| Study characteristics |
| Methods |
Study design: multicentre, randomised, double‐blind, placebo‐controlled
Intention‐to‐treat: yes; LOCF method
Country: USA |
| Participants |
Number randomised: 239 (cilostazol n = 119; placebo n = 120)
Age (mean years ± SD): cilostazol = 64.8 ± 9.4; placebo = 64.5 ± 8.8
Sex M/F: cilostazol = 90/29; placebo = 90/30
Inclusion criteria: > 40 years; IC caused by lower extremity PAOD for at least 6 months; baseline ICD ≥ 54 m (one minute); ACD variance no greater than 20% between two screen visits and maximum allowable ACD of 805 m (15 minutes)
Exclusion criteria: limb‐threatening PAOD including gangrene or ischaemic rest pain; surgical or endovascular procedures during previous 3 months; gross obesity; hypertension; current malignancy; Buerger's disease or DVT in previous 3 months; inability to complete treadmill testing for reasons unrelated to IC; bleeding problems |
| Interventions |
Treatment: 100 mg cilostazol, twice daily
Control: placebo
Duration: 16 weeks |
| Outcomes |
ACD, ICD, ABI, physician and patient perception of effect of study drug, QoL (SF‐36, WIQ)
Treadmill tests performed at two baseline visits and weeks 8, 12 and 16 after randomisation |
| Funding |
Otsuka America Pharmaceutical Inc. |
| Declaration of interests |
Not reported. Two of the authors (J Heckman and Dr. Forbes) were employed by Otsuka America Pharmaceutical Inc. |
| Notes |
Variable‐grade, constant‐speed treadmill test, beginning at 0% incline with a speed of 3.2 km/h, increasing by 3.5% every 3 minutes
Two‐week screening period |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Insufficient description of sequence generation methods |
| Allocation concealment (selection bias) |
Unclear risk |
Insufficient description of allocation concealment methods |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Although study used a placebo, there was insufficient description to determine if blinding was adequate. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Blinding of assessors not adequately discussed |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Reasons for discontinuation were given and all participants accounted for. |
| Selective reporting (reporting bias) |
Low risk |
Although no protocol was available all relevant outcomes were reported on. |
| Other bias |
Low risk |
No evidence of other bias |
