Treatment for superficial thrombophlebitis of
the leg.
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. To assess the efficacy and safety of topical, medical, and
surgical treatments in patients presenting with ST of the legs. 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. 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 an objective diagnosis of a thrombus in
a superficial vein.
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 (986 patients), so this update considered 30
studies involving 6507 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 about 3000
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
0.40; 95% CI 0.22 to 0.72 and RR 0.42; 95% CI 0.23 to 0.75, respectively) and
NSAIDs (RR 0.41; 95% CI 0.23 to 0.75) 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 six weeks 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.