3. METHODOLOGY
3.2. Procedure
Overview
This rapid review identified four eligible secondary research publications, one published in 2003, two in 2004 and one in 2006. The methodological quality of these reviews was generally high, with all using comprehensive search strategies and appraisal methodology.
All four systematic reviews reported safety and effectiveness data on various varicose vein treatments. Reviews generally identified similar adverse events associated with varicose vein treatments, including infection, bleeding, bruising, ecchymosis, skin discolouration,
thrombotic events and paraesthesia. The most commonly reported measures of effectiveness included abolition of reflux, recurrence of varicose veins, symptom reduction, quality of life and time required to return to work or normal activity.
Due to the lack of evidence comparing ELT with ligation and stripping, the MSAC (2003) review was used to make indirect comparisons, which significantly decreased the validity of its findings. Those reviews that used level IV evidence or poor-quality RCTs as the basis of their findings were less reliable, because these types of studies are generally prone to substantial bias (MSAC 2003; Adi et al 2004; Jia et al 2006).
Although it was the intention of many of the reviews to pool trial data to produce quantitative results, this was often not possible due to the heterogeneity of trials in each review. Only Jia et al (2006) found sufficient homogeneity for meta-analyses; however, the results of these were not applicable to the current review.
Sclerotherapy versus phlebectomy
One systematic review, reporting results from two RCTs, found no significant difference between sclerotherapy and phlebectomy in complication rates (Rigby et al 2004). The relative effectiveness of avulsion phlebectomy and sclerotherapy appeared to depend on the veins treated. The RCT examining treatment of lateral accessory varicose veins found varicose vein recurrence rates for phlebectomy to be significantly better than sclerotherapy at both 1- and 2-year follow-up. The second RCT reported on treatment of larger, main trunk (saphenous) varicose veins, and found stab avulsion phlebectomy to have a significantly higher rate of vein recurrence than sclerotherapy alone at 10-year follow-up.
Sclerotherapy versus surgery Safety
Jia et al (2006) found side effects following foam sclerotherapy to be rare, with only skin matting, staining or pigmentation and localised pain at the injection site occurring at a median rate of greater than 5% of patients. Few direct comparisons were made between sclerotherapy and surgery (ligation with or without stripping); the one study that did make such a
comparison found no significant difference in the occurrence of adverse events between sclerotherapy and surgery (ligation with stripping), reported in Rigby et al (2004).
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Effectiveness
Sclerotherapy generally entailed higher rates of varicose vein recurrence and re-treatment than surgical interventions (Rigby et al 2004; Jia et al 2006). The review by Jia et al (2006) reported on one RCT with long-term (10 years) follow-up that found foam sclerotherapy had
significantly higher rates of recurrence of new veins compared with surgery (ligation without stripping). The authors concluded foam sclerotherapy appears efficacious in treating all types of superficial venous disease, despite insufficient evidence to reliably compare the relative effectiveness of sclerotherapy and surgery (ligation with or without stripping).
The review by Rigby et al (2004) cast doubts over the durability of sclerotherapy as a treatment for varicose veins compared to surgery (ligation with or without stripping).
Sclerotherapy showed superior short-term clinical and cosmetic results (≤ 12 months), but this effectiveness declined rapidly; surgery (ligation with or without stripping) was consistently found to be more durable and require fewer re-treatments over the long-term (≥ 2 years).
One RCT also found differences in re-treatment rates between the interventions increased with patient age. Where reported, patients who underwent sclerotherapy required significantly less time on average to return to work than those who underwent conventional surgery (ligation with stripping). The authors concluded that it appears there is a place for both procedures in the management of varicose veins, with a trade-off between initial results and long-term benefits. The authors suggested that on the basis of the evidence available, the extent of a patient’s varicose veins should govern the choice of intervention; sclerotherapy may be best suited to patients with minor, superficial varicose veins not related to reflux in the saphenous system.
Surgery versus endovenous laser therapy
As there was no available literature directly comparing ELT to surgery, the review by MSAC (2003) was forced to make indirect comparisons, which provide a simple presentation of the safety and effectiveness profile of ELT but may be misleading and are prone to bias.
Safety
The review by MSAC (2003) found that common adverse events after ELT included pain, ecchymosis, induration and phlebitis. The majority of events were mild and self-limiting, generally resolving within a month of treatment; in a small number of cases adverse events persisted past 6 months, but this primarily occurred when surgical ligation of the saphenous vein was performed before ELT. Serious adverse events after ELT were rare. Common adverse events after surgery (ligation with stripping) included paraesthesia, infection, bruising and haematoma, with more serious thrombotic events uncommon. The majority of events resolved soon after treatment; in a small number of cases adverse events had not resolved within 4 months, and some cases of paraesthesia persisted for over 3 years. The authors concluded that ELT was as safe as surgery (ligation and stripping).
Effectiveness
The review by MSAC (2003) summarised studies that suggested superior rates of reflux abolition, recurrence, re-treatment and recanalisation/neovascularisation after ELT than
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surgery (ligation and stripping); however, this could not be confirmed due to a lack of direct comparative evidence, differences in the way reflux is assessed after the two interventions and the fact that the majority of ELT studies provided short-term follow-up (≤ 6 months) data on the treated limbs. Regarding improvement of varicose vein symptoms, the review reported clinically relevant reductions in symptoms such as pain and oedema after ELT, and reductions in symptoms as measured on venous severity scoring scales after surgery (ligation with
stripping). The review reported no work stoppage amongst a large cohort of its patient sample following ELT, whereas a considerable number of days to return to normal activities and work were generally required after surgery (ligation with stripping). The authors
concluded that from the available literature, ELT appears to be effective in occluding the saphenous vein in the short-term (≤ 6 months); however, it could not be determined whether ELT was as effective, or more effective, as surgery (ligation with stripping).
Surgery versus radiofrequency ablation Safety
One review reported on adverse events in studies comparing surgery to RFA (Adi et al 2004).
Serious adverse events associated with RFA were rare. Adi et al (2004) included one RCT that reported no significant difference in occurrence of adverse events between treatments, while a second RCT found significantly fewer cases of ecchymosis, haematoma and tenderness for RFA compared to surgery (ligation with stripping) up to 3 weeks after treatment. The long-term safety of RFA was supported by case-series evidence of up to 2 years’ follow-up;
however, evidence from this type of study is prone to substantial bias.
Effectiveness
Adi et al (2004) included two RCTs that reported no significant difference in the reflux free status of patients following RFA and vein stripping with and without ligation. Some short-term benefits were seen for RFA, with RCT evidence significantly favouring RFA over saphenous stripping, with or without ligation, with regards to post-procedural pain and analgesic usage (≤ 2 weeks), quality of life (≤ 1 week), and days required to return to work and normal activity. The authors concluded that long-term clinical outcomes of RFA had not been well established by comparative studies.
Conclusions
Four reviews, all published between 2003 and 2006, were identified as eligible for inclusion in this rapid review. All were systematic reviews of the existing literature regarding various treatments for varicose veins. One review compared ELT with surgery (MSAC 2003), one compared RFA with surgery (Adi et al 2004), one compared sclerotherapy with surgery (Rigby et al 2004) and one focused on foam sclerotherapy (Jia et al 2006). Conclusions based on the results of the review are summarised below:
1. Ligation with stripping plus avulsion is generally regarded as the ‘gold standard’ treatment for primary long saphenous veins, with good long-term effectiveness (≥ 12 months) at the cost of short-term inconvenience and discomfort compared to less invasive procedures.
2. Compression stockings are often used as a first-line treatment for varicose veins;
however, no evidence was found to support the effectiveness of this.
3. There appears to be a place for both surgery and sclerotherapy in the management of varicose veins. There also appears to be a trade-off between initial results and long-term benefits, with sclerotherapy showing better immediate and early outcomes, but surgery producing more durable long-term outcomes (≥ 12 months).
4. There is little evidence for the use of sclerotherapy to treat symptomatic varicose veins in patients with demonstrated saphenous reflux. Sclerotherapy and phlebectomy may be best suited to patients with minor superficial varicose veins not related to reflux in the
saphenous system, or as a post-treatment or adjunctive procedure to other treatments.
5. ELT appears to be as safe as conventional surgery with junction ligation and vein stripping, and is effective for occluding saphenous veins in the short-term (≤ 6 months);
however, it is unclear how ELT compares with other interventions, especially the ‘gold standard’ of surgery (ligation with stripping).
6. Evidence suggests some potential quality of life benefits for patients undergoing RFA compared with surgery (vein stripping with or without junction ligation) in the immediate postoperative period (≤ 2 weeks); however, there is not enough evidence to assess long-term effectiveness. Data suggests short-long-term safety (≤ 3 weeks) of RFA is comparable to conventional surgery, with case-series evidence tentatively supporting its long-term safety (≤ 2 years).
A lack of high-quality comparative evidence means it is difficult to make meaningful
judgments regarding the relative safety and effectiveness of treatments for varicose veins. It is also unclear from the evidence retrieved whether some treatments are more or less effective in particular patient subgroups, dependent on the aetiology of the varicose veins. High-quality comparative studies (such as well-designed RCTs) are needed before newer varicose vein treatments and surgery (ligation plus stripping) can be definitively compared. The extent of varicose veins should govern the intervention of choice, with no single treatment universally employed.
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Acknowledgements
The authors wish to acknowledge Dr Ann Scott for her assistance during the preparation of this review.
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