Eur J Vasc Endovasc Surg (2017) -, 1e8

Acute Effects of Graduated Elastic Compression Stockings in Patients with

Symptomatic Varicose Veins: A Randomised Double Blind Placebo
Controlled Trial5
Stavros K. Kakkos *, Marios Timpilis, Panayiotis Patrinos, Konstantinos M. Nikolakopoulos, Chrysanthi P. Papageorgopoulou,
Anastasia K. Kouri, Ioannis Ntouvas, Spyros I. Papadoulas, George C. Lampropoulos, Ioannis A. Tsolakis
Department of Vascular Surgery, University Hospital of Patras, Patras, Greece

WHAT THIS PAPER ADDS

There is currently lack of high quality trial evidence that graduated elastic compression stockings (GECS) improve
symptoms in patients with varicose veins. In this randomised double blind placebo controlled trial in patients
presenting with primary varicose veins causing calf pain or aching, GECS were more effective than placebo
stockings in reducing the patient score for pain or aching in the most affected leg, providing trial evidence for
the first time.

Objectives: To investigate the effectiveness of graduated elastic compression stockings (GECS) below the knee in
improving symptoms in patients with varicose veins in the absence of high quality evidence.
Methods: This was a randomised double blind placebo controlled trial. Thirty patients with no experience of
elastic stockings, presenting with primary varicose veins causing calf pain or aching were randomised to a GECS
(18-21 mmHg at the ankle level, n¼15) or a placebo stocking (0 mmHg, n¼15). Pain or aching of the index leg
after 1 week was the primary outcome measure. In patients with bilateral varicose veins the leg with the most
severe pain/aching was considered. Other defined symptoms were secondary outcome measures. All symptoms
were scored on a visual analogue scale (VAS).
Results: The two study groups were well balanced at baseline. At the completion of the study after 1 week, GECS
were more effective than placebo stockings in reducing pain or aching (VAS score 1.73.0 vs. 4.52.8 for
placebo, p¼.02), while non-significant trends were observed for some of the remaining symptoms of the index
leg, including feeling of swelling (VAS score 0.91.9 vs. 3.33.5 for placebo), paraesthesiae (VAS score 0.20.6
vs. 2.13.1 for placebo), and the number of symptoms other than pain or aching (1.31.1 vs. 2.81.7 for
placebo). Number needed to treat (95% CI) for a 50% or complete improvement of pain or aching in the index leg
was 2 (95% CI 1.2e5.5) and 2 (95% CI 1.2e5.3), respectively. Mean daily use of the placebo stockings and GECS
was 8.0 hours and 10.2 hours, respectively (p¼.13).
Conclusions: Among patients with varicose veins, GECS seem effective in ameliorating symptoms, particularly
pain or aching, compared with placebo stockings after 1 week of use. Long-term studies are justified.
Ó 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.
Article history: Received 28 March 2017, Accepted 6 October 2017, Available online XXX
Keywords: Varicose veins, Elastic stockings, Randomised controlled trial

INTRODUCTION compression,1,2 including its use as a standalone modal-

Treatment of venous diseases of the lower limbs using
compression has been performed effectively for centuries.
However, there is little published evidence (and what exists
is of low quality) to demonstrate the efficacy of
5
Presented at the 18th Annual Meeting of the European Venous Forum,
29 Junee1 July, 2017, Porto, Portugal. Abstract published in Phlebology
2017; 32(8): 570e1.
* Corresponding author. Department of Vascular Surgery, University
Hospital of Patras, Patras, 26504, Greece.
E-mail address: kakkos@upatras.gr (Stavros K. Kakkos).
1078-5884/Ó 2017 European Society for Vascular Surgery. Published by
Elsevier Ltd. All rights reserved.
https://doi.org/10.1016/j.ejvs.2017.10.004
ity,3e5 after venous surgery,6 or to prevent post-thrombotic
syndrome.7 More specifically, there are no clinical trials
demonstrating any possible benefit of graduated elastic
compression stockings (GECS) in patients with varicose
veins of the lower extremities, including a particular type
and compression profile across the CEAP clinical class
spectrum.1,2,4 The only randomised trials that compared
GECS with placebo stockings investigated low compression
profile stockings in the active arm.8,9 In contrast, the
effectiveness of therapeutic GECS (around 20 mmHg or
more at the ankle level) has been tested in non-randomised
studies comparing two GECS types worn sequentially, or
more often patient symptoms before use were compared

Please cite this article in press as: Kakkos SK, et al., Acute Effects of Graduated Elastic Compression Stockings in Patients with Symptomatic Varicose Veins:
A Randomised Double Blind Placebo Controlled Trial, European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/
j.ejvs.2017.10.004
2 Stavros K. Kakkos et al.
with those reported with the stockings in place, facts that
introduce a certain degree of bias.4
The aim of the present study was to compare the acute
effects of wearing below knee active (18-21 mmHg) or
placebo GECS (0 mmHg) on pain or aching and also on a
number of secondary symptoms and signs, using a modified
version of the revised Venous Clinical Severity Score (rVCSS)
obtained at baseline and after 1 week in patients with
primary varicose veins.
PATIENTS AND METHODS
Patients with primary varicose veins of the lower extrem-
ities were recruited through the vascular outpatient clinics
of the University Hospital and the vascular outpatient clinic
of a primary care provider, all in Patras, Greece between
December 2015 and August 2016. Inclusion criteria included
primary varicose veins causing pain/aching located only at
calf level in patients of both genders, aged 18-90 years.
Exclusion criteria included venous ulceration, venous
eczema, itching, superficial vein thrombosis, peripheral
arterial disease (intermittent claudication, critical limb
ischaemia, or a vascular intervention), symptoms not of
venous origin, and previous use of elastic stockings. The
following baseline information was recorded: age, gender,
body mass index (BMI), comorbidities, the presence of
family history of varicose veins, prolonged standing, num-
ber of pregnancies (for women), patient age when varicose
veins occurred, laterality of varicose veins, varicose vein
complications, history of treatment for varicose veins, and
CEAP clinical class. Duplex scanning was performed in a
standard fashion to exclude deep vein pathology and
investigate superficial vein pathology by identifying reflux
distribution.
Outcome measures
The primary outcome measure of the trial was dull pain or
aching graded by the patient using a visual analogue scale
(VAS, 1-10 at baseline) of the leg with the varicose veins.10 For
bilateral varicose veins, the leg with the highest VAS score
was considered to be the index leg. Secondary outcomes
included leg symptoms of heaviness, swelling sensation,
varicose vein throbbing, burning sensation, paraesthesiae,
night cramps and restless legs, and insomnia, considered to
be a secondary symptom caused by the leg symptoms,10,11 all
graded with VAS (0-10), a modification of previously
described methodology.12e15 The same outcome measures of
the index leg were assessed for the contralateral leg, all
graded similarly with VAS (0-10), only if there were varicose
veins. These were also considered to be secondary outcomes.
Other secondary outcome measures included a modified
version of the revised Venous Clinical Severity Score (rVCSS-
S),16,17 which did not account for the attribute of compres-
sion, and ankle circumference (in cm) measured just above
the malleolus, at the smallest point, both for the index and
contralateral (if applicable) leg. All outcome measure scores
and readings were recorded at baseline and after 1 week of
GECS or placebo stocking use, with the aim of investigating
Please cite this article in press as: Kakkos SK, et al., Acute Effects of Graduated Elastic Compression Stockings in Patients with Symptomatic Varicose Veins:
A Randomised Double Blind Placebo Controlled Trial, European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/
j.ejvs.2017.10.004
the acute effects of the former. Compliance was monitored by
log sheets on which patients entered the hours they had used
their stockings each day. Complaints of complications of the
two types of stockings were noted in addition of any pruritus
(graded on a 0-10 VAS).
Description of active and placebo GECS
Active Comparator: Graduated elastic stockings VARISAN
TOP, off the shelf knee length Class 1 (18-21 mmHg, RAL
certified, at the ankle level) (Cizeta Medicali S. p. A., Cug-
giono, MI, Italy).
The placebo comparator was a similar looking knee
length VARISAN diabetic (0 mmHg at the ankle level; Cizeta
Medicali).
Randomisation and blinding
On patient agreement to participate in the trial (signed
informed consent), randomisation was performed using
sequentially numbered, sealed, opaque envelopes that
contained a paper slip showing the randomisation group.
This parallel group trial had a 1:1 allocation ratio. A member
of the group who was unaware of the clinical characteristics
of the patients handled all randomisation envelopes and
notified the manufacturer’s local distributor by sending the
randomisation group, leg measurements required to fit the
stockings, and patient’s address. A pair of active or placebo
GECS was sent by courier to the patient the same or next
day. The randomisation group was not communicated to the
patient or outcome assessors. To guarantee blinding of
patients and outcome assessors for performance bias and
detection bias, respectively, all stocking labels were
removed by the manufacturer’s local distributor before
shipping, so that the two stocking types looked similar.
Additionally, all patients were instructed to remove their
stocking and conceal them from the outcome assessors at
the time of their follow-up visit. The ethics committee of
the University Hospital of Patras approved the study pro-
tocol (approval No 35/18.02.2015).
Statistical analysis
A priori power calculations were based on a previous study
in which a mean VAS of 4.5/10 before use of a Class 1
(20 mmHg) GECS was reduced to 1.5/10 afterwards.18
Assuming a reduction of mean VAS of 4.5/10 to 3.5/10
using a placebo stocking, and also a standard deviation of
1.5 for the two groups, a total of 24 patients (12 in each
group) would be required to demonstrate statistical signif-
icance (a¼0.05) at a power of 90%. To compensate for
possible losses to follow-up or patient withdrawal from the
study, it was decided to include a total of 30 patients (15 in
each group). Pre-planned interim statistical analysis after 15
patients were randomised and followed up revealed a non-
significant trend for the primary outcome measure, so that
the study was continued and finished as planned.
All data were entered into a Microsoft Office Access
database (Microsoft Inc., Redmond, WA, USA) and analysed
with IBM SPSS Statistics 24 (IBM Corp., Armonk, NY, USA).
Acute Effects of Graduated Elastic Compression
Figure 1. CONSORT flowchart showing the number of patients during the phases of the study.
Categorical data were analysed with the chi-square test or
alternatively the Fisher’s exact test, whenever the expected
count of one or more variables was less than 5. Continuous
data were normally distributed on testing with the
Kolmogorov-Smirnov test and parametric tests were used to
analyse them, including the unpaired samples t test and
Pearson correlation. MedCalc free statistical calculator
(http://www.medcalc.org, MedCalc Software bvba, Ostend,
Belgium) was used to calculate the relative risk of Class 1
stockings not reducing the pain or aching in the index leg by
50% or 100%, and also the number needed to treat (NNT)
with class 1 stockings to reduce pain or aching in the index
leg by 50% or 100%. The level of significance for the primary
outcome was set at 0.05, while for the 23 secondary out-
comes (pain/aching in the contralateral leg, all other
symptoms bilaterally, number of symptoms, rVCSS-S and
ankle circumference), the Bonferroni correction was
applied, reducing the level of significance to 0.002.
The Randomised Elastic Compression in chronic VENous
disease (RECVEN) study is registered with ClinicalTrials.gov
(identifier: NCT02641600).
RESULTS
Thirty patients were randomised as planned, 15 in each of
the two study groups. The CONSORT flow diagram is shown
in Fig. 1. One patient in each group withdrew consent,
which left 14 patients in each group. Table 1 shows the
baseline characteristics of the two study groups, which
were comparable.
Please cite this article in press as: Kakkos SK, et al., Acute Effects of Graduated Elastic Compression Stockings in Patients with Symptomatic Varicose Veins:
A Randomised Double Blind Placebo Controlled Trial, European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/
j.ejvs.2017.10.004
3
Baseline and follow-up VAS scores of patient symptoms,
rVCSS(-S), the number of symptoms, and ankle circumfer-
ence, for the two legs separately, stratified by study group
are shown in Table 2. Baseline values were almost
completely comparable, except for insomnia caused by
symptoms from the index leg. At the completion of the
study after 1 week, active stockings were more effective
than placebo stockings in reducing pain/aching (Fig. 2A),
while a non-significant trend was noted for the feeling of
swelling (Fig. 2B), paraesthesiae (Fig. 2C), and the number
of symptoms other than pain/aching (Fig. 3A). Restricting
the analysis to patients with CEAP C2 CVD did not change
the results for pain/aching. Non-significant trends towards
increased efficacy of the active stocking group vs. the
control for some of the remaining symptoms and measures
of the index leg were observed (Table 2). All but two pa-
tients randomised to active stockings reported either some
improvement (n¼3) or complete resolution (n¼9) of the
primary efficacy measure of pain/aching. Improvement of
more than 50% of pain/aching was reported in 11 patients,
for a mean  standard deviation absolute decrease of VAS
of 5.52.9. Conversely only two patients randomised to
placebo stockings reported complete resolution of their
pain and another five patients some improvement. In the
remaining seven patients, there was no change, while no
patient reported deterioration. Improvement of more than
50% of pain/aching was reported in four patients. The
relative risk of not achieving an improvement of 50% or
greater was 0.3 (95% CI 0.10e0.86, p¼.026) and for not
4 Stavros K. Kakkos et al.

Table 1. Patient demographics, risk factors, pertinent history, and 0.29 h a day. Another patient with a history of sciatica and
disease classification at baseline for the two study groups, placebo unilateral varicose veins causing some calf cramps in addi-
and Class 1 stockings. tion to calf pain (VAS¼5), who was allocated to the active
Patient group p value stockings group with good compliance (mean daily use
Placebo Class 1 10.5 hours), reported complete resolution of her calf
stockings stockings symptoms and occurrence of thigh cramps. A third patient
(n¼15) (n¼15) with bilateral varicose veins, allocated to the active stock-
Age, mean  SD, 53.711.2 52.913.2 .85
ings group with good compliance (mean daily use 10 hours),
years
and good response or resolution of her symptoms, reported
Gender, male/ 1/14 1/14 1.00
female that the top part of her stockings was too tight.
BMI, mean  SD 26.84.6 25.84.1 .52 Mean daily use of the placebo and active stockings was
Family history of 10 (66.7%) 12 (80%) .68 8.0 hours and 10.2 hours, respectively (p¼.13, missing data
varicose veins (%) in one patient randomised to active stockings). There was
Prolonged standing 12 (80%) 12 (80%) 1.00 no association between daily use and absolute reduction of
(%) VAS for the primary efficacy outcome of pain/aching in the
Number of 3.11.5 2.41.9 .28 active stockings group (correlation coefficient 0.076,
pregnancies p¼.81).
Patient age when 45.13.8 42.615.8 .65
varicose veins
occurred, DISCUSSION
mean  SD, years
Bilateral varicose 11 (73.3%) 12 (80%) 1.00 This study demonstrated that in patients with primary
veins (%) varicose veins causing calf pain or aching, GECS were more
Index leg, L/R 12/3 8/7 .25 effective than placebo stockings in reducing patient VAS
Varicose vein 0 (0%) 1 (6.7%)a 1.00 scores for pain or aching in the most affected leg. The study
complications (%) provides the first trial evidence for this primary efficacy
History of 0 (0%) 1 (6.7%)b 1.00 outcome. Additionally, non-significant trends were
treatment for observed for other symptoms including the feeling of
varicose veins (%) swelling, paraesthesiae and the number of symptoms other
Comorbidities 6 (40%) 6 (40%) 1.00 than pain or aching.
CEAP clinical class, 9/3/2/1 11/1/3/0 .49
This study was unique because for the first time, Class 1
2/3/4a/4b
GECS were compared with placebo stockings; this was made
Duplex findings
Main GSV (n¼13), GSV(n¼11), .48 possible only because RCT patients with varicose veins were
incompetent tributaries GSV&SSV (n¼1), included who were not only naïve to elastic stockings but
vein(s) of the only (n¼1)c SSV (n¼1), also unaware of the difference between the two trial
index leg tributaries stockings. Placebo stockings have been validated by a pre-
only (n¼2) vious study,19 and also used in RCTs. In one study with a
Main GSV (n¼10), GSV (n¼8), .11 cross-over design and duration of 15 days, the efficacy of
incompetent none (n¼4)c tributaries Class 1 compression stockings exerting 10-15 mmHg at the
vein(s) of the only (n¼4), ankle, much lower than the 18-21 mmHg RAL compression
contralateral leg none (n¼3) profile at the ankle level of the active stockings used in the
GSV ¼ great saphenous vein; SSV ¼ small saphenous vein. present study, were compared with placebo stockings.9 The
a
Superficial vein thrombosis. results of that study showed that global painful discomfort
b
Liquid sclerotherapy.
c and each symptom of CVD was improved with the excep-
Not performed in one patient who withdrew consent.
tion of paraesthesiae and that the relief of symptoms with
low compression profile stockings was twice the benefit
achieving a complete improvement was 0.22 (95% CI 0.06e reported with placebo stockings.9 These findings are very
0.85, p¼.023). Based on the above results, NNT (95% CI) for similar to the findings from the present study except for the
a 50% and also complete improvement was 2 (95% CI 1.2e much larger improvement observed herein (Table 2). The
5.5) and 2 (95% CI 1.2e5.3), respectively. magnitude of the treatment effect in the present study
In the contralateral leg, similar non-significant trends leaves little room for improvement in the patient popula-
towards increased efficacy of the active stocking group vs. tion, for example by increasing compression pressure, as
the control for most of the symptoms and measures were also demonstrated by another RCT comparing GECS with a
observed (Table 2). Ankle circumference readings were not 20 mmHg compression profile as used in this study, with
significantly different at baseline and after 1 week for the GECS with a 30 mmHg compression profile.18
index and contralateral legs of the two study groups. Nevertheless, active GECS in the present study were
One patient with bilateral varicose veins allocated in the effective in improving pain/aching; a non-significant trend
placebo stockings group reported pruritus (VAS¼2, bilat- for improvement in feeling of swelling, paraesthesiae, and
erally) after wearing her stockings, which she used for only other symptoms of the index leg deserves further study.
Please cite this article in press as: Kakkos SK, et al., Acute Effects of Graduated Elastic Compression Stockings in Patients with Symptomatic Varicose Veins:
A Randomised Double Blind Placebo Controlled Trial, European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/
j.ejvs.2017.10.004
Acute Effects of Graduated Elastic Compression 5

Table 2. Results of symptom scoring using a 0-10 visual analogue scale at baseline and after 1 week for the two study groups, placebo and
active stockings
Baseline After 1 week
Placebo stockings (n¼15) Class 1stockings (n¼15) p value Placebo stockings Class 1stockings p value
(n¼14) (n¼14)
Pain or aching
Index leg 6.92.2 7.41.8 .47 4.52.8 1.73.0 .02
Contralateral leg 3.73.5 3.32.8 .77 1.92.6 0.61.8 .17
Heaviness
Index leg 5.92.4 6.93.2 .35 4.03.1 2.43.1 .17
Contralateral leg 3.63.2 4.33.5 .62 2.13.0 1.42.1 .52
Feeling of swelling
Index leg 4.53.4 5.53.9 .46 3.33.5 0.91.9 .03
Contralateral leg 1.92.6 3.33.8 .31 1.22.4 1.12.1 .91
Throbbing
Index leg 2.53.8 1.72.7 .51 1.42.7 0.91.9 .10
Contralateral leg 0.41.2 0.20.6 .62 0.10.3 0.00.0 .34
Paraesthesiae (tingling)
Index leg 2.53.4 1.72.7 .84 2.13.1 0.20.6 .04
Contralateral leg 0.81.8 1.83.2 .40 0.41.3 0.00.0 .34
Night cramps
Index leg 1.72.7 3.23.6 .19 0.92.0 0.00.0 .14
Contralateral leg 0.61.6 1.72.6 .26 0.00.0 0.00.0 N/A
Burning sensation
Index leg 3.94.1 4.93.9 .53 2.43.4 0.81.8 .14
Contralateral leg 2.03.1 2.53.2 .71 0.91.2 0.00.0 .04
Restless legs
Index leg 0.52.1 0.00.0 .33 0.00.0 0.00.0 N/A
Contralateral leg 0.51.5 0.00.0 .34 0.00.0 0.00.0 N/A
Insomnia
Index leg 0.92.5 4.44.4 .02 0.00.0 0.932.4 .18
Contralateral leg 0.00.0 1.32.7 .12 0.00.0 0.00.0 N/A
Pruritus
Index leg 0.00.0 0.00.0 N/A 0.10.5 0.00.0 .34
Contralateral leg 0.00.0 0.00.0 N/A 0.20.6 0.00.0 .34
No of other symptoms
Index leg 3.41.4 4.12.0 .29 2.81.7 1.31.1 .01
Contralateral leg 2.11.7 2.51.9 .60 1.51.6 0.60.8 .10
rVCSS(-S)
Index leg 4.51.7 4.71.3 .72 3.81.5 3.11.2 .22
Contralateral leg 3.31.2 3.31.5 .97 2.91.0 2.20.9 .10
Ankle circumference (in mm)a
Index leg 23.52.1 231.9 .44 22.91.8 22.71.2 .69
Contralateral leg 23.21.9 231.3 .72 22.71.7 22.61.1 .97
Pain/aching of the index leg was the primary efficacy outcome measure, while pain/aching of the contralateral leg, the remaining
symptoms, their number and sum, rVCSS(-S) and ankle circumference were all secondary outcome measures. Pruritus was also
included as a safety measure. Results are presented as mean  SD. Significant p values appear in bold.
a
Missing values at F/U in one and three patients of the placebo and active stockings group, respectively. Bonferroni correction is applied
for the secondary outcome measures.

Non-significant reductions of the remaining symptoms of compression stockings are effective as the sole and initial
the index leg or those on the contralateral side that could treatment of varicose veins.”4 The present RCT has for the
be the result of lack of statistical power, thus requiring a first time provided the trial evidence that is required.
larger patient sample, were determined in this study by the The very short duration of this RCT perhaps accounts for
prerequisite symptom of pain or aching. Likewise, rVCSS(-S) the very good patient compliance in using their GECS.
and ankle circumference were similar between the two Compliance could become suboptimal over a greater length
study groups. of time with GECS use only when symptoms are more
Existing studies investigating the effect of GECS in pa- intense. This could lead some patients to have surgery,
tients with CVD have been graded as having low quality,5,20 which has been shown to have a greater effect on patient
while a Cochrane review concluded that “there is insuffi- symptoms than GECS.21 The better, although not signifi-
cient, high quality evidence to determine whether or not cantly different compliance with active stockings compared
Please cite this article in press as: Kakkos SK, et al., Acute Effects of Graduated Elastic Compression Stockings in Patients with Symptomatic Varicose Veins:
A Randomised Double Blind Placebo Controlled Trial, European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/
j.ejvs.2017.10.004
6 Stavros K. Kakkos et al.

(A) Baseline
10
After one week

VAS score for pain/aching (mean and 95% CI)

8

Placebo stockings Active stockings

Study group
(B) Baseline
VAS score for swelling sensation (mean and 95% CI)

8
After one week

Placebo stockings Active stockings

Study group
Baseline
6 (C) After one week
VAS score for paresthesia (mean and 95% CI)

Placebo stockings Active stockings

Study group
Figure 2. At the completion of the study after 1 week, active Class 1 GECS, were more effective than placebo stockings in reducing pain or
aching (A), while a non-significant trend was observed for the feeling of swelling (B) and paraesthesiae (C). Results are presented as mean
and 95% CI.

Please cite this article in press as: Kakkos SK, et al., Acute Effects of Graduated Elastic Compression Stockings in Patients with Symptomatic Varicose Veins:
A Randomised Double Blind Placebo Controlled Trial, European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/
j.ejvs.2017.10.004
Acute Effects of Graduated Elastic Compression 7

Baseline
6
After one week

No of venous symptoms (mean and 95% CI)

5

Placebo stocking Active stocking

Study group
Figure 3. At the completion of the study after 1 week, active Class 1 GECS were more effective than placebo stockings in reducing the
number of symptoms other than pain or aching, although the difference was not statistically significant. Results are presented as mean and
95% CI.

with placebo stockings could be a result of the improved CONFLICT OF INTEREST

effectiveness of the former group.
The trial has a few limitations. Although sufficient, the
study had a small size, and was underpowered for most
other symptoms of the index and contralateral leg limiting
generalisability in a disease with many different pre-
sentations. Additionally there were relatively few patients
with CEAP C3-4 CVD to perform a subgroup analysis, so that
further testing may be required, to include patients with
CEAP C5-C6 CVD. It also requires confirmation by a second
RCT to decrease the imprecision resulting from the small
absolute number of patients with a positive response
(counteracted though by the large treatment effect). Also,
some of the positive aspects of the secondary findings may
have been the result of multiple testing, despite a priori
determination of the outcome measures. That only patients
who had not used GECS in the past were included may be
viewed as a limiting factor for generalisability; however,
there is no reason to believe that GECS do not work equally
well in patients who have used them before. Additionally
the short duration of the RCT, as discussed above, may be
regarded as another limitation, although this time period
was chosen to prevent potential bias caused by suboptimal
compliance in the long term in the active stocking group.
Compliance in such a long-term trial could be assessed with
a Thermotrack device sewn inside the GECS.22
In conclusion, among patients with varicose veins, GECS
seem effective in ameliorating symptoms, particularly pain
or aching compared with placebo stockings after 1 week of
use, based on trial evidence. Long-term studies are justified.
Please cite this article in press as: Kakkos SK, et al., Acute Effects of Graduated Elastic Compression Stockings in Patients with Symptomatic Varicose Veins:
A Randomised Double Blind Placebo Controlled Trial, European Journal of Vascular and Endovascular Surgery (2017), https://doi.org/10.1016/
j.ejvs.2017.10.004
None.
FUNDING
The study was partially funded by VICAN e N. Anagnostakis
S.A., Athens, Greece. The funder provided the two types of
stockings used in the trial with no other involvement.
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