WGO Graded Evidence: Inflammatory Bowel Disease

Level: Clinical Trials: 33 Abstracts

Legend:   : Special Mention  : Important  : Very Important  : Key Development
	Infliximab, azathioprine, or combination therapy for Crohn's disease. Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens G, Diamond RH, Broussard DL, Tang KL, van der Woude CJ,Rutgeerts P; SONIC Study Group., N Engl J Med. 2010 Apr 15;362(15):1383-95.
	Narrow-band imaging versus high-definition endoscopy for the diagnosis ofneoplasia in ulcerative colitis. van den Broek FJ, Fockens P, van Eeden S, Stokkers PC, Ponsioen CY, Reitsma JB,Dekker E., Endoscopy. 2011 Feb;43(2):108-15. Epub 2010 Dec 16.
	Randomised clinical trial: improvement in health outcomes with certolizumab pegolin patients with active Crohn's disease with prior loss of response toinfliximab. Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ., Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi:10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
	Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is aseffective as twice-daily dosing for maintenance of remission of ulcerativecolitis. Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M,Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S., Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. Epub 2010 Jan 11.
	Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Sandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF, Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520
	Adverse events associated with common therapy regimens for moderate-to-severe Crohn's disease. Marehbian J, Arrighi HM, Hass S, Tian H, Sandborn WJ, Am J Gastroenterol. 2009 Oct;104(10):2524-33
	Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study. Valentine JF, Fedorak RN, Feagan B, Fredlund P, Schmitt R, Ni P, Humphries TJ, Gut. 2009 Oct;58(10):1354-62
	Randomised clinical trial: a comparative dose-finding study of three arms of dualrelease mesalazine for maintaining remission in ulcerative colitis. Kruis W, Jonaitis L, Pokrotnieks J, Mikhailova TL, Horynski M, Bátovský M,Lozynsky YS, Zakharash Y, Rácz I, Kull K, Vcev A, Faszczyk M, Dilger K, GreinwaldR, Mueller R; International Salofalk OD Study Group., Aliment Pharmacol Ther. 2011 Feb;33(3):313-22. doi:10.1111/j.1365-2036.2010.04537.x. Epub 2010 Dec 8.
	Randomised clinical trial: delayed-release oral mesalazine 4.8 g/day vs. 2.4g/day in endoscopic mucosal healing--ASCEND I and II combined analysis. Lichtenstein GR, Ramsey D, Rubin DT., Aliment Pharmacol Ther. 2011 Mar;33(6):672-8. doi:10.1111/j.1365-2036.2010.04575.x. Epub 2011 Jan 23.
	Anti-CD3 antibody visilizumab is not effective in patients with intravenouscorticosteroid-refractory ulcerative colitis. Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S,Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR., Gut. 2010 Nov;59(11):1485-92.
	Direct comparison of two different mesalamine formulations for the maintenance ofremission in patients with ulcerative colitis: a double-blind, randomized study. Ito H, Iida M, Matsumoto T, Suzuki Y, Aida Y, Yoshida T, Takano Y, Hibi T., Inflamm Bowel Dis. 2010 Sep;16(9):1575-82.
	Direct comparison of two different mesalamine formulations for the induction ofremission in patients with ulcerative colitis: a double-blind, randomized study. Ito H, Iida M, Matsumoto T, Suzuki Y, Sasaki H, Yoshida T, Takano Y, Hibi T., Inflamm Bowel Dis. 2010 Sep;16(9):1567-74.
	Newly developed antibiotic combination therapy for ulcerative colitis: adouble-blind placebo-controlled multicenter trial. Ohkusa T, Kato K, Terao S, Chiba T, Mabe K, Murakami K, Mizokami Y, Sugiyama T,Yanaka A, Takeuchi Y, Yamato S, Yokoyama T, Okayasu I, Watanabe S, Tajiri H, SatoN; Japan UC Antibiotic Therapy Study Group., Am J Gastroenterol. 2010 Aug;105(8):1820-9. Epub 2010 Mar 9.
	Clinical trial: controlled, open, randomized multicentre study comparing theeffects of treatment on quality of life, safety and efficacy of budesonide ormesalazine enemas in active left-sided ulcerative colitis. Hartmann F, Stein J; BudMesa-Study Group., Aliment Pharmacol Ther. 2010 Aug;32(3):368-76. Epub 2010 May 11.
	Treatment of ulcerative colitis with adalimumab or infliximab: long-termfollow-up of a single-centre cohort. Gies N, Kroeker KI, Wong K, Fedorak RN., Aliment Pharmacol Ther. 2010 Aug;32(4):522-8. Epub 2010 May 25.
	Surveillance programmes for neoplasia in colitis. Rutter MD., J Gastroenterol. 2011 Jan;46 Suppl 1:1-5. Epub 2010 Aug 27.
	Histomorphometric analysis reveals reduced bone mass and bone formation inpatients with quiescent Crohn's disease. Oostlander AE, Bravenboer N, Sohl E, Holzmann PJ, van der Woude CJ, Dijkstra G,Stokkers PC, Oldenburg B, Netelenbos JC, Hommes DW, van Bodegraven AA, Lips P;Dutch Initiative on Crohn and Colitis (ICC)., Gastroenterology. 2011 Jan;140(1):116-23. Epub 2010 Sep 18.
	Clinical trial: effects of an oral preparation of mesalazine at 4 g/day onmoderately active ulcerative colitis. A phase III parallel-dosing study. Hiwatashi N, Suzuki Y, Mitsuyama K, Munakata A, Hibi T., J Gastroenterol. 2011 Jan;46(1):46-56. Epub 2010 Sep 29.
	Clinical trial: colectomy after rescue therapy in ulcerative colitis - 3-yearfollow-up of the Swedish-Danish controlled infliximab study. Gustavsson A, Järnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlén P,Grännö C, Vilien M, Ström M, Verbaan H, Hellström PM, Magnuson A, Halfvarson J,Tysk C., Aliment Pharmacol Ther. 2010 Oct;32(8):984-9. doi:10.1111/j.1365-2036.2010.04435.x. Epub 2010 Aug 18.
	Anti-CD3 antibody visilizumab is not effective in patients with intravenouscorticosteroid-refractory ulcerative colitis. Sandborn WJ, Colombel JF, Frankel M, Hommes D, Lowder JN, Mayer L, Plevy S,Stokkers P, Travis S, Van Assche G, Baumgart DC, Targan SR., Gut. 2010 Nov;59(11):1485-92.
	Fontolizumab in moderate to severe Crohn's disease: a phase 2, randomized,double-blind, placebo-controlled, multiple-dose study. Reinisch W, de Villiers W, Bene L, Simon L, Rácz I, Katz S, Altorjay I, Feagan B,Riff D, Bernstein CN, Hommes D, Rutgeerts P, Cortot A, Gaspari M, Cheng M, PearceT, Sands BE., Inflamm Bowel Dis. 2010 Feb;16(2):233-42.
	Randomized, placebo-controlled, double-blind trial of Boswellia serrata inmaintaining remission of Crohn's disease: good safety profile but lack ofefficacy. Holtmeier W, Zeuzem S, Preiss J, Kruis W, Böhm S, Maaser C, Raedler A, Schmidt C,Schnitker J, Schwarz J, Zeitz M, Caspary W., Inflamm Bowel Dis. 2011 Feb;17(2):573-82.
	Anxiety and depression in patients with inflammatory bowel disease: comparisonswith chronic liver disease patients and the general population. Häuser W, Janke KH, Klump B, Hinz A., Inflamm Bowel Dis. 2011 Feb;17(2):621-32.
	Budesonide 9 mg is at least as effective as mesalamine 4.5 g in patients withmildly to moderately active Crohn's disease. Tromm A, Bunganic I, Tomsová E, Tulassay Z, Lukáš M, Kykal J, Bátovský M, Fixa B,Gabalec L, Safadi R, Kramm HJ, Altorjay I, Löhr H, Koutroubakis I, Bar-Meir S,Stimac D, Schäffeler E, Glasmacher C, Dilger K, Mohrbacher R, Greinwald R;International Budenofalk Study Group., Gastroenterology. 2011 Feb;140(2):425-434.e1; quiz e13-4. Epub 2010 Nov 9.
	E-health empowers patients with ulcerative colitis: a randomised controlled trialof the web-guided 'Constant-care' approach. Elkjaer M, Shuhaibar M, Burisch J, Bailey Y, Scherfig H, Laugesen B, Avnstrøm S, Langholz E, O'Morain C, Lynge E, Munkholm P., Gut. 2010 Dec;59(12):1652-61.
	Efficacy of methotrexate in ulcerative colitis: failure or promise. Herfarth HH, Osterman MT, Isaacs KL, Lewis JD, Sands BE., Inflamm Bowel Dis. 2010 Aug;16(8):1421-30.
	A randomized controlled trial of growth hormone in active pediatric Crohndisease. Denson LA, Kim MO, Bezold R, Carey R, Osuntokun B, Nylund C, Willson T, BonkowskiE, Li D, Ballard E, Collins M, Moyer MS, Klein DJ., J Pediatr Gastroenterol Nutr. 2010 Aug;51(2):130-9.
	Treatment of relapsing mild-to-moderate ulcerative colitis with the probioticVSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind,randomized, placebo-controlled study. Tursi A, Brandimarte G, Papa A, Giglio A, Elisei W, Giorgetti GM, Forti G, MoriniS, Hassan C, Pistoia MA, Modeo ME, Rodino' S, D'Amico T, Sebkova L, Sacca' N, Di Giulio E, Luzza F, Imeneo M, Larussa T, Di Rosa S, Annese V, Danese S, GasbarriniA., Am J Gastroenterol. 2010 Oct;105(10):2218-27. Epub 2010 Jun 1.
	Clinical trial: once-daily mesalamine granules for maintenance of remission ofulcerative colitis - a 6-month placebo-controlled trial. Lichtenstein GR, Gordon GL, Zakko S, Murthy U, Sedghi S, Pruitt R, Merchant K,Shaw A, Bortey E, Forbes WP., Aliment Pharmacol Ther. 2010 Oct;32(8):990-9. doi:10.1111/j.1365-2036.2010.04438.x. Epub 2010 Aug 18.
	Evaluation of the intestinal colonization by microencapsulated probiotic bacteriain comparison with the same uncoated strains. Del Piano M, Carmagnola S, Andorno S, Pagliarulo M, Tari R, Mogna L, Strozzi GP, Sforza F, Capurso L., J Clin Gastroenterol. 2010 Sep;44 Suppl 1:S42-6.
	Treatment of relapsing mild-to-moderate ulcerative colitis with the probioticVSL#3 as adjunctive to a standard pharmaceutical treatment: a double-blind,randomized, placebo-controlled study. Tursi A, Brandimarte G, Papa A, Giglio A, Elisei W, Giorgetti GM, Forti G, MoriniS, Hassan C, Pistoia MA, Modeo ME, Rodino' S, D'Amico T, Sebkova L, Sacca' N, Di Giulio E, Luzza F, Imeneo M, Larussa T, Di Rosa S, Annese V, Danese S, GasbarriniA., Am J Gastroenterol. 2010 Oct;105(10):2218-27. Epub 2010 Jun 1.
	The use of probiotics in healthy volunteers with evacuation disorders and hardstools: a double-blind, randomized, placebo-controlled study. Del Piano M, Carmagnola S, Anderloni A, Andorno S, Ballarè M, Balzarini M,Montino F, Orsello M, Pagliarulo M, Sartori M, Tari R, Sforza F, Capurso L., J Clin Gastroenterol. 2010 Sep;44 Suppl 1:S30-4.
	Clinical trial: oral colon-release parnaparin sodium tablets (CB-01-05 MMX) foractive left-sided ulcerative colitis. Celasco G, Papa A, Jones R, Moro L, Bozzella R, Surace MM, Naccari GC, GasbarriniG., Aliment Pharmacol Ther. 2010 Feb 1;31(3):375-86. Epub 2009 Nov 5.