129 research outputs found

    Systematic review of the safety and efficacy of foam sclerotherapy for venous disease of the lower limbs

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    Background: Foam sclerotherapy is a potential treatment for lower limb venous disease. Methods: A systematic review, with no restriction on study design, to assess the safety and efficacy of foam sclerotherapy. Results: 69 studies were included. For serious adverse events including pulmonary embolism and deep vein thrombosis, the median event rates were less than 1%. Median rate for visual disturbance was 1.4%. Median rates for some other adverse events were more common, including headache (4.2%), thrombophlebitis (4.7%), matting/skin staining/pigmentation (17.8%) and pain at the site of injection (25.6%). Median rate for complete occlusion of treated veins was 87.0% and for recurrence or development of new veins was 8.1%. Evidence from meta-analysis for complete occlusion suggests that foam sclerotherapy is associated with a lower rate compared with surgery (RR 0.86, 95% CI 0.67 to 1.10) and a higher rate compared with liquid sclerotherapy (RR 1.39, 95% CI 0.91 to 2.11). However, there was substantial heterogeneity across the studies in the meta-analysis. Conclusion: Serious adverse events were rare. There is insufficient evidence to reliably compare the effectiveness of foam sclerotherapy with other minimally invasive therapies or surgery. Evidence from high quality randomised controlled trials is required.This manuscript is based on a systematic review commissioned and funded by the National Institute for Health and Clinical Excellence (NICE) through its Interventional Procedures Programme. The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Executive Health Department

    Systematic review, network meta-analysis and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins

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    Background A Health Technology Assessment was conducted to evaluate the relative clinical effectiveness and cost-effectiveness of minimally invasive techniques (foam sclerotherapy (FS), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA)) for managing varicose veins, in comparison with traditional surgery. Methods A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of minimally invasive techniques compared with other treatments, principally surgical stripping, in terms of recurrence of varicose veins, Venous Clinical Severity Score (VCSS), pain and quality of life. Network meta-analysis and exploratory cost-effectiveness modelling were performed. Results The literature search conducted in July 2011 identified 1453 unique citations: 31 RCTs (51 papers) satisfied the criteria for effectiveness review. Differences between treatments were negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be most cost-effective. Total FS costs were estimated to be lowest, and FS was marginally more effective than surgery. However, relative effectiveness was sensitive to the model time horizon. Threshold analysis indicated that EVLA and RFA might be considered cost-effective if their costs were similar to those for surgery. These findings are subject to various uncertainties, including the risk of bias present in the evidence base and variation in reported costs. Conclusion This assessment of currently available evidence suggests there is little to choose between surgery and the minimally invasive techniques in terms of efficacy or safety, so the relative cost of the treatments becomes one of the deciding factors. High-quality RCT evidence is needed to verify and further inform these findings
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