Randomised clinical trial: Vancomycin or metronidazole in patients with primary sclerosing cholangitis - A pilot study

Alimentary Pharmacology and Therapeutics

Volumn 37, Issue 6, 2013, Pages 604-612

  Tabibian, J H ^a   Weeding, E ^a   Jorgensen, R A ^a   Petz, J L ^a   Keach, J C ^a   Talwalkar, J A ^a   Lindor, K D ^b  

^a MAYO CLINIC   (United States)

^b ARIZONA STATE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALKALINE PHOSPHATASE; BILIRUBIN; C REACTIVE PROTEIN; METRONIDAZOLE; URSODEOXYCHOLIC ACID; VANCOMYCIN;

ADULT; AGED; ALKALINE PHOSPHATASE BLOOD LEVEL; ANOREXIA; ARTICLE; BILIRUBIN BLOOD LEVEL; CLINICAL ARTICLE; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; EYE BURNING; FATIGUE; FEMALE; HUMAN; INFLUENZA; LOW DRUG DOSE; MALE; MAYO PRIMARY SCLEROSING CHOLANGITIS RISK SCORE; MIGRAINE; NAUSEA; PATIENT COMPLIANCE; PILOT STUDY; PRIMARY SCLEROSING CHOLANGITIS; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM;

ADULT; AGED; ANTI-BACTERIAL AGENTS; BILIRUBIN; BIOLOGICAL MARKERS; CHOLANGITIS, SCLEROSING; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; METRONIDAZOLE; MIDDLE AGED; PILOT PROJECTS; VANCOMYCIN; YOUNG ADULT;

EID: 84874117027     PISSN: 02692813     EISSN: 13652036     Source Type: Journal    
DOI: 10.1111/apt.12232     Document Type: Article

References (49)

1. Angulo P, Lindor KD,. Primary sclerosing cholangitis. Hepatology 1999; 30: 325-32.
2. Tabiban JH, Lindor KD,. Primary sclerosing cholangitis: a review and update on therapeutic developments. Expert Rev Gastroenterol Hepatol 2013; 7: 103-14.
3. Graziadei IW,. Live donor liver transplantation for primary sclerosing cholangitis: is disease recurrence increased? Curr Opin Gastroenterol 2011; 27: 301-5.
4. Kugelmas M, Spiegelman P, Osgood MJ, et al,. Different immunosuppressive regimens and recurrence of primary sclerosing cholangitis after liver trans-plantation. Liver Transpl 2003; 9: 727-32.
5. Lindor KD,. New treatment strategies for primary sclerosing cholangitis. Dig Dis 2011; 29: 113-6.
6. Lindor KD,. Ursodiol for primary sclerosing cholangitis. Mayo primary sclerosing cholangitis-ursodeoxycholic acid study group. N Engl J Med 1997; 336: 691-5.
7. Mendes F,. Current and future therapy for primary sclerosing cholangitis. Gastroenterol Hepatol (N Y) 2008; 4: 258-60.
8. Lindor KD, Kowdley KV, Luketic VA, et al,. High-dose ursodeoxycholic acid for the treatment of primary sclerosing cholangitis. Hepatology 2009; 50: 808-14.
9. LaRusso NF, Wiesner RH, Ludwig J, MacCarty RL, Beaver SJ, Zinsmeister AR,. Prospective trial of penicillamine in primary sclerosing cholangitis. Gastroenterology 1988; 95: 1036-42.
10. Knox TA, Kaplan MM,. Treatment of primary sclerosing cholangitis with oral methotrexate. Am J Gastroenterol 1991; 86: 546-52.
11. Olsson R, Broome U, Danielsson A, et al,. Colchicine treatment of primary sclerosing cholangitis. Gastroenterology 1995; 108: 1199-203.
12. Schramm C, Schirmacher P, Helmreich-Becker I, Gerken G, zum Buschenfelde KH, Lohse AW,. Combined therapy with azathioprine, prednisolone, and ursodiol in patients with primary sclerosing cholangitis. A case series. Ann Intern Med 1999; 131: 943-6.
13. Angulo P, Batts KP, Jorgensen RA, LaRusso NA, Lindor KD,. Oral budesonide in the treatment of primary sclerosing cholangitis. Am J Gastroenterol 2000; 95: 2333-7.
14. Bharucha AE, Jorgensen R, Lichtman SN, LaRusso NF, Lindor KD,. A pilot study of pentoxifylline for the treatment of primary sclerosing cholangitis. Am J Gastroenterol 2000; 95: 2338-42.
15. Lindor KD, Wiesner RH, Colwell LJ, Steiner B, Beaver S, LaRusso NF,. The combination of prednisone and colchicine in patients with primary sclerosing cholangitis. Am J Gastroenterol 1991; 86: 57-61.
16. Pollheimer MJ, Halilbasic E, Fickert P, Trauner M,. Pathogenesis of primary sclerosing cholangitis. Best Pract Res Clin Gastroenterol 2011; 25: 727-39.
17. Tabibian JH, O'Hara SP, Larusso NF,. Primary sclerosing cholangitis: the gut-liver axis. Clin Gastroenterol Hepatol 2012; 10: 819.
18. Aron JH, Bowlus CL,. The immunobiology of primary sclerosing cholangitis. Semin Immunopathol 2009; 31: 383-97.
19. Wiesner RH, Grambsch PM, Dickson ER, et al,. Primary sclerosing cholangitis: natural history, prognostic factors and survival analysis. Hepatology 1989; 10: 430-6.
20. Oriishi T, Sata M, Toyonaga A, Sasaki E, Tanikawa K,. Evaluation of intestinal permeability in patients with inflammatory bowel disease using lactulose and measuring antibodies to lipid A. Gut 1995; 36: 891-6.
21. Murphy MS, Eastham EJ, Nelson R, Pearson AD, Laker MF,. Intestinal permeability in Crohn's disease. Arch Dis Child 1989; 64: 321-5.
22. Lepage P, Hasler R, Spehlmann ME, et al,. Twin study indicates loss of interaction between microbiota and mucosa of patients with ulcerative colitis. Gastroenterology 2011; 141: 227-36.
23. Broome U, Olsson R, Loof L, et al,. Natural history and prognostic factors in 305 Swedish patients with primary sclerosing cholangitis. Gut 1996; 38: 610-5.
24. Worthington J, Cullen S, Chapman R,. Immunopathogenesis of primary sclerosing cholangitis. Clin Rev Allergy Immunol 2005; 28: 93-103.
25. Lichtman SN, Okoruwa EE, Keku J, Schwab JH, Sartor RB,. Degradation of endogenous bacterial cell wall polymers by the muralytic enzyme mutanolysin prevents hepatobiliary injury in genetically susceptible rats with experimental intestinal bacterial overgrowth. J Clin Invest 1992; 90: 1313-22.
26. Lichtman SN, Keku J, Schwab JH, Sartor RB,. Hepatic injury associated with small bowel bacterial overgrowth in rats is prevented by metronidazole and tetracycline. Gastroenterology 1991; 100: 513-9.
27. Davies YK, Cox KM, Abdullah BA, Safta A, Terry AB, Cox KL,. Long-term treatment of primary sclerosing cholangitis in children with oral vancomycin: an immunomodulating antibiotic. J Pediatr Gastroenterol Nutr 2008; 47: 61-7.
28. Cox KL, Cox KM,. Oral vancomycin: treatment of primary sclerosing cholangitis in children with inflammatory bowel disease. J Pediatr Gastroenterol Nutr 1998; 27: 580-3.
29. Tada S, Ebinuma H, Saito H, Hibi T,. Therapeutic benefit of sulfasalazine for patients with primary sclerosing cholangitis. J Gastroenterol 2006; 41: 388-9.
30. Elfaki DA, Lindor KD,. Antibiotics for the treatment of primary sclerosing cholangitis. Am J Ther 2011; 18: 261-5.
31. Stanich PP, Bjornsson E, Gossard AA, Enders F, Jorgensen R, Lindor KD,. Alkaline phosphatase normalization is associated with better prognosis in primary sclerosing cholangitis. Dig Liver Dis 2011; 43: 309-13.
32. Rankin JG, Boden RW, Goulston SJ, Morrow W,. The liver in ulcerative colitis; treatment of pericholangitis with tetracycline. Lancet 1959; 2: 1110-2.
33. Boner AL, Peroni D, Bodini A, Delaini G, Piacentini G,. Azithromycin may reduce cholestasis in primary sclerosing cholangitis: a case report and serendipitous observation. Int J Immunopathol Pharmacol 2007; 20: 847-9.
34. Kozaiwa K, Tajiri H, Sawada A, et al,. Three paediatric cases of primary sclerosing cholangitis treated with ursodeoxycholic acid and sulphasalazine. J Gastroenterol Hepatol 1998; 13: 825-9.
35. Broccoletti T, Spaziano M, Capuano G, et al,. Refractory primary sclerosing cholangitis becoming responsive after sulphasalazine treatment of an underlying silent colitis. Ital J Pediatr 2002; 28: 515-7.
36. Mistilis SP, Skyring AP, Goulston SJ,. Effect of long-term tetracycline therapy, steroid therapy and colectomy in pericholangitis associated with ulcerative colitis. Australas Ann Med 1965; 14: 286-94.
37. Kim WR, Therneau TM, Wiesner RH, et al,. A revised natural history model for primary sclerosing cholangitis. Mayo Clin Proc 2000; 75: 688-94.
38. Farkkila M, Karvonen AL, Nurmi H, et al,. Metronidazole and ursodeoxycholic acid for primary sclerosing cholangitis: a randomized placebo-controlled trial. Hepatology 2004; 40: 1379-86.
39. Silveira MG, Torok NJ, Gossard AA, et al,. Minocycline in the treatment of patients with primary sclerosing cholangitis: results of a pilot study. Am J Gastroenterol 2009; 104: 83-8.
40. Harada K, Nakanuma Y,. Biliary innate immunity: function and modulation. Mediators Inflamm 2010; 2010: 1-9.
41. Mueller T, Beutler C, Pico AH, et al,. Enhanced innate immune responsiveness and intolerance to intestinal endotoxins in human biliary epithelial cells contributes to chronic cholangitis. Liver Int 2011; 31: 1574-88.
42. Sasatomi K, Noguchi K, Sakisaka S, Sata M, Tanikawa K,. Abnormal accumulation of endotoxin in biliary epithelial cells in primary biliary cirrhosis and primary sclerosing cholangitis. J Hepatol 1998; 29: 409-16.
43. Seki E, De Minicis S, Osterreicher CH, et al,. TLR4 enhances TGF-beta signaling and hepatic fibrosis. Nat Med 2007; 13: 1324-32.
44. Bjornsson E, Cederborg A, Akvist A, Simren M, Stotzer PO, Bjarnason I,. Intestinal permeability and bacterial growth of the small bowel in patients with primary sclerosing cholangitis. Scand J Gastroenterol 2005; 40: 1090-4.
45. Lichtman SN, Keku J, Clark RL, Schwab JH, Sartor RB,. Biliary tract disease in rats with experimental small bowel bacterial overgrowth. Hepatology 1991; 13: 766-72.
46. Lichtman SN, Sartor RB,. Hepatobiliary injury associated with experimental small-bowel bacterial overgrowth in rats. Immunol Res 1991; 10: 528-31.
47. Yamada S, Ishii M, Kisara N, Nagatomi R, Toyota T,. Macrophages are essential for lymphocyte infiltration in formyl peptide-induced cholangitis in rat liver. Liver 1999; 19: 253-8.
48. Yamada S, Ishii M, Liang LS, Yamamoto T, Toyota T,. Small duct cholangitis induced by N-formyl L-methionine L-leucine L-tyrosine in rats. J Gastroenterol 1994; 29: 631-6.
49. Fisk JD, Ritvo PG, Ross L, Haase DA, Marrie TJ, Schlech WF,. Measuring the functional impact of fatigue: initial validation of the fatigue impact scale. Clin Infect Dis 1994; 18 (Suppl. 1): S79-83.