Pentoxifylline for treating venous leg ulcers.

BACKGROUND: Healing of venous leg ulcers is improved by the use of compression bandaging but some venous ulcers remain unhealed, and some people are unsuitable for compression therapy. Pentoxifylline, a drug which helps blood flow, has been used to treat venous leg ulcers but to date there has been no systematic review.

OBJECTIVES: To assess the effects of pentoxifylline (oxpentifylline or Trental 400) for treating venous leg ulcers, compared with placebo, or other therapies, in the presence or absence of compression therapy.

SEARCH STRATEGY: We searched the Cochrane Peripheral Vascular Diseases and Wounds Groups specialised registers (date of last search was May 2001), and reference lists of relevant articles. We hand searched relevant journals and conference proceedings, and contacted Hoechst (the manufacturer of the drug) and experts in the field.

SELECTION CRITERIA: Randomised trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression, in patients with venous leg ulcers.

DATA COLLECTION AND ANALYSIS: Details from eligible trials were extracted and summarised by one reviewer using a coding sheet. Data extraction was independently verified by one other reviewer.

MAIN RESULTS: Nine trials involving 572 adults were included. The quality of trials was variable. Eight trials compared pentoxifylline with placebo; in five of these trials patients received compression therapy. In one trial pentoxifylline was compared with defibrotide in patients who also received compression. Combining eight trials that compared pentoxifylline with placebo (with or without compression) demonstrated that pentoxifylline is more effective than placebo in terms of complete ulcer healing or significant improvement (relative risk of healing with pentoxifylline compared with placebo 1.41, 95% confidence interval 1.19 -1.66). Pentoxifylline plus compression is more effective than placebo plus compression (relative risk of healing with pentoxifylline 1.30, 95% confidence interval 1.10-1.54). A comparison between pentoxifylline and defibrotide found no difference in healing rates. More adverse effects were reported in patients receiving pentoxifylline, although this was not statistically significant (relative risk of adverse effects with pentoxifylline 1.25, 95% confidence interval 0.87-1.80). Nearly half of the reported adverse effects were gastrointestinal.

REVIEWER'S CONCLUSIONS: Pentoxifylline appears to be an effective adjunct to compression bandaging for treating venous ulcers. There was no cost effectiveness data available and healthcare commissioners may therefore conclude that it not be considered a routine adjunct. Pentoxifylline in the absence of compression may be effective for treating venous leg ulcers, although the evidence should be cautiously interpreted. The majority of adverse effects are gastrointestinal disturbances (indigestion, diarrhoea and nausea).