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then progress through varying severities of lipodermatosclerosis to ulceration. The chance
of any individual with varicose veins developing skin damage is both uncertain and small
with between 3% and 6% reporting “skin problems” (19,20). Among those who do
develop skin changes the risk of ulceration is also unpredictable, but any signs of venous
damage to the skin of the leg is usually regarded as an indication to consider preventative
measures—either in the form of compression hosiery or treatment of the varicose veins.
Treatments for Varicose Veins
There are currently three established treatment options for varicose veins. These are
conservative, sclerotherapy and surgery. There are also a number of newer therapies that
are based on Endovascular approaches. However, there is limited published information of
sufficient rigor and quality, to determine any of the treatment options relative effective-
ness (7). There is also disagreement regarding the indications for treatment (21).
Conservative treatment refers to a range of measures that encompassing life-style
advice and compression hosiery. People can develop complex rituals which they use
to ease any symptoms they associate with their varicose veins (9). Clinicians tend to
concentrate on providing explanations, reassurance, suggesting lifestyle changes and
prescribing compression hosiery. There is a need for reassurance and education as there
are widespread misconceptions that varicose veins are associated with a likelihood of
DVT, heart disease and amputation (9,10). Compression hosiery can be useful in helping
the symptoms and treating complications (22). However, many patients find compression
hosiery unacceptable and it tends to be used regularly only by those who are extremely
motivated (23–25). There are uncertainties about both clinical and cost effectiveness of
conservative measures. They are subject to variation in advice given by doctors and their
acceptability to patients (10).
Sclerotherapy is usually undertaken on an outpatient basis. It involves the injection
of a sclerosant (e.g., sodium tetradecyl sulfate) into the varicosities followed by a period of
compression treatment using bandaging or compression hosiery. Sclerotherapy became
popular in the 1960s (26) but it has been less widely used in recent decades (27).
Sclerotherapy is now generally considered to be most appropriate for varicose veins below
the knee (where compression is easier to apply than above the knee) in the absence of
saphenous vein reflux (10).
Surgical treatment involves day case or inpatient operation and general anaesthetic.
It requires a period of recuperation and time off work. There is also an increased possibility
of complications compared to sclerotherapy (4). Recurrence of varicose veins is not
uncommon and it has been reported that about 20% of patients seen in secondary care with
varicose veins have previously been treated surgically. In terms of surgical technique there
is controversy regarding the need for stripping the long saphenous vein (LSV), the level to
which it should be stripped, in which direction and with what technique (28). Where the
vein strip was extended to the ankle, the direction of the strip had been shown to be
important in terms of nerve injury. It has been reported that nerve injury was increased if
the vein was stripped in an upward direction (ankle to groin) (28). Additional fears about
stripping include the risk of deep vein damage, increased trauma to the tissues and damage
to the saphenous nerve, set against the potential benefit in reducing recurrence rates.
Endovascular treatments for varicose veins. Relatively new surgical techniques
for ablation of veins are available using radiofrequency (29) or laser (30), as well as a new
sclerosantfoam; (31–33) however, the effectiveness andcosts have not yetbeen fully assessed.
Palfreyman and Michaels248
INDICATIONS FOR TREATMENT OF VARICOSE VEINS
When assessing whether or not varicose veins should be treated, there are a number of
questions that need answering.
1. Do varicose vein treatments work? This examines the effectiveness of treatments
2. How much do varicose vein treatments cost? This involves assigning monetary
cost to interventions but also include other costs such as complications
3. Do varicose vein treatments make patients happy? This question addresses
whether the treatment improves the patients quality of life but also whether
patients are satisfied with treatment.
In the real world there is a complex interaction between effectiveness, cost and
quality of life. The health service providers use some or all of these when examining the
cost-effectiveness of treatments. The treatments for varicose veins, therefore, need to be
effective, have reasonable costs and improve the patient’s quality of life. However, the
priorities of the patient, clinician and health service provider may not be the same and can
be diametrically opposed.
Effectiveness
The question of effectiveness should be easy to answer. Do the current treatments for
varicose veins work? In order to answer such a question there is a need to examine the
evidence for the treatments that are currently available.
Surgery Versus Sclerotherapy
The two most common interventions for varicose veins are surgery and sclerotherapy.
However, there is little comparative data regarding their effectiveness (7,13,34).
One source of the comparative effectiveness of surgery compared to sclerotherapy is
a Cochrane Collaboration systematic review undertaken by Rigby et al. (34). This
systematic review found a total of 63 papers that considered surgery and sclerotherapy but
found only seven randomized controlled trials. In these trials there was a wide variation in
terms of the outcome measures included to assess the effectiveness of treatments. The
trials relied on subjective assessment of the results of the interventions. Subjective
measures are always open to bias and no single classification system has been uniformly
adopted. This lack of consensus meant that studies developed and used their own
classification system and these had not always been piloted or validated. Objective
measures such as duplex scanning and foot volumetry can be used but these have not been
universally employed and their relationship with clinical benefit is uncertain.
The quality of the included studies was not of the highest standard with the studies
being underpowered and being potentially open to bias due to lack of blinding of outcome
assessement and unclear randomization procedures.
The review concluded that there was insufficient evidence to preferentially
recommend the use of sclerotherapy or surgery. However there was a general trend to
better results after surgery than sclerotherapy although this was only consistent when the
follow-up period was three years or more. Sclerotherapy had some short term benefit in
the first year but these rapidly deteriorated so that by five years, surgery was the most
effective intervention due to higher recurrence rates following sclerotherapy.
Indications for Treatments of Varicose Veins 249
Surgery Versus Conservative Treatment
There is currently a lack of high quality evidence available comparing surgery and
conservative treatment of varicose veins. The only randomized controlled trial currently
published is a NHS Health Technology Assessment Programme monograph by Michaels
et al. (10).
The study randomized 246 participants with uncomplicated varicose veins between
surgery and conservative measures (lifestyle advice and compression hosiery). The study
found that those randomized to conservative treatment were dissatisfied and over half
(51.6%) chose to withdraw from conservative treatment and undergo surgery. The surgical
arm of the trial showed better results in terms of self-reported symptom relief, anatomical
extent, quality of life and patient satisfaction at one-year follow up.
Sclerotherapy Versus Conservative Treatment
A Cochrane Collaboration systematic review was undertaken by Tisi and Beverley (35).
Their review aimed to examine all randomized controlled trials comparing injection
sclerotherapy and conservative treatments (graduated compression stockings and/or
observation). They also examined differences in sclerosants and techniques for
sclerotherapy. A total of twenty-eight studies were identified for inclusion in their review.
Of these 16 were excluded as they did not meet the inclusion criteria or were non-
randomized studies.
The review concluded that there was no evidence to support the claims of Fegan (26)
regarding the type and duration of compression following sclerotherapy. The review also
found no effect of the types and duration of compression on the incidence of superficial
thrombophlebitis, obliteration of varicose veins or recurrence rate. In addition they found
no difference in results relating to the strength of STD used.
The review concluded that the available evidence on the effectiveness of sclero-
therapy was limited and of poor quality. There was a particular lack of evidence
comparing sclerotherapy with compression stockings.
Other Treatment for Varicose Veins
There are a number of publications examining less widely used treatments for varicose
veins including hydrotherapy and drug treatments.
A randomized controlled trial comparing hydrotherapy and no hydrotherapy (36,37)
reported significant reductions in leg volumes and ankle/calf circumference for the
hydrotherapy group. However, the study was exploratory in nature, only randomized 61
patients and did not include an a priori sample size calculation. There have been no other
studies that have duplicated these findings.
A number of drug treatments have been examined for the treatment of varicose veins
including oxerutins (a group of chemicals derived from a naturally occurring bioflavonoid
called rutin) (38,39). Both the studies found no statistically significant differences between
those randomized to oxerutins and those randomized to placebo. Two other drug studies
randomized between heptaminol adenosine phosphate (HAP—a cardiac stimulant and
vasodilator) and placebo (40) and calcium dobesilate (a vasoprotectant and capillary
dilator) and placebo (41). Although some improvements were seen in venous outflow for
HAP it is unclear whether this is of clinical significance.
One study examined a homeopathic preparation (Poikiven) and placebo (42). The
study reported significant improvements in objective measures (plesthysmography and leg
Palfreyman and Michaels250
circumference) but there were significant differences between the groups at baseline and
the analysis was not based on intention to treat.
Cost and Effectiveness
Evidence of effectiveness does not necessarily mean that treatments can be or should be
adopted because resources for health care interventions are not unlimited and the effect on
resources may influence whether health care providers will undertake to provide the
treatment (43). Where evidence exists that there is therapeutic equivalence between two or
more treatment options, the cheaper option is preferred (44). Cost therefore needs to be
included in any evaluation of health care.
Cost-effectiveness is a measure of the cost per unit of effectiveness and is a measure
of economic efficiency. The costs are valued in monetary terms and compared with a
single primary outcome (45). The outcome that is increasingly being used is the cost per
Quality Adjusted Life Year (QALY) gained. The QALY is a measure that combines the
length of life and quality of life (valued on an index where one represents perfect health
and zero represents death) (46). In the real world with limited resources it allows different
treatments to be compared and the most effective care to be obtained for the least cost (47).
There is however limited evidence for the cost-effectiveness of the treatments for
varicose veins. The currently published evidence concentrates on clinical effectiveness
rather than cost-effectiveness (34). Michaels et al. (10) found that there were some
differences in both costs and outcomes between surgery and conservative treatment.
Surgical treatment for varicose veins was associated with a modest health benefit for a
small additional NHS cost relative to conservative treatment. If £30,000 is taken as the
maximum acceptable cost effectiveness ratio, based on the probable threshold set by the
United Kingdom NICE (44), then on the basis of the results for patients with severe
varicose veins, surgical treatment appeared to be highly cost-effective with a ratio of less
than £5000 per QALY.
The results for sclerotherapy for minor varicose veins were insufficient for cost
effectiveness analysis and were examined by economic modeling. This found that
sclerotherapy had some benefit over conservative treatment but that surgery remained
cost-effective when compared to sclerotherapy.
Quality of Life
Quality of life is a concept of which people have an intuitive understanding but it can be
difficult to relate this to health (48,49). The potential benefit to patients of including
measures of quality of life into evaluations of treatment is that treatment decisions are
based on their own priorities and preferences (50).
One aim of treatment is to maximize a person’s quality of life by reducing the impact
of the disease on the patients. Yet patients with severe disease do not necessarily report
having a poor quality of life (51). The relationship between symptoms and quality of life is
not linear or necessarily direct. Carr et al. (48) reported problems with measuring health
related quality of life. These included differing expectations, which are specific to
individuals, assessment may be at different stages of illness and the expectation of
“normal” quality of life may change over time.
A number of generic and a disease-specific quality of life tools have been used to
examine outcomes from varicose vein treatments. However, there are a limited number of
studies that have used validated Quality of Life instruments and these have produced
conflicting results. One of the most widely used generic instruments is the SF-36.
Indications for Treatments of Varicose Veins 251
It contains 36 questions measuring health across eight dimensions. These are: physical
functioning, role limitation due to physical health, social functioning, vitality, pain, mental
health, role limitation because of emotional problems and general health. Responses to
each question within a dimension are combined to generate a score from 0 to 100, where
100 is “best possible health” and 0 is “worst possible health.” It generates a profile of eight
dimension scores and two summary scores for physical and mental health (52).
Some studies with the SF-36 have shown that patients with varicose veins have
reduced QoL compared to the general population (53), but others have shown no
significant difference (54,55). A large international study undertaken in Belgium, France,
Canada and Italy (56) found that impairment in quality of life was associated with related
venous disease rather than the presence of varicose veins per se.
Michaels et al. used the SF-6D (57) and EQ-5D (58) as primary outcome measures
for varicose vein treatments. The SF-6D is a single summary preference-based measure of
health derived from the SF-36 and can be regarded as a continuous outcome scored on a
0 to 1.00 scale, with 1.00 indicating “full health” (59). The EQ-5D (commonly referred to
as the Euroqol) contains five questions, which measure health across the five dimensions
of mobility, self-care, usual activities, pain/discomfort and anxiety depression. It provides
a simple descriptive profile and generates a single index value for heath status, based on
societal valuations, where full health is assigned a value of 1 and death a value of 0 (58).
The scores from the SF-6D and EQ-5D can be used to derive QALYs. Michaels et al. (10)
showed that the QALY gain was greater for surgery compared to sclerotherapy at two-
years.
A further important issue related to quality of life is that these measures do not
necessarily produce a complete picture of the motivations and expectations of treatment
(48,49). One method of forming a complete picture from the patients perspective is to
directly ask the patient through the qualitative methods of interviews and focus groups.
0
20000
40000
60000
80000
100000
120000
140000
160000
180000
200000
Number
Aortic Aneurysm
Claudication
DVT
Leg ulcer
Lymphoedema
Varicose Veins
Key word
Google December 2004
plus "treatment"
Figure 1 Number of hits on Google.
Palfreyman and Michaels252
Qualitative studies where the patients are asked directly about having varicose veins
have shown that it can affect patients social activities, feelings of self-worth, how they
dress and interact (9). Palfreyman et al. (9) also showed that patients will actively seek
surgery in preference to sclerotherapy and conservative treatment.
Patient, Clinician, or Provider Priorities?
The treatment for varicose veins highlights the dilemma of whose values and priorities
should be used to determine treatment. Patients seem to prefer surgery and are seeking
treatment from healthcare clinicians (9,10). Varicose veins provide a significant workload
for vascular surgeons and the majority of patients see surgery as an appropriate treatment
for varicose veins (13). However, some healthcare providers in the United Kingdom are
limiting surgery for varicose veins to those with complications (60).
The relative importance of varicose veins to thegeneral public compared to clinicians
and healthcare providers can be assessed using a proxy measure comparing the prevalence
of literature on the subject on the Internet and in medical publications. This was assessed by
recording the relative number of hits on the Internet and Medline for varicose veins.
Undertaking a simple search of common vascular conditions and treatment using
Google illustrates that the number of hits for varicose veins is almost twice that of the next
highest, claudication (Fig. 1). In comparison, a search of Medline showed that, although
varicose veins come second in terms of the number of published journals there are less
than half as many fewer articles compared to aortic aneurysm (Fig. 2).
CONCLUSION
The indications for treatment of varicose veins will vary dependent on the perspective
considered and is likely to be different in various health care settings. A system that is
constructed on the basis of consumer-led demand, such as in the United States, is more
0
5000
10000
15000
20000
25000
Number
Aortic
Aneurysm
Claudication
DVT
Leg ulcer
Lymphoedema
Varicose Veins
Key word
Medline 1951 to 2004
plus "treatment"
Figure 2 Number of hits on Medline.
Indications for Treatments of Varicose Veins 253
likely to respond to the obvious pressure for treatment from patients. However, a system
that is funded centrally and is led by healthcare providers will seek to limit varicose vein
treatments as they could potentially be spending the limited resources on a condition that
has a greater impact on life-expectancy and morbidity.
However, despite doubts about the relationship between symptoms and varicose
veins, the best evidence currently available suggests that surgery and sclerotherapy both
produce benefits—particularly from the patients perspective. Even when viewed in terms
of the health care funders, treatment is still likely to be cost-effective in appropriately
selected patients.
KEY POINTS
† Varicose veins are common and have a major impact on health budgets and
surgical waiting lists.
† Patients may report a wide range of symptoms, which they attribute to their
varicose veins.
† Symptom severity does not correlate with the extent of visible varicose veins.
† In patients referred for surgery, pain and itching are the most common
symptoms.
† Symptoms such as aching, heaviness, itching, and swelling may not improve
after treatment.
† There is little evidence regarding the cost effectiveness of the currently available
treatments.
† Sclerotherapy tends to have short-term benefits but surgical treatments appear
more effective when follow-up is 3 years or more.
† Surgery appears to be better than conservative treatments for uncomplicated
varicose veins in terms of symptom relief, quality of life, and patient satisfaction.
† Surgery for severe varicose veins is highly cost effective and results in improved
quality of life in appropriately selected patients.
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Palfreyman and Michaels256
20
Conservative Treatments:
Medical/Drug Therapies
Stavros K. Kakkos
Vascular Unit, Ealing Hospital, Southall, U.K.
Michel Perrin
University of Lyon, Lyon, France
Keith F. Cutting
Vascular Unit, Ealing Hospital, Southall, U.K.
George Geroulakos
Vascular Unit, Ealing Hospital, Southall, and Department
of Vascular Surgery, Imperial College, London, U.K.
COMPRESSION
Historical Aspects
Leg compression has been used to treat varicose veins and leg ulcers since ancient times,
probably before Hippocrates’ era. Leg wrapping with bandages was used by Hippocrates,
Celsus, Ambrose Pare
´
, and others, but it was Wiseman in 1676 who introduced a laced
stocking made of a number of different materials but primarily of soft leather (1). The
dermatologist Unna in 1893 used zinc and lanolin impregnated bandages to treat leg
ulcers, offering compression with antimicrobial properties. Elastic compression in the
form of bandages or stockings was developed during the nineteenth century. Elastic
stockings initially exerted uniform compression, but in the 1940s Jobst introduced graded
elastic stockings, which are widely used nowadays (1).
Types of Compression
Table 1 shows the different types of compression with particular emphasis to their
characteristics. Elastic stockings are the most widely used form of compression, perhaps
because they are generally easy to apply and comfortable to wear. This advantage renders
them practical, but they are also cost-effective because they do not lose their elastic
properties for several weeks. Thigh or knee length types are available, the former useful in
varicose veins with thigh involvement or post-thrombotic leg. Various compression
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