Inflammatory bowel disease: clinical symptoms and acute-phase proteins were more effective for tapering steroids than clinical symptoms alone.

Clinical bottom line (level 1b)

  1. Patients with inflammatory bowel disease who were on steroids which are tapered on the basis of clinical symptoms and serum orosomucoid are less likely to be off steroids than patients just tapered on clinical symptoms alone (NNH = 3 at 12 months) .
  2. However, fewer patients failed to achieve remission or had a subsequent relapse in the next year (NNT = 3 at 12 months) .
Kjeldsen et al: Scandinavian Journal of Gastroenterology 1997; 32: 933-941
Expires May 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: university hospital, Denmark

88 patients (aged mean 41 years, 55% male) active ulcerative colitis (33%) or Crohn's disease (67%) requiring steroids for control of disease activity

Excluded if
  • Harvey-Bradshaw index < 6 in Crohn's disease; clinical index < 5 in UC
  • orosomucoid < 1.60 U/l
  • aged <18
  • critically ill
  • inability to co-operate
  • impaired renal function
  • ongoing severe infection
  • other causes for elevation of acute-phase proteins
  • malignancy or life-expectancy < 1 year
  • pregnancy or breast-feeling
  • treatment with azathioprine within four months or metronidazole within one month
  • topical treatment with glucocorticoids


    • Note:
  • Patients were stratified for Crohn's disease or ulcerative colitis.


    • Control Group: (n = 44, 44 analysed): tapering of dose of prednisolone if improvement in disease indices was two or more
    Experimental Group: (n = 44, 44 analysed): tapering of prednisolone dose if improvement in disease indices was two or more and a decrease in serum concentration of orosomucoid 13.5% or more
    Patients were initially on 75 mg or 40 mg prednisolone - the dose was reduced by 5-10 mg weekly if possible. Disease severity was assessed by Harvey-Bradshaw index for Crohn's disease, and a clinical index for ulcerative colitis.
    100% followed for 12 months
    Outcome notes:
    • failure or relapse : failure to achieve remission (Harvey-Bradshaw index 4 or less, ulcerative colitis clinical index 3 or less and orosomucoid < 1.42 U/l ) or subsequent relapse; Harvey-Bradshaw index > 4, ulcerative colitis clinical index > 3

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    continued prednisolone 12 months 16
    (36.4%)    		 33
    (75.0%)    		 -106%
    (-216% to -35%)    		 -38.6%
    (-57.8% to -19.5%)    		 -3
    (-5 to -2)
    failure or relapse unknown 27
    (61.4%)    		 12
    (27.3%)    		 56%
    (24% to 74%)    		 34.1%
    (14.6% to 53.6%)    		 3
    (2 to 7)

    Comments

    1. Orosomucoid is an acute-phase protein.
    2. Multivariate regression analysis showed that elevated orosomucoid and previous attacks of disease were significantly associated with subsequent relapse.

    Citation

    1. Kjeldsen J, Lauritsen K, Schaffalitzke de Muckadell OB: Serum concentration of orosomucoid: improved decision-making for tapering prednisolone therapy in patients with active inflammatory bowel disease?. Scandinavian Journal of Gastroenterology 1997; 32: 933-941
    Search Terms: Crohn* in Cochrane
    Contributor: Chris Ball and Clare Wotton, October 2000
    Reviewer:

    Clinical Question.
    Patient inflammatory bowel disease
    Intervention or Exposure steroids which are tapered on the basis of clinical symptoms and orosomucoid
    Comparison steroids tapered on clinical symptoms alone
    Outcome stopped steroids, relapse or failure