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32 Varicose Veins KCE Reports 164 5.6 DRUGS 5.6.1 One Cochrane review on the effect of phlebotonics for chronic venous insufficiency One Cochrane review (with database searches from 2005) has evaluated the use of oral phlebotonics for the treatment of chronic venous insufficiency (CVI) 37 . No paper has been found on the effect of these medications on varicose veins specifically. Fifty-nine RCTs were included in this review. They assessed the use of these drugs to improve the outcomes of oedema, venous ulcers, trophic disorders and subjective symptoms. This Cochrane review did not find evidence supporting the use of phlebotonics for CVI. The included RCTs in this review had several overall limitations. Firstly, diagnosis criteria and CVI definitions were often not used or reported, making the study populations heterogeneous. Secondly, the study outcomes were not well reported in the studies. The results were not separated into the different stages of CVI which meant interpretation on the use of drugs for the treatment of varicose veins was limited. 5.6.2 Lack of evidence in one RCT One RCT supported by the industry studied 509 patients with chronic venous disease randomised to calcium dobesilate or placebo during 3 months. This trial found no significant difference between the groups for the main outcomes i.e. QoL, oedema and symptoms after three months. A significant overall improvement in QoL in both groups suggested a placebo effect 89 . An improvement in QoL was observed 9 months after the end of the treatment but this observation was based on a secondary analysis. Summary: drugs The studies on medications targeted chronic venous disease patient population rather than varicose vein patients specifically. Overall there is no evidence to support the effectiveness of phlebotonics. 5.7 OTHER CONSERVATIVE TREATMENTS No systematic reviews or RCTs on other conservative treatments, such as exercise and weight loss for the treatment of varicose veins, were identified.
KCE Reports 164 Varicose Veins 33 6 SAFETY CONSIDERATIONS Complications and post-procedural adverse events have been reported where data was available in the included SRs and RCTs described above. However, the RCTs were poorly designed to identify possible complications, in particular due to their small sample size. As a consequence, non-RCTs reporting on safety outcomes were identified from the database search to supplement the safety data. This section provides an overall summary of the safety findings from the included SR and RCTs and relevant non-RCT studies reporting on the safety aspects of the interventions (see details in appendix 9.7). 6.1 ENDOVENOUS LASER THERAPY Adverse events reported from included studies in section 5.1 were: • pain • bruising • haematoma • thermal injury • hyperpigmentation • thrombophlebitis / risk of deep venous thrombosis • temporary paraesthesia Similar adverse events were found in the additional publications that reported on safety outcomes. • A systematic review of EVLT induced complications by Van Den Bos et al. (2009) concluded that ecchymoses and pain are frequently reported whereas nerve injury, skin burns, deep venous thrombosis and pulmonary embolism rarely occur (< 1%) 54 . • A large cohort study of 1985 EVLT ablations report similar complications and this study also reported two cases (0.13%) of deep venous thrombosis 120 . • A smaller cohort study of 150 patients reported two patients with sural nerve paraesthesia and six patients with superficial thrombophlebitis 121 . • A prospective single arm non-RCT by Rathod et al. (2010) 122 studied the use of a higher wavelength of 1470-nm and reported similar safety data to the EVLT study 121 described above. Additionally, the authors reported a dosedependent relationship for the paraesthesia rate; with a significantly greater (p=0.009) paraesthesia rate in those exposed to a greater energy density (greater than 100 J/cm). 6.2 RADIOFREQUENCY ABLATION Adverse events reported from included studies in section 5.2 were: • pain • bruising • haematoma • Thermal injury • thrombophlebitis / risk of deep venous thrombosis • temporary paraesthesia A prospective case series of 225 patients (295 limbs) reported similar adverse events: haematomas (1.4%), ecchymoses (5.8%) paraesthesia (3.4%) and pigmentations (3.1%) being the most common side effects 123 .
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