Lofberg 1996.
| Methods | Randomized, double‐blind, placebo‐controlled, multicenter study with three parallel groups | |
| Participants | Patients > 18 years of age with CD restricted to the terminal ileum or ileocecal region, in clinical remission defined by a CDAI < 150 (N = 90) METHOD OF INDUCTION OF REMISSION: 10 week course of either budesonide or prednisolone in a clinical trial EXCLUSION CRITERIA: 1) Septic complications, 2) Active inflammation of the rectum, 3) Peptic ulcer disease, 4) Diabetes mellitus, 5) Hyperglycemia, 6) Significant hepatic, renal or cardiovascular disease, 7) Patients receiving total parenteral, enteric or polymeric nutrition, 8) Ileostomy or previous small bowel resection >100 cm | |
| Interventions | Group 1: CIR budesonide (Entocort) 6 mg daily for 12 months (n = 32) Group 2: CIR budesonide (Entocort) 3 mg daily for 12 months (n = 31) Group 3: Placebo for 12 months (n = 27) |
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| Outcomes | 1) Proportion of patients with disease in remission defined as CDAI < 150 at specific time points 2) Time to relapse of disease (defined as CDAI > 150 and an increase of at least 60 points from baseline) 3) Adverse events 4) ACTH stimulation test (normal response defined as baseline plasma cortisol concentration > 150 nmol/L and a concentration of > 400 nmol/L or an increase of at least 200 nmol/L at 30 or 60 minutes) |
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| Notes | Additional unpublished data obtained from study sponsor | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Patients were randomized in blocks at each centre |
| Allocation concealment (selection bias) | Unclear risk | No description provided |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Described as double blind Appearance of placebo was identical to that of the study mediation Blinding of outcome assessors was not described; however, the primary outcome (based on the CDAI) is predominately based on patient reports (diary) and is consequently at low risk of bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were similar across groups |
| Selective reporting (reporting bias) | Low risk | All key outcomes were included |
| Other bias | Low risk | No additional sources of bias were identified |