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Heparina no fraccionada o de bajo peso molecular para la inducción de la remisión en la colitis ulcerosa

Appendices

Appendix 1. Search strategies

MEDLINE

1. ulcerative colitis.mp. or exp ulcerative colitis/
2. (proctocolitis or proctosigmoiditis or rectocolitis or rectosigmoiditis or proctitis).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
3. 1 or 2
4. heparin.mp. or exp heparin/
5. (unfractionated heparin or low molecular weight heparin).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
6. 4 or 5
7. 3 and 6

EMBASE

1. ulcerative colitis.mp. or exp ulcerative colitis/
2. (proctocolitis or proctosigmoiditis or rectocolitis or rectosigmoiditis or proctitis).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
3. 1 or 2
4. heparin.mp. or exp heparin/
5. (unfractionated heparin or low molecular weight heparin).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]
6. 4 or 5
7. 3 and 6

CENTRAL

#1. (ulcerat* and colitis) or proctocolitis or proctosigmoiditis or rectocolitis or rectosigmoiditis or proctitis
#2. heparin
#3. unfractionated heparin
#4. low molecular weight heparin
#5. #2 or #3 or #4
#6. #1 and #5

SR‐IBD

1. heparin*

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
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Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Comparison 1 LMWH versus placebo, Outcome 1 Clinical remission.
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Analysis 1.1

Comparison 1 LMWH versus placebo, Outcome 1 Clinical remission.

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Comparison 1 LMWH versus placebo, Outcome 2 Clinical improvement.
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Analysis 1.2

Comparison 1 LMWH versus placebo, Outcome 2 Clinical improvement.

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Comparison 1 LMWH versus placebo, Outcome 3 Endoscopic improvement.
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Analysis 1.3

Comparison 1 LMWH versus placebo, Outcome 3 Endoscopic improvement.

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Comparison 1 LMWH versus placebo, Outcome 4 Endoscopic remission.
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Analysis 1.4

Comparison 1 LMWH versus placebo, Outcome 4 Endoscopic remission.

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Comparison 1 LMWH versus placebo, Outcome 5 Histological improvement.
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Analysis 1.5

Comparison 1 LMWH versus placebo, Outcome 5 Histological improvement.

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Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 1 Clinical remission.
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Analysis 2.1

Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 1 Clinical remission.

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Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 2 Clinical improvement.
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Analysis 2.2

Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 2 Clinical improvement.

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Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 3 Endoscopic remission.
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Analysis 2.3

Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 3 Endoscopic remission.

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Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 4 Endoscopic improvement.
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Analysis 2.4

Comparison 2 LMWH + standard therapy versus standard therapy, Outcome 4 Endoscopic improvement.

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Comparison 3 UFH versus corticosteroids, Outcome 1 Clinical improvement.
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Analysis 3.1

Comparison 3 UFH versus corticosteroids, Outcome 1 Clinical improvement.

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Summary of findings for the main comparison. LMWH compared to Placebo for induction of remission in ulcerative colitis

LMWH compared to Placebo for induction of remission in ulcerative colitis

Patient or population: patients with induction of remission in ulcerative colitis
Settings: Outpatient
Intervention: LMWH
Comparison: 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

Placebo

LMWH

Endoscopic remission
Follow‐up: mean 8 weeks

157 per 10001

211 per 1000
(104 to 427)

RR 1.34
(0.66 to 2.72)

141
(1 study)

⊕⊝⊝⊝
very low2,3

*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 study
2 industry funded study and lack of sufficient details on central randomization
3 Very sparse data (26 events)

Figuras y tablas -
Summary of findings for the main comparison. LMWH compared to Placebo for induction of remission in ulcerative colitis
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Summary of findings 2. LMWH + standard therapy compared to Standard therapy for induction of remission in ulcerative colitis

LMWH + standard therapy compared to Standard therapy for induction of remission in ulcerative colitis

Patient or population: patients with induction of remission in ulcerative colitis
Settings: Outpatient
Intervention: LMWH + standard therapy
Comparison: Standard therapy

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Standard therapy

LMWH + standard therapy

Clinical remission
Follow‐up: mean 12 weeks

389 per 10001

311 per 1000
(124 to 793)

RR 0.8
(0.32 to 2.04)

34
(1 study)

⊕⊝⊝⊝
very low2,3

Clinical improvement
Follow‐up: mean 12 weeks

778 per 10001

879 per 1000
(646 to 1000)

RR 1.13
(0.83 to 1.53)

34
(1 study)

⊕⊝⊝⊝
very low2,4

Endoscopic remission
Follow‐up: mean 12 weeks

389 per 10001

311 per 1000
(124 to 793)

RR 0.8
(0.32 to 2.04)

34
(1 study)

⊕⊝⊝⊝
very low2,3

Endoscopic improvement
Follow‐up: mean 12 weeks

611 per 10001

691 per 1000
(422 to 1000)

RR 1.13
(0.69 to 1.85)

34
(1 study)

⊕⊝⊝⊝
very low2,5

*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 study
2 Open‐label trial (lack of blinding and allocation concealment)
3 Very sparse data (12 events)
4 Very sparse data (28 events)
5 Very sparse data (22 events)

Figuras y tablas -
Summary of findings 2. LMWH + standard therapy compared to Standard therapy for induction of remission in ulcerative colitis
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Summary of findings 3. UFH compared to Corticosteroids for induction of remission in ulcerative colitis

UFH compared to Corticosteroids for induction of remission in ulcerative colitis

Patient or population: patients with induction of remission in ulcerative colitis
Settings: Outpatient
Intervention: UFH
Comparison: Corticosteroids

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Corticosteroids

UFH

Clinical improvement
Follow‐up: mean 12 weeks

692 per 10001

42 per 1000
(0 to 609)

RR 0.06
(0 to 0.88)

25
(1 study)

⊕⊝⊝⊝
very low2,3

*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 study
2 Single‐blind trial and lack of sufficient details on allocation concealment and randomization sequence
3 Very sparse data (9 events)

Figuras y tablas -
Summary of findings 3. UFH compared to Corticosteroids for induction of remission in ulcerative colitis
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Comparison 1. LMWH versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical remission Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

2 Clinical improvement Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3 Endoscopic improvement Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4 Endoscopic remission Show forest plot

1

141

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [0.66, 2.72]

5 Histological improvement Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only
Figuras y tablas -
Comparison 1. LMWH versus placebo
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Comparison 2. LMWH + standard therapy versus standard therapy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical remission Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.32, 2.04]

2 Clinical improvement Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.83, 1.53]

3 Endoscopic remission Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

0.80 [0.32, 2.04]

4 Endoscopic improvement Show forest plot

1

34

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.69, 1.85]
Figuras y tablas -
Comparison 2. LMWH + standard therapy versus standard therapy
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Comparison 3. UFH versus corticosteroids

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical improvement Show forest plot

1

25

Risk Ratio (M‐H, Fixed, 95% CI)

0.06 [0.00, 0.88]
Figuras y tablas -
Comparison 3. UFH versus corticosteroids
Ir a la tabla de la revisión