{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T20:27:36Z","timestamp":1793219256034,"version":"4.5.0"},"reference-count":23,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2005,12,22]],"date-time":"2005-12-22T00:00:00Z","timestamp":1135209600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2006,1]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p><jats:bold>Background\u2002<\/jats:bold> Rectal budesonide is an effective treatment of active ulcerative proctitis or proctosigmoiditis.<\/jats:p><jats:p><jats:bold>Aim\u2002<\/jats:bold> To compare the therapeutic efficacy, tolerability and safety, and patient's preference of budesonide foam vs. budesonide enema.<\/jats:p><jats:p><jats:bold>Methods\u2002<\/jats:bold> Patients with active ulcerative proctitis or proctosigmoiditis (clinical activity index &gt;4 and endoscopic index \u22654) were eligible for this double\u2010blind, double\u2010dummy, randomized, multicentre study. They received 2\u2003mg\/25\u2003mL budesonide foam and placebo enema (<jats:italic>n<\/jats:italic>\u2003=\u2003265), or 2\u2003mg\/100\u2003mL budesonide enema and placebo foam (<jats:italic>n<\/jats:italic>\u2003=\u2003268) for 4\u2003weeks. Primary endpoint was clinical remission (clinical activity index \u22644) at the final\/withdrawal visit (per protocol).<\/jats:p><jats:p><jats:bold>Results\u2002<\/jats:bold> A total of 541 patients were randomized \u2013 533 were evaluable for intention\u2010to\u2010treat analysis and 449 for per protocol analysis. Clinical remission rates (per protocol) were 60% for budesonide foam and 66% for budesonide enema (<jats:italic>P<\/jats:italic>\u2003=\u20030.02362 for non\u2010inferiority of foam vs. enema within a predefined non\u2010inferiority margin of 15%). Both formulations were safe and no drug\u2010related serious adverse events were observed. Because of better tolerability and easier application most patients preferred foam (84%).<\/jats:p><jats:p><jats:bold>Conclusion\u2002<\/jats:bold> Budesonide foam is as effective as budesonide enema in the treatment of active ulcerative proctitis or proctosigmoiditis. Both budesonide formulations are safe, and most patients prefer foam.<\/jats:p>","DOI":"10.1111\/j.1365-2036.2006.02743.x","type":"journal-article","created":{"date-parts":[[2005,12,22]],"date-time":"2005-12-22T04:28:33Z","timestamp":1135225713000},"page":"303-312","source":"Crossref","is-referenced-by-count":81,"title":["Budesonide foam versus budesonide enema in active ulcerative proctitis and proctosigmoiditis"],"prefix":"10.1111","volume":"23","author":[{"given":"V.","family":"GROSS","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"BAR\u2010MEIR","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"LAVY","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"O.","family":"MICKISCH","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Z.","family":"TULASSAY","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"PRONAI","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"KUPCINSKAS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"KIUDELIS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"POKROTNIEKS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00c1.","family":"KOV\u00c1CS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"FASZCZYK","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"RAZBADAUSKAS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B.","family":"MARGUS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"STOLTE","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"M\u00dcLLER","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.","family":"GREINWALD","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"THE INTERNATIONAL BUDESONIDE FOAM STUDY GROUP","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2005,12,22]]},"reference":[{"key":"e_1_2_7_2_2","doi-asserted-by":"publisher","DOI":"10.3109\/00365528708991947"},{"key":"e_1_2_7_3_2","doi-asserted-by":"publisher","DOI":"10.3109\/00365529108998618"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.3109\/00365529209011158"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/00042737-199402000-00007"},{"key":"e_1_2_7_6_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.1994.tb00335.x"},{"key":"e_1_2_7_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.1994.tb00340.x"},{"key":"e_1_2_7_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.1995.tb00421.x"},{"key":"e_1_2_7_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(95)27423-5"},{"issue":"3","key":"e_1_2_7_10_2","first-page":"A223","article-title":"Treatment of active distal ulcerative colitis (UC) and maintenance of remission with Entocort\u00ae enema: a randomised controlled dosage study","volume":"41","author":"Lindgren S","year":"1997","journal-title":"Gut"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(98)70131-3"},{"key":"e_1_2_7_12_2","first-page":"A170","article-title":"Treatment with glucocorticosteroid enemas in children with ulcerative colitis; a randomised single\u2010blind multicenter comparison between budesonide and prednisolone","volume":"45","author":"Ejderhamn J","year":"1999","journal-title":"Gut"},{"key":"e_1_2_7_13_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-2000-14869"},{"key":"e_1_2_7_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(98)84386-2"},{"key":"e_1_2_7_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-004-6687-x"},{"key":"e_1_2_7_16_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.298.6666.82"},{"key":"e_1_2_7_17_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.32.2.174"},{"key":"e_1_2_7_18_2","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(87)90621-4"},{"key":"e_1_2_7_19_2","doi-asserted-by":"publisher","DOI":"10.2307\/2530245"},{"key":"e_1_2_7_20_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.1999.01286.x"},{"key":"e_1_2_7_21_2","volume-title":"Statistische Testverfahren f\u00fcr gruppensequentielle und adaptive Pl\u00e4ne in klinischen Studien. 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