O'Donnell 2009.
| Methods | Study design: single‐centre, randomised, double‐blind, placebo‐controlled
Intention to treat: yes Country: Northern Ireland |
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| Participants | Number randomised: 106 (cilostazol n = 51; placebo n = 55) Age (median years): cilostazol = 64.2; placebo = 66.1 Sex (M/F): cilostazol = 34/17; placebo = 39/16 Inclusion criteria: aged 30 to 90 years (both sexes); had PAD with intermittent claudication with an ABI < 0.9 stable on optimal medical therapy for 3 months Exclusion criteria: current or previous acute or critical limb ischaemia; severe claudication prohibiting treadmill testing; endovascular or surgical procedures within the preceding 6 months; non‐atherosclerotic co‐morbidity that had limited their walking before the onset of claudication pain; predisposition to bleeding; a history of uncontrolled cardiac, respiratory, renal or liver disease; use of omeprazole or diltiazem |
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| Interventions | Treatment: cilostazol 100 mg, twice daily, oral route Control: placebo, twice daily, oral route Duration: 24 weeks |
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| Outcomes | ICD, ACD, oxygen‐derived free‐radical generation, antioxidant consumption, other inflammatory cascade markers, quality of life (SF‐36, WIQ, VascuQol); measured at baseline and weeks 6 and 24 | |
| Notes | Calibrated treadmill test with a constant speed of 3.2 km/h and constant 10% gradient Four‐week stabilisation run‐in period |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patient‐treatment randomisation and allocation was performed independently by the Department of Research Pharmacology in the Belfast City Hospital". Insufficient information on sequence generation |
| Allocation concealment (selection bias) | Low risk | "Both, the patient and the primary investigator, were blinded to study‐drug allocation, which was completed using the sealed‐envelope method" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Both, the patient and the primary investigator, were blinded to study‐drug allocation". "Study‐drug un‐blinding was performed at the end of the study, following the completion of all clinical assessments and laboratory analyses for all patients" |
| 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 | Dropouts were similar between treatment groups |
| Selective reporting (reporting bias) | Low risk | Although no study protocol is available, all outcomes appear to be reported on |
| Other bias | Low risk | Placebo provided by Otsuka Pharmaceutical Inc |