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Review
. 2021 Dec 10;12(12):CD001732.
doi: 10.1002/14651858.CD001732.pub3.

Injection sclerotherapy for varicose veins

Ricardo de Ávila Oliveira  1 , Rachel Riera  2 , Vladimir Vasconcelos  3 , Jose Cc Baptista-Silva  4
Affiliations
Review

Injection sclerotherapy for varicose veins

Ricardo de Ávila Oliveira et al. Cochrane Database Syst Rev. .

Abstract

Background: Varicose veins are enlarged and tortuous veins, affecting up to one-third of the world's population. They can be a cause of chronic venous insufficiency, which is characterised by oedema, pigmentation, eczema, lipodermatosclerosis, atrophie blanche, and healed or active venous ulcers. Injection sclerotherapy (liquid or foam) is widely used for treatment of varicose veins aiming to transform the varicose veins into a fibrous cord. However, there is limited evidence regarding its effectiveness and safety, especially in patients with more severe disease. This is the second update of the review first published in 2002.

Objectives: To assess the effectiveness and safety of injection sclerotherapy for the treatment of varicose veins.

Search methods: For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, and LILACS databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries, on 20 July 2021.

Selection criteria: We included all randomised controlled trials (RCTs) (including cluster-randomised trials and first phase cross-over studies) that used injection sclerotherapy for the treatment of varicose veins.

Data collection and analysis: Two review authors independently assessed, selected and extracted data. Disagreements were cross-checked by a third review author. We used Cochrane's Risk of bias tool to assess the risk of bias. The outcomes of interest were cosmetic appearance, complications, residual varicose veins, quality of life (QoL), persistence of symptoms, and recurrent varicose veins. We calculated risk ratios (RRs) or mean difference (MD) with 95% confidence intervals (CIs). We used the worst-case-scenario for dichotomous data imputation for intention-to-treat analyses. For continuous outcomes, we used the 'last-observation-carried-forward' for data imputation if there was balanced loss to follow-up. We assessed the certainty of the evidence using the GRADE approach.

Main results: We included 23 new RCTs for this update, bringing the total to 28 studies involving 4278 participants. 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. The certainty of the evidence was downgraded for risk of bias, low number of studies providing information for each outcome, low number of participants, clinical differences between the study participants, and wide CIs. Sclerotherapy versus placebo Foam sclerotherapy may improve cosmetic appearance as measured by IPR-V (independent photography review - visible varicose veins scores) compared to placebo (polidocanol 1%: mean difference (MD) -0.76, 95% CI -0.91 to -0.60; 2 studies, 223 participants; very low-certainty evidence); however, deep vein thrombosis (DVT) rates may be slightly increased in this intervention group (RR 5.10, 95% CI 1.30 to 20.01; 3 studies, 302 participants; very low-certainty evidence). Residual varicose vein rates may be decreased following polidocanol 1% compared to placebo (RR 0.19, 95% CI 0.13 to 0.29; 2 studies, 225 participants; very low-certainty evidence). Following polidocanol 1% use, there may be 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, 299 participants; very low-certainty evidence), 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, 223 participants; low-certainty evidence). Recurrent varicose veins were not reported for this comparison. Foam sclerotherapy versus foam sclerotherapy with different concentrations Three individual RCTs reported no evidence of a difference in cosmetic appearance after comparing different concentrations of the intervention; data could not be pooled for two of the three studies (RR 1.11, 95% CI 0.84 to 1.47; 1 study, 80 participants; very low-certainty evidence). Similarly, there was no clear difference in rates of thromboembolic complications when comparing one foam concentration with another (RR 1.47, 95% CI 0.41 to 5.33; 3 studies, 371 participants; very low-certainty evidence). Three RCTs investigating higher concentrations of polidocanol foam indicated the rate of residual varicose veins may be slightly decreased in the polidocanol 3% foam group compared to 1% (RR 0.67, 95% CI 0.43 to 1.04; 3 studies, 371 participants; moderate-certainty evidence). No clear improvement in QoL was detected. Two RCTs 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, 148 participants; low-certainty evidence). Foam sclerotherapy versus liquid sclerotherapy One RCT 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, 126 participants; very low-certainty evidence). None of the RCTs investigated thromboembolic complications, QoL or persistence of symptoms. Six studies individually showed there may be a benefit to polidocanol 3% foam over liquid sclerotherapy in reducing residual varicose vein rate; pooling data from two studies showed a RR of 0.51, with 95% CI 0.41 to 0.65; 203 participants; very low-certainty evidence. 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, 286 participants; very low-certainty evidence). Sclerotherapy versus sclerotherapy with different substances Four RCTs compared sclerotherapy versus sclerotherapy with any other substance. We were unable to combine the data due to heterogeneity or assess the certainty of the evidence due to insufficient data.

Authors' conclusions: There is a very low to low-certainty evidence that, compared to placebo, sclerotherapy is an effective and safe treatment for varicose veins concerning cosmetic appearance, residual varicose veins, QoL, and persistence of symptoms. Rates of DVT may be slightly increased and there were no data concerning recurrent varicose veins. There was limited or no evidence for one concentration of foam compared to another; foam compared to liquid sclerotherapy; foam compared to any other substance; or one technique compared to another. There is a need for high-quality trials using standardised sclerosant doses, with clearly defined core outcome sets, and measurement time points to increase the certainty of the evidence.

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Conflict of interest statement

RAO: none known RR: none known VV: none known JCBS: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 1: Cosmetic appearance: medical related IPR‐V adjusted mean change from baseline (intermediate term)
1.2
1.2. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 2: Cosmetic appearance: participant self assessment PA‐V adjusted mean change from baseline (intermediate term)
1.3
1.3. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 3: DVT (short and intermediate term)
1.4
1.4. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 4: Phlebitis or thrombophlebitis rates (intermediate term)
1.5
1.5. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 5: Phlebitis or thrombophlebitis rates (intermediate term)
1.6
1.6. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 6: Haemorrhagic complications (short term)
1.7
1.7. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 7: Neurologic complications (dizziness, TIA) (short term)
1.8
1.8. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 8: Residual varicose veins (intermediate term)
1.9
1.9. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 9: Quality of life: VEINES‐QOL score change from baseline (intermediate term)
1.10
1.10. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 10: Persistence of symptoms: absolute change from baseline score for the VVSymQ (total score) (intermediate term)
1.11
1.11. Analysis
Comparison 1: Foam sclerotherapy versus placebo, Outcome 11: Persistence of symptoms: mean change from baseline score for the VCSS (total score) (intermediate term)
2.1
2.1. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 1: Cosmetic appearance: number of participants with cosmetic improvement (short term) ‐ polidocanol 3% foam versus polidocanol 1% foam
2.2
2.2. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 2: Cosmetic appearance: number of participants with cosmetic improvement (long term) ‐ polidocanol 3% foam versus polidocanol 1% foam
2.3
2.3. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 3: Cosmetic appearance: adjusted mean PA‐V (intermediate term) ‐ polidocanol foam versus polidocanol foam
2.4
2.4. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 4: Cosmetic appearance: adjusted mean IPR‐V (intermediate term) ‐ polidocanol foam versus polidocanol foam
2.5
2.5. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 5: Thromboembolic complications (intermediate term) ‐ polidocanol 3% foam versus polidocanol 1% foam
2.6
2.6. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 6: Thromboembolic complications (intermediate term) ‐ polidocanol 3% foam versus polidocanol 1% foam (sensitivity analysis)
2.7
2.7. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 7: DVT (short and intermediate term) ‐ polidocanol foam lower concentration versus polidocanol foam higher concentration
2.8
2.8. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 8: PE (short term) ‐ polidocanol 1% foam versus polidocanol 3% foam
2.9
2.9. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 9: Skin pigmentation rates (long term) ‐ polidocanol 3% foam versus polidocanol 1% foam
2.10
2.10. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 10: Phlebitis or thrombophlebitis rates (intermediate term) ‐ polidocanol < 1% foam versus polidocanol ≥ 1% foam
2.11
2.11. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 11: Phlebitis or thrombophlebitis ‐ polidocanol 3% foam versus polidocanol 1% foam
2.12
2.12. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 12: Haemorrhagic complications (intermediate term) ‐ polidocanol foam lower concentration versus polidocanol foam higher concentration
2.13
2.13. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 13: Neurologic complications (dizziness, TIA) (intermediate term) ‐ polidocanol foam lower concentration versus polidocanol foam higher concentration
2.14
2.14. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 14: Residual varicose veins (intermediate term) ‐ polidocanol foam lower concentration versus polidocanol foam higher concentration
2.15
2.15. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 15: Residual varicose veins (long term) ‐ polidocanol 3% foam versus polidocanol 1% foam
2.16
2.16. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 16: Residual varicose veins (long term) ‐ polidocanol 3% foam versus polidocanol 1% foam (sensitivity analysis)
2.17
2.17. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 17: Quality of life: adjusted mean change VEINES‐QOL (intermediate term) ‐ polidocanol foam versus polidocanol foam
2.18
2.18. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 18: Persistence of symptoms: adjusted mean change from baseline VCSS score (intermediate term) ‐ polidocanol foam versus polidocanol foam
2.19
2.19. Analysis
Comparison 2: Foam sclerotherapy versus foam sclerotherapy with different concentrations, Outcome 19: Recurrent varicose veins (long term) ‐ polidocanol 3% foam versus polidocanol 1% foam
3.1
3.1. Analysis
Comparison 3: Foam sclerotherapy versus liquid sclerotherapy, Outcome 1: Cosmetic appearance: participant satisfaction (long term) ‐ polidocanol foam versus polidocanol liquid
3.2
3.2. Analysis
Comparison 3: Foam sclerotherapy versus liquid sclerotherapy, Outcome 2: Skin pigmentation (long term) ‐ polidocanol foam versus polidocanol liquid
3.3
3.3. Analysis
Comparison 3: Foam sclerotherapy versus liquid sclerotherapy, Outcome 3: Residual varicose veins (long term) ‐ polidocanol foam versus polidocanol liquid
3.4
3.4. Analysis
Comparison 3: Foam sclerotherapy versus liquid sclerotherapy, Outcome 4: Residual varicose veins (long term) ‐ polidocanol foam versus polidocanol liquid (sensitivity analysis)
3.5
3.5. Analysis
Comparison 3: Foam sclerotherapy versus liquid sclerotherapy, Outcome 5: Recurrent varicose veins (long term) ‐ STS 3% liquid versus STS 3% foam
4.1
4.1. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 1: Cosmetic appearance: disappearance of varicose veins (long term) ‐ polidocanol 3% versus STS 1.5%
4.2
4.2. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 2: DVT (short and intermediate term) ‐ Varisolve polidocanol foam versus any market sclerosant (liquid or foam)
4.3
4.3. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 3: Skin pigmentation (intermediate term) ‐ Varisolve polidocanol foam versus any market sclerosant (liquid or foam)
4.4
4.4. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 4: Haematoma (short term) ‐ Varisolve polidocanol foam versus any market sclerosant (liquid or foam)
4.5
4.5. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 5: Skin pigmentation (long term) ‐ STS 1.5% versus polidocanol 3%
4.6
4.6. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 6: Skin necrosis (long term) ‐ STS 1.5% versus polidocanol 3%
4.7
4.7. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 7: Residual varicose veins (long term) ‐ Varisolve polidocanol foam versus any market sclerosant (liquid or foam)
4.8
4.8. Analysis
Comparison 4: Sclerotherapy versus sclerotherapy with different substances, Outcome 8: Matting (long term) ‐ STS 1.5% versus polidocanol 3%
5.1
5.1. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 1: Phlebitis or thrombophlebitis rates (short term) ‐ polidocanol 1% foam ‐ antegrade versus retrograde technique
5.2
5.2. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 2: Skin pigmentation rates (long term) ‐ polidocanol 1% foam ‐ antegrade versus retrograde technique
5.3
5.3. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 3: Thrombophlebitis rates (short term) ‐ polidocanol 3% foam injected by catheter associated to tumescent technique versus polidocanol 3% foam injected by needle
5.4
5.4. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 4: Detection of polidocanol foam in deep veins ‐ few injections versus multiple injections
5.5
5.5. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 5: Residual varicose veins (long term) ‐ visual foam sclerotherapy versus ultrasound guided foam + visual foam sclerotherapy
5.6
5.6. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 6: Residual varicose veins (long term) ‐ multiple/fractionated injections versus few/single injections
5.7
5.7. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 7: Residual varicose veins (intermediate term) ‐ polidocanol 1% foam retrograde versus antegrade technique
5.8
5.8. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 8: Residual varicose veins (intermediate term) ‐ microcatheter directed foam sclerotherapy versus catheter directed foam sclerotherapy
5.9
5.9. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 9: Residual varicose veins (intermediate term) ‐ needle foam sclerotherapy versus catheter directed foam sclerotherapy
5.10
5.10. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 10: Residual varicose veins (intermediate term) ‐ needle foam sclerotherapy versus microcatheter directed foam sclerotherapy
5.11
5.11. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 11: Residual varicose veins (short term) ‐ polidocanol 3% foam injected by catheter versus polidocanol 3% foam injected by needle
5.12
5.12. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 12: Participants not requiring retreatment (long term) ‐ polidocanol 3% foam injected by catheter versus polidocanol 3% foam injected by needle
5.13
5.13. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 13: QoL: AVVQ (long term) ‐ catheter‐directed foam sclerotherapy with tumescence versus ultrasound‐guided foam sclerotherapy
5.14
5.14. Analysis
Comparison 5: Sclerotherapy versus sclerotherapy with different techniques, Outcome 14: VCSS (long term) ‐ ultrasound guided foam + visual foam sclerotherapy versus visual foam sclerotherapy
6.1
6.1. Analysis
Comparison 6: Sclerotherapy versus compression conservative treatment, Outcome 1: Cosmetic appearance: good symptomatic improvement and cosmetic result (long term) liquid STS versus compression
6.2
6.2. Analysis
Comparison 6: Sclerotherapy versus compression conservative treatment, Outcome 2: Ulcer (short, intermediate and long term) ‐ liquid STS versus compression
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References

References to studies included in this review

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    1. Todd KL, Wright DI. The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence. Phlebology 2014;29(9):608-18. [DOI: 10.1177/0268355513497709] - DOI - PubMed
Ukritmanoroat 2011 {published data only}
    1. Ukritmanoroat T. Comparison of efficacy and safety between foam sclerotherapy and conventional sclerotherapy: a controlled clinical trial. Journal of the Medical Association of Thailand 2011;94(Suppl 2):S35-40. - PubMed
Wright 2006 {published data only}
    1. Wright D, Gobin JP, Bradbury AW, Coleridge-Smith P, Spoelstra H, Berridge D, et al. Varisolve polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial. Phlebology 2006;21(4):180-90.
    1. Wright D. European randomized controlled trial of Varisolve PD microfoam compared with alternative therapy in management of moderate to severe varicose veins: preliminary results. In: UIP World Congress Chapter Meeting; 2003. San Diego, 2003.
Yamaki 2009 {published data only}
    1. Yamaki T, Nozaki M, Sakurai H, Takeuchi M, Soejima K, Kono T. Multiple small-dose injections can reduce the passage of sclerosant foam into deep veins during foam sclerotherapy for varicose veins. European Journal of Vascular and Endovascular Surgery 2009;37(3):343-8. - PubMed
Yamaki 2012 {published data only}
    1. Yamaki T, Hamahata A, Soejima K, Kono T, Nozaki M, Sakurai H. Prospective randomised comparative study of visual foam sclerotherapy alone or in combination with ultrasound-guided foam sclerotherapy for treatment of superficial venous insufficiency: preliminary report. European Journal of Vascular and Endovascular Surgery 2012;43(3):343-7. - PubMed
Zeh 2003 {published data only}
    1. Zeh RG. Expanding sclerosing properties of polidocanol foam with Gelofusine. In: UIP World Congress Chapter Meeting (www.phlebology.org/AbstractUIP.htm#79); 2003. San Diego, 2003.
Zhang 2009 {published data only}
    1. Zhang J, Schliephake D, Malouf M, Otto J, Jing Z, Gu Y. Polidocanol/lauromacrogol 400 vs. placebo for sclerotherapy of C1 and C2 non-saphenous trunk varicose veins: a double-blind, randomized, controlled, multicenter clinical trial (Esachina study) performed in the P.R. of China. In: XVI World Congress of the Union Internationale de Phlebologie Abstract Book. 2009:54.
Zhang 2014 {published data only}
    1. Zhang WG, Yan RH, Zong HM, Wang QC, Chen DQ, Xu YP. Foam sclerotherapy of lauromacrogol for the treatment of lower extremity varicose veins: comparison study of two different injection ways. Journal of Interventional Radiology 2014;23(5):392-6.

References to studies excluded from this review

Ariyoshi 1996 {published data only}
    1. Ariyoshi H, Kambayashi J, Tominaga S, Hatanaka T. The possible risk of lower-limb sclerotherapy causing an extended hypercoagulable state. Surgery Today 1996;26(5):323-7. - PubMed
Biemans 2013 {published data only}
    1. Biemans AAM, Kockaert M, Akkersdijk GP, Van den Bos RR, De Maeseneer MGR, Cuypers P, et al. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. Journal of Vascular Surgery 2013;58(3):727-34. - PubMed
    1. Biemans AAM, Kockaert M, Van Den Bos RR, Cuypers P, Neumann HAM, Nijsten TEC. A randomized comparative study of the three most commonly performed treatments for varicose veins, results after one year. Nederlands Tijdschrift voor Dermatologie en Venereologie 2012;22(2):78-84.
    1. Van der Velden SK, Biemans AA, De Maeseneer MG, Kockaert MA, Cuypers PW, Hollestein LM, et al. Five-year results of a randomized clinical trial of conventional surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy in patients with great saphenous varicose veins. British Journal of Surgery 2015;102(10):1184-94. - PubMed
Brittenden 2015 {published data only}
    1. Brittenden J, Cotton SC, Elders A, Ramsay CR, Norrie J, Burr J, et al. A randomized trial comparing treatments for varicose veins (CLASS). New England Journal of Medicine 2014;371:1218-27. [DOI: 10.1056/NEJMoa1400781] - DOI - PubMed
    1. Brittenden J, Cotton SC, Elders A, Tassie E, Scotland G, Ramsay CR, et al. Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial. Health Technology Assessment 2015;19(27):1-342. - PMC - PubMed
    1. ISRCTN51995477. Randomised controlled trial comparing foam sclerotherapy, alone or in combination with endovenous laser therapy, with conventional surgery as a treatment for varicose veins. isrctn.com/ISRCTN51995477 (first received 25 February 2008).
    1. Lancet protocol 09PRT/2275. The CLASS Study: Comparison of LAser, Surgery and foam Sclerotherapy as a treatment for varicose veins (EudraCT 2008-001069-26). thelancet.com/protocol-reviews/09PRT-2275 (accessed 24 September 2020).
Lattimer 2012 {published data only}
    1. ISRCTN03080206. Endovenous laser therapy (EVLT) versus ultrasound guided foam sclerotherapy (UGFS) for the treatment of varicose veins. isrctn.com/ISRCTN03080206 (first received 21 January 2010).
    1. Kalodiki E, Azzam M, Schnatterbeck P, Geroulakos G, Lattimer CR. The Discord Outcome Analysis (DOA) as a reporting standard at three months and five years in randomised varicose vein treatment trials. European Journal of Vascular and Endovascular Surgery 2018;57(2):267-74. [DOI: 10.1016/j.ejvs.2018.09.013] - DOI - PubMed
    1. Lattimer CR, Azzam M, Kalodiki E, Shawish E, Trueman P, Geroulakos G. Cost and effectiveness of laser with phlebectomies compared with foam sclerotherapy in superficial venous insufficiency. Early results of a randomised controlled trial. European Journal of Vascular and Endovascular Surgery 2012;43:594-600. - PubMed
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    1. Lattimer CR, Kalodiki E, Azzam M, Makris GC, Somiayajulu S, Geroulakos G. Interim results on abolishing reflux alongside a randomized clinical trial on laser ablation with phlebectomies versus foam sclerotherapy. International Angiology 2013;32(4):394-403. - PubMed
Leung 2016 {published data only}
    1. Leung CC, Carradice D, Wallace T, Chetter IC. Endovenous laser ablation versus mechanochemical ablation withClariVein(®) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial. Trials 2016;17(1):421. - PMC - PubMed
Mishra 2016 {published data only}
    1. Mishra M, Soni R, Mohil R, Sinha A. Comparative study of outcome of duplex ultrasound-guided,catheter-directed foam sclerotherapy and radio-frequency ablation in the management of great saphenous varicose veins. Indian Journal of Surgery 2016;78(5):375-81. - PMC - PubMed
NCT02462720 {published data only}
    1. NCT02462720 2015. COMFORT: multicenter study to evaluate pain following treatment of varicose vein with Varithena® compared to radiofrequency ablation. clinicaltrials.gov/show/NCT02462720 2015 (first received 4 June 2015).
Ragg 2015a {published data only}
    1. Ragg JC. Initial and permanent vein lumen minimization obtained with endovenous occlusion techniques by using hyaluronan solution instead of tumescent fluid. In: Scientific Programme and Book of Abstracts; 16th Meeting of the European Venous Forum; 2015; St Petersburg, Russia. Vol. 58. 2015.
Rasmussen 2011 {published data only}
    1. ISRCTN08060326. Endovenous laser ablation (EVLA), radio frequency (RF), foam sclerotherapy and stripping for treatment of varicose veins. isrctn.com/ISRCTN08060326 (first received 31 July 2009). [DOI: 10.1186/ISRCTN08060326] - DOI
    1. Lawaetz M, Rasmussen LH, Bjoern L, Blemings A, Eklof B. Randomized trial comparing RF, laser, foam sclerotherapy and stripping in varicose veins. Phlebology 2010;25:307.
    1. Lawaetz M, Serup J, Lawaetz B, Bjoern L, Blemings A, Eklof B, et al. Comparison of endovenous radiofrequency ablation, laser ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Extended 5-year follow-up of a RCT. Phlebology 2017;32(2):13-4. - PubMed
    1. Rasmussen L, Lawaetz M, Serup J, Bjoern L, Vennits B, Blemings A, et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy, and surgical stripping for great saphenous varicose veins with 3-year follow-up. Journal of Vascular Surgery 2013;1(4):349-56. - PubMed
    1. Rasmussen LH, Lawaetz M, Bjoern L, Vennits B, Blemings A, Eklof B. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. British Journal of Surgery 2011;98(8):1079-87. - PubMed
Theivacumar 2008 {published data only}
    1. Theivacumar NS, Dellagrammaticas D, Mavor AI, Gough MJ. Endovenous laser ablation: does standard above-knee great saphenous vein ablation provide optimum results in patients with both above-and below-knee reflux? A randomized controlled trial. Journal of Vascular Surgery 2008;48(1):173-8. - PubMed
    1. Theivacumar SN, Dellagrammaticas D, Darwood RJ, Mavor AI, Gough MJ. Endovenous laser ablation (EVLA): is standard above-knee great saphenous vein (AK-GSV) ablation sufficient? A randomised controlled trial. Vascular Society of Great Britain & Ireland Yearbook 2007;71.
Vahaaho 2015 {published data only}
    1. Vahaaho S, Alback A, Halmesmki K, Mahmoud O, Venermo M. RCT comparing the long-term results of UGFS, EVLA and open surgery in the treatment of GSV reflux. In: XXIX Annual Meeting European Society for Vascular Surgery; 2015. 2015.
Vernermo 2016 {published data only}
    1. NCT01298908. Comparison of treatments in venous insufficiency. clinicaltrials.gov/ct2/show/study/NCT01298908 (first received 18 February 2011).
    1. Venermo M, Saarinen J, Eskelinen E, Vahaaho S, Saarinen E, Railo M, Finnish Venous Study Collaborators. Randomized clinical trial comparing surgery, endovenous laser ablation and ultrasound-guided foam sclerotherapy for the treatment of great saphenous varicose veins. British Journal of Surgery 2016;103(11):1438-44. - PMC - PubMed
    1. Venermo M. A randomised trial of three VV treatment strategies. ESVS 18-21 September 2013, Budapest, Hungary 2013.
Zafarghandi 2017 {published data only}
    1. Zafarghandi MR, Farsavian H, Davoudi M, Farsavian AA. Outcome of ultrasonography-guided foam sclerotherapy versus stab avulsion ambulatory phlebectomy in the treatment of varicosis in small veins of the leg: a single blinded randomized clinical triaI. Iranian Journal of Radiology 2017;14(3):e21742.

References to studies awaiting assessment

Labas 2003 {published data only}
    1. Labas P, Ohrádka B, Cambal M, Ringelband R. The results of compression sclerotherapy. Comparative study of two techniques and two sclerosants. Phlebologie 2000;29:137-41.
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Satokawa 2003 {published data only}
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Schadeck 1995b {published data only}
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SLCTR/2008/014 {published data only}
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Varnagy 1985 {published data only}
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References to other published versions of this review

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