TITLE

A DOUBLE BLIND, PLACEBO CONTROLLED RANDOMISED TRIAL OF CURCUMIN EXTRACT IN THE TREATMENT OF STEROID DEPENDENT INFLAMMATORY BOWEL DISEASE

AUTHOR(S)
Atkinson, R.J.; Hunter, J.O.
PUB. DATE
April 2003
SOURCE
Gut;Apr2003 Supplement 1, Vol. 52, pA63
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Introduction: Nuclear factor kappa B (NFkB) is a pro-inflammatory transcription factor which plays an integral part in the pathogenesis of inflammatory bowel disease (IBD). Curcumin has anti-inflammatory properties through prevention of NFkB activation and is effective in the TNBS model of colitis. We present the results of a trial of Curcuma extract (PYM 50014) as a steroid sparing agent in patients with IBD. Methods: 27 patients with steroid dependent colitis were entered into the 16 week study. All patients were in remission on 5-30mg prednisolone per day, were 6 weeks from their last clinical relapse and were not on any other steroid sparing agent (e.g. azathioprine). Disease activity was assessed by either Ulcerative Colitis Index (UCI) or Crohn's disease activity Index (CDAI), standard laboratory parameters (C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), platelet count, albumin) and flexible sigmoidoscopy. Randomisation to PYM 50014 (3×220mg b.i.d) or placebo was at 2 weeks and steroid reduction began 2 weeks later. Patients were assessed every two weeks and their prednisolone reduced as long as they remained in remission. Primary end points were remission at 16 weeks, or relapse, when the minimum effective dose of prednisolone was calculated. Results: 13 patients received PYM 50014 (8 UC, 5 CD) and 14 placebo (8 UC, 6 CD). The groups were matched for sex, duration of disease and disease activity, although the PYM 50014 group tended to be younger (36.9 ± 10.35; 52.3 ± 12.72 years). 5 (38%) patients in the PYM 50014 and 6 (43%) in the placebo group 16 week treatment period. The average total steroid reduction was 45.2% on PYM50014 and 56.8% on placebo. There were no significant differences between the groups, whether or not patients were analysed according to disease type. Discussion: Whilst apparently safe, PYM 50014 does not appear to enable steroid dependant patients to reduce their steroid requirements. There may be...
ACCESSION #
9747712

 

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