Summary of findings 1. Pentoxifylline compared with placebo for treatment of people with intermittent claudication.
| Pentoxifylline compared with placebo for treatment of people with intermittent claudication | ||||||
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Patient or population: people with intermittent claudication Settings: worldwide, single and multicentre outpatient studies Intervention: pentoxifylline Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with pentoxifylline | |||||
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PFWD (change in metres) (4–40 weeks' follow‐up) |
— | — | 1890 (11 RCTs) | ⊕⊕⊝⊝a,b Low | Most of the individual studies supported pentoxifylline for improving PFWD but this could not be evaluated in a meta‐analysis. | |
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TWD (change in metres) (8–52 weeks' follow‐up) |
— | — | 2110 (14 RCTs) | ⊕⊕⊝⊝a,b Low | All but 1 individual study supported pentoxifylline for improving TWD but this could not be evaluated in a meta‐analysis. | |
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ABI (pre‐exercise/baseline ABI compared with follow‐up ABI) (4 studies with 8 weeks' follow‐up and 1 study with 24 weeks' follow‐up) |
— | — | 902 (5 RCTs) | ⊕⊕⊕⊝b Moderate | All studies individually reported there was no difference in ABI between the treatment groups. | |
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QoL (SF‐36, WIQ and unspecified) (1 study with 4 weeks' follow‐up and 2 studies with 24 weeks' follow‐up) |
— | — | 1179 (3 RCTs) | ⊕⊕⊕⊝b Moderate | 2 larger studies both evaluated QoL with SF‐36 and WIQ and found no difference between treatment groups. The third, much smaller and shorter study using an unspecified method to assess QoL found improved QoL in the pentoxifylline treatment group. | |
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Side effects (number of cases or proportion) (4–52 weeks' follow‐up) |
— | — | 1837 (9 RCTs) |
⊕⊕⊝⊝a,b Low | None of the studies reported major side effects and most reported no side effects in either treatment group but the reporting and types of side effects varied greatly. | |
| *The risk in the intervention group (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). ABI: ankle‐brachial pressure index; CI: confidence interval; PFWD: pain‐free walking distance;QoL: quality of life; RCT: randomised controlled trial; SF‐36: 36‐item Short Form; TWD: total walking distance; WIQ: Walking Impairment Questionnaire. | ||||||
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GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded one level due to risk of bias concerns (many individual studies did not report allocation and randomisation methods) and inconsistencies between individual study reports. bDowngraded one level because imprecision could not be evaluated (lack of reporting and heterogeneity).