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Respuestas clínicas Cochrane

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Study flow diagram
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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.
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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.
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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.

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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

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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

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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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