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Cochrane Database of Systematic Reviews

Esteroides anabolizantes para el tratamiento de las úlceras por presión

Información

DOI:
https://doi.org/10.1002/14651858.CD011375.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 20 junio 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Heridas

Copyright:
  1. Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

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Autores

  • Cho Naing

    Correspondencia a: College of Public Health, Medical and Veterinary Sciences, Division of Tropical Health and Medicine, James Cook University, Townsville, Australia

    [email protected]

    School of Postgraduate Studies, International Medical University, Kuala Lumpur, Malaysia

  • Maxine A Whittaker

    College of Public Health, Medical and Veterinary Sciences, Division of Tropical Health and Medicine, James Cook University, Townsville, Australia

Contributions of authors

Cho Naing: conceived and designed the review; extracted data; checked the quality of data extraction; analysed and interpreted data; performed statistical analysis; produced the first draft of the review; contributed to writing and editing the review; approved the final review prior to submission; secured funding; wrote to study author/experts/companies; provided data; and is a guarantor of the review.

Maxine Whittaker: conceived, designed and coordinated the review; checked quality assessment; produced the first draft of the review; contributed to writing or editing the review; approved the final review prior to submission; secured funding; and is a guarantor of the review.

Contributions of editorial base:

Nicky Cullum (Editor): edited the protocol; advised on methodology, interpretation and protocol content.

Jo Dumville (Editor): edited the review; advised on methodology, interpretation and review content.

Gill Rizzello and Sally Bell‐Syer (Managing Editors): co‐ordinated the editorial process. Advised on interpretation and content; edited the review.

Reetu Child and Naomi Shaw (Information Specialists): designed the search strategy, ran the searches and edited the search methods section.

Ursula Gonthier (Editorial Assistant): Edited the plain language summary and reference sections of the review.

Sources of support

Internal sources

  • School of Postgraduate Studies, International Medical University, Malaysia.

    support to CN

  • College of Public Health, Medical and Veterinary Sciences, Division of Tropical Health and Medicine, James Cook University, Australia.

    support to MAW and CN

External sources

  • Swiss Tropical and Public Health Institute, Basel, Switzerland.

    Support to CN

  • The National Institute for Health Research (NIHR), UK.

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

Declarations of interest

Cho Naing: none known
Maxine A Whittaker: none known

Acknowledgements

We would like to thank Dr Helene Moustgaard (Nordic Cochrane Centre) for her Danish translation services. We are grateful to the peer reviewers David Margolis, Gill Worthy, Anne‐Marie Glenny, Ross Atkinson, Audrey Demetriou and Janet Wale, for the comments provided and valuable input; and to Evan Kontopantelis and Gero Langer who provided feedback on the protocol. We would also like to thank copy‐editors Elizabeth Royle and Denise Mitchell for their contribution. Dr Vanessa Racloz provided valuable assistance in designing the review and providing content; Dr Kyan Aung also provided us with papers. We are grateful to the participants and researchers who took part in the trial, and offer our special thanks to Professor William A. Bauman for giving us additional information related to the trial.

Version history

Published

Title

Stage

Authors

Version

2017 Jun 20

Anabolic steroids for treating pressure ulcers

Review

Cho Naing, Maxine A Whittaker

https://doi.org/10.1002/14651858.CD011375.pub2

2014 Nov 12

Anabolic steroids for treating pressure ulcers

Protocol

Cho Naing, Maxine A Whittaker, Kyan Aung, Vanessa Racloz

https://doi.org/10.1002/14651858.CD011375

Differences between protocol and review

Only one study was included in this review. Thus, the planned data pooling, assessment of heterogeneity and sensitivity analysis were not possible.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Female; Humans; Male; Middle Aged;

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.

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.
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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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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 3

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

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Comparison 1 Oxandrolone compared with placebo, Outcome 1 Completed healing at 24 week.
Figuras y tablas -
Analysis 1.1

Comparison 1 Oxandrolone compared with placebo, Outcome 1 Completed healing at 24 week.

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Comparison 1 Oxandrolone compared with placebo, Outcome 2 Non‐serious adverse events.
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Analysis 1.2

Comparison 1 Oxandrolone compared with placebo, Outcome 2 Non‐serious adverse events.

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Comparison 1 Oxandrolone compared with placebo, Outcome 3 Serious adverse events.
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Analysis 1.3

Comparison 1 Oxandrolone compared with placebo, Outcome 3 Serious adverse events.

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Summary of findings for the main comparison. Anabolic steroids for treating pressure ulcers

Anabolic steroids for treating pressure ulcers

Patient or population: people with pressure ulcers
Settings: any

Intervention: anabolic steroids

Comparison: placebo or no anabolic steroids

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Certainty of the evidence
(GRADE)

Assumed risk

Corresponding risk

Control

Anabolic steroids

Proportion of wounds completely healed at 24 weeks

298 per 1000

241 per 1000
(155 to 376)

RR 0.81

(0.52 to 1.26)

212
(1 trial)

⊕⊝⊝⊝
very low1,2,3

Non‐serious adverse events

29 per 1000

131 per 1000
(33 to 443)

RR 3.85

(1.12 to 13.26)

212
(1 trial)

⊕⊕⊝⊝

low2,3,4

Serious adverse events

154 per 1000

83 per 1000
(38 to 180)

RR 0.54

(0.25 to 1.17)

212
(1 trial)

⊕⊝⊝⊝
very low1,2,3

*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: we are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different.
Low quality:our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect.
Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

1A wide 95% CI, which spanned both benefit and harm.
2Most of the participants in the oxandrolone group (98.2%) and all participants in the placebo group (100%) were men.
3Total sample size (n = 212) was lower than the original target sample size (n = 400): not downgraded as early stopping according to futility stopping criteria will not lead to substantial bias.
4A wide 95% CI.

Figuras y tablas -
Summary of findings for the main comparison. Anabolic steroids for treating pressure ulcers
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Table 1. List of reported non‐serious adverse events

Description

Oxandrolone group

n = 108

Placebo group

n = 104

Elevated liver enzyme levels

5

1

Deep venous thrombosis

3

0

Elevated prostate specific antigen

0

1

Severe osteomyelitisa

1

0

Sepsis, secondary cellulitisa

1

0

Medical illnessa

2

1

aIn the trial investigators' judgement these events were not associated with oxandrolone

Figuras y tablas -
Table 1. List of reported non‐serious adverse events
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Table 2. List of reported serious adverse events

Description

Oxandrolone group

n = 108

Placebo group

n = 104

Deatha

3

5

Myocutaneous flap surgerya

5

9

Elevated bladder stone removal liver enzyme levelsa

1

0

Small bowel obstruction, renal failurea

0

1

Oral cancera

0

1

aIn the trial investigators' judgement these events were not associated with oxandrolone

Figuras y tablas -
Table 2. List of reported serious adverse events
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Comparison 1. Oxandrolone compared with placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Completed healing at 24 week Show forest plot

1

212

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.52, 1.26]

2 Non‐serious adverse events Show forest plot

1

212

Risk Ratio (M‐H, Fixed, 95% CI)

3.85 [1.12, 13.26]

3 Serious adverse events Show forest plot

1

212

Risk Ratio (M‐H, Fixed, 95% CI)

0.54 [0.25, 1.17]
Figuras y tablas -
Comparison 1. Oxandrolone compared with placebo
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