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Cochrane Database of Systematic Reviews

Orale Einnahme von Aspirin zur Behandlung von venösen Beingeschwüren

Información

DOI:
https://doi.org/10.1002/14651858.CD009432.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 18 febrero 2016see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Heridas

Copyright:
  1. Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

  • Paulo Eduardo de Oliveira Carvalho

    Correspondencia a: Evidence Based Health Actions Department and Thoracic Surgery Department, Marilia Medical School, Marilia, Brazil

    [email protected]

    [email protected]

  • Natiara G Magolbo

    Evidence Based Health Actions Department and Thoracic Surgery Department, Marilia Medical School, Marilia, Brazil

  • Rebeca F De Aquino

    Department of Medicine, Federal University of São Paulo, São Paulo, Brazil

  • Carolina D Weller

    Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia

Contributions of authors

Paulo de Oliveira Carvalho: conceived the review; designed the review; coordinated the review; extracted data; checked the quality of data extraction; undertook and checked quality assessment; analysed or interpreted data; performed statistical analysis; checked the quality of the statistical analysis; produced the first draft of the review; contributed to writing or editing the review; made an intellectual contribution to the review; approved the final review prior to submission; secured funding; performed previous work that was the foundation of the current review; performed translations; and is a guarantor of the review.

Natiara Magolbo: conceived the review; designed the review; extracted data; undertook quality assessment; produced the first draft of the review; performed previous work that was the foundation of the current review; wrote to study author / experts / companies; and provided data.

Rebeca De Aquino: conceived the review; designed the review; extracted data; undertook quality assessment; produced the first draft of the review; performed previous work that was the foundation of the current review; wrote to study author / experts / companies; and provided data.

Carolina Weller: extracted data; analysed or interpreted data; contributed to writing or editing the review; made an intellectual contribution to the review; approved the final review prior to submission; advised on the review; and provided data.

Contributions of editorial base:

Editors: Nicky Cullum edited the protocol; advised on methodology, interpretation and protocol content; approved the final protocol prior to submission.
Joan Webster: edited the protocol; advised on methodology, interpretation and protocol content; approved the final protocol prior to submission.

Managing Editors: Sally Bell‐Syer and Gill Rizzello, coordinated the editorial process; advised on interpretation and content. Edited the review.

Ruth Foxlee: designed the search strategy, Rocio Rodriguez Lopez ran the searches.

Sources of support

Internal sources

  • Evidence Based Actions Department From Marília Medical School ‐ FAMEMA, Brazil.

External sources

  • FAPESP‐ Fundação de Amparo à Pesquisa do Estado de São Paulo, Brazil.

  • This project was supported by the National Institute for Health Research via Cochrane Infrastructure funding to Cochrane Wounds. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health, UK.

Declarations of interest

Paolo Eduardo de Oliveira Carvalho: none known.
Natiara Magolbo: none known.
Rebeca De Aquino: none known.
Carolina Weller: none known.

Acknowledgements

We would like to thank:

  • Peer referees: Susan O' Meara, Liz McInnes, Duncan Chambers, Gill Worthy, Mike Clark, Una Adderley and Jane Nadel, for their valuable and constructive feedback.

  • FAPESP (Fundaçao de Amparo à Pesquisa do Estado de São Paulo) for the support granted.

  • Copy editors, Jenny Bellorini and Elizabeth Royle.

Version history

Published

Title

Stage

Authors

Version

2016 Feb 18

Oral aspirin for treating venous leg ulcers

Review

Paulo Eduardo de Oliveira Carvalho, Natiara G Magolbo, Rebeca F De Aquino, Carolina D Weller

https://doi.org/10.1002/14651858.CD009432.pub2

2011 Nov 09

Oral aspirin for treating venous leg ulcers

Protocol

Natiara G Magolbo, Rebeca F De Aquino, Paulo Eduardo de Oliveira Carvalho

https://doi.org/10.1002/14651858.CD009432

Differences between protocol and review

Proportion of ulcer recurrence and mean time until recurrence were not specified in the protocol, but these outcomes appeared in the del Río Solá 2012 trial and were considered important by the review team, so they were included in the review.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

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

Flow diagram of included and excluded studies
Figuras y tablas -
Figure 2

Flow diagram of included and excluded studies

Comparison 1 Oral aspirin versus control, Outcome 1 Number of people with healed ulcer.
Figuras y tablas -
Analysis 1.1

Comparison 1 Oral aspirin versus control, Outcome 1 Number of people with healed ulcer.

Comparison 1 Oral aspirin versus control, Outcome 2 Time to recurrence (days).
Figuras y tablas -
Analysis 1.2

Comparison 1 Oral aspirin versus control, Outcome 2 Time to recurrence (days).

Summary of findings for the main comparison. Oral aspirin for venous leg ulcers

Oral aspirin for venous leg ulcers

Patient or population: patients with venous leg ulcers
Settings: hospital outpatients in UK and Spain
Intervention: oral aspirin

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 aspirin

Average time for ulcer healing

22 weeks

12 weeks

Not estimable

51 (1 study)

⊕⊕⊝⊝
low1,2

P values and confidence intervals were not reported

Reduction of ulcer area (median)

0 cm²

6.5cm²

Not estimable

20
(1 study)

⊕⊕⊝⊝
low2,3

P value < 0.002

Follow‐up: 4 months

Proportion of healed ulcers in the trial period

No healed ulcers

38% of healed ulcers

Not estimable

20
(1 study)

⊕⊕⊝⊝
low2,3

P value < 0.007

Follow‐up: 4 months

Major bleeding

See comment

See comment

Not estimable

20
(1 study)

⊕⊕⊝⊝
low2,3

No events were observed in either group, follow‐up: 4 months

Another study reported 2 hospitalisations for unknown reasons, intervention group not specified

Average time of ulcer recurrence

16.33 days

SD: 7.5

39 days

SD: 6.0

Not estimable

51
(1 study)

⊕⊕⊝⊝
low1,2

P value = 0.007

Post hoc assessment not pre‐specified in protocol

Mortality

See comment

See comment

Not estimable

See comment

See comment

Mortality not reported

Other adverse events

See comment

See comment

Not estimable

71
(2 study)

See comment

No events were observed in either group. del Río Solá reported 2 hospitalisations for unknown reasons, the group of these patients were not specified and they were removed from the study

*The basis for the assumed risk (for example, 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; SD: standard deviation

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 Allocation concealment and blinding of outcome assessment were not described. Participants and personnel were not blinded. There was a high risk of bias from incomplete outcome data.There were some inconsistencies in the reporting of the data
2 The study results are based on one small study with insufficient data to estimate the effect precisely
3 Selection, performance and reporting biases were unclear

Figuras y tablas -
Summary of findings for the main comparison. Oral aspirin for venous leg ulcers
Table 1. Data extracted from included studies

Study identification

 Layton

 del Río Solá

Country        

United Kingdom

Spain

Period

Not reported

2001 to 2005

Centres

Academic Unit of Dermatology, General Infirmary at Leeds, West Yorkshire

University Hospital of Valladolid

Source of funding

 Not specified

 Not specified

Method

Study design

Prospective randomized, double‐blind

Prospective randomized trial

Power calculation

Not described

Yes

Method of randomisation

Not described

Generated by computer program

Concealment of allocation

Not described

Not described

Number of participants randomized

20

51

Number of participants analyzed

20

47

Number of participants excluded after randomizations

0

0

Number of participant withdrawals and reasons

0

4 people; 2 people needed hospitalisation and left the study and 2 people opted for treatment in another service

Intention‐to‐treat analysis

Yes

Yes

Participants

Inclusion criteria

People with chronic venous leg ulcer

Venous leg ulcer ≥ 2 cm

Ankle‐brachial rate < 0.9

No contraindication to taking aspirin

Exclusion criteria

Ulcer diameter < 2 cm

Already taking aspirin, anticoagulants or non‐steroidal anti‐inflammatory

Doppler flowmetry ankle‐brachial rate < 0.9

People with diabetes mellitus, rheumatoid arthritis, peripheral arterial disease and neurologic disease

Previous or concomitant therapy with aspirin

Aspirin

Control

P value

Aspirin

Control

P value

Number of participants

10

10

 

23

 28

 

Age (years)

62.2 years (mean)

(48‐81)

66 years (mean)

(46 ‐ 85)

 

60.50 years (SD:12.07)

58.59 years (SD:16.55)

reported as non significant

Sex

3 female, 7 male

5 female, 5 male

 

10 female, 13 male

19 female, 9 male

reported as non significant

Ulcer duration before the study

11.4 years (mean)

(1‐24)

10.5 years (mean)

(2‐22)

 

6‐12 months

> 12 months

 

1 Number of ulcers

Not reported

Not reported

Not reported

Not reported

reported as non significant

Initial ulcer surface area (cm²)

16.5 cm² (mean)

(2.5‐39.5)

14.25 cm² (mean)

(1.5‐48.5)

25.15 cm²

24.87 cm²

P=0.944

Signs of ulcer infection

Not reported

Not reported

Yes, 20 patients

Yes, 22 patients

P=0.094

Any comorbidity

Not reported

Not reported

9 patients

10 patients

Previously treated

\not reported

Not reported

10 patients

20 patients

Interventions

Aspirin 300 mg/day

Placebo

Aspirin 300 mg/day

No drug treatment

Outcomes

Follow‐up (months)

4 months

4 months

42 months mean (24‐61)

42 months mean (24‐61)

2 Withdrawals

0

0

2 people

2 people

Duration of the study to complete ulcer healing

Not reported

Not reported

Not reported

12.4 weeks

16.5 weeks

P=0.07 Mann‐Whitney

Healing period

Not reported

Not reported

Not reported

Reported as short in the aspirin group

Reported as short in the aspirin group

P=0.04

log‐rank test = 3.90

OR = 0.93 95% CI 0.25‐3.5

Average time to complete ulcer healing (weeks)

Not reported

Not reported

Not reported

12

22

Not reported

Number of participants with complete ulcer healing in the trial period

Not reported

Not reported

Not reported

17 (74%)

21 (75%)

reported as non significant

Proportion of ulcers healed in the trial period

38% of the ulcers

0% of the ulcers

< 0.007

(x² test)

Not reported

Not reported

Not reported

Change in ulcer areas in the trial period (second month; ulcer area cm²)

15.5 cm² (median)

1 cm² of reduction

(6.07% of reduction)

No reduction

< 0.01 (x² test)

 Not reported

 Not reported

Not reported

Reduction in ulcer size in the trial period (fourth month; ulcer area cm²)

10.0 cm² (median)

6.5 cm² of reduction (39.4% of reduction)

No reduction

< 0.002 (x² test)

Not reported

Not reported

Not reported

Improvement assessed by reduction in ulcer size

52% of the ulcers

26% of the ulcers

< 0.007

(x² test)

Not reported

Not reported

Not reported

Increase in ulcer size in the trial period

10% of the ulcers

26% of the ulcers

< 0.004

(x² test)

Not reported

Not reported

Not reported

Ulcers size unchanged in the trial period

0% of the ulcers

48% of the ulcers

< 0.001

(x2 test)

Not reported

Not reported

Not reported

Proportion of participants with ulcers healed in the trial period

Not reported

Not reported

Not reported

17 (74%)

21 (75%)

reported as non significant

Proportion of participants with ulcer recurrence

Not reported

Not reported

Not reported

25%

33.33%

0.74

Average time for ulcer recurrence (days)

Not reported

Not reported

Not reported

39 (SD 6)

16.33 (SD 7.5)

P=0.007 Kaplan‐Meier

adverse effects

0

0

0

0

Not reported

  1. Layton reported 12 people (60%) and del Rio 28 people (54%) with multiples ulcers but they did not specified the number in each group

  2. del Rio Solá reported that two people were hospitalised and were withdrawn from the study, but did not specify the cause of hospitalisation or their trial group

Figuras y tablas -
Table 1. Data extracted from included studies
Comparison 1. Oral aspirin versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of people with healed ulcer Show forest plot

1

51

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.71, 1.36]

2 Time to recurrence (days) Show forest plot

1

51

Mean Difference (IV, Fixed, 95% CI)

22.67 [18.96, 26.38]

Figuras y tablas -
Comparison 1. Oral aspirin versus control