Cochrane · systematic review · CD007698
Oral budesonide for induction of remission in ulcerative colitis
Sherlock, ME, MacDonald, JK, Griffiths, AM, et al. · Cochrane Database of Systematic Reviews · 2015 · Cochrane Library
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
35
current version
GRADE rated
35
No studies
0
Included studies
NR
No studies 0 · 0%Ungraded 0 · 0%Very low 6 · 17.1%Low 13 · 37.1%Moderate 16 · 45.7%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Questions and results
Current version onlyBudesonide MMX® 9 mg versus placebo for induction of remission in ulcerative colitis
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Remission (combined clinical and endoscopic remission) Budesonide MMX® 9 mg vs placebo | RR 2.25 [1.5, 3.39] | 3 studies · 900 participants | Moderate Downgraded: imprecision |
Clinical improvement Budesonide MMX® 9 mg vs placebo | RR 1.3 [0.99, 1.7] | 2 studies · 442 participants | Moderate Downgraded: imprecision |
Endoscopic improvement Budesonide MMX® 9 mg vs placebo | RR 1.29 [1.01, 1.66] | 2 studies · 442 participants | Moderate Downgraded: imprecision |
Histologic remission Budesonide MMX® 9 mg vs placebo | RR 1.51 [1.11, 2.06] | 3 studies · 900 participants | Low Downgraded: imprecision, inconsistency |
Endoscopic remission Budesonide MMX® 9 mg vs placebo | RR 1.56 [1.13, 2.16] | 2 studies · 695 participants | Moderate Downgraded: imprecision |
Serious adverse events Budesonide MMX® 9 mg vs placebo | RR 0.88 [0.33, 2.4] | 2 studies · 513 participants | Low Downgraded: imprecision |
Adverse events Budesonide MMX® 9 mg vs placebo | RR 1.09 [0.95, 1.26] | 3 studies · 971 participants | Moderate Downgraded: inconsistency |
Budesonide MMX® 6 mg versus placebo for induction of remission in ulcerative colitis
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Remission (combined clinical and endoscopic remission Budesonide MMX® 6 mg vs placebo | RR 1.8 [0.94, 3.42] | 2 studies · 440 participants | Low Downgraded: imprecision |
Clinical improvement Budesonide MMX® 6 mg vs placebo | RR 0.99 [0.73, 1.33] | 2 studies · 440 participants | Low Downgraded: imprecision, inconsistency |
Endoscopic improvement Budesonide MMX® 6 mg vs placebo | RR 0.96 [0.73, 1.27] | 2 studies · 440 participants | Moderate Downgraded: imprecision |
Histologic remission Budesonide MMX® 6 mg vs placebo | RR 1.23 [0.63, 2.4] | 2 studies · 440 participants | Low Downgraded: imprecision |
Serious adverse events Budesonide MMX® 6 mg vs placebo | RR 0.63 [0.21, 1.91] | 2 studies · 512 participants | Low Downgraded: imprecision |
Adverse events Budesonide MMX® 6 mg vs placebo | RR 1.13 [0.97, 1.32] | 2 studies · 512 participants | Very low Downgraded: imprecision, inconsistency |
Withdrawal due to adverse events Budesonide MMX® 6 mg vs placebo | RR 1.1 [0.55, 2.22] | 2 studies · 512 participants | Low Downgraded: imprecision, inconsistency |
Budesonide 10 mg versus prednisolone 40 mg for induction of remission in ulcerative colitis
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Endoscopic improvement Budesonide 10 mg vs prednisolone 40 mg | RR 0.94 [0.66, 1.33] | 1 study · 72 participants | Low Downgraded: risk of bias, imprecision |
Endoscopic remission Budesonide 10 mg vs prednisolone 40 mg | RR 0.75 [0.23, 2.42] | 1 study · 72 participants | Very low Downgraded: risk of bias, imprecision |
Histologic remission Budesonide 10 mg vs prednisolone 40 mg | RR 0.56 [0.15, 2.06] | 1 study · 72 participants | Very low Downgraded: risk of bias, imprecision |
Adverse event ‐ Reduction in plasma cortisol below lower reference limit Budesonide 10 mg vs prednisolone 40 mg | RR 0.02 [0, 0.3] | 1 study · 67 participants | Very low Downgraded: risk of bias, imprecision |
Study withdrawals Budesonide 10 mg vs prednisolone 40 mg | RR 1.12 [0.47, 2.65] | 1 study · 72 participants | Very low Downgraded: risk of bias, imprecision |
Withdrawal due to adverse event Budesonide 10 mg vs prednisolone 40 mg | RR 0.98 [0.4, 2.41] | 1 study · 72 participants | Very low Downgraded: risk of bias, imprecision |
Budesonide versus mesalamine for induction of remission in ulcerative colitis
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Clinical remission (ITT analysis) Budesonide vs mesalamine | RR 0.72 [0.57, 0.91] | 1 study · 343 participants | Moderate Downgraded: imprecision |
Endoscopic improvement Gross 2011 Budesonide vs mesalamine | RR 0.84 [0.74, 0.95] | 1 study · 343 participants | Moderate Downgraded: imprecision |
Endoscopic remission (EI ≤ 1) Budesonide vs mesalamine | RR 0.78 [0.58, 1.04] | 1 study · 343 participants | Moderate Downgraded: imprecision |
Histologic remission Gross 2011 Budesonide vs mesalamine | RR 0.81 [0.66, 0.99] | 1 study · 343 participants | Moderate Downgraded: imprecision |
Adverse events Gross 2011 Budesonide vs mesalamine | RR 1.05 [0.73, 1.5] | 1 study · 343 participants | Moderate Downgraded: imprecision |
Remission (combined clinical and endoscopic remission) Budesonide vs mesalamine | RR 1.48 [0.81, 2.71] | 1 study · 247 participants | Low Downgraded: imprecision |
Clinical improvement Budesonide vs mesalamine | RR 0.98 [0.69, 1.4] | 1 study · 247 participants | Moderate Downgraded: imprecision |
Serious adverse events Budesonide vs mesalamine | RR 0.75 [0.17, 3.28] | 1 study · 254 participants | Low Downgraded: imprecision |
Budesonide MMX® 9 mg versus Entocort EC 9mg for induction of remission in ulcerative colitis
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Remission (combined clinical and endoscopic remission) Budesonide MMX® 9 mg vs Entocort EC 9mg | RR 1.38 [0.72, 2.65] | 1 study · 212 participants | Low Downgraded: imprecision |
Clinical improvement Budesonide MMX® 9 mg vs Entocort EC 9mg | RR 1.28 [0.9, 1.82] | 1 study · 212 participants | Moderate Downgraded: imprecision |
Endoscopic improvement Budesonide MMX® 9 mg vs Entocort EC 9mg | RR 1.14 [0.82, 1.6] | 1 study · 212 participants | Moderate Downgraded: imprecision |
Histologic remission Budesonide MMX® 9 mg vs Entocort EC 9mg | RR 1.21 [0.64, 2.31] | 1 study · 212 participants | Low Downgraded: imprecision |
Serious adverse events Budesonide MMX® 9 mg vs Entocort EC 9mg | RR 3.94 [0.45, 34.74] | 1 study · 254 participants | Low Downgraded: imprecision |
Adverse events Budesonide MMX® 9 mg vs Entocort EC 9mg | RR 1.01 [0.81, 1.26] | 1 study · 254 participants | Moderate Downgraded: imprecision |
Withdrawal due to adverse events Budesonide MMX® 9 mg vs Entocort EC 9mg | RR 0.94 [0.56, 1.58] | 1 study · 254 participants | Moderate Downgraded: imprecision |
Comparison
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Clinical Remission | no estimate extracted | 1 study · 72 participants | Ungraded |
Clinical Improvement | no estimate extracted | 1 study · 72 participants | Ungraded |
Endoscopic Improvement | RR 0.94 [0.66, 1.33] | 1 study · 72 participants | Low Downgraded: risk of bias |
Histologic Remission | RR 0.56 [0.15, 2.06] | 1 study · 72 participants | Low Downgraded: risk of bias |
Endoscopic Mucosal Healing | RR 0.75 [0.23, 2.42] | 1 study · 72 participants | Low Downgraded: risk of bias |
Change in Disease Activity Index Score | no estimate extracted | 1 study · 72 participants | Ungraded |
Quality of Life, Hospital admissions, need for intravenous corticosteroids | no estimate extracted | 1 study · 72 participants | Ungraded |
Adverse Events | RR 0.02 | 1 study · 67 participants | Low Downgraded: risk of bias |
Total Study Withdrawals | RR 0.97 [0.41, 2.28] | 1 study · 72 participants | Low Downgraded: risk of bias |
Comparison
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Clinical Remission | RR 0.72 [0.57, 0.91] | 1 study · 343 participants | High |
Clinical Improvement | RR 0.75 [0.63, 0.89] | 1 study · 343 participants | High |
Endoscopic Improvement | no estimate extracted | 1 study · 343 participants | Ungraded |
Histologic Remission | RR 0.8 [0.66, 0.98] | 1 study · 343 participants | High |
Endoscopic Mucosal Healing | RR 0.76 [0.64, 0.91] | 1 study · 285 participants | High |
Change in Disease Activity Index Score | no estimate extracted | 1 study · 343 participants | Ungraded |
Quality of Life, Hospital admissions, need for intravenous corticosteroids | no estimate extracted | 1 study · 343 participants | Ungraded |
Adverse Events | no estimate extracted | 1 study · 343 participants | Ungraded |
Total Study Withdrawals | no estimate extracted | 1 study · 343 participants | Ungraded |
Comparison
Population: Adult patients with active ulcerative colitis
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Clinical Remission | RR 1.41 [0.59, 3.39] | 1 study · 32 participants | Moderate Downgraded: risk of bias |
Clinical Improvement | RR 1.41 [0.59, 3.39] | 1 study · 32 participants | Moderate Downgraded: risk of bias |
Endoscopic Improvement | Mean Difference 0.11 | 1 study · 31 participants | Moderate Downgraded: risk of bias |
Histologic Improvement at 4 weeks | no estimate extracted | 1 study · 31 participants | Ungraded |
Endoscopic Mucosal Healing at 4 weeks | no estimate extracted | 1 study · 32 participants | Ungraded |
Change in Disease Activity Index Score at 4 weeks | no estimate extracted | 1 study · 32 participants | Moderate Downgraded: risk of bias |
Quality of Life, Hospital admissions, need for intravenous corticosteroids | no estimate extracted | 1 study · 32 participants | Ungraded |
Adverse Events | no estimate extracted | 1 study · 32 participants | Moderate Downgraded: risk of bias |
Study Withdrawals | no estimate extracted | 1 study · 32 participants | Ungraded |