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National Clinical Guideline Centre (UK). Varicose Veins in the Legs: The Diagnosis and Management of Varicose Veins. London: National Institute for Health and Care Excellence (NICE); 2013 Jul. (NICE Clinical Guidelines, No. 168.)
Graduated compression hosiery is widely used as first line treatment for varicose veins. Compression stockings work by compressing the superficial veins to keep them collapsed and empty of blood and thereby pushing more blood into the deep venous system. This results in a reduction of venous pressure in the leg and subsequently a decrease in leg swelling. The compression is graduated, exerting an external pressure which is higher at the ankle (minimum 14mmHg) than the calf and thigh, thus increasing blood velocity within the deep venous system. It is recognised that the amount of pressure required is dependent on the severity of the condition.
There are many different makes and types of graduated compression hosiery available on prescription and to buy. These include different lengths (knee or thigh length) and different compression strengths. Confusingly, the British and European standards for classifying the strength of compression hosiery differ and are presented below (Table 46). Class III may be more effective, but consideration should be given to the manual dexterity of the person as they are more difficult to put on. The most frequently prescribed graduated compression hosiery for symptoms of venous hypertension is European standard class II. Adherence with hosiery is an important consideration as the effectiveness of this treatment is dependent on it being worn.
Table 46
Comparison of compression hosiery standards.
Alongside compression therapy, general health advice about exercise and weight loss has been proposed as a way of reducing severity of symptoms and prevention of the progression of varicose veins. Elevation of the legs above the level of the heart when sitting down has also been suggested as useful in alleviating symptoms.
This chapter aims to answer two questions:
- The efficacy and cost effectiveness of compression therapy versus no treatment or lifestyle advice.
- The efficacy and cost effectiveness of compression therapy versus interventional treatment (foam sclerotherapy, endothermal ablation or surgery).
8.1. Review question: What is the clinical and cost effectiveness of compression therapy compared with no treatment or lifestyle advice in people with leg varicose veins?
For full details see review protocol in appendix C.
Table 47PICO characteristics of review question
| Population | Adults with varicose veins in the legs |
|---|---|
| Intervention/s | Compression therapy, specifically compression hosiery (compression stockings). Both above knee and below knee compression hosiery will be included. [There will be no comparison between types or intensities of compression therapy]. |
| Comparison/s |
|
| Outcomes |
|
| Study design | Randomised control trials and observational studies |
8.1.1. Clinical Evidence
We searched for randomised control trials comparing the effectiveness of compression treatment to no treatment as an intervention for varicose veins. Three studies were included in this review. Two were cross-over trials 4,5 and one was a parallel trial 52.
Comparators were no treatment 52, a non-compressive stocking 5 and a non-specified placebo 4. The only outcomes covered by these studies were patient-reported symptoms and adverse events.
Because of the paucity of RCT evidence an additional search for observational studies was conducted. Five studies were found. Three were prospective single group studies observing the effects of compression applied as an intervention 48,57,64. These did not fully match the review question, because as single group studies they could not compare compression to no treatment or lifestyle advice, and were instead before-after designs. However, since the pre-compression stage could be regarded as equivalent to no treatment, it was deemed acceptable to consider the evidence from these reports, despite the high threats to internal validity, such as time or placebo effects, inherent in a before-after design. Two additional studies were retrospective surveys of previous and present compression therapy use 78,84, where compression was not applied as part of the study. All observational study data have been analysed in a narrative form (section 8.1.1.1.2).
Summary of included studies
Information on the populations, interventions and outcomes used in all 8 studies are summarised in Table 48 and Table 49. See also the study selection flow chart in appendix D, forest plots in appendix I, clinical evidence tables in appendix G and exclusion list in appendix J.
Table 48
Summary of the RCTs included in the review.
Table 49
Summary of the observational studies included in the review.
Table 50
Clinical evidence profile (GRADE table): compression versus no treatment (RCT studies only).
8.1.1.1. Narrative summary
8.1.1.1.1. RCT (for outcomes that are not appropriate for GRADE due to incomplete outcome reporting)
Minor adverse events
Benigni, 2003 5 reported a significant difference, favouring the compression group, of minor adverse events (a slipping sensation, a warming sensation or a feeling of pressure) between the compression and control groups at the end of the full cross-over trial. No statistics were provided.
Compliance
Benigni, 2003 5 reported compliance as not significantly different between groups, without group statistics being given.
Krijnen, 1997 52 asked 15 participants who had been given stockings but who hadn’t worn them every day (and thus been excluded from results for other outcomes) for the predominant single reason for their non-compliance. Five felt that the stockings were too tight, two stated they suffered from red and swollen skin, two stated that the stockings kept sliding down, and two reported an itch. Other reasons given did not relate to adverse effects.
8.1.1.1.2. Observational studies
Disease Specific Quality of life (score ranges from 0-190, with 190 being the worst score)
Lurie, 201157 reported an improvement in the specific quality of life and outcome response – venous (SQOR-V) scale from a mean (sd) 62.5(20.6) pre-compression to 48.9(17.9) post compression.
Patient assessed symptoms
Motykie, 1999 64 reported a significant improvement in all symptom outcomes between baseline and one month, and also baseline and 16 months (Table 51).
Table 51
Symptom outcomes in the Motykie1999 study.
Junger, 1996 48 reported that subjective treatments in all patients decreased during treatment, except for a feeling of “coldness”, which increased. There were no complaints by patients about feelings of constriction. No numerical data were presented.
Lurie, 201157 reported an improvement in a symptom score from mean (sd) 16.9(9.8) pre-compression to 6.3(5.8) post compression. This was generated by part of the SQOR-V form, comprising severity of pain, heaviness, itching, night cramps, heat or burning, tingling, throbbing, restless legs, swelling. The symptom score was the sum of the scores of these 9 symptoms, each on a 6 point scale; a higher score indicated worse symptoms, with 54 the worst score.
Pannier, 2007 78 reported that 71.3% of the interviewed participants using compression said their medical condition had improved with compression therapy. This included:
- reduction in swelling (84.2%)
- reduction in heaviness (89.4%)
- reduction in leg pain after prolonged standing (60.9%)
- reduction in tension in the legs (78.9%)
Minor adverse events
Motykie, 1999 64 reported that adverse events of numbness, sweating, itchiness and new pain existed after compression treatment. However these adverse events were mild (all scored as <1.5/5 on a scale where 5 is the worst possible), and improved as therapy progressed from 1 month to 16 months.
Pannier 200778 reported the following adverse events:
- pruritus (8.4%)
- eczemas (1.6%)
- constrictions under compression therapy (8.4%)
- slipping of stockings (3.6%)
Compliance
Motykie, 1999 64 reported that 92/112 (82%) were still wearing stockings at 1 month and 78/112 (69.6%) were still wearing stockings at 16 months.
Raju, 2007 84 reported that out of the patients who had been prescribed stockings, full compliance (daily use) was reported by 28%, full and partial (most days use) compliance by 44% and full, partial and minimal (occasional use) compliance by 49.33%. Primary reasons for non-use of stocking, of those that were recommended stockings by their doctor are given in Table 52, were:
Table 52
Primary reasons for non-use of stocking.
8.1.2. Economic evidence
8.1.2.1. Literature review
No cost effectiveness evidence was identified for this question.
8.1.2.2. Unit costs
In the absence of recent UK cost effectiveness evidence, unit costs are provided in Table 53 and Table 54 to aid consideration of the cost effectiveness of compression hosiery compared to no treatment.
Table 53
Types of compression hosiery and unit costs.
Table 54
Unit costs and quantity of the components of compression therapy.
8.1.2.3. Economic considerations
Based on the figures provided in Table 54, it is estimated that the annual costs of compression hosiery would be approximately £234. This estimate is based on the assumption that compression stockings have a life expectancy of 3 months, after which they lose their strength. Patients are given two pairs of “made-to-measure” thigh-high stockings for use over a six month period. The cost of lifestyle advice was assumed negligible.
In practice, some people may be prescribed below-knee standard compression stockings instead of thigh-high “made-to-measure” stocking. If below-knee standard compression stockings are prescribed it is estimated (assuming the average price of a pair of standard below-knee compression stockings is £10.54) that the annual costs of compression therapy would be roughly £107.
Assuming the difference in costs of compression hosiery and the no-treatment option is £234, compression hosiery will be cost-effective at the £20,000 per QALY threshold if it provides an improvement of 0.012 quality-adjusted life years (QALYs) relative to no treatment. If the difference in the costs of compression hosiery and no-treatment option is £107, compression hosiery will be cost- effective if it provides an improvement of 0.005 QALYs relative to no treatment or lifestyle advice.
The unknown in this analysis is whether compression therapy will offer an improvement of 0.012 (0.005) QALYs relative to no treatment or lifestyle advice. The review of the clinical effectiveness evidence on compression versus no treatment (lifestyle advice) did not report any single measure of health-related quality of life, however it did show that compression hosiery is more effective (Table 50) than no treatment. For example, the number of people reporting heavy or tired legs was found to be lower with compression (risk ratio of 0.52 [95% CI: 0.36 – 0.73]), and the number of people with a decrease in complaints at the end of treatment was greater for compression (risk ratio of 4.82 [95% CI: 1.82 – 12.73]), compared to no-treatment or lifestyle advice. Compression was also more effective than no-treatment in reducing the number of people with cramps and ankle swelling.
8.1.2.4. New cost-effectiveness analysis
New analysis was not prioritised for this question.
8.1.3. Evidence statements
8.1.3.1. Clinical
8.1.3.1.1. RCT studies only
Patient reported symptoms
Patient reported pain
- 2 studies comprising 178 participants found that compression led to a relative reduction in the rates of patients experiencing pain / no improvement in pain, but the uncertainty of this effect is too large from which to draw clear conclusions regarding benefits or harms [VERY LOW QUALITY].
- 2 studies comprising 249 participants found that compression led to a relative reduction in the level of pain, but the uncertainty of this effect is too large from which to draw clear conclusions regarding benefits or harms [VERY LOW QUALITY].
Patient reported heavy or tired legs
- 2 studies comprising 177 participants found that compression was associated with relatively lower rates of patients experiencing heavy or tired legs / no improvement in heavy or tired legs. This was a large enough effect to show a clearly appreciable clinical benefit of using compression stockings [LOW QUALITY].
- 1 study comprising 132 participants found that compression led to a relative reduction in the level of heavy or tired legs, but the uncertainty of this effect is too large from which to draw clear conclusions regarding benefits or harms [LOW QUALITY].
Patient reported cramps
- 1 study comprising 116 participants found that compression was associated with relatively lower rates of patients experiencing no improvement in cramps. However, this was not a large enough effect to show a clearly appreciable clinical benefit of using compression stockings [VERY LOW QUALITY].
- 1 study comprising 132 participants found that compression led to a relative reduction in the level of night cramps, but the uncertainty of this effect is far too large from which to draw clear conclusions regarding benefits or harms [LOW QUALITY].
Patient reported swelling
- 1 study comprising 114 participants found that compression was associated with relatively lower rates of patients experiencing no improvement in swelling. However, this was not a large enough effect to show a clearly appreciable clinical benefit of using compression stockings [VERY LOW QUALITY].
- 1 study comprising 132 participants found that compression led to a relative reduction in the level of ankle swelling, but the uncertainty of this effect is too large from which to draw clear conclusions regarding benefits or harms [VERY LOW QUALITY].
Patient reported body image dissatisfaction
- 1 study comprising 132 participants found that compression led to a relative reduction in the level of body image dissatisfaction but the uncertainty of this effect is too large from which to draw clear conclusions regarding benefits or harms [LOW QUALITY].
Overall complaints of symptoms
- 1 study comprising 64 participants found that compression was associated with relatively higher rates of patients experiencing a reduction in overall complaints. This was a large enough effect to show clearly appreciable clinical benefit [LOW QUALITY].
8.1.3.1.2. Observational study evidence
Evidence from observational data suggests that compression may improve quality of life and reduce symptoms, but the potential for bias in this evidence is extremely high.
Observational data also suggests that adverse events such as numbness, sweating, itchiness, pain, eczema, constriction and slippage of stockings occur with compression therapy, but that these are mild and infrequent.
Observational compliance was reported as being relatively low, with full compliance at only 28% in one study. Another study reported a higher figure of almost 70% but the level of compliance was unclear, and may have included very occasional use.
8.1.3.2. Economic
No cost effectiveness evidence was found for this question. The annual cost of compression therapy was estimated to be £107-£234.
8.2. Review questions: What is the clinical and cost effectiveness of compression therapy compared with a) stripping surgery; or b) endothermal ablation; or c) foam sclerotherapy in people with leg varicose veins?
For full details see review protocol in appendix C.
Table 55PICO characteristics of review question
| Population | Adults with varicose veins in the legs |
|---|---|
| Intervention/s | Compression therapy, specifically compression hosiery (compression stockings) |
| Comparison/s | Foam sclerotherapy ± crossectomy OR Stripping surgery + ligation [± phlebectomy] OR Endothermal ablation [± foam sclerotherapy/phlebectomy] |
| Outcomes |
|
| Study design | Randomised controlled trials |
8.2.1. Clinical evidence
We searched for randomised controlled trials comparing the effectiveness of compression therapy and interventional therapies such as foam sclerotherapy, stripping surgery or endothermal ablation for improving outcomes for varicose veins.
Summary of included studies
No RCTs were found comparing compression to either foam sclerotherapy or endothermal ablation.
Two RCTs were found comparing compression therapy to stripping surgery62,61. Note that all the data contained in Michaels 200661 were also found in Michaels 200662, the latter being an HTA report comprising 2 randomised controlled trials relevant to this review question.
Because of the paucity of RCT evidence an additional search for observational studies was conducted. None were identified.
The summary of the included study can be seen in Table 56. See also the study selection flow chart in appendix D, forest plots in appendix I, clinical evidence tables in appendix G and exclusion list in appendix J.
Table 56
Summary of studies included in the review.
Table 57
Clinical evidence profile (GRADE table): compression versus surgery for varicose veins.
8.2.2. Economic evidence
8.2.2.1. Literature review
Three studies39,62,89 were included that included the relevant comparisons. These are summarised in the economic evidence profile below (Table 58). See also the study selection flow chart in appendix E and study evidence tables in appendix H.
Table 58
Economic evidence profile: Compression hosiery.
One study33 was excluded. The excluded study is summarised in appendix K, with reasons for exclusion given.
8.2.2.2. New cost-effectiveness analysis
This area was prioritised for new cost-effectiveness analysis, in which compression hosiery was compared to various interventional treatments. Results are summarised in the economic evidence profile below (Table 58). Full details can be found in appendix L, and a summary in section 9.6.
8.2.3. Evidence statements
8.2.3.1. Clinical
8.2.3.1.1. Compression versus surgery
Quality of life
SF-6D
- 1 year follow-up: 1 study comprising 173 participants showed that surgery was associated with a better quality of life rating at 1 year compared to compression. However this was not a large enough effect to show a clearly appreciable clinical benefit of using surgery [LOW QUALITY].
- 2 year follow-up: 1 study comprising 91 participants showed that surgery was associated with a better quality of life rating at 2 years compared to compression. However this was not a large enough effect to show a clearly appreciable clinical benefit of using surgery [LOW QUALITY].
EQ 5D
- I year follow-up: 1 study comprising 179 participants showed that surgery was associated with a better quality of life rating at 1 year compared to compression. However this was not a large enough effect to show a clearly appreciable clinical benefit of using surgery [LOW QUALITY].
- 2 year follow-up: 1 study comprising 78 participants showed that surgery and compression did not differ in their effects on quality of life at 2 years [MODERATE QUALITY].
Patient assessed symptoms
Aching at 1 year
- 1 study comprising 172 participants showed that surgery was associated with lower rates of aching at 1 year compared to compression. This was a large enough effect to show a clearly appreciable clinical benefit of using surgery [MODERATE QUALITY].
Heaviness at 1 year
- 1 study comprising 172 participants showed that surgery was associated with lower rates of heaviness at 1 year compared to compression. This was a large enough effect to show a clearly appreciable clinical benefit of using surgery [MODERATE QUALITY].
Itching at 1 year
- 1 study comprising 172 participants showed that surgery was associated with lower rates of itching at 1 year compared to compression. This was a large enough effect to show a clearly appreciable clinical benefit of using surgery [MODERATE QUALITY].
Swelling at 1 year
- 1 study comprising 172 participants showed that surgery was associated with lower rates of swelling at 1 year compared to compression. This was a large enough effect to show a clearly appreciable clinical benefit of using surgery [MODERATE QUALITY].
Body image concerns at 1 year
- 1 study comprising 172 participants showed that surgery was associated with lower rates of body image concerns at 1 year compared to compression. This was a large enough effect to show a clearly appreciable clinical benefit of using surgery [MODERATE QUALITY].
Adverse events –
Neural damage (foot drop)
- 1 study comprising 246 patients showed that surgery was associated with a higher rate of neural damage compared to compression, but the uncertainty of this effect is too large from which to draw clear conclusions about relative benefit and harm [VERY LOW QUALITY].
Patient reported outcomes
Patient dissatisfaction
- 1 study comprising 172 patients showed that surgery was associated with less patient dissatisfaction than compression. This was a large enough effect to show a clearly appreciable clinical benefit of using surgery [MODERATE QUALITY].
8.2.3.2. Economic
- Three existing cost-utility analyses found surgery to be cost-effective compared to conservative care. These studies were directly applicable, with minor or potentially serious limitations.
- Our original economic analysis also found interventional treatments to be cost-effective compared to conservative care; specifically endothermal treatment was identified as the cost-effective strategy. This evidence is directly applicable with minor limitations.
8.3. Recommendations and link to evidence
The recommendations for this section were made in conjunction with the recommendations for interventional treatment and can be found in section 9.7.
- Review question: What is the clinical and cost effectiveness of compression therapy compared with no treatment or lifestyle advice in people with leg varicose veins?
- Review questions: What is the clinical and cost effectiveness of compression therapy compared with a) stripping surgery; or b) endothermal ablation; or c) foam sclerotherapy in people with leg varicose veins?
- Recommendations and link to evidence
- Conservative Management - Varicose Veins in the LegsConservative Management - Varicose Veins in the Legs
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