;119(6):1631‐6. - PubMed
Kjaergard 2001
-
- Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality and discrepancies between large and small randomized trials in meta‐analyses. Annals of Internal Medicine 2001;135(11):982‐9. - PubMed
Lammert 2013
Lazaridis 2007
-
- Lazaridis KN, Talwalkar JA. Clinical epidemiology of primary biliary cholangitis: incidence, prevalence, and impact of therapy. Journal of Clinical Gastroenterology 2007;41(5):494‐500. - PubMed
Leung 2005
-
- Leung PS, Coppel RL, Gershwin ME. Etiology of primary biliary cholangitis: the search for the culprit. Seminars in Liver Disease 2005;25(3):327‐36. - PubMed
Li Wei 2012
Lindor 2009
-
- Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ, et al. Primary biliary cholangitis. Hepatology 2009;50(1):291‐308. - PubMed
Lu 2006
-
- Lu G, Ades AE. Assessing evidence inconsistency in mixed treatment comparisons. Journal of the American Statistical Association 2006;101(474):447‐59.
Lundh 2017
Macaskill 2001
-
- Macaskill P, Walter SD, Irwig L. A comparison of methods to detect publication bias in meta‐analysis. Statistics in Medicine 2001;20(4):641‐54. - PubMed
Metcalf 1997
-
- Metcalf JV, Bhopal RS, Gray J, Howel D, James OF. Incidence and prevalence of primary biliary cholangitis in the city of Newcastle upon Tyne, England. International Journal of Epidemiology 1997;26(4):830‐6. - PubMed
Mills 2012
-
- 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. - PubMed
Moher 1998
-
- Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, et al. Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta‐analyses?. Lancet 1998;352(9128):609‐13. - PubMed
Myers 2009
-
- Myers RP, Shaheen AA, Fong A, Burak KW, Wan A, Swain MG, et al. Epidemiology and natural history of primary biliary cholangitis in a Canadian health region: a population‐based study. Hepatology 2009;50(6):1884‐92. - PubMed
NCBI 2014
-
- NCBI. Liver cirrhosis, biliary, 2014. www.ncbi.nlm.nih.gov/mesh/68008105 (accessed 19 October 2014).
Newell 1992
-
- Newell DJ. Intention‐to‐treat analysis: implications for quantitative and qualitative research. International Journal of Epidemiology 1992;21(5):837‐41. - PubMed
OpenBUGS 3.2.3 [Computer program]
-
- Members of OpenBUGS Project Management Group. OpenBUGS. Version 3.2.3. Members of OpenBUGS Project Management Group, 2014.
Ormarsdottir 2004
-
- Ormarsdottir S, Mallmin H, Naessen T, Petren‐Mallmin M, Broome U, Hultcrantz R, et al. An open, randomized, controlled study of transdermal hormone replacement therapy on the rate of bone loss in primary biliary cholangitis. Journal of Internal Medicine 2004;256(1):63‐9. - PubMed
Parikh‐Patel 2001
-
- Parikh‐Patel A, Gold EB, Worman H, Krivy KE, Gershwin ME. Risk factors for primary biliary cholangitis in a cohort of patients from the United States. Hepatology 2001;33(1):16‐21. - PubMed
Paumgartner 2002
-
- Paumgartner G, Beuers U. UDCA in cholestatic liver disease: mechanisms of action and therapeutic use revisited. Hepatology 2002;36(3):525‐31. - PubMed
Perez 2009
Pla 2007
-
- Pla X, Vergara M, Gil M, Dalmau B, Cistero B, Bella RM, et al. Incidence, prevalence and clinical course of primary biliary cholangitis in a Spanish community. European Journal of Gastroenterology and Hepatology 2007;19(10):859‐64. - PubMed
Prince 2005
Prince 2010
-
- Prince MI, Ducker SJ, James OF. Case‐control studies of risk factors for primary biliary cholangitis in two United Kingdom populations. Gut 2010;59(4):508‐12. - PubMed
Puhan 2014
-
- Puhan MA, Schünemann HJ, Murad MH, Li T, Brignardello‐Petersen R, Singh JA, et al. A GRADE Working Group approach for rating the quality of treatment effect estimates from network meta‐analysis. BMJ (Clinical Research Ed.) 2014;349:g5630. - PubMed
Rautiainen 2007
-
- Rautiainen H, Salomaa V, Niemela S, Karvonen AL, Nurmi H, Isoniemi H, et al. Prevalence and incidence of primary biliary cholangitis are increasing in Finland. Scandinavian Journal of Gastroenterology 2007;42(11):1347‐53. - PubMed
RevMan 2014 [Computer program]
-
- The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.
Royle 2003
-
- Royle P, Milne R. Literature searching for randomized controlled trials used in Cochrane reviews: rapid versus exhaustive searches. International Journal of Technology Assessment in Health Care 2003;19(4):591‐603. - PubMed
Rudic 2011a
Rudic 2011b
Rudic 2012a
Rudic 2012b
Salanti 2011
-
- Salanti G, Ades AE, Ioannidis JP. Graphical methods and numerical summaries for presenting results from multiple‐treatment meta‐analysis: an overview and tutorial. Journal of Clinical Epidemiology 2011;64(2):163‐71. - PubMed
Salanti 2012
-
- Salanti G. Indirect and mixed‐treatment comparison, network, or multiple‐treatments meta‐analysis: many names, many benefits, many concerns for the next generation evidence synthesis tool. Research Synthesis Methods 2012;3(2):80‐97. - PubMed
Savović 2012a
-
- Savović J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized controlled trials: combined analysis of meta‐epidemiological studies. Health Technology Assessment 2012;16(35):1‐82. - PubMed
Savović 2012b
-
- Savović J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized controlled trials. Annals of Internal Medicine 2012;157(6):429‐38. - PubMed
Schulz 1995
-
- Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995;273(5):408‐12. - PubMed
Schulz 2010
Selmi 2010
-
- Selmi C, Gershwin ME. The etiology mystery in primary biliary cholangitis. Digestive Diseases 2010;28(1):105‐15. - PubMed
Severini 1993
-
- Severini TA. Bayesian interval estimates which are also confidence intervals. Journal of the Royal Statistical Society. Series B (Methodological) 1993;55(2):533‐40.
Song 2008
Sood 2004
-
- Sood S, Gow PJ, Christie JM, Angus PW. Epidemiology of primary biliary cholangitis in Victoria, Australia: high prevalence in migrant populations. Gastroenterology 2004;127(2):470‐5. - PubMed
Stata/SE 14.2 [Computer program]
-
- StataCorp LP. Stata/SE 14.2 for Windows[64‐bit x86‐64]. Version 14. College Station: StataCorp LP, 2017.
Talwalkar 2005
-
- Talwalkar JA, Angulo P, Keach JC, Petz JL, Jorgensen RA, Lindor KD. Mycophenolate mofetil for the treatment of primary biliary cholangitis in patients with an incomplete response to UDCA. Journal of Clinical Gastroenterology 2005;39(2):168‐71. - PubMed
Talwalkar 2006
-
- Talwalkar JA, Donlinger JJ, Gossard AA, Keach JC, Jorgensen RA, Petz JC, et al. Fluoxetine for the treatment of fatigue in primary biliary cholangitis: a randomized, double‐blind controlled trial. Digestive Diseases and Sciences 2006;51(11):1985‐91. - PubMed
Ter Borg 2004
Thorlund 2011
-
- Thorlund K, Engstrøm J, Wetterslev J, Brok J, Imberger G, Gluud C. User manual for Trial Sequential Analysis (TSA). Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, Denmark. Available from www.ctu.dk/tsa 2011:1‐115.
Thorlund 2012
TSA 2011 [Computer program]
-
- Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen. TSA version 0.9. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen, 2011.
Turner 2012
Van Valkenhoef 2012
-
- Valkenhoef G, Lu G, Brock B, Hillege H, Ades AE, Welton NJ. Automating network meta‐analysis. Research Synthesis Methods 2012;3(4):285‐99. - PubMed
Ware 2014
-
- Ware JE. SF‐36® health survey update, 2014. www.sf‐36.org/tools/sf36.shtml (accessed on 8 October 2014).
Wetterslev 2008
-
- Wetterslev J, Thorlund K, Brok J, Gluud C. Trial Sequential Analysis may establish when firm evidence is reached in cumulative meta‐analysis. Journal of Clinical Epidemiology 2008;61(1):64‐75. - PubMed
Wetterslev 2017
Wood 2008
Yin 2015
Zhang 2015
Zhu 2015a
Zhu 2015b
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Other Literature Sources
Miscellaneous
