de Albuquerque 2008.
| Methods | Study design: randomised, double‐blind, placebo‐controlled
Intention to treat: unclear Country: Brazil |
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| Participants | Number randomised: 48 (cilostazol n = 17; pentoxifylline n = 15; placebo n = 16) Age (mean years ± SD): cilostazol = 64.0 ± 9.0; pentoxifylline = 64.0 ± 10.0; placebo = 63.0 ± 9.0 Sex %M: cilostazol = 64.7%; pentoxifylline = 60.0% placebo = 50.0% Inclusion criteria: Age 45 to 85 years; intermittent claudication for at least 6 months; resting ABI ≤ 0.90; duplex evidence of PAD Exclusion criteria: Critical limb ischaemia (Fontaine classification III and IV); symptomatic coronary artery disease (angina); congestive heart failure; arterial revascularisation indication; less than 6 month of diagnosed PAD |
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| Interventions | Treatment 1: cilostazol 100 mg, twice daily, orally Treatment 2: pentoxifylline 600 mg, twice daily Control: placebo, twice daily Duration: 20 weeks |
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| Outcomes | PFWD, MWD, blood analysis (CRP, triglycerides, HDL, LDL), urine analysis (8‐epi‐prostaglandin F2a), endothelial function by forearm blood flow, adverse events, change in ABI; measured at baseline and then every 4 weeks until 20 weeks | |
| Notes | Calibrated treadmill at a constant speed of 3.2 km/h; incline was increased every 3 min | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were randomly assigned to 20 weeks of treatment…". Insufficient description of sequence generation methods |
| Allocation concealment (selection bias) | Low risk | Use of coded envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patients or researchers were not able to distinguish among treatment capsules |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of assessors is not adequately discussed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Appears all participants completed the trial, no loss‐to‐follow‐up reported |
| Selective reporting (reporting bias) | High risk | All outcomes included in description of methods are reported on, but for PFWD and MWD (Table 2) there is no breakdown for the different treatment groups |
| Other bias | Low risk | No indication of other bias |