The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding, selective outcome reporting), and by inconsistency (unexplained variability in results).
A Cochrane review[Abstract] 1 included 24 studies with a total of 3 377 subjects. Seventeen studies compared pentoxifylline versus placebo. In the 7 remaining studies, pentoxifylline was compared with flunarizine (1 study), aspirin (1 study), Gingko biloba extract (1 study), nylidrin hydrochloride (1 study), prostaglandin E1 (2 studies) and buflomedil and nifedipine (1 study). Pooled analysis was not possible due to considerable heterogeneity between the included studies with regards to multiple variables including duration of treatment, dose of pentoxifylline, baseline walking distance and patient characteristics.
In a total of 17 studies which compared pentoxifylline with placebo, of which 14 reported total walking distance (TWD) and 11 reported to pain-free walking distance (PFWD), the difference in percentage improvement in TWD for pentoxifylline over placebo ranged from 1.2% to 155.9%, and for PFWD the difference ranged from -33.8% to 73.9%. Pooling of the studies was not possible, but most included studies suggested a possible improvement in PFWD and TWD for pentoxifylline over placebo. There was no statistically significant difference in ankle brachial pressure index (ABI) between the pentoxifylline and placebo groups. Pentoxifylline was generally well tolerated. Two larger studies that evaluated quality of life (QoL) and used validated QoL tools found no evidence of a difference between pentoxifyllinen and placebo. One small, short-term study, which did not specify which QoL tool was used, reported improved QoL in the pentoxifylline group.
Exercise is the treatment of choice, and it is unclear whether oral pentoxifylline confers additional benefits to patients who can and do participate in therapeutic exercise regimens.
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