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Figure 1
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Flowchart of last search of the Group's Trials Register: 25 May 2012.
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Figure 2

Flowchart of last search of the Group's Trials Register: 25 May 2012.

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Risk of bias graph: review authors' judgements about each risk of bias domain presented as percentages across all included studies
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Figure 3

Risk of bias graph: review authors' judgements about each risk of bias domain presented as percentages across all included studies

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Risk of bias summary: review authors' judgements about each risk of bias domain for each included study
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Figure 4

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

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Comparison 1 L‐carnitine versus placebo, Outcome 1 Change in ulcer size (surface area or volume).
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Analysis 1.1

Comparison 1 L‐carnitine versus placebo, Outcome 1 Change in ulcer size (surface area or volume).

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Comparison 2 RGD peptide matrix versus placebo, Outcome 1 Incidence of complete closure.
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Analysis 2.1

Comparison 2 RGD peptide matrix versus placebo, Outcome 1 Incidence of complete closure.

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Comparison 2 RGD peptide matrix versus placebo, Outcome 2 Change in size of ulcers healed.
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Analysis 2.2

Comparison 2 RGD peptide matrix versus placebo, Outcome 2 Change in size of ulcers healed.

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Comparison 2 RGD peptide matrix versus placebo, Outcome 3 Adverse events.
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Analysis 2.3

Comparison 2 RGD peptide matrix versus placebo, Outcome 3 Adverse events.

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Summary of findings for the main comparison. Isoxuprine compared to placebo for leg ulcer in people with sickle cell disease

Isoxuprine compared to placebo for leg ulcer in people with sickle cell disease

Patient or population: patients with leg ulcer in people with sickle cell disease
Settings:
Intervention: Isoxuprine
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

Isoxuprine

Incidence of complete closure
Follow‐up: 6 months

See comment

See comment

Not estimable

54 ulcers
(1 study; Serjeant 1977)

⊕⊝⊝⊝
very low1,2,3

This trial shows inconsistency between units of randomisation (30 participants) and unit of analysis (54 ulcers).

*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).

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 Sequence generation, allocation concealment, blinding: unclear. Incomplete outcome data and selective report.
2 Underpowered for this outcome.
3 Few ulcers (N= 54) and healed ulcers (N = 11).

CI: confidence interval
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Summary of findings for the main comparison. Isoxuprine compared to placebo for leg ulcer in people with sickle cell disease
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Summary of findings 2. Arginine butyrate plus standard local care compared to standard local care for sickle cell in people with sickle cell disease

arginine butyrate plus standard local care compared to standard local care for sickle cell in people with sickle cell disease

Patient or population: sickle cell in people with sickle cell disease
Settings:
Intervention: arginine butyrate plus standard local care
Comparison: standard local care

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 local care

arginine butyrate plus standard local care

Complete healing
Follow‐up: 12 weeks

See comment

See comment

Not estimable

23 participants

62 ulcers
(1 study; McMahon 2010)

⊕⊝⊝⊝
very low1,2,3

This trial shows inconsistency between units of randomisation (23 participants) and unit of analysis (62 ulcers).

Change in ulcer size
Follow‐up: 12 weeks

See comment

See comment

Not estimable

(1 study; McMahon 2010)

⊕⊝⊝⊝
very low1,2,3

This trial shows inconsistency between units of randomisation (23 participants) and unit of analysis (62 ulcers).

*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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

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 Unclear allocation concealment
2 Underpowered for this outcome.
3 Few participants (23 participants; 62 ulcers) and events (N = 13 complete closure).

CI: confidence interval
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Summary of findings 2. Arginine butyrate plus standard local care compared to standard local care for sickle cell in people with sickle cell disease
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Summary of findings 3. L‐carnitine compared to placebo for leg ulcer in people with sickle cell disease

L‐carnitine compared to placebo for leg ulcer in people with sickle cell disease

Patient or population: leg ulcer in people with sickle cell disease
Settings:
Intervention: L‐carnitine
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

L‐carnitine

Change in ulcer size
Follow‐up: 12 weeks

See comment

See comment

Not estimable

15
(1 study; Serjeant 1997)

⊕⊝⊝⊝
very low1,2,3

Mean difference: ‐3.90 (95% CI ‐13.44 to 5.64).

*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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

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 Random sequence generation: unclear.
2 Underpowered for this outcome.
3 Few participants (N = 15). Blinding levels were not described.

CI: confidence interval
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Summary of findings 3. L‐carnitine compared to placebo for leg ulcer in people with sickle cell disease
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Summary of findings 4. RGD peptide matrix compared to placebo for leg ulcer in people with sickle cell disease

RGD peptide matrix compared to placebo for leg ulcer in people with sickle cell disease

Patient or population: patients with leg ulcer in people with sickle cell disease
Settings:
Intervention: RGD peptide matrix
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

RGD peptide matrix

Complete closure
Follow‐up: 10 weeks

See comment

See comment

Not estimable

55
(1 study; Wethers 1994)

⊕⊝⊝⊝
very low1,2,3

Risk ratio: 0.40 (95% CI 0.15 to 1.04).

Change in size ulcers healed
cm2
Follow‐up: 10 weeks

See comment

See comment

Not estimable

55
(1 study; Wethers 1994)

⊕⊝⊝⊝
very low1,2,3

Mean difference: 6.60 (95% CI 5.51 to 7.69).

Total adverse events
Follow‐up: 10 weeks

See comment

See comment

Not estimable

55
(1 study; Wethers 1994)

⊕⊝⊝⊝
very low1,2,3

Risk ratio: 0.76 (95 CI 0.50 to 1.17).

Related study treatment adverse events
Follow‐up: 10 weeks

See comment

See comment

Not estimable

33
(1 study; Wethers 1994)

⊕⊝⊝⊝
very low1,2,3

Risk Ratio: 1.41 (95% CI 0.27 to 7.38).

*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% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).

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 Sequence generation and allocation concealment: unclear
2 Underpowered to address this outcome
3 Few participants (N = 55) and events (N = 14)

CI: confidence interval
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Summary of findings 4. RGD peptide matrix compared to placebo for leg ulcer in people with sickle cell disease
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Comparison 1. L‐carnitine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Change in ulcer size (surface area or volume) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 All randomised patients

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]
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Comparison 1. L‐carnitine versus placebo
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Comparison 2. RGD peptide matrix versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Incidence of complete closure Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Change in size of ulcers healed Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 Adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Total

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Related study treatment

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
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Comparison 2. RGD peptide matrix versus placebo
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