Money 1998.
| Methods | Study design: multicentre, randomised, double‐blind, placebo‐controlled
Intention to treat: yes; LOCF method Country: USA |
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| 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; intermittent claudication 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 intermittent claudication; bleeding problems |
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| 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, quality of life (SF‐36, WIQ) Treadmill tests performed at two baseline visits and weeks 8, 12 and 16 after randomisation |
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| 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 |
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| 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 is insufficient description to determine if blinding is 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 are given and all participants accounted for |
| Selective reporting (reporting bias) | Low risk | Although no protocol was available all relevant outcomes are reported on |
| Other bias | Unclear risk | Study supported by Otsuka America Pharmaceutical Inc |