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

Gut2 versionsAMSTAR 2: not assessed
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

Show all 2 versions

Budesonide MMX® 9 mg versus placebo for induction of remission in ulcerative colitis

Population: Adult patients with active ulcerative colitis
7 questions
OutcomeEffectEvidenceStatus / GRADE
Remission (combined clinical and endoscopic remission)
Budesonide MMX® 9 mg vs placebo
RR 2.25 [1.5, 3.39]3 studies · 900 participantsModerate
Downgraded: imprecision
Clinical improvement
Budesonide MMX® 9 mg vs placebo
RR 1.3 [0.99, 1.7]2 studies · 442 participantsModerate
Downgraded: imprecision
Endoscopic improvement
Budesonide MMX® 9 mg vs placebo
RR 1.29 [1.01, 1.66]2 studies · 442 participantsModerate
Downgraded: imprecision
Histologic remission
Budesonide MMX® 9 mg vs placebo
RR 1.51 [1.11, 2.06]3 studies · 900 participantsLow
Downgraded: imprecision, inconsistency
Endoscopic remission
Budesonide MMX® 9 mg vs placebo
RR 1.56 [1.13, 2.16]2 studies · 695 participantsModerate
Downgraded: imprecision
Serious adverse events
Budesonide MMX® 9 mg vs placebo
RR 0.88 [0.33, 2.4]2 studies · 513 participantsLow
Downgraded: imprecision
Adverse events
Budesonide MMX® 9 mg vs placebo
RR 1.09 [0.95, 1.26]3 studies · 971 participantsModerate
Downgraded: inconsistency

Budesonide MMX® 6 mg versus placebo for induction of remission in ulcerative colitis

Population: Adult patients with active ulcerative colitis
7 questions
OutcomeEffectEvidenceStatus / GRADE
Remission (combined clinical and endoscopic remission
Budesonide MMX® 6 mg vs placebo
RR 1.8 [0.94, 3.42]2 studies · 440 participantsLow
Downgraded: imprecision
Clinical improvement
Budesonide MMX® 6 mg vs placebo
RR 0.99 [0.73, 1.33]2 studies · 440 participantsLow
Downgraded: imprecision, inconsistency
Endoscopic improvement
Budesonide MMX® 6 mg vs placebo
RR 0.96 [0.73, 1.27]2 studies · 440 participantsModerate
Downgraded: imprecision
Histologic remission
Budesonide MMX® 6 mg vs placebo
RR 1.23 [0.63, 2.4]2 studies · 440 participantsLow
Downgraded: imprecision
Serious adverse events
Budesonide MMX® 6 mg vs placebo
RR 0.63 [0.21, 1.91]2 studies · 512 participantsLow
Downgraded: imprecision
Adverse events
Budesonide MMX® 6 mg vs placebo
RR 1.13 [0.97, 1.32]2 studies · 512 participantsVery 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 participantsLow
Downgraded: imprecision, inconsistency

Budesonide 10 mg versus prednisolone 40 mg for induction of remission in ulcerative colitis

Population: Adult patients with active ulcerative colitis
6 questions
OutcomeEffectEvidenceStatus / GRADE
Endoscopic improvement
Budesonide 10 mg vs prednisolone 40 mg
RR 0.94 [0.66, 1.33]1 study · 72 participantsLow
Downgraded: risk of bias, imprecision
Endoscopic remission
Budesonide 10 mg vs prednisolone 40 mg
RR 0.75 [0.23, 2.42]1 study · 72 participantsVery 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 participantsVery 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 participantsVery 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 participantsVery 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 participantsVery low
Downgraded: risk of bias, imprecision

Budesonide versus mesalamine for induction of remission in ulcerative colitis

Population: Adult patients with active ulcerative colitis
8 questions
OutcomeEffectEvidenceStatus / GRADE
Clinical remission (ITT analysis)
Budesonide vs mesalamine
RR 0.72 [0.57, 0.91]1 study · 343 participantsModerate
Downgraded: imprecision
Endoscopic improvement Gross 2011
Budesonide vs mesalamine
RR 0.84 [0.74, 0.95]1 study · 343 participantsModerate
Downgraded: imprecision
Endoscopic remission (EI ≤ 1)
Budesonide vs mesalamine
RR 0.78 [0.58, 1.04]1 study · 343 participantsModerate
Downgraded: imprecision
Histologic remission Gross 2011
Budesonide vs mesalamine
RR 0.81 [0.66, 0.99]1 study · 343 participantsModerate
Downgraded: imprecision
Adverse events Gross 2011
Budesonide vs mesalamine
RR 1.05 [0.73, 1.5]1 study · 343 participantsModerate
Downgraded: imprecision
Remission (combined clinical and endoscopic remission)
Budesonide vs mesalamine
RR 1.48 [0.81, 2.71]1 study · 247 participantsLow
Downgraded: imprecision
Clinical improvement
Budesonide vs mesalamine
RR 0.98 [0.69, 1.4]1 study · 247 participantsModerate
Downgraded: imprecision
Serious adverse events
Budesonide vs mesalamine
RR 0.75 [0.17, 3.28]1 study · 254 participantsLow
Downgraded: imprecision

Budesonide MMX® 9 mg versus Entocort EC 9mg for induction of remission in ulcerative colitis

Population: Adult patients with active ulcerative colitis
7 questions
OutcomeEffectEvidenceStatus / 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 participantsLow
Downgraded: imprecision
Clinical improvement
Budesonide MMX® 9 mg vs Entocort EC 9mg
RR 1.28 [0.9, 1.82]1 study · 212 participantsModerate
Downgraded: imprecision
Endoscopic improvement
Budesonide MMX® 9 mg vs Entocort EC 9mg
RR 1.14 [0.82, 1.6]1 study · 212 participantsModerate
Downgraded: imprecision
Histologic remission
Budesonide MMX® 9 mg vs Entocort EC 9mg
RR 1.21 [0.64, 2.31]1 study · 212 participantsLow
Downgraded: imprecision
Serious adverse events
Budesonide MMX® 9 mg vs Entocort EC 9mg
RR 3.94 [0.45, 34.74]1 study · 254 participantsLow
Downgraded: imprecision
Adverse events
Budesonide MMX® 9 mg vs Entocort EC 9mg
RR 1.01 [0.81, 1.26]1 study · 254 participantsModerate
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 participantsModerate
Downgraded: imprecision