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Budesonide as induc...
Budesonide as induction therapy for incomplete microscopic colitis : A randomised, placebo-controlled multicentre trial
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- Münch, Andreas (författare)
- Linköpings universitet,Avdelningen för molekylär medicin och virologi,Medicinska fakulteten,Region Östergötland, Mag- tarmmedicinska kliniken
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- Mihaly, Emese (författare)
- Department of Internal Medicine, Semmelweis Egyetem, Budapest, Hungary
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- Nagy, Ferenc (författare)
- First Department of Medicine, Szegedi Egyetem ÁOKI sz., Szeged, Hungary
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- Madisch, Ahmed (författare)
- Medical Department I, KRH Klinikum Siloah ,Hannover, Germany
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- Kupcinskas, Juozas (författare)
- Department of Gastroenterology, Institute for Digestive Research, Lithuanian University of Health Sciences, Kaunas, Lithuania,Lithuanian Univ Hlth Sci, Lithuania
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- Miehlke, Stephan (författare)
- Center for Digestive Diseases, Internal Medicine Center Eppendorf, Hamburg, Germany; Centre for Interdisciplinary Endoscopy, University Hospital Eppendorf, Hamburg, Germany,Internal Med Ctr Eppendorf, Germany; Univ Hosp Eppendorf, Germany
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- Bohr, Johan, 1957- (författare)
- Örebro universitet,Institutionen för hälsovetenskaper,Region Örebro län,Division of Gastroenterology,Orebro Univ Hosp, Sweden
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- Bouma, Gerd (författare)
- Department of Gastroenterology, Vrije Universiteit Medical Centre, Amsterdam, Netherlands,Vrije Univ Med Ctr, Netherlands
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- Guardiola, Jordi (författare)
- Department of Digestive Diseases, Hospital Universitario de Bellvitge, Barcelona, Spain,Hosp Univ Bellvitge, Spain
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- Belloc, Blanca (författare)
- Department of Gastroenterology, Hospital San Jorge – University of Zaragoza, Huesca, Spain,Univ Zaragoza, Spain
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- Shi, Chunliang (författare)
- Department of Gastroenterology, Norrlands Universitetssjukhus, Umeå, Sweden
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- Aust, Daniela (författare)
- Institute for Pathology, University Hospital Carl Gustav Carus, Dresden, Germany,Univ Hosp Carl Gustav Carus, Germany
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- Mohrbacher, Ralf (författare)
- Clinical Research and Development Department, Dr Falk Pharma GmbH, Freiburg, Germany
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- Greinwald, Roland (författare)
- Clinical Research and Development Department, Dr Falk Pharma GmbH, Freiburg, Germany
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- Munck, Lars Kristian (författare)
- Department of Gastroenterology, Zealand University Hospital, Køge, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark,Zealand Univ Hosp, Denmark; Univ Copenhagen, Denmark
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(creator_code:org_t)
- 2021-08-20
- 2021
- Engelska.
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Ingår i: United European Gastroenterology journal. - : Sage Publications. - 2050-6406 .- 2050-6414. ; 9:7, s. 837-847
- Relaterad länk:
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https://doi.org/10.1...
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https://onlinelibrar...
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https://liu.diva-por... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- Background and aims: Incomplete microscopic colitis (MCi) is a subtype of microscopic colitis (MC). Budesonide is recommended as a first-line treatment for MC. However, randomised trials on efficacy of treatment in MCi are missing. We therefore performed a randomised, placebo-controlled trial to evaluate budesonide as induction therapy for MCi.Methods: Patients with active MCi were randomly assigned to either budesonide 9 mg once daily or placebo for 8 weeks in a double-blind, double-dummy design. The primary endpoint was clinical remission, defined as a mean of <3 stools/day and a mean of <1 watery stool/day in the 7 days before week 8.Results: Due to insufficient patient recruitment, the trial was discontinued prematurely. The intention-to-treat analysis included 44 patients (21 budesonide and 23 placebo). The primary endpoint of clinical remission at week 8 was obtained by 71.4% on budesonide and 43.5% on placebo (p = 0.0582). All clinical secondary endpoints were in favour of budesonide. Budesonide decreased the number of soft or watery stools (16.3 vs. 7.7, p = 0.0186) and improved health-related quality of life for all four dimensions of the short health scale. Adverse events with a suspected relation to study drug were reported in one patient in the budesonide group and two patients in the placebo group. Neither serious nor severe adverse events occurred during the double-blind phase.Conclusions: Budesonide decreased the frequency of soft or watery stools and improved the patients' quality of life significantly in MCi, but the primary endpoint was not met due to the low sample size (type 2 error). Budesonide was safe and well tolerated during the 8-weeks treatment course.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Gastroenterologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Gastroenterology and Hepatology (hsv//eng)
Nyckelord
- budesonide
- drug
- incomplete microscopic colitis
- induction therapy
- MCi
- microscopic colitis
- QoL
- quality of life
- randomised clinical trial
- watery diarrhoea
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
Till lärosätets databas
- Av författaren/redakt...
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Münch, Andreas
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Mihaly, Emese
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Nagy, Ferenc
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Madisch, Ahmed
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Kupcinskas, Juoz ...
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Miehlke, Stephan
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visa fler...
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Bohr, Johan, 195 ...
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Bouma, Gerd
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Guardiola, Jordi
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Belloc, Blanca
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Shi, Chunliang
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Aust, Daniela
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Mohrbacher, Ralf
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Greinwald, Rolan ...
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Munck, Lars Kris ...
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Gastroenterologi
- Artiklar i publikationen
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United European ...
- Av lärosätet
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Örebro universitet
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Linköpings universitet