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Tasas de respuesta y de remisión placebo en los ensayos aleatorios de tratamiento de inducción y mantenimiento para la colitis ulcerosa
Vipul Jairath, GY Zou, Claire E Parker, John K MacDonald, Turki AlAmeel, Mohammad Al Beshir, Majid A Almadi, Talal Al‐Taweel, Nathan SS Atkinson, Sujata Biswas, Thomas Chapman, Parambir S Dulai, Mark A Glaire, Daniël R Hoekman, Andreas Koutsoumpas, Elizabeth Minas, Mahmoud H Mosli, Mark Samaan, Reena Khanna, Simon Travis, Geert D'Haens, William J Sandborn, Brian G Feagan | 8 septiembre 2017

Respuestas clínicas Cochrane

Topics

Temas

Study flow diagram.
Figuras y tablas -
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.
Figuras y tablas -
Figure 2

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

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Comparison 1 5‐ASA versus placebo, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission.
Figuras y tablas -
Analysis 1.1

Comparison 1 5‐ASA versus placebo, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission.

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Comparison 1 5‐ASA versus placebo, Outcome 2 Development of Any Adverse Event.
Figuras y tablas -
Analysis 1.2

Comparison 1 5‐ASA versus placebo, Outcome 2 Development of Any Adverse Event.

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Comparison 1 5‐ASA versus placebo, Outcome 3 Development of Any Adverse Event (Sensitivity analysis).
Figuras y tablas -
Analysis 1.3

Comparison 1 5‐ASA versus placebo, Outcome 3 Development of Any Adverse Event (Sensitivity analysis).

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Comparison 1 5‐ASA versus placebo, Outcome 4 Withdrawal from Study due to Adverse Event.
Figuras y tablas -
Analysis 1.4

Comparison 1 5‐ASA versus placebo, Outcome 4 Withdrawal from Study due to Adverse Event.

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Comparison 1 5‐ASA versus placebo, Outcome 5 Withdrawal from Study due to Adverse Event (Sensitivity analysis).
Figuras y tablas -
Analysis 1.5

Comparison 1 5‐ASA versus placebo, Outcome 5 Withdrawal from Study due to Adverse Event (Sensitivity analysis).

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Comparison 1 5‐ASA versus placebo, Outcome 6 Exclusion/Withdrawal after Entry (not due to relapse).
Figuras y tablas -
Analysis 1.6

Comparison 1 5‐ASA versus placebo, Outcome 6 Exclusion/Withdrawal after Entry (not due to relapse).

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Comparison 2 5‐ASA versus sulfasalazine, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission.
Figuras y tablas -
Analysis 2.1

Comparison 2 5‐ASA versus sulfasalazine, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission.

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Comparison 2 5‐ASA versus sulfasalazine, Outcome 2 Failure to Maintain Remission (trials without olsalazine).
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Analysis 2.2

Comparison 2 5‐ASA versus sulfasalazine, Outcome 2 Failure to Maintain Remission (trials without olsalazine).

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Comparison 2 5‐ASA versus sulfasalazine, Outcome 3 Development of Any Adverse Event.
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Analysis 2.3

Comparison 2 5‐ASA versus sulfasalazine, Outcome 3 Development of Any Adverse Event.

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Comparison 2 5‐ASA versus sulfasalazine, Outcome 4 Withdrawal from Study due to Adverse Event.
Figuras y tablas -
Analysis 2.4

Comparison 2 5‐ASA versus sulfasalazine, Outcome 4 Withdrawal from Study due to Adverse Event.

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Comparison 2 5‐ASA versus sulfasalazine, Outcome 5 Exclusion/Withdrawal after Entry (not due to relapse).
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Analysis 2.5

Comparison 2 5‐ASA versus sulfasalazine, Outcome 5 Exclusion/Withdrawal after Entry (not due to relapse).

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Comparison 3 Once daily versus conventional dosing, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission at 6 months.
Figuras y tablas -
Analysis 3.1

Comparison 3 Once daily versus conventional dosing, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission at 6 months.

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Comparison 3 Once daily versus conventional dosing, Outcome 2 Failure to Maintain Clinical or Endoscopic Remission at 12 months.
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Analysis 3.2

Comparison 3 Once daily versus conventional dosing, Outcome 2 Failure to Maintain Clinical or Endoscopic Remission at 12 months.

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Comparison 3 Once daily versus conventional dosing, Outcome 3 Failure to adhere to study medication regimen at study endpoint.
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Analysis 3.3

Comparison 3 Once daily versus conventional dosing, Outcome 3 Failure to adhere to study medication regimen at study endpoint.

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Comparison 3 Once daily versus conventional dosing, Outcome 4 Failure to adhere to study medication regimen (Sensitivity analysis ‐ excluding outliers).
Figuras y tablas -
Analysis 3.4

Comparison 3 Once daily versus conventional dosing, Outcome 4 Failure to adhere to study medication regimen (Sensitivity analysis ‐ excluding outliers).

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Comparison 3 Once daily versus conventional dosing, Outcome 5 Development of Any Adverse Event.
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Analysis 3.5

Comparison 3 Once daily versus conventional dosing, Outcome 5 Development of Any Adverse Event.

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Comparison 3 Once daily versus conventional dosing, Outcome 6 Withdrawal due to adverse event.
Figuras y tablas -
Analysis 3.6

Comparison 3 Once daily versus conventional dosing, Outcome 6 Withdrawal due to adverse event.

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Comparison 3 Once daily versus conventional dosing, Outcome 7 Exclusion/Withdrawal after Entry (not due to relapse).
Figuras y tablas -
Analysis 3.7

Comparison 3 Once daily versus conventional dosing, Outcome 7 Exclusion/Withdrawal after Entry (not due to relapse).

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Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission at 12 months.
Figuras y tablas -
Analysis 4.1

Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 1 Failure to Maintain Clinical or Endoscopic Remission at 12 months.

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Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 2 Development of Any Adverse Event.
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Analysis 4.2

Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 2 Development of Any Adverse Event.

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Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 3 Withdrawal from Study due to Adverse Event.
Figuras y tablas -
Analysis 4.3

Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 3 Withdrawal from Study due to Adverse Event.

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Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 4 Exclusion/Withdrawal after Entry (not due to relapse).
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Analysis 4.4

Comparison 4 5‐ASA versus comparator 5‐ASA, Outcome 4 Exclusion/Withdrawal after Entry (not due to relapse).

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Comparison 5 5‐ASA (dose ranging), Outcome 1 Failure to Maintain Clinical or Endoscopic Remission.
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Analysis 5.1

Comparison 5 5‐ASA (dose ranging), Outcome 1 Failure to Maintain Clinical or Endoscopic Remission.

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Comparison 5 5‐ASA (dose ranging), Outcome 2 Development of Any Adverse Event.
Figuras y tablas -
Analysis 5.2

Comparison 5 5‐ASA (dose ranging), Outcome 2 Development of Any Adverse Event.

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Comparison 5 5‐ASA (dose ranging), Outcome 3 Withdrawal from Study due to Adverse Event.
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Analysis 5.3

Comparison 5 5‐ASA (dose ranging), Outcome 3 Withdrawal from Study due to Adverse Event.

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Comparison 5 5‐ASA (dose ranging), Outcome 4 Exculsion/Withdrawal after Entry (not due to relapse).
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Analysis 5.4

Comparison 5 5‐ASA (dose ranging), Outcome 4 Exculsion/Withdrawal after Entry (not due to relapse).

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Summary of findings for the main comparison. Oral 5‐ASA versus placebo for maintenance of remission in ulcerative colitis

Oral 5‐ASA versus placebo for maintenance of remission in ulcerative colitis

Patient or population: Patients with quiescent ulcerative colitis
Settings: Outpatients
Intervention: Oral 5‐ASA versus 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

Oral 5‐ASA versus placebo

Failure to maintain clinical or endoscopic remission at study end‐point

584 per 10001

403 per 1000
(362 to 450)

RR 0.69
(0.62 to 0.77)

1,298
(7 studies)

⊕⊕⊕⊕
high

Any adverse event

393 per 10001

369 per 1000
(303 to 452)

RR 0.94
(0.77 to 1.15)

774
(3 studies)

⊕⊕⊕⊝
moderate2

Withdrawal due to adverse event

42 per 10001

36 per 1000
(19 to 68)

RR 0.86
(0.46 to 1.63)

1096
(5 studies)

⊕⊕⊕⊝
moderate3

*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 estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to sparse data (320 events).
3 Downgraded one level due to sparse data (41 events).

Figuras y tablas -
Summary of findings for the main comparison. Oral 5‐ASA versus placebo for maintenance of remission in ulcerative colitis
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Summary of findings 2. Oral 5‐ASA versus SASP for maintenance of remission in ulcerative colitis

Oral 5‐ASA versus SASP for maintenance of remission in ulcerative colitis

Patient or population: Patients with quiescent ulcerative colitis
Settings: Outpatients
Intervention: Oral 5‐ASA versus SASP

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

Oral 5‐ASA versus SASP

Failure to maintain clinical or endoscopic remission at study end‐point

429 per 10001

489 per 1000
(442 to 545)

RR 1.14
(1.03 to 1.27)

1,655
(12 studies)

⊕⊕⊕⊕
high

Any adverse event

158 per 10001

169 per 1000
(130 to 221)

RR 1.07
(0.82 to 1.40)

1,138
(7 studies)

⊕⊕⊕⊝
moderate2

Withdrawal due to adverse event

54 per 10001

69 per 1000
(47 to 101)

RR 1.27
(0.87 to 1.87)

1,585
(10 studies)

⊕⊕⊕⊝
moderate3

*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 estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to sparse data (182 events).
3 Downgraded one level due to sparse data (97 events).

Figuras y tablas -
Summary of findings 2. Oral 5‐ASA versus SASP for maintenance of remission in ulcerative colitis
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Summary of findings 3. Once daily dosing versus conventional dosing for maintenance of remission in ulcerative colitis

Once daily dosing versus conventional dosing for maintenance of remission in ulcerative colitis

Patient or population: Patients with quiescent ulcerative colitis
Settings: Outpatients
Intervention: Once daily oral 5‐ASA versus conventional dosing of 5‐ASA

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

OD versus conventional

Failure to maintain clinical or endoscopic remission at 6 months

184 per 10001

188 per 1000
(157 to 228)

RR 1.02
(0.85 to 1.23)

1,871
(3 studies)

⊕⊕⊝⊝
low2,3

Failure to maintain clinical or endoscopic remission at 12 months

314 per 10001

286 per 1000
(258 to 317)

RR 0.91
(0.82 to 1.01)

3,127
(8 studies)

⊕⊕⊕⊝
moderate4

Failure to adhere to study medication regimen

87 per 10001

106 per 1000
(79 to 143)

RR 1.22
(0.91 to 1.64)

1,462
(6 studies)

⊕⊕⊕⊝
moderate5,6

Development of any adverse event

453 per 10001

453 per 1000
(417 to 489)

RR 1.00
(0.92 to 1.08)

2,714
(6 studies)

⊕⊕⊕⊕
high

Withdrawal due to adverse events

15 per 10001

20 per 1000
(12 to 32)

RR 1.31
(0.80 to 2.13)

3,737
(7 studies)

⊕⊕⊝⊝
low7,8

*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 estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to risk of bias. Two studies in the pooled analysis were single‐blind (investigator blind).
3 Downgraded one level due to sparse data (349 events).
4 Downgraded one level due to risk of bias. One study in the pooled analysis was open‐label and was rated as a high risk of bias due to lack of blinding. Four studies in the pooled analysis were single‐blind (investigator blinded).
5 Downgraded one level due to sparse data (146 events).
6 Adherence was calculated using objective data (pill count or pharmacy data) in 4 of 6 studies in the analysis. One study used patient self‐report to calculate adherence and one study did not describe how adherence was assessed.
7 Downgraded one level due to sparse data (64 events).
8 Downgraded one level due to risk of bias. One study in the pooled analysis was open‐label and was rated as a high risk of bias due to lack of blinding. Three studies in the pooled analysis were single‐blind (investigator blinded).

Figuras y tablas -
Summary of findings 3. Once daily dosing versus conventional dosing for maintenance of remission in ulcerative colitis
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Summary of findings 4. Oral 5‐ASA versus comparator 5‐ASA formulation for maintenance of remission in ulcerative colitis

Oral 5‐ASA versus comparator 5‐ASA formulation for maintenance of remission in ulcerative colitis

Patient or population: Patients with quiescent ulcerative colitis
Settings: Outpatients
Intervention: Oral 5‐ASA versus 5‐ASA (different formulations)

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

Oral 5‐ASA versus 5‐ASA

Failure to maintain clinical or endoscopic remission at 12 months

407 per 10001

440 per 1000
(370 to 521)

RR 1.08
(0.91 to 1.28)

707
(6 studies)

⊕⊕⊝⊝
low2,3

Development of any adverse event

686 per 10001

645 per 1000
(569 to 734)

RR 0.94
(0.83 to 1.07)

357
(4 studies)

⊕⊕⊝⊝
low4,5

Withdrawal due to adverse events

44 per 10001

55 per 1000
(25 to 122)

RR 1.25
(0.56 to 2.78)

457
(5 studies)

⊕⊝⊝⊝
very low6,7

*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 estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded one level due to sparse data (300 events).
3 Downgraded one level due to risk of bias. Two studies in pooled analysis were single blind and one was open label.
4 Downgraded one level due to sparse data (236 events).
5 Downgraded one level due to risk of bias. One study in the pooled analysis was open label.
6 Downgraded two levels due to very sparse data (23 events) and very wide confidence intervals.
7 Downgraded one level due to risk of bias. One study in the pooled analysis due was single blind and another was open label.

Figuras y tablas -
Summary of findings 4. Oral 5‐ASA versus comparator 5‐ASA formulation for maintenance of remission in ulcerative colitis
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Summary of findings 5. High dose oral 5‐ASA versus low dose 5‐ASA for maintenance of remission in ulcerative colitis

High dose oral 5‐ASA versus low dose 5‐ASA for maintenance of remission in ulcerative colitis

Patient or population: Patients with quiescent ulcerative colitis
Settings: Outpatients
Intervention: High dose oral 5‐ASA versus low dose 5‐ASA

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

High dose 5‐ASA versus low dose 5‐ASA

Failure to maintain clinical or endoscopic remission at 12 months

357 per 10001

286 per 1000
(164 to 493)

RR 0.80
(0.46 to 1.38)

112
(1 study)

⊕⊝⊝⊝
very low2,3

Asacol 4.8 g/day versus 2.4 g/day

Failure to maintain clinical or endoscopic remission at 12 months

330 per 10001

251 per 1000
(69 to 921)

RR 0.76
(0.21 to 2.79)

216
(2 studies)

⊕⊝⊝⊝
very low34,5

Balsalazide 6.0 g/day versus 3.0 g/day

Failure to maintain clinical or endoscopic remission at 12 months

554 per 10001

366 per 1000
(249 to 537)

RR 0.66
(0.45 to 0.97)

133
(1 study)

⊕⊕⊕⊝
moderate6

Balsalazide 4.0 g/day versus 2.0 g/day

Failure to maintain clinical or endoscopic remission at 12 months

392 per 10001

255 per 1000
(192 to 337)

RR 0.65
(0.49 to 0.86)

429
(1 study)

⊕⊕⊕⊝
moderate7

Salofalk granules 3.0 g OD versus 1.5 g OD

*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; OD: once daily

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 estimates come from control arm of meta‐analysis, based on included trials.
2 Downgraded two levels due to very sparse data (36 events).
3 Downgraded one due to high risk of bias (open label study).
4 Downgraded one level due to sparse data (61 events) and very wide confidence intervals.
5 Downgraded two levels due to very serious inconsistency (I2 = 86%).
6 Downgraded one level due to sparse data (61 events) and wide confidence intervals.
7 Downgraded one level due to sparse data (138 events).

Figuras y tablas -
Summary of findings 5. High dose oral 5‐ASA versus low dose 5‐ASA for maintenance of remission in ulcerative colitis
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Comparison 1. 5‐ASA versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure to Maintain Clinical or Endoscopic Remission Show forest plot

7

1298

Risk Ratio (M‐H, Fixed, 95% CI)

0.69 [0.62, 0.77]

1.1 Dose of 5‐ASA: <1 g

1

133

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.59, 1.00]

1.2 Dose of 5‐ASA: 1 ‐ 1.9 g

5

859

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.56, 0.76]

1.3 Dose of 5‐ASA: >or=2 g

2

306

Risk Ratio (M‐H, Fixed, 95% CI)

0.73 [0.60, 0.89]

2 Development of Any Adverse Event Show forest plot

4

875

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.69, 1.39]

2.1 Dose of 5‐ASA: <1 g

1

133

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.51, 1.31]

2.2 Dose of 5‐ASA: 1 ‐ 1.9 g

2

436

Risk Ratio (M‐H, Random, 95% CI)

1.02 [0.86, 1.20]

2.3 Dose of 5‐ASA: >or=2 g

2

306

Risk Ratio (M‐H, Random, 95% CI)

1.69 [0.14, 20.58]

3 Development of Any Adverse Event (Sensitivity analysis) Show forest plot

3

774

Risk Ratio (M‐H, Random, 95% CI)

0.94 [0.77, 1.15]

3.1 Dose of 5‐ASA: <1 g

1

133

Risk Ratio (M‐H, Random, 95% CI)

0.82 [0.51, 1.31]

3.2 Dose of 5‐ASA: 1 ‐ 1.9 g

2

436

Risk Ratio (M‐H, Random, 95% CI)

1.02 [0.86, 1.20]

3.3 Dose of 5‐ASA: >or=2 g

1

205

Risk Ratio (M‐H, Random, 95% CI)

0.52 [0.25, 1.12]

4 Withdrawal from Study due to Adverse Event Show forest plot

6

1197

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [0.78, 2.30]

4.1 Dose of 5‐ASA: <1 g

1

133

Risk Ratio (M‐H, Fixed, 95% CI)

1.43 [0.15, 13.38]

4.2 Dose of 5‐ASA: 1 ‐ 1.9 g

4

758

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.50, 2.23]

4.3 Dose of 5‐ASA: >or=2 g

2

306

Risk Ratio (M‐H, Fixed, 95% CI)

1.80 [0.78, 4.15]

5 Withdrawal from Study due to Adverse Event (Sensitivity analysis) Show forest plot

5

1096

Risk Ratio (M‐H, Fixed, 95% CI)

0.86 [0.46, 1.63]

5.1 Dose of 5‐ASA: <1 g

1

133

Risk Ratio (M‐H, Fixed, 95% CI)

1.43 [0.15, 13.38]

5.2 Dose of 5‐ASA: 1 ‐ 1.9 g

4

758

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.50, 2.23]

5.3 Dose of 5‐ASA: >or=2 g

1

205

Risk Ratio (M‐H, Fixed, 95% CI)

0.33 [0.07, 1.60]

6 Exclusion/Withdrawal after Entry (not due to relapse) Show forest plot

5

1074

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.88, 1.44]

6.1 Dose of 5‐ASA: <1 g

1

177

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.58, 1.40]

6.2 Dose of 5‐ASA: 1 ‐ 1.9 g

3

591

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.87, 1.71]

6.3 Dose of 5‐ASA: >or=2 g

2

306

Risk Ratio (M‐H, Fixed, 95% CI)

1.26 [0.69, 2.29]
Figuras y tablas -
Comparison 1. 5‐ASA versus placebo
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Comparison 2. 5‐ASA versus sulfasalazine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure to Maintain Clinical or Endoscopic Remission Show forest plot

12

1655

Risk Ratio (M‐H, Fixed, 95% CI)

1.14 [1.03, 1.27]

2 Failure to Maintain Remission (trials without olsalazine) Show forest plot

7

749

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.92, 1.26]

3 Development of Any Adverse Event Show forest plot

7

1138

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.82, 1.40]

4 Withdrawal from Study due to Adverse Event Show forest plot

10

1585

Risk Ratio (M‐H, Fixed, 95% CI)

1.27 [0.87, 1.87]

5 Exclusion/Withdrawal after Entry (not due to relapse) Show forest plot

9

1497

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [1.04, 1.63]
Figuras y tablas -
Comparison 2. 5‐ASA versus sulfasalazine
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Comparison 3. Once daily versus conventional dosing

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure to Maintain Clinical or Endoscopic Remission at 6 months Show forest plot

3

1871

Risk Ratio (M‐H, Fixed, 95% CI)

1.02 [0.85, 1.23]

1.1 Asacol (OD vs BID or TID)

2

1045

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [0.83, 1.46]

1.2 MMX (OD) vs Asacol (BID)

1

826

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.75, 1.23]

2 Failure to Maintain Clinical or Endoscopic Remission at 12 months Show forest plot

8

3127

Risk Ratio (M‐H, Fixed, 95% CI)

0.91 [0.82, 1.01]

2.1 Asacol (OD vs BID or TID)

3

1256

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.79, 1.15]

2.2 MMX (OD) vs Asacol (BID)

1

331

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.74, 1.33]

2.3 Pentasa (OD vs BID)

2

654

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.60, 0.93]

2.4 MMX (OD vs BID)

1

451

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.87, 1.47]

2.5 Salofalk granules (OD vs TID)

1

435

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.60, 1.10]

3 Failure to adhere to study medication regimen at study endpoint Show forest plot

8

2126

Risk Ratio (M‐H, Random, 95% CI)

1.18 [0.69, 2.03]

4 Failure to adhere to study medication regimen (Sensitivity analysis ‐ excluding outliers) Show forest plot

6

1462

Risk Ratio (M‐H, Fixed, 95% CI)

1.22 [0.91, 1.64]

5 Development of Any Adverse Event Show forest plot

6

2714

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.92, 1.08]

6 Withdrawal due to adverse event Show forest plot

7

3737

Risk Ratio (M‐H, Fixed, 95% CI)

1.31 [0.80, 2.13]

7 Exclusion/Withdrawal after Entry (not due to relapse) Show forest plot

7

3737

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.85, 1.15]
Figuras y tablas -
Comparison 3. Once daily versus conventional dosing
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Comparison 4. 5‐ASA versus comparator 5‐ASA

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure to Maintain Clinical or Endoscopic Remission at 12 months Show forest plot

6

707

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.91, 1.28]

1.1 Asacol comparator

5

615

Risk Ratio (M‐H, Fixed, 95% CI)

1.05 [0.87, 1.26]

1.2 Salofalk comparator

1

92

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [0.86, 1.98]

2 Development of Any Adverse Event Show forest plot

4

357

Risk Ratio (M‐H, Fixed, 95% CI)

0.94 [0.83, 1.07]

2.1 Asacol comparator

3

265

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.85, 1.08]

2.2 Salofalk comparator

1

92

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.51, 1.34]

3 Withdrawal from Study due to Adverse Event Show forest plot

5

457

Risk Ratio (M‐H, Fixed, 95% CI)

1.25 [0.56, 2.78]

3.1 Asacol comparator

4

365

Risk Ratio (M‐H, Fixed, 95% CI)

1.64 [0.61, 4.42]

3.2 Salofalk comparator

1

92

Risk Ratio (M‐H, Fixed, 95% CI)

0.69 [0.16, 2.90]

4 Exclusion/Withdrawal after Entry (not due to relapse) Show forest plot

5

457

Risk Ratio (M‐H, Fixed, 95% CI)

1.23 [0.90, 1.70]

4.1 Asacol comparator

4

365

Risk Ratio (M‐H, Fixed, 95% CI)

1.21 [0.81, 1.80]

4.2 Salofalk comparator

1

92

Risk Ratio (M‐H, Fixed, 95% CI)

1.28 [0.76, 2.16]
Figuras y tablas -
Comparison 4. 5‐ASA versus comparator 5‐ASA
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Comparison 5. 5‐ASA (dose ranging)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Failure to Maintain Clinical or Endoscopic Remission Show forest plot

10

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

1.1 Asacol 4.8 g versus 2.4 g/day

1

112

Risk Ratio (M‐H, Random, 95% CI)

0.8 [0.46, 1.38]

1.2 Asacol 3.2 g versus 2 g/day

1

262

Risk Ratio (M‐H, Random, 95% CI)

1.07 [0.83, 1.37]

1.3 Asacol 2.4 g versus 1.2 g/day

1

156

Risk Ratio (M‐H, Random, 95% CI)

0.95 [0.78, 1.16]

1.4 Asacol 1.6 g versus 0.8 g/day

1

177

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.78, 1.32]

1.5 Balsalazide 6.0 g versus 3.0 g/day

2

216

Risk Ratio (M‐H, Random, 95% CI)

0.76 [0.21, 2.79]

1.6 Balsalazide 4.0 g versus 2.0 g/day

1

133

Risk Ratio (M‐H, Random, 95% CI)

0.66 [0.45, 0.97]

1.7 Olsalazine 2.0 g versus 1.0 g/day

1

127

Risk Ratio (M‐H, Random, 95% CI)

1.01 [0.66, 1.54]

1.8 Salofalk granules 3 g versus 1.5 g OD

1

429

Risk Ratio (M‐H, Random, 95% CI)

0.65 [0.49, 0.86]

1.9 Pentasa 3.0 g versus 1.5 g/day

1

169

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.48, 1.15]

2 Development of Any Adverse Event Show forest plot

5

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2.1 Asacol 2.4 g versus 1.2 g/day

1

156

Risk Ratio (M‐H, Fixed, 95% CI)

2.85 [0.12, 68.95]

2.2 Asacol 1.6 g versus 0.8 g/day

1

177

Risk Ratio (M‐H, Fixed, 95% CI)

1.86 [1.18, 2.95]

2.3 Balsalazide 6.0 g versus 3.0 g/day

1

88

Risk Ratio (M‐H, Fixed, 95% CI)

1.4 [0.88, 2.24]

2.4 Olsalazine 2.0 g versus 1.0 g/day

1

127

Risk Ratio (M‐H, Fixed, 95% CI)

1.37 [0.94, 1.99]

2.5 Salofalk granules 3 g versus 1.5 g OD

1

429

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.61, 0.91]

3 Withdrawal from Study due to Adverse Event Show forest plot

7

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 Asacol 2.4 g versus 1.2 g/day

1

156

Risk Ratio (M‐H, Fixed, 95% CI)

2.85 [0.12, 68.95]

3.2 Asacol 1.6 g versus 0.8 g/day

1

177

Risk Ratio (M‐H, Fixed, 95% CI)

0.34 [0.04, 3.25]

3.3 Balsalazide 6.0 g versus 3.0 g/day

2

196

Risk Ratio (M‐H, Fixed, 95% CI)

0.59 [0.21, 1.70]

3.4 Balsalazide 4.0 g versus 2.0 g/day

1

133

Risk Ratio (M‐H, Fixed, 95% CI)

1.43 [0.54, 3.80]

3.5 Salofalk granules 3 g versus 1.5 g OD

1

429

Risk Ratio (M‐H, Fixed, 95% CI)

0.98 [0.29, 3.33]

3.6 Pentasa 3.0 g versus 1.5 g/day

1

169

Risk Ratio (M‐H, Fixed, 95% CI)

1.06 [0.07, 16.69]

4 Exculsion/Withdrawal after Entry (not due to relapse) Show forest plot

8

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 Asacol 2.4 g versus 1.2 g/day

1

156

Risk Ratio (M‐H, Fixed, 95% CI)

0.95 [0.38, 2.40]

4.2 Asacol 1.6 g versus 0.8 g/day

1

177

Risk Ratio (M‐H, Fixed, 95% CI)

1.23 [0.80, 1.90]

4.3 Balsalazide 6.0 g versus 3.0 g/day

2

196

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.26, 0.84]

4.4 Balsalazide 4.0 g versus 2.0 g/day

1

133

Risk Ratio (M‐H, Fixed, 95% CI)

1.27 [0.77, 2.12]

4.5 Olsalazine 2.0 g versus 1.0 g/day

1

127

Risk Ratio (M‐H, Fixed, 95% CI)

1.75 [0.83, 3.70]

4.6 Salofalk granules 3 g versus 1.5 g OD

1

429

Risk Ratio (M‐H, Fixed, 95% CI)

0.66 [0.46, 0.93]

4.7 Pentasa 3.0 g versus 1.5 g/day

1

169

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.44, 1.55]
Figuras y tablas -
Comparison 5. 5‐ASA (dose ranging)
Ir a la tabla de la revisión