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Study flow diagram.
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Figure 1

Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 5‐ASA compared to placebo, outcome: 1.1 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.
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Figure 3

Forest plot of comparison: 1 5‐ASA compared to placebo, outcome: 1.1 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.

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Forest plot of comparison: 1 5‐ASA compared to placebo, outcome: 1.5 Adverse events.
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Figure 4

Forest plot of comparison: 1 5‐ASA compared to placebo, outcome: 1.5 Adverse events.

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Funnel plot of comparison: 1 5‐ASA compared to placebo, outcome: 1.8 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.
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Figure 5

Funnel plot of comparison: 1 5‐ASA compared to placebo, outcome: 1.8 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.

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Comparison 1 5‐ASA compared to placebo, Outcome 1 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.
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Analysis 1.1

Comparison 1 5‐ASA compared to placebo, Outcome 1 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.

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Comparison 1 5‐ASA compared to placebo, Outcome 2 Sensitivity analysis ‐ Relapse, drop‐outs classed as relapse, grouped by length of follow‐up, random effects.
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Analysis 1.2

Comparison 1 5‐ASA compared to placebo, Outcome 2 Sensitivity analysis ‐ Relapse, drop‐outs classed as relapse, grouped by length of follow‐up, random effects.

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Comparison 1 5‐ASA compared to placebo, Outcome 3 Sensitivity analysis ‐ Relapse, drop‐outs ignored, grouped by length of follow‐up.
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Analysis 1.3

Comparison 1 5‐ASA compared to placebo, Outcome 3 Sensitivity analysis ‐ Relapse, drop‐outs ignored, grouped by length of follow‐up.

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Comparison 1 5‐ASA compared to placebo, Outcome 4 Sensitivity analysis ‐ Relapse, drop‐outs ignored, grouped by length of follow‐up, random effects.
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Analysis 1.4

Comparison 1 5‐ASA compared to placebo, Outcome 4 Sensitivity analysis ‐ Relapse, drop‐outs ignored, grouped by length of follow‐up, random effects.

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Comparison 1 5‐ASA compared to placebo, Outcome 5 Adverse events.
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Analysis 1.5

Comparison 1 5‐ASA compared to placebo, Outcome 5 Adverse events.

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Comparison 1 5‐ASA compared to placebo, Outcome 6 Withdrawals due to adverse events.
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Analysis 1.6

Comparison 1 5‐ASA compared to placebo, Outcome 6 Withdrawals due to adverse events.

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Comparison 1 5‐ASA compared to placebo, Outcome 7 Serious adverse events.
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Analysis 1.7

Comparison 1 5‐ASA compared to placebo, Outcome 7 Serious adverse events.

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Comparison 1 5‐ASA compared to placebo, Outcome 8 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.
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Analysis 1.8

Comparison 1 5‐ASA compared to placebo, Outcome 8 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up.

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Summary of findings for the main comparison. 5‐ASA compared to placebo for maintenance of medically‐induced remission in Crohn's disease

5‐ASA compared to placebo for maintenance of medically‐induced remission in Crohn's disease

Patient or population: patients with maintenance of medically‐induced remission in Crohn's disease
Settings:
Intervention: 5‐ASA compared to placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

5‐ASA compared to placebo

Relapse, drop‐outs classed as relapse, grouped by length of follow‐up ‐ 12 months

535 per 10001

525 per 1000
(487 to 573)

RR 0.98
(0.91 to 1.07)

2014
(11 studies)

⊕⊕⊕⊝
moderate2

Relapse, drop‐outs classed as relapse, grouped by length of follow‐up ‐ 24 months

679 per 10003

672 per 1000
(543 to 835)

RR 0.99
(0.8 to 1.23)

161
(1 study)

⊕⊕⊝⊝
low4,5

Relapse, drop‐outs classed as relapse, grouped by length of follow‐up ‐ Pediatric

688 per 10003

736 per 1000
(591 to 914)

RR 1.07
(0.86 to 1.33)

132
(1 study)

⊕⊕⊕⊝
moderate6

Adverse events

329 per 10001

346 per 1000
(313 to 385)

RR 1.05
(0.95 to 1.17)

1814
(10 studies)

⊕⊕⊝⊝
low,7,8

Withdrawals due to adverse events

130 per 10001

144 per 1000
(114 to 179)

RR 1.11
(0.88 to 1.38)

1833
(10 studies)

⊕⊕⊝⊝
low8,9

Serious adverse events

7 per 10001

10 per 1000
(2 to 60)

RR 1.43
(0.24 to 8.44)

576
(3 studies)

⊕⊕⊝⊝
low10

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio;

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 Control group risk comes from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to unknown risk of bias.
3 Control group risk comes from control arm of the included study.
4 Downgraded one level due to unknown risk of bias.
5 Downgraded one level due to sparse data (109 events).
6 Downgraded one level due to sparse data (94 events).
7 Downgraded one level due to unknown risk of bias.
8 Downgraded one level due to unexplained heterogeneity (I2 = 55%).
9 Downgraded one level due to sparse data (246 events).
10 Downgraded two levels due to very sparse data (5 events).

Figuras y tablas -
Summary of findings for the main comparison. 5‐ASA compared to placebo for maintenance of medically‐induced remission in Crohn's disease
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Table 1. Randomised patients with unknown outcome

Study

Total Unknown ‐ n(%)

5‐ASA unknown ‐ n(%)

Placebo unknown ‐ n(%)

Anonymous 1990

55 (22%)

23 (19%)

32 (26%)

Arber 1995

10 (17%)

6 (21%)

4 (13%)

Cezard 2009

30 (23%)

21 (31%)

9 (14%)

De Franchis 1997

17 (14%)

8 (14%)

9 (15%)

Gendre 1993 (Eng)

42 (26%)

23 (29%)

19 (23%)

Mahmud 2001

82 (25%)

55 (33%)

27 (17%)

Modigliani 1996

44 (34%)

17 (26%)

27 (42%)

Prantera 1992

15 (12%)

10 (16%)

5 (8%)

Sutherland 1997

92 (31%)

47 (33%)

45 (30%)

Thompson 1995

98 (34%)

52 (38%)

46 (31%)

Wellman 1988

2 (3%)

2 (6%)

0 (0%)
Figuras y tablas -
Table 1. Randomised patients with unknown outcome
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Comparison 1. 5‐ASA compared to placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up Show forest plot

12

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 12 months

11

2014

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.91, 1.07]

1.2 24 months

1

161

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.80, 1.23]

1.3 Pediatric

1

132

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.86, 1.33]

2 Sensitivity analysis ‐ Relapse, drop‐outs classed as relapse, grouped by length of follow‐up, random effects Show forest plot

12

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 12 months

11

2014

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.88, 1.08]

2.2 24 months

1

161

Risk Ratio (M‐H, Random, 95% CI)

0.99 [0.80, 1.23]

2.3 Pediatric

1

132

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.86, 1.33]

3 Sensitivity analysis ‐ Relapse, drop‐outs ignored, grouped by length of follow‐up Show forest plot

12

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 12 Months

10

1438

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.79, 1.01]

3.2 24 Months

1

119

Risk Ratio (M‐H, Fixed, 95% CI)

0.94 [0.68, 1.29]

3.3 Pediatric

1

102

Risk Ratio (M‐H, Fixed, 95% CI)

0.97 [0.72, 1.31]

4 Sensitivity analysis ‐ Relapse, drop‐outs ignored, grouped by length of follow‐up, random effects Show forest plot

12

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

4.1 12 Months

10

1438

Risk Ratio (M‐H, Random, 95% CI)

0.89 [0.76, 1.05]

4.2 24 Months

1

119

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.68, 1.29]

4.3 Pediatric

1

102

Risk Ratio (M‐H, Random, 95% CI)

0.97 [0.72, 1.31]

5 Adverse events Show forest plot

10

1814

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.95, 1.17]

6 Withdrawals due to adverse events Show forest plot

10

1833

Risk Ratio (M‐H, Fixed, 95% CI)

1.11 [0.88, 1.38]

7 Serious adverse events Show forest plot

3

576

Risk Ratio (M‐H, Fixed, 95% CI)

1.43 [0.24, 8.44]

8 Relapse, drop‐outs classed as relapse, grouped by length of follow‐up Show forest plot

11

2014

Odds Ratio (M‐H, Fixed, 95% CI)

0.97 [0.81, 1.16]
Figuras y tablas -
Comparison 1. 5‐ASA compared to placebo
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