Ferguson 1998.
| Methods | Randomized, double‐blind, placebo‐controlled, multicenter study with three parallel groups | |
| Participants | Patients 18‐65 years old with CD limited to the ileal or ileocecal region or ascending colon, in clinical remission defined by a CDAI < 150 (N = 75) METHOD OF INDUCTION OF REMISSION: 12‐week course of budesonide in a clinical trial EXCLUSION CRITERIA: 1) Ileostomy or previous small bowel resection >100 cm, 2) Pregnant or breast‐feeding, 3) History of drug/alcohol abuse, 4) Active infection, 5) Active fistulae, 6) Rectal inflammation, 7) Hyperglycemia, 8) Significant hepatic/renal/cardiovascular disease, 9) Significant mental abnormality, 10) Any other steroid therapy, cholestyramine, azathioprine, 6‐mercaptopurine, methotrexate, cyclosporine, metronidazole, tinidazole, sulfasalazine, other aminosalicylates, H2‐blockers, proton pump inhibitors or parenteral, enteral or polymeric nutrition | |
| Interventions | Group 1: CIR budesonide (Entocort) 3 mg twice daily (6 mg/day) for 12 months (n = 22)_ Group 2: CIR budesonide (Entocort) 3 mg once daily for 12 months (n = 26) Group 3: Placebo for 12 months (n = 27) |
|
| 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) CDAI changes 4) Adverse events 5) Baseline plasma cortisol 6) ACTH test |
|
| Notes | Additional unpublished data obtained from study sponsor | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization was completed in blocks |
| Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes were used to assign treatment |
| 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 |