The quality of evidence is downgraded by study limitations (unclear allocation concealment and lack of blinding), and by imprecise results (few patients and outcome events).
A Cochrane review [Abstract] 1 included 28 studies with a total of 4 278 subjects. The studies differed in their design, and in which sclerotherapy method, agent or concentration was used. None of the included RCTs compared sclerotherapy to no intervention or to any pharmacological therapy.
Sclerotherapy versus placebo: Foam sclerotherapy improved cosmetic appearance as measured by IPR-V (independent photography review - visible varicose veins scores) compared to placebo (polidocanol 1%: MD -0.76, 95% CI -0.91 to -0.60; 2 studies, n=223). Deep vein thrombosis (DVT) rates increased in the intervention group (RR 5.10, 95% CI 1.30 to 20.01; 3 studies, n=302). Residual varicose vein rates decreased following polidocanol 1% compared to placebo (RR 0.19, 95% CI 0.13 to 0.29; 2 studies, n=225). There was a possible improvement in QoL as assessed using the VEINES-QOL/Sym questionnaire (MD 12.41, 95% CI 9.56 to 15.26; 3 studies, n=299), and possible improvement in varicose vein symptoms as assessed using the Venous Clinical Severity Score (VCSS) (MD -3.25, 95% CI -3.90 to -2.60; 2 studies, n=223). Recurrent varicose veins were not reported.Foam sclerotherapy versus foam sclerotherapy with different concentrations:Three studies reported no difference in cosmetic appearance after comparing different concentrations of the intervention; data could not be pooled for 2 of the 3 studies (RR 1.11, 95% CI 0.84 to 1.47; 1 study, n=80). There was no clear difference in rates of thromboembolic complications (RR 1.47, 95% CI 0.41 to 5.33; 3 studies, n=371). The rate of residual varicose veins was slightly decreased in the polidocanol 3% foam group compared to 1% (RR 0.67, 95% CI 0.43 to 1.04; 3 studies, n=371). No clear improvement in QoL was detected. Two studies reported improved VCSS scores with increasing concentrations of foam. Persistence of symptoms were not reported for this comparison. There was no clear difference in recurrent varicose vein rates (RR 0.91, 95% CI 0.62 to 1.32; 1 study, n=148).Foam sclerotherapy versus liquid sclerotherapy:One study reported on cosmetic appearance with no evidence of a difference between foam or liquid sclerotherapy (patient satisfaction scale MD 0.2, 95% CI -0.27 to 0.67; 1 study, n=126). None of the studies investigated thromboembolic complications, QoL or persistence of symptoms. Six studies individually showed there was a benefit to polidocanol 3% foam over liquid sclerotherapy in reducing residual varicose vein rate; pooling data from 2 studies showed a RR of 0.51, with 95% CI 0.41 to 0.65 (n=203). One study reported no clear difference in recurrent varicose vein rates when comparing sodium tetradecyl sulphate (STS) foam or liquid (RR 1.10, 95% CI 0.86 to 1.42; 1 study, n=286).
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