Elsevier

The Lancet

Volume 359, Issue 9317, 4 May 2002, Pages 1550-1554
The Lancet

Articles
Pentoxifylline for treatment of venous leg ulcers: a systematic review

https://doi.org/10.1016/S0140-6736(02)08513-6Get rights and content

Summary

Introduction

Venous ulcers are usually treated with compression therapy, but, because this treatment may not be effective for some people, adjuvant therapy could be beneficial. We did a systematic review of randomised controlled trials that compared pentoxifylline (with and without compression treatment) with placebo, or other treatments, in patients with venous leg ulcers.

Methods

We identified eight trials (547 adults), five of which compared pentoxifylline and compression with placebo and compression (n=445), and three of which compared pentoxifylline alone with placebo (102). Our main aim was to determine whether pentoxifylline, with or without compression, was effective in treatment of venous leg ulcers. Analysis was by intention to treat.

Findings

Pentoxifylline was more effective than placebo in complete healing or substantial improvement of venous leg ulcers (relative risk 1·49, 95% Cl 1·11–2·01). Pentoxifylline with compression was also more effective than placebo and compression in complete healing (1·30, 1·10–1·54). Patients taking pentoxifylline had no more adverse events than those on placebo (1·25, 0·87–1·80). The most frequent adverse event was mild gastrointestinal disturbance (43%).

Interpretation

Our results suggest that pentoxifylline gives additional benefit to compression for venous leg ulcers, and is possibly effective for patients not receiving compression.

Introduction

Most leg ulcers are venous.1 High compression treatment (three-layer or four-layer short-stretch bandaging, or Unna boot) is an effective cure for venous ulcers,2 but despite compression, almost 30% of people remain unhealed after 1 year of treatment.3 Adjuvants to compression treatment could be beneficial. Pentoxifylline, a haemorrheological agent, reduces the viscosity of blood by increasing the flexibility of erythrocytes, encouraging migration of white cells, inhibition of aggregation of platelets, and lowering of the viscosity of plasma,4 actions that might correct microcirculatory disorders. Trials5, 6 of the clinical effectiveness of pentoxifylline have had conflicting results, and the usefulness of the drug remains unclear.7 We therefore systematically reviewed randomised controlled trials to quantify the effect of pentoxifylline (Trental, Aventis Pharma, Lyon, France) on healing in venous leg ulcers, either as an adjuvant to compression, or compared with placebo.

Section snippets

Methods

We searched the CENTRAL registers of the Cochrane Wounds Group and the Cochrane Peripheral Vascular Diseases Group to September, 2000. We identified no new controlled trials in our search of the Wound Review Group register to April, 2001. The CENTRAL registers differ from the Cochrane Controlled Trials Register in that they contain references that have not been confirmed as controlled trials, or trials that have not yet been forwarded for inclusion in the Cochrane register. The register of the

Results

We included eight trials (table 2),5, 6, 8, 9, 10, 11, 12, 13 two of which were not written in English.11, 12 In most studies, the primary outcome was either complete healing of the patients' reference ulcer (usually the largest ulcer) or of all ulcers on the reference leg,5, 6, 9 or data was provided for individual patients, from which we could calculate the number of patients healed.11, 12 In one trial,10 data were presented in a life table, from which the number of patients healed was

Discussion

Our results showed that pentoxifylline improves healing rates compared with placebo. Pentoxifylline was effective for treatment of leg ulcers, but the evidence for pentoxifylline on it's own is not as strong as that for this drug as an adjuvant to compression treatment. The finding is stronger in trials that lasted longer than 12 weeks, although this result could be because the longer trials were of better quality than the shorter trials.

Although which microcirculatory events link venous

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