| Study characteristics |
| Methods |
Study design: randomised, double‐blind, placebo‐controlled
Intention‐to‐treat: unclear
Country: Brazil |
| 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; IC 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 months of diagnosed PAD |
| Interventions |
Treatment 1: cilostazol 100 mg, twice daily, orally
Treatment 2: pentoxifylline 600 mg, twice daily
Control: placebo, twice daily
Duration: 20 weeks |
| 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 |
| Funding |
"Cilostazol, pentoxifylline, and placebo were generous gifts from LIBBS, Brazil." Study supported by grants from the National Research Council (CNPq 52 1850/96‐7) and from Research Supporting Agency of Rio de Janeiro State (FAPERJ E‐26/170. 522/00) |
| Declaration of interests |
Not reported |
| 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 was 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 were reported on, but for PFWD and MWD (Table 2); there was no breakdown for the different treatment groups. |
| Other bias |
Low risk |
No evidence of other bias |
