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Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figures and Tables -
Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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.

Comparison 1 01 Pentoxifylline (Overall), Outcome 1 01 Healing or significant improvement.
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Analysis 1.1

Comparison 1 01 Pentoxifylline (Overall), Outcome 1 01 Healing or significant improvement.

Comparison 1 01 Pentoxifylline (Overall), Outcome 2 Sensitivity analysis: excluding open or single blind studies.
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Analysis 1.2

Comparison 1 01 Pentoxifylline (Overall), Outcome 2 Sensitivity analysis: excluding open or single blind studies.

Comparison 1 01 Pentoxifylline (Overall), Outcome 3 Sensitivity analysis: excluding trials with short treatment duration.
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Analysis 1.3

Comparison 1 01 Pentoxifylline (Overall), Outcome 3 Sensitivity analysis: excluding trials with short treatment duration.

Comparison 1 01 Pentoxifylline (Overall), Outcome 4 Sensitivity analysis: excluding trials that did not report healing only as an outcome.
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Analysis 1.4

Comparison 1 01 Pentoxifylline (Overall), Outcome 4 Sensitivity analysis: excluding trials that did not report healing only as an outcome.

Comparison 1 01 Pentoxifylline (Overall), Outcome 5 Sensitivity analysis: excluding trials not using compression.
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Analysis 1.5

Comparison 1 01 Pentoxifylline (Overall), Outcome 5 Sensitivity analysis: excluding trials not using compression.

Comparison 1 01 Pentoxifylline (Overall), Outcome 6 Sensitivity analysis: excluding trials that recruited hard‐to‐heal patients only.
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Analysis 1.6

Comparison 1 01 Pentoxifylline (Overall), Outcome 6 Sensitivity analysis: excluding trials that recruited hard‐to‐heal patients only.

Comparison 1 01 Pentoxifylline (Overall), Outcome 7 Side effects.
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Analysis 1.7

Comparison 1 01 Pentoxifylline (Overall), Outcome 7 Side effects.

Comparison 2 02 Pentoxifylline with compression, Outcome 1 01 Complete healing.
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Analysis 2.1

Comparison 2 02 Pentoxifylline with compression, Outcome 1 01 Complete healing.

Comparison 2 02 Pentoxifylline with compression, Outcome 2 01 Sensitivity analysis: hard‐to‐heal patients.
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Analysis 2.2

Comparison 2 02 Pentoxifylline with compression, Outcome 2 01 Sensitivity analysis: hard‐to‐heal patients.

Comparison 2 02 Pentoxifylline with compression, Outcome 3 Sensitivity analysis: normal healing patients.
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Analysis 2.3

Comparison 2 02 Pentoxifylline with compression, Outcome 3 Sensitivity analysis: normal healing patients.

Comparison 3 03 Pentoxifylline without compression, Outcome 1 01 Complete healing or significant improvement.
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Analysis 3.1

Comparison 3 03 Pentoxifylline without compression, Outcome 1 01 Complete healing or significant improvement.

Comparison 4 04 Pentoxifylline vs defibrotide, Outcome 1 01 Complete healing at 3 months.
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Analysis 4.1

Comparison 4 04 Pentoxifylline vs defibrotide, Outcome 1 01 Complete healing at 3 months.

Table 1. Quality assessment by trial

Trial ID: pts / arm

Incl / excl criteria

Power calc.

Randomisation

Allocation
concealed

Baseline equivalence

Blinding

Outcomes

ITT Analysis

Weitgasser 1983: 60 pts in two arms

Yes / No

Not reported

Method not reported

Unclear

Comparable for age and sex, but no other data reported

Double

Appropriate (healing response operationally defined as good, satisfactory, no change or worse

No ‐ one pt withdrew and was excluded from the analysis

Schürmann 1986: 24 pts in 2 arms

No / Yes

Not reported

Method not reported

Unclear

Mean ulcer size favoured control group. Other information reported

Single

Appropriate (ulcer size at baseline and trial completion reported

Not reported ‐ no withdrawals

Arenas 1988: 30 pts in 2 arms

No / Yes

Not reported

Method not reported

Unclear

Not reported

Double

Appropriate (healing response operationally defined as healing & significant improvement, improvement, no change or worse

No ‐ five pts withdrew and were excluded from the analysis

Colgan 1990: 80 pts in 2 arms

Yes / No

Not reported

Randomisation by balanced blocks of eight in separate lists for each centre

Unclear

Yes

Double

Appropriate ‐ numbers of ulcers healed

Not reported but withdrawals included in results as treatment failures

Apollonio 1992

Yes / Yes

Not reported

Method not reported

Unclear

Yes

Not reported

Appropriate ‐ numbers of ulcers healed

Not reported but no withdrawals

Barbarino 1992: 12 pts in 2 arms

Yes / Yes

Not reported

Method not reported

Unclear

Yes

Double

Appropriate ‐ ulcer size at baseline and trial conclusion reported

Not reported but no withdrawals

Pizarro 1996: 60 pts in 4 arms

Yes / No

Not reported

Method not reported

Unclear

Mean ulcer duration and ABI favoured control group

Double

Appropriate ‐ number of ulcers healed

No ‐ 11 pts excluded, but not reported from which groups

Herdy 1997: 12 pts in 2 arms

Yes / Yes

Not reported

Method not reported

Unclear

Mean ulcer size favoured control group and mean ulcer duration favoured PTX group

Not reported

Appropriate ‐ ulcer size at baseline and trial completion

Not reported, but no withdrawals

Dale 1999: 200 pts in 2 arms within a factorial trial

Yes / Yes

Yes

Sequential sealed envelopes

Adequate

Yes

Double

Appropriate ‐ numbers of ulcers healed

Yes

Falanga 1999: 131 pts in 3 arms

Yes / Yes

Yes

Method of randomisation not reported

Adequate:
randomisation by pharmaceutical company

Mean ulcer size favoured PTX 2400mg and placebo groups

Double

Appropriate ‐ numbers of ulcers healed (but numbers extrapolated from life analysis table)

No ‐ 2 pts excluded

Belcaro 2002: 172 pts in 2 arms

Yes / Yes

Not reported

Method not reported but followed same method as Colgan

Unclear

Yes

Double

Appropriate ‐ numbers of ulcers healed

No ‐ 12 pts excluded from the analysis

Nikolovska 2002: 80 pts in 2 arms

Yes / Yes

Yes

Method not reported

Unclear

Yes

Open label

Appropriate ‐ numbers of ulcers healed

Not reported but withdrawals included in analysis

Figures and Tables -
Table 1. Quality assessment by trial
Comparison 1. 01 Pentoxifylline (Overall)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 01 Healing or significant improvement Show forest plot

11

841

Risk Ratio (M‐H, Random, 95% CI)

1.70 [1.30, 2.24]

2 Sensitivity analysis: excluding open or single blind studies Show forest plot

9

737

Risk Ratio (M‐H, Fixed, 95% CI)

1.60 [1.38, 1.85]

3 Sensitivity analysis: excluding trials with short treatment duration Show forest plot

6

693

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [1.34, 1.80]

4 Sensitivity analysis: excluding trials that did not report healing only as an outcome Show forest plot

9

751

Risk Ratio (M‐H, Fixed, 95% CI)

1.56 [1.34, 1.80]

5 Sensitivity analysis: excluding trials not using compression Show forest plot

7

659

Risk Ratio (M‐H, Fixed, 95% CI)

1.51 [1.30, 1.76]

6 Sensitivity analysis: excluding trials that recruited hard‐to‐heal patients only Show forest plot

7

517

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [1.10, 1.54]

7 Side effects Show forest plot

9

629

Risk Ratio (M‐H, Fixed, 95% CI)

1.56 [1.10, 2.22]

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Comparison 1. 01 Pentoxifylline (Overall)
Comparison 2. 02 Pentoxifylline with compression

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 01 Complete healing Show forest plot

7

659

Risk Ratio (M‐H, Random, 95% CI)

1.56 [1.14, 2.13]

2 01 Sensitivity analysis: hard‐to‐heal patients Show forest plot

3

264

Risk Ratio (M‐H, Fixed, 95% CI)

2.36 [1.74, 3.19]

3 Sensitivity analysis: normal healing patients Show forest plot

4

395

Risk Ratio (M‐H, Fixed, 95% CI)

1.20 [1.01, 1.43]

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Comparison 2. 02 Pentoxifylline with compression
Comparison 3. 03 Pentoxifylline without compression

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 01 Complete healing or significant improvement Show forest plot

4

182

Risk Ratio (M‐H, Fixed, 95% CI)

2.25 [1.49, 3.39]

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Comparison 3. 03 Pentoxifylline without compression
Comparison 4. 04 Pentoxifylline vs defibrotide

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 01 Complete healing at 3 months Show forest plot

1

23

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.81, 1.55]

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Comparison 4. 04 Pentoxifylline vs defibrotide