PMID- 8964395
OWN - NLM
STAT- MEDLINE
DCOM- 19961212
LR  - 20220310
IS  - 0016-5085 (Print)
IS  - 0016-5085 (Linking)
VI  - 110
IP  - 6
DP  - 1996 Jun
TI  - Oral budesonide versus prednisolone in patients with active extensive and 
      left-sided ulcerative colitis.
PG  - 1713-8
AB  - BACKGROUND & AIMS: Systemic glucocorticosteroids (GCSs) have proven efficacy in 
      active ulcerative colitis but cause undesired systemic side effects. Therefore, 
      new GCSs with high topical activity and a high rate of metabolism may be of 
      clinical value in this condition. The aim of this study was to explore the 
      efficacy and safety of the topically acting GCS budesonide in an oral 
      controlled-release formulation in extensive or left-sided, mild to moderately 
      active ulcerative colitis. METHODS: A 9-week, randomized, double-blind, 
      controlled trial was performed, and treatments with 10 mg budesonide or 40 mg 
      prednisolone daily, both gradually tapered, were compared. Endoscopic improvement 
      and effect on endogenous plasma cortisol were assessed. RESULTS: Thirty-four 
      patients were administered budesonide, and 38 patients were administered 
      prednisolone. Mean endoscopic scores improved significantly in both groups but 
      without difference between the groups. Five patients in the budesonide group and 
      7 patients in the prednisolone group deteriorated and were withdrawn from the 
      study. Morning plasma cortisol levels were suppressed in the prednisolone group 
      (entry, 449 nmol/L; 2 weeks, 116 nmol/L; 4 weeks, 195 nmol/L) but were unchanged 
      in the budesonide group. CONCLUSIONS: The GCS budesonide administered in an oral 
      controlled-release formulation seems to give an overall treatment result in 
      active ulcerative colitis approaching that of prednisolone but without 
      suppression of plasma cortisol levels. This concept merits further evaluation.
FAU - Lofberg, R
AU  - Lofberg R
AD  - Department of Gastroenterology, Huddinge University Hospital, Stockholm, Sweden.
FAU - Danielsson, A
AU  - Danielsson A
FAU - Suhr, O
AU  - Suhr O
FAU - Nilsson, A
AU  - Nilsson A
FAU - Schioler, R
AU  - Schioler R
FAU - Nyberg, A
AU  - Nyberg A
FAU - Hultcrantz, R
AU  - Hultcrantz R
FAU - Kollberg, B
AU  - Kollberg B
FAU - Gillberg, R
AU  - Gillberg R
FAU - Willen, R
AU  - Willen R
FAU - Persson, T
AU  - Persson T
FAU - Salde, L
AU  - Salde L
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Gastroenterology
JT  - Gastroenterology
JID - 0374630
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Pregnenediones)
RN  - 51333-22-3 (Budesonide)
RN  - 9PHQ9Y1OLM (Prednisolone)
RN  - WI4X0X7BPJ (Hydrocortisone)
SB  - IM
CIN - Gastroenterology. 1996 Jun;110(6):2000-2. PMID: 8964430
MH  - Administration, Oral
MH  - Administration, Topical
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anti-Inflammatory Agents/therapeutic use
MH  - Budesonide
MH  - Colitis, Ulcerative/blood/*drug therapy/pathology
MH  - Colonoscopy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Hydrocortisone/blood
MH  - Male
MH  - Middle Aged
MH  - Pilot Projects
MH  - Prednisolone/adverse effects/*therapeutic use
MH  - Pregnenediones/adverse effects/*therapeutic use
MH  - Treatment Outcome
EDAT- 1996/06/01 00:00
MHDA- 1996/06/01 00:01
CRDT- 1996/06/01 00:00
PHST- 1996/06/01 00:00 [pubmed]
PHST- 1996/06/01 00:01 [medline]
PHST- 1996/06/01 00:00 [entrez]
AID - S0016508596002582 [pii]
AID - 10.1053/gast.1996.v110.pm8964395 [doi]
PST - ppublish
SO  - Gastroenterology. 1996 Jun;110(6):1713-8. doi: 10.1053/gast.1996.v110.pm8964395.