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Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet]. Chichester, UK: John Wiley & Sons, Ltd; 2003-.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet].

Treatment for superficial thrombophlebitis of the leg

This version published: 2013; Review content assessed as up-to-date: November 23, 2012.

Link to full article: [Cochrane Library]

Plain language summary

Superficial thrombophlebitis (ST) is a relatively common inflammatory process associated with a blood clot (thrombus) that affects the superficial veins. Symptoms and signs include local pain, itching, tenderness, reddening of the skin, and hardening of the surrounding tissue. There is some evidence to suggest an association between ST and venous thromboembolism (VTE). Treatment aims to relieve the local symptoms and to prevent the extension of the clot into a deep vein, ST recurrence, or the development of more serious events caused by VTE.

This review included 30 randomised controlled trials involving 6462 participants. Treatment ranged from subcutaneous injections of fondaparinux to low molecular weight heparin, unfractionated heparin, oral non‐steroidal anti‐inflammatory drugs (NSAIDs), topical treatment, and surgery. One large study, accounting for half of the patients included in the review, showed that treatment with fondaparinux for 45 days was associated with a significant reduction in symptomatic VTE, ST extension, and recurrence of ST with no increase in bleeding relative to placebo. Both low molecular weight heparin and NSAIDs reduced the incidence of extension or recurrence of ST without any significant effect on symptomatic VTE. Topical treatments relieved local symptoms but the trials did not report on progression to VTE. Surgical treatment and wearing elastic stockings were associated with a lower rate of VTE and progression of the ST compared with elastic stockings alone. The methodological quality of most of the trials was poor.

Fondaparinux appears to be an adequate treatment option in patients with ST. Further research is needed to assess the role of low molecular weight heparin or NSAIDs and to demonstrate the efficacy, if any, of oral treatments, topical treatment, or surgery in terms of VTE and ST progression.

Abstract

Background: The optimal treatment of superficial thrombophlebitis (ST) of the legs remains poorly defined. While improving or relieving the local painful symptoms, treatment should aim at preventing venous thromboembolism (VTE), which might complicate the natural history of ST. This is the second update of a review first published in 2007.

Objectives: To assess the efficacy and safety of topical, medical, and surgical treatments in patients presenting with ST of the legs.

Search methods: For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co‐ordinator searched the Specialised Register (last searched November 2012) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 11). We handsearched the reference lists of relevant papers and conference proceedings.

Selection criteria: Randomised controlled trials (RCTs) evaluating topical, medical, and surgical treatments for ST of the legs that included participants with a clinical diagnosis of ST of the legs or objective diagnosis of a thrombus in a superficial vein.

Data collection and analysis: Two authors assessed the trials for inclusion in the review, extracted the data, and assessed the quality of the studies. Data were independently extracted from the included studies and any disagreements resolved by consensus.

Main results: We identified four additional trials (941 patients), so this update considered 30 studies involving 6462 participants with ST of the legs.Treatment ranged from fondaparinux, low molecular weight heparin (LMWH), unfractionated heparin (UFH), non‐steroidal anti‐inflammatory agents (NSAIDs), topical treatment, oral treatment, intramuscular treatment, and intravenous treatment to surgery. Only a minority of trials compared treatment with placebo rather than an alternative treatment, none evaluated the same treatment comparisons on the same study outcomes (which precluded meta‐analysis), and many of the studies were small and of poor quality. In one large, placebo‐controlled RCT of 3002 patients, subcutaneous fondaparinux was associated with a significant reduction in symptomatic VTE (RR 0.15; 95% CI 0.04 to 0.50), ST extension (RR 0.08; 95% CI 0.03 to 0.22), and ST recurrence (RR 0.21; 95% CI 0.08 to 0.54) with comparable rates of major bleeding (RR 0.99; 95% CI 0.06 to 15.86) relative to placebo. In a further placebo‐controlled trial, both prophylactic and therapeutic doses of LMWH (RR 0.44; 95% CI 0.26 to 0.74 and RR 0.46; 95% CI 0.27 to 0.77, respectively) and NSAIDs (RR 0.46; 95% CI 0.27 to 0.78) reduced the extension and recurrence of ST in comparison to placebo, with no significant effects on symptomatic VTE nor major bleeding. Overall, topical treatments improved local symptoms compared with placebo but no data were provided on the effects on VTE and ST extension. Surgical treatment combined with elastic stockings was associated with a lower VTE rate and ST progression compared with elastic stockings alone. However, the majority of studies that compared different oral treatment, topical treatment, or surgery did not report VTE, ST progression, adverse events, or treatment side effects.

Authors' conclusions: Prophylactic dose fondaparinux given for 45 days appears to be a valid therapeutic option for ST of the legs. The evidence on oral treatments, topical treatment, or surgery is too limited and does not inform clinical practice about the effects of these treatments in terms of VTE and ST progression. Further research is needed to assess the role of the new oral direct thrombin and activated factor‐X inhibitors, LMWH, and NSAIDs; the optimal doses and duration of treatment; and whether a combination therapy may be more effective than single treatment. Adequately designed and conducted studies are required to clarify the role of topical and surgical treatments.

Editorial Group: Cochrane Peripheral Vascular Diseases Group.

Publication status: Edited (no change to conclusions).

Citation: Di Nisio M, Wichers IM, Middeldorp S. Treatment for superficial thrombophlebitis of the leg. Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD004982. DOI: 10.1002/14651858.CD004982.pub5. Link to Cochrane Library. [PubMed: 23633322]

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

PMID: 23633322

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