Robust double-blind randomised controlled trials (RCT) that compared pharmacological agents with placebo in patients with moderate intermittent claudication (Fontaine stage II) and an ankle-brachial pressure index (ABI) of less than 0.9 that reported data for the outcomes maximal walking distance or pain-free walking distance were eligible for inclusion. Robust studies were defined based on sample size: those with fewer than 56 patients were excluded.
Treadmill tests were used to evaluate walking with protocols that involved either constant or graded loads (most were 3km/h). Specific interventions assessed by the included studies were: anti-platelet agents (ticlopidine, cloricromene, mesoglycan, indobufen, defibrotide); lipid lowering agents (atorvastatin, simvastatin, policosanol,avasimibe); phosphodiesterase inhibitors (cilostazol, pentoxifylline, phosphodiesterase inhibitor); prostaglandins (prostoglandin, iloprost); proteoglycans (heparan sulfate,calcium-heparin, sulodexide, L-arginine); vasodilators (naftidrofuryl, inositol nicotinate); calcium chelators (EDTA); CNS-stimulators (hydroxytryptamine); propionul-L-carnitine; and prostacyclin. Duration of follow-up ranged from 0 to 18 months.
Two reviewers independently assessed studies for inclusion.