Network meta-analysis of randomized controlled trials: Efficacy and safety of UDCA-based therapies in primary biliary cirrhosis

Medicine (United States)

Volumn 94, Issue 11, 2015, Pages e609-

  Zhu, Gui Qi ^a,b,c   Shi, Ke Qing ^a,c   Huang, Sha ^a,b   Huang, Gui Qian ^a   Lin, Yi Qian ^a,c   Zhou, Zhi Rui ^d,e   Braddock, Martin ^f   Chen, Yong Ping ^a,c   Zheng, Ming Hua ^a,c  

^a THE FIRST AFFILIATED HOSPITAL OF WENZHOU MEDICAL UNIVERSITY   (China)

^b School of the First Clinical Medical Sciences   (China)

^c WENZHOU MEDICAL UNIVERSITY   (China)

^d FUDAN UNIVERSITY SHANGHAI CANCER CENTER   (China)

^e FUDAN UNIVERSITY   (China)

^f ASTRAZENECA   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BEZAFIBRATE; COLCHICINE; CORTICOSTEROID; METHOTREXATE; URSODEOXYCHOLIC ACID;

ARTICLE; CLINICAL ASSESSMENT; CLINICAL PROTOCOL; COCHRANE LIBRARY; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL (TOPIC); DISEASE ASSOCIATION; DRUG EFFICACY; DRUG SAFETY; HIGH RISK PATIENT; HUMAN; LIVER TRANSPLANTATION; MEDLINE; META ANALYSIS; MONOTHERAPY; MORTALITY; OUTCOME ASSESSMENT; PRIMARY BILIARY CIRRHOSIS; PRIORITY JOURNAL; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT; RISK FACTOR; SCOPUS; SENSITIVITY ANALYSIS; SYSTEMATIC REVIEW; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; DRUG COMBINATION; LIVER CIRRHOSIS, BILIARY;

DRUG THERAPY, COMBINATION; HUMANS; LIVER CIRRHOSIS, BILIARY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; URSODEOXYCHOLIC ACID;

EID: 84929668879     PISSN: 00257974     EISSN: 15365964     Source Type: Journal    
DOI: 10.1097/MD.0000000000000609     Document Type: Article

References (50)

1. Talwalkar JA, Lindor KD. Primary biliary cirrhosis. Lancet. 2003;362:53-61.
2. Kaplan MM, Cheng S, Price LL, et al. A randomized controlled trial of colchicine plus ursodiol versus methotrexate plus ursodiol in primary biliary cirrhosis: ten-year results. Hepatology (Baltimore, MD). 2004;39:915-923.
3. Corpechot C, Abenavoli L, Rabahi N, et al. Biochemical response to ursodeoxycholic acid and long-term prognosis in primary biliary cirrhosis. Hepatology (Baltimore, MD). 2008;48:871-877.
4. Heathcote EJ, Cauch-Dudek K, Walker V, et al. The Canadian Multicenter Double-blind Randomized Controlled Trial of ursodeoxycholic acid in primary biliary cirrhosis. Hepatology (Baltimore, MD). 1994;19:1149-1156.
5. Lindor KD, Dickson ER, Baldus WP, et al. Ursodeoxycholic acid in the treatment of primary biliary cirrhosis. Gastroenterology. 1994;106:1284-1290.
6. Lindor KD, Therneau TM, Jorgensen RA, et al. Effects of ursodeoxycholic acid on survival in patients with primary biliary cirrhosis. Gastroenterology. 1996;110:1515-1518.
7. Gong Y, Huang ZB, Christensen E, et al. Ursodeoxycholic acid for primary biliary cirrhosis. Cochrane Database Syst Rev. 2008;(3):CD000551.
8. Rudic JS, Poropat G, Krstic MN, et al. Ursodeoxycholic acid for primary biliary cirrhosis. Cochrane Database Syst Rev. 2012;12:CD000551.
9. Ikeda T, Tozuka S, Noguchi O, et al. Effects of additional administration of colchicine in ursodeoxycholic acid-treated patients with primary biliary cirrhosis: A prospective randomized study. J Hepatol. 1996;24:88-94.
10. Poupon RE, Huet PM, Poupon R, et al. A randomized trial comparing colchicine and ursodeoxycholic acid combination to ursodeoxycholic acid in primary biliary cirrhosis. UDCA-PBC Study Group Hepatol (Baltimore, MD). 1996;24:1098-1103.
11. Dickson ER, Grambsch PM, Fleming TR, et al. Prognosis in primary biliary cirrhosis: model for decision making. Hepatology (Baltimore, MD). 1989;10:1-7.
12. Tanaka A, Harada K, Ebinuma H, et al. Primary biliary cirrhosis-autoimmune hepatitis overlap syndrome: A rationale for corticosteroids use based on a nation-wide retrospective study in Japan. Hepatol Res. 2011;41:877-886.
13. Itakura J, Izumi N, Nishimura Y, et al. Prospective randomized crossover trial of combination therapy with bezafibrate and UDCA for primary biliary cirrhosis. Hepatol Res. 2004;29:216-222.
14. Song F, Altman DG, Glenny AM, et al. Validity of indirect comparison for estimating efficacy of competing interventions: empirical evidence from published meta-analyses. BMJ. 2003;326:472.
15. Sutton A, Ades AE, Cooper N, et al. Use of indirect and mixed treatment comparisons for technology assessment. Pharmacoeconomics. 2008;26:753-767.
16. Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: The PRISMA statement. Int J Surg. 2010;8:336-341.
17. Higgins JP, Altman DG, Gotzsche PC, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011;343:d5928.
18. Bowden J, Tierney JF, Copas AJ, et al. Quantifying displaying and accounting for heterogeneity in the meta-analysis of RCTs using standard and generalised Q statistics. BMC Med Res Methodol. 2011;11:41.
19. Lindor KD, Gershwin ME, Poupon R, et al. Primary biliary cirrhosis. Hepatology (Baltimore, MD). 2009;50:291-308.
20. Zhu GQ, You J, Shi KQ, et al. Systematic review with network meta-analysis: Adjuvant chemotherapy for resected colorectal liver metastases. Medicine (Baltimore). 2015;94:e379.
21. Zhu GQ, Shi KQ, You J, et al. Systematic review with network meta-analysis: Adjuvant therapy for resected biliary tract cancer. Aliment Pharmacol Ther. 2014;40:759-770.
22. Lindor KD, Dickson ER, Jorgensen RA, et al. The combination of ursodeoxycholic acid and methotrexate for patients with primary biliary cirrhosis: The results of a pilot study. Hepatology (Baltimore, MD). 1995;22:1158-1162.
23. Leuschner U, Fischer H, Hubner K. Ursodeoxycholic acid in the treatment of primary biliary cirrhosis: results of a controlled study. Zeitschrift Gastroenterol Verhandlungsband. 1989;24:133.
24. Oka H, Toda G, Ikeda Y, et al. A multi-center double-blind controlled trial of ursodeoxycholic acid for primary biliary cirrhosis. Gastroenterol Jpn. 1990;25:774-780.
25. Poupon RE, Balkau B, Eschwege E, et al. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. UDCA-PBC Study Group. N Engl J Med. 1991;324:1548-1554.
26. Battezzati PM, Podda M, Bianchi FB, et al. Ursodeoxycholic acid for symptomatic primary biliary cirrhosis. Preliminary analysis of a double-blind multicenter trial Italian Multicenter Group for the Study of UDCA in PBC. J Hepatol. 1993;17:332-338.
27. Hwang SJ, Chan CY, Lee SD, et al. Ursodeoxycholic acid in the treatment of primary biliary cirrhosis: A short-term, randomized, double-blind controlled, cross-over study with long-term follow up. J Gastroenterol Hepatol. 1993;8:217-223.
28. Turner IB, Myszor M, Mitchison HC, et al. A two year controlled trial examining the effectiveness of ursodeoxycholic acid in primary biliary cirrhosis. J Gastroenterol Hepatol. 1994;9:162-168.
29. Combes B, Carithers RL Jr, Maddrey WC, et al. A randomized, double-blind, placebo-controlled trial of ursodeoxycholic acid in primary biliary cirrhosis. Hepatology (Baltimore, MD). 1995;22:759-766.
30. Vuoristo M, Farkkila M, Karvonen AL, et al. A placebo-controlled trial of primary biliary cirrhosis treatment with colchicine and ursodeoxycholic acid. Gastroenterology. 1995;108:1470-1478.
31. Eriksson LS, Olsson R, Glauman H, et al. Ursodeoxycholic acid treatment in patients with primary biliary cirrhosis. A Swedish multicentre, double-blind, randomized controlled study. Scand J Gastroenterol. 1997;32:179-186.
32. Gonzalez-Koch A, Brahm J, Antezana C, et al. The combination of ursodeoxycholic acid and methotrexate for primary biliary cirrhosis is not better than ursodeoxycholic acid alone. J Hepatol. 1997;27:143-149.
33. Chazouilleres O, Wendum D, Serfaty L, et al. Primary biliary cirrhosis-autoimmune hepatitis overlap syndrome: clinical features and response to therapy. Hepatology (Baltimore, MD). 1998;28:296-301.
34. Leuschner M, Maier KP, Schlichting J, et al. Oral budesonide and ursodeoxycholic acid for treatment of primary biliary cirrhosis: results of a prospective double-blind trial. Gastroenterology. 1999;117:918-925.
35. Almasio PL, Floreani A, Chiaramonte M, et al. Multicentre randomized placebo-controlled trial of ursodeoxycholic acid with or without colchicine in symptomatic primary biliary cirrhosis. Aliment Pharmacol Therap. 2000;14:1645-1652.
36. Pares A, Caballeria L, Rodes J, et al. Long-term effects of ursodeoxycholic acid in primary biliary cirrhosis: results of a double-blind controlled multicentric trial. UDCA-Cooperative Group from the Spanish Association for the Study of the Liver. J Hepatol. 2000;32:561-566.
37. Battezzati PM, Zuin M, Crosignani A, et al. Ten-year combination treatment with colchicine and ursodeoxycholic acid for primary biliary cirrhosis: A double-blind, placebo-controlled trial on symptomatic patients. Aliment Pharmacol Therap. 2001;15:1427-1434.
38. Gunsar F, Akarca US, Ersoz G, et al. Clinical and biochemical features and therapy responses in primary biliary cirrhosis and primary biliary cirrhosis-autoimmune hepatitis overlap syndrome. Hepato-gastroenterology. 2002;49:1195-1200.
39. Papatheodoridis GV, Hadziyannis ES, Deutsch M, et al. Ursodeoxycholic acid for primary biliary cirrhosis: final results of a 12-year, prospective, randomized, controlled trial. Am J Gastroenterol. 2002;97:2063-2070.
40. Kanda T, Yokosuka O, Imazeki F, et al. Bezafibrate treatment: A new medical approach for PBC patients? J Gastroenterol. 2003;38:573-578.
41. Ozaslan E, Efe C, Akbulut S, et al. Therapy response and outcome of overlap syndromes: Autoimmune hepatitis and primary biliary cirrhosis compared to autoimmune hepatitis and autoimmune cholangitis. Hepato-gastroenterology. 2010;57:441-446.
42. Leung J, Bonis PA, Kaplan MM. Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cirrhosis. Clin Gastroenterol Hepatol. 2011;9:776-780.
43. Combes B, Emerson SS, Flye NL, et al. Methotrexate (MTX) plus ursodeoxycholic acid (UDCA) in the treatment of primary biliary cirrhosis. Hepatology (Baltimore, MD). 2005;42:1184-1193.
44. Iwasaki S, Ohira H, Nishiguchi S, et al. The efficacy of ursodeoxycholic acid and bezafibrate combination therapy for primary biliary cirrhosis: A prospective, multicenter study. Hepatol Res. 2008;38:557-564.
45. Cooper NJ, Sutton AJ, Morris D, et al. Addressing between-study heterogeneity and inconsistency in mixed treatment comparisons: Application to stroke prevention treatments in individuals with nonrheumatic atrial fibrillation. Stat Med. 2009;28:1861-1881.
46. Poupon RE, Poupon R, Balkau B. Ursodiol for the long-term treatment of primary biliary cirrhosis. The UDCA-PBC Study Group. N Engl J Med. 1994;330:1342-1347.
47. Zhang Y, Lu J, Dai W, et al. Combination therapy of ursodeoxycholic Acid and corticosteroids for primary biliary cirrhosis with features of autoimmune hepatitis: A meta-analysis. Gastroenterol Res Pract. 2013;2013:490731.
48. Chazouilleres O, Wendum D, Serfaty L, et al. Long term outcome and response to therapy of primary biliary cirrhosis-autoimmune hepatitis overlap syndrome. J Hepatol. 2006;44:400-406.
49. Heurgue A, Vitry F, Diebold MD, et al. Overlap syndrome of primary biliary cirrhosis and autoimmune hepatitis: A retrospective study of 115 cases of autoimmune liver disease. Gastroenterol Clin Biol. 2007;31:17-25.
50. Rudic JS, Poropat G, Krstic MN, et al. Bezafibrate for primary biliary cirrhosis. Cochrane Database Syst Rev. 2012;1:CD009145.