Elam 1998.
| Methods | Study design: multicentre, randomised, double‐blind, placebo‐controlled
Intention to treat: yes Country: USA |
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| Participants | Number randomised: 189 (cilostazol n = 95; placebo n = 94) Age (mean years): cilostazol = 66.7; placebo = 65.8 Sex M/F: cilostazol = 83/12; placebo = 76/18 Inclusion criteria: men and women > 40 years; chronic stable intermittent claudication secondary to PAD Exclusion criteria: women with childbearing potential; gross obesity; poorly controlled hypertension or diabetes; history of malignancy; current alcohol or drug abuse; renal disease; bleeding tendencies |
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| Interventions | Treatment: cilostazol 100 mg, twice daily, orally
Control: placebo, twice daily, orally Duration: 12 weeks |
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| Outcomes | Lipid profiles, ICD, ACD, ABI Outcomes evaluated at baseline 2, 4, 6, 8 and 12 weeks (treadmill tests conducted at two baseline visits, and weeks 8 and 12) |
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| Notes | "Delayed‐incline" treadmill method, where incline loading was delayed until the third minute then gradually increased by 3.5% increments every three minutes, with a constant speed of 3.2 km/h Minimum two‐week lead‐in 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 | Low risk | "All lipid analyses were blinded to the investigators and patients after randomization". Although it was not directly addressed for other outcomes, it is assumed blinding was adequate |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients who completed the study were comparable between treatment groups |
| Selective reporting (reporting bias) | High risk | In the methods the authors state both pain‐free and maximum walking distances as primary exercise variables, but only maximum walking distance is reported on |
| Other bias | Unclear risk | Study supported by Otsuka America Pharmaceutical Inc |