Pentoxifylline for treating venous leg ulcers. 2007

A Jull, and B Arroll, and V Parag, and J Waters
University of Auckland, Clinical Trials Research Unit, Private Bag 92019, Auckland, New Zealand. a.jull@ctru.auckland.ac.nz

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. An earlier version of this review included 9 randomised controlled trials, but more research has been since been conducted and an updated review is required. OBJECTIVE 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. METHODS For this second update we searched the Cochrane Wounds Group Specialised Register, CENTRAL, MEDLINE, EMBASE and Cinahl (date of last search was February 2007), and reference lists of relevant articles. METHODS Randomised trials comparing pentoxifylline with placebo or other therapy in the presence or absence of compression, in people with venous leg ulcers. METHODS Details from eligible trials were extracted and summarised by one author using a coding sheet. Data extraction was independently verified by one other author. RESULTS Twelve trials involving 864 participants were included. The quality of trials was variable. Eleven trials compared pentoxifylline with placebo or no treatment; in seven of these trials patients received compression therapy. In one trial pentoxifylline was compared with defibrotide in patients who also received compression. Combining 11 trials that compared pentoxifylline with placebo or no treatment (with or without compression) demonstrated that pentoxifylline is more effective than placebo in terms of complete ulcer healing or significant improvement (RR 1.70, 95% CI 1.30 to 2.24). Significant heterogeneity was associated with differences in sample populations (hard-to-heal samples compared with "normal" healing samples). Pentoxifylline plus compression is more effective than placebo plus compression (RR 1.56, 95% CI 1.14 to 2.13). Pentoxifylline in the absence of compression appears to be more effective than placebo or no treatment (RR 2.25, 95% CI 1.49 to 3.39). A comparison between pentoxifylline and defibrotide found no statistically significant difference in healing rates. More adverse effects were reported in people receiving pentoxifylline (RR 1.56, 95% CI 1.10 to 2.22). Nearly three-quarters (72%) of the reported adverse effects were gastrointestinal. CONCLUSIONS Pentoxifylline is an effective adjunct to compression bandaging for treating venous ulcers and may be effective in the absence of compression. The majority of adverse effects were gastrointestinal disturbances.

UI MeSH Term Description Entries
D007871 Leg Ulcer Ulceration of the skin and underlying structures of the lower extremity. About 90% of the cases are due to venous insufficiency (VARICOSE ULCER), 5% to arterial disease, and the remaining 5% to other causes. Leg Ulcers,Ulcer, Leg,Ulcers, Leg
D010431 Pentoxifylline A METHYLXANTHINE derivative that inhibits phosphodiesterase and affects blood rheology. It improves blood flow by increasing erythrocyte and leukocyte flexibility. It also inhibits platelet aggregation. Pentoxifylline modulates immunologic activity by stimulating cytokine production. Agapurin,BL-191,Oxpentifylline,Pentoxil,Torental,Trental,BL 191,BL191
D011089 Polydeoxyribonucleotides A group of 13 or more deoxyribonucleotides in which the phosphate residues of each deoxyribonucleotide act as bridges in forming diester linkages between the deoxyribose moieties. Polydeoxyribonucleotide
D003131 Combined Modality Therapy The treatment of a disease or condition by several different means simultaneously or sequentially. Chemoimmunotherapy, RADIOIMMUNOTHERAPY, chemoradiotherapy, cryochemotherapy, and SALVAGE THERAPY are seen most frequently, but their combinations with each other and surgery are also used. Multimodal Treatment,Therapy, Combined Modality,Combined Modality Therapies,Modality Therapies, Combined,Modality Therapy, Combined,Multimodal Treatments,Therapies, Combined Modality,Treatment, Multimodal,Treatments, Multimodal
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000284 Administration, Oral The giving of drugs, chemicals, or other substances by mouth. Drug Administration, Oral,Administration, Oral Drug,Oral Administration,Oral Drug Administration,Administrations, Oral,Administrations, Oral Drug,Drug Administrations, Oral,Oral Administrations,Oral Drug Administrations
D001458 Bandages Material used for wrapping or binding any part of the body. Dressings,Bandage,Dressing
D014665 Vasodilator Agents Drugs used to cause dilation of the blood vessels. Vasoactive Antagonists,Vasodilator,Vasodilator Agent,Vasodilator Drug,Vasorelaxant,Vasodilator Drugs,Vasodilators,Vasorelaxants,Agent, Vasodilator,Agents, Vasodilator,Antagonists, Vasoactive,Drug, Vasodilator,Drugs, Vasodilator
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical

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