Dawson 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: 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 intermittent claudication 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 |
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| 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 |
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| 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 |
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| 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 is 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 mention ABI results in the abstract with no explicit description |
| Other bias | Unclear risk | Study supported by Otsuka America Pharmaceutical Inc |