| Study characteristics |
| Methods |
Study design: multicentre, randomised, double‐blind, placebo‐controlled
Intention‐to‐treat: yes; LOCF method
Country: USA |
| Participants |
Number randomised: 81 (cilostazol n = 54; placebo n = 27)
Age (mean years ± SE): cilostazol = 66 ± 1.1; placebo = 67 ± 2.0
Sex M/F: cilostazol = 38/16; placebo = 24/3
Inclusion criteria: ≥ 40 years; stable IC secondary to chronic occlusive arterial disease ≥ 6 months; ICD on treadmill between 30 and 200 m and had to be within ± 35% value of previous visit; confirmation of diagnosis of chronic occlusive arterial disease; doppler‐measured ankle systolic blood pressure ≥ 20 mmHg
Exclusion criteria: limb‐threatening chronic limb ischaemia (ischaemic rest pain, ulceration or gangrene); lower extremity surgical or endovascular arterial reconstruction or sympathectomy in previous 6 months; uncontrolled hypertension; inability to complete the treadmill walking test for reasons other than intermittent claudication; MI within previous 6 months; DVT within previous 3 months; severe concomitant disease; substance abuse; or gross obesity |
| Interventions |
Treatment: cilostazol 100 mg, twice daily, orally
Control: placebo, twice daily
Duration: 12 weeks |
| Outcomes |
ICD, ACD, ABI, and subjective assessments of symptoms by patient and physician
Outcomes evaluated at baseline (multiple visits), 2, 4, 8 and 12 weeks after initiation of therapy |
| Funding |
Otsuka America Pharmaceutical Inc. |
| Declaration of interests |
Not reported |
| Notes |
Constant speed treadmill test at 3.2 km/h and a fixed incline of 12.5%
Two‐week baseline period to stabilise concomitant medications, followed by a two to four‐week single‐blind placebo lead‐in phase |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Randomization was stratified by treatment center and patients use of calcium channel blocker". 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 |
Low risk |
Study used an 'identical' placebo. |
| 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 |
Table 2 gives explanations for withdrawals and exclusions, which were similar between treatment groups and unlikely to affect outcomes. |
| Selective reporting (reporting bias) |
High risk |
Authors only briefly mentioned ABI results in the abstract with no explicit description. |
| Other bias |
Low risk |
No evidence of other bias |
