Treatment by medical compression stockings among 144

Journal des Maladies Vasculaires (2014) 39, 389—393
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ORIGINAL ARTICLE
Treatment by medical compression
stockings among 144 consecutive patients
with non-complicated primary varicose
veins: Results on compliance
Étude observationnelle sur l’observance au traitement par
bas médicaux de compression chez 144 patients consécutifs
souffrant de varices primitives non compliquées
D. Rastel
Selurl Philangio, 30, place Louis-Jouvet, 38100 Grenoble, France
Received 24 March 2014; accepted 10 September 2014
Available online 23 October 2014
KEYWORDS
Compression
stockings;
Varicose veins
MOTS CLÉS
Bas de compression ;
Varices
Summary Compression stockings are the major long-term treatment of non-complicated primary varicose veins recommended by international consensus. Nevertheless there are few data
concerning the patient compliance to treatment. Hundred and forty-four patients with varicose
veins of primary origin were prospectively recruited and questioned about their compression
therapy: 29.2% patients are wearing compression stockings, and for 10.4% on a daily basis;
32.6% do not wear their compression mainly because it is not well tolerated; 38.2% do not have
compression treatment because it is not recommended or not prescribed by the physician.
© 2014 Elsevier Masson SAS. All rights reserved.
Résumé
Objectif. — Le traitement par compression est l’une des premières recommandations thérapeutiques dans la prise en charge au long cours de l’insuffisance veineuse superficielle non
compliquée mais il est peu évalué, notamment en ce qui concerne l’adhésion au traitement ce
qui sera l’objectif de cette étude.
Patients et méthode. — Il s’agit d’un travail d’analyse des motifs d’adhésion ou de non-adhésion
au traitement d’une population monocentrique de 144 patients consécutifs atteints de varices
primitives non compliquées.
E-mail address: [email protected]
http://dx.doi.org/10.1016/j.jmv.2014.09.001
0398-0499/© 2014 Elsevier Masson SAS. All rights reserved.
390
D. Rastel
Résultats. — On constate que 29,2 % des patients portent une compression dont 10,4 % au quotidien ; 32,6 % ne portent plus de compression, principalement en raison d’intolérances ; 38,2 %
n’ont jamais porté de compression, principalement parce qu’elle n’a pas été recommandée par
le médecin ou non prescrite.
Conclusion. — Le taux d’adhésion au traitement par compression par bas chez les patients
variqueux non compliqués est faible. Les résultats confortent l’hypothèse avancée par d’autres
auteurs d’un manque d’argument solide pour un port de longue durée et d’un manque de temps
d’explication.
Introduction
Compression therapy by stockings improves the hemodynamic of various venous disorders of lower limbs due to
transient or chronic venous hypertension [1]. The effect
is based on a pressure applied to the skin in order to
increase the tissues pressure aiming to improve the transmural pressure equilibrium [2]. Generally medical compression
stockings (MCS) are difficult to apply and remove, generating frequent but non-severe side effects, thus the treatment
compliance is low if the patient is not properly educated
and trained [3—5]. These difficulties (lack of time for education and training) could explain why the physician prescribes
lower pressure instead of recommended pressure in pathologies that would require high pressures [6]. When venous
disorders are limited to non-complicated varicose veins,
symptomatic or not, according to the French recommendations, MCS with a 15 mmHg to 36 mmHg at the ankle
are recommended (based on a physician consensus) for a
lifetime [7]. The expected objectives are to improve the
quality of life of symptomatic patients, to reduce the risk of
hemorrage in light venous dilations, to prevent from venous
edemas and probably to prevent skin complications such
as venous ulcers [8]. Since very few data are available on
the use of MCS among patients with varicose veins, it was
interesting to investigate this use even in a small group of
interviewed outpatients in one phlebological consultation
center.
Patients and method
This was an observational study. Patients were included
prospectively at the medical consultation from January to
April 2012. All the patients had a venous check involving an ultra-sound examination (a pathological reflux was
recorded if superior to 500 ms for superficial veins and superior to 1000 ms for deep veins). The selected population
only involved those suffering from varicose veins of primary origin (varicose vein = diameter more than 3 mm; C2
of the CEAP classification) [9]. Patients suffering from more
complex superficial disorders (healing or healed ulcers,
lipodermatosclerosis. . .) or involving deep venous disorders or with periperal arterial or neurologic disease were
excluded. Patients who had undergone a surgery within the
last 2 months before the inclusion day were also excluded.
Patients with only symptoms or telangiectasias or reticular vein dilations with or whithout symptoms were neither
included. Patients with varicose veins and feelings of edema
or clinically evident edema were included. Edema was
defined either as a pitting edema clinically stated or based
on an ultra-sound examination result. In that latter case
patients had edema if at least one hypo-echogenic subcutis layer with anterior-posterior dimensions of more than
1 mm was seen at the ankle. Symptoms were recorded and
attributed to a venous origin when at least three out of
four criteria were present in the four-criteria score for CVD
defined in a previous work [10] (the presence of three criteria has a specificity of 0.96 and a sensitivity of 0.75).
Patients who have had a first prescription of MCS in a 6month period before the inclusion day were also excluded
(so only mild and long-term compliance to MCS therapy
was expected to be observed) and patients using or having
used bandages were included only if bandages were used as
an emergency treatment (such as transient acute edema,
popliteal fossa cyst rupture. . .) and not instead of a MCS
already previously prescribed.
The data were acquired by the investigator during a faceto-face interview at the beginning of the consultation. The
questions could be repeated during the medical consultation if the investigator judged that the answer was not
precise enough. The investigator was considered as a vascular physician having competency in compression therapy
(education and training). Patients were asked if they were
wearing compression therapy, at what frequency of use and
the reason of non-compliance. In the absence of standard or
consensus about the compression stockings patient compliance stratification, it was decided, according to a daily
clinical experience on compression therapy, to classify them
as follows: daily wearing patients are patients wearing
their compression stockings more than 300 days per year
and 8 hours a day; seasonal wearers are patients wearing
between 200 to 300 days a year and 8 hours a day; occasional wearers are patients wearing less than 200 days per
year or between 200 to 300 days a year but less than 8 hours
a day. They are stated as non-wearers if they have worn their
compression stockings less than 4 days from the prescription
or delivery date or not at all (Table 1). When necessary, comparison of two groups were made using a Student t-test for
numerical data and Chi2 test.
Results
Hundred and forty-four patients with varicose veins were
recruited. The mean age was 54.4 ± 16.1 years (range
between 17 to 89 years). Hundred and twenty-four patients
(85.5%) were female. Hundred and nine patients (75.6%)
were C1 , 2 EP AsPr according to basic CEAP and 35 patients
(24.1%) had bilateral edema: 26 were C2 , 3 EP AsPr and 9 were
C2 , 3 , 4a EP AsPr. No unilateral edema was observed and no
patients were only C2 EP AsPr. Four patients had a superficial thrombosis more than 2 years ago. Ninety-eight patients
(67.8%) had symptoms of venous origin. Eighty patients
Treatment by medical compression stockings among 144 consecutive patients
391
Table 1 Ranking of patient according to the wearing time of medical compression stockings.
Classification des patients en fonction de la durée de port des bas médicaux de compression.
Classification
Content
Comments
Wearing
Daily wearing
> 300 days per year; 8 hours a day
Allowed to stop wearing sometime but no more
than 2 consecutive days
Means that they are not wearing in ‘‘hot
period’’ like in summer
Means they are wearing for travelling (short or
long flight, train, bus, car), in case of transient
lower leg pain, edema, following venous
procedures like surgery
Seasonal wearing
200 to 300 days a year; 8 hours a day
Occasional wearing
< 200 days per year or between 200 to 300 days a year
but less than 8 hours a day
No wearing
Stop
Never
< 4 days from the prescription or delivery date
(55.2%) had both legs affected by the varicosis. Hemodynamically, out of 225 legs with venous incompetency, 80
(35.6%) had a great saphenous vein incompetency (with or
without incompetent tributaries), 18 (8%) had a short saphenous vein incompetency and 127 (56.4%) refluxes limited
to thigh or leg tributaries. Mean ankle diameter was of
22.5 ± 2.5 cm and mean calf diameter was of 38.2 ± 3.8 cm.
No significant difference was seen between left and right
ankle and left and right calf diameters (P > 0.05). Eighty-nine
patients (61.8%) bought and wore at least once the medical
compression stockings. Among MCS, 4 were panties, 16 thigh
length stockings and 79 calf stockings (88.8%). Class 1 (10 to
15 mmHg at the ankle) represented 6 prescriptions, Class 2
(> 15 to 20 mmHg) 74 prescriptions (83.1%) and Class 3 (> 20
to 35 mmHg) 3 prescriptions and unknown for 6 patients.
All patients, except for one, were wearing their compression on both lower limbs even if only one limb was affected
by varicose veins. Forty-two patients (29.2%) were wearing
their stockings: 15 patients (10.4%) reported daily wearing and 27 patients (18.7%) seasonal or occasional wearing.
Hundred and two patients (70.8%) were classified as ‘‘no
wearing’’. Among the last group, 55 patients (38.2%) never
used the stockings (not prescribed nor bought) and 47
patients (32.6%) abandoned the stockings after one day or a
short period of wearing (Table 2). The three main reasons of
Table 2 Patient compliance to MCS treatment in noncomplicated primary varicose veins.
Observance au traitement par bas médicaux de compression des patients souffrant de varices primitives non
compliquées.
n = 144
Wearing, 42 (29.2%)
Daily wearing
Seasonal wearing
Occasional wearing
No wearing, 102 (70.8%)
Stop
Never
15 (10.4%)
17 (11.8%)
10 (7%)
47 (32.6%)
55 (38.2%)
MCS were prescribed and bought
MCS not prescribed or not bought
‘‘no wearing’’ MCS when varicose veins are present are ‘‘no
reasons’’ or ‘‘not prescribed’’ (51.2%), not well tolerated
(28.4%) and ineffective or aggravating symptoms (7.8%) and
many other reasons to stop wearing compression are listed
(Tables 3 and 4). Among them the difficulties of putting on
MCS represent the cause of stopping MCS treatment in only
6.4% of patients. Within the group who experienced a bad
feeling of striction half of the patients did not position their
calf correctly while putting on the stockings: the band was
positioned higher than recommended. There was no difference in no wearing between age groups: 29/41 (70.7%) for
< 65 yo and 73/103 (70.8%) for ≥ 65 yo (P > 0.05).
Discussion
70.8% of patients with varicose veins do not wear, even
occasionally, compression therapy and 10.4% wear the
compression therapy on a daily basis. Hence, it is clear that
compliance to treatment is low as already mentioned: 29.2%
of wearing in this population, 37% and 25.6% in Raju and
Polish surveys respectively, 30% in the Bonn study [4,5,11].
The diminution of the compliance probably occurs early:
25% loss in the Brazilian survey at 4 weeks [12]. These figures, of course, cannot be explained in France by ineffective
MCS or with very variable pressures since MCS are all controlled before commercialization. MCS are submitted before
being commercialized to independant certification in France
whereas it is not the case in the USA. MCS have to fulfill
specifications mainly represented by a normalized pressure
measurement (Norme AFNOR G 30 102 B) which is a first step
that guaranties the patient to receive the correct ‘‘pressure
dosage’’ (although bio-availability of pressure is not limited
to this pressure).
In deep venous thrombosis, 62.5% of French vascular
physicians prescribe lower pressure than recommended
pressure [6]. The main explanation provided by the prescriber is not having enough time to explain the rationale
and how to use the stockings. This is a surprising reason
since pharmacists are more and more involved in France in
patient education, and could enhance the prescriber’s mission. A lower pressure could be a cause of non-compliance
392
D. Rastel
Table 3 Patients reasons for non-adherence to medical compression stockings therapy in non-complicated primary varicose
veins when patients stopped wearing compression.
Motifs de non-adhésion au traitement par bas médicaux de compression des patients souffrant de varices primitives non
compliquées.
Patients who stopped wearing compression
n = 47
Not well tolerated
Feeling of striction
Pruritus
Cooling or burning sensation
Effective on symptoms but discomfort
General feeling of discomfort
Ineffective
Not convinced over long term
Unable to state a specific reason
Difficulties for putting on or off
Aggravating the symptoms
29 (61.2%)
7
3
2
3
14
6 (12.7%)
4 (8.5%)
4 (8.5%)
3 (6.4%)
2 (4.3%)
20/29 patients had symptoms
5 patients had their stockings not correctly positioned at the band
2 pruritus after putting off the stockings
At the foot level only
Including slipping down (n = 2)
5/6 patients had symptoms
1 patient had a bad remembering
to treatment (patient do not feel enough pressure, no quick
relief of symptoms. . .).
In fact, it is not the case for varicose veins since more
than 80% of prescriptions are of class 2 (15—20 mmHg at the
ankle) which is the range of pressure that is in the middle of the HAS recommendations [7] but lower than the
international consensus [13]. So and conversely the other
hypothesis of poor adherence in the Bonn study was a too
high level of pressure of MCS [11]. However, it is not supported by our results.
Unfortunately in other surveys we do not have precise
data on which range of pressure is prescribed and used by the
patients with varicose veins. Consequently it becomes hard
to analyse or compare the results. Moreover, several other
factors prevent from doing a comparative work: the different standards for fabric and pressure measurement, the
cost and repayment/insurance policies and the absence of
clear definition of the different levels of patient compliance
(mainly the unclear or different definitions of ‘‘daily users’’
and ‘‘occasional users’’). In these big surveys, increasing the
number of centers including patients probably also increases
the risk of having different patients reported claims and the
meaning of an item (e.g. sweating) could be different from
one center to another, from physicians to physicians. Nevertheless, once this important point has been highlighted
Table 4 Patients reasons for not having worn medical
compression stockings in non-complicated primary varicose
veins.
Motifs de non-port d’une compression médicale par bas
chez les patients souffrant de varices primitives non
compliquées.
Patients who never wore a stocking
Not recommended or not prescribed by doctor
Unable to state a specific reason
Refused/Bad opinion about compression
Never heard of compression therapy
n = 55
39
10
5
1
(70.9%)
(18.1%)
(9%)
(1,8%)
and knowing that there are no other consistent results, the
hereafter comparisons need to be considered with caution.
Surprisingly, even following an insisting interview, 8.5%
of patients who stop wearing MCS and 18.1% of patients
who have never worn MCS in this trial were unable to state
any specific reason. It was up to 30% of patients in Raju’s
survey, which is very high. Conversely all patients in the
Polish survey informed the physician about their reluctancies to wear stockings. It could be explained by the fact
that the cost of MCS is a prominent cause of non-wearing
stockings in Poland and not in the two other studies and
also because 46.6% of patients in the Polish survey never
had any MCS prescriptions (38.2% and 25% in this trial and
Raju’s data respectively). Neither aesthetic nor the cost of
MCS are a main cause in our figures. The medical textile
industry commercializes nowadays, at least in France, MCS
with a good level of cosmetic stockings hence only a few
patients are requesting more aesthetic medical hosieries:
2% to 15.3% [4,5,11,12]. It remains that in all studies side
effects of MCS are an important item in compression therapy: 18.4 to 44.3% [4,5,11,12]. Even if items rank differently
from study to study, they cover more or less similar complaints: pruritus, striction, hot legs. However, contrary to
other results, sweating was never mentioned as a side effect
of compression therapy. The main expected effects of MCS
at the stage of non-complicated primary varicose veins are
the decrease of symptoms and the prevention of progression
of the disease.
Reduction of symptoms is well documented. Nevertheless, decrease of symptoms does not mean a good
compliance to the treatment since 12.5% of patients who
do not tolerate MCS have their symptoms improved by
the stockings although they have stopped the treatment.
For 27.1% of patients, a prescription of MCS was not recommended by physicians or MCS were not prescribed.
Compression therapy is highly recommended in advanced
stages of venous disorders due to venous hypertension. The
effect of MCS in prevention of non-complicated primary
varicose veins remains to be demonstrated [7]. Although
reporting on an other indication (ulcer), a recent work highlighted that insufficient knowledge about the benefit of
Treatment by medical compression stockings among 144 consecutive patients
compression by the patient would be the major reason of
non-adherence [14].
Hence the physician himself is probably not convinced
about the effect of MCS on that disorder and does not prescribe or is not able to convince the patient to wear MCS over
a long-term period. Patients who are prescribed compression
therapy should be aware, like for drugs, by their physician,
of the rationale of the effects and the possible side effects of
the treatment. Unlike for drugs the compression therapy by
stockings needs to be tested before use. The wearing test
offers a better compliance to treatment and similarly the
number of given pairs at the beginning of treatment is also
a strong factor of compliance highlighted in France [15].
Conclusion
Compliance to MCS in patients suffering from primary noncomplicated varicose veins is low. Evaluating the level of
compliance is at present time only based on the patient
reported outcomes. There is a crucial need in a validated
score to measure the patient compliance to compression
therapy usable in both situations: clinical studies and daily
practice. This survey is also providing a compliance stratification that seems closer to the patient’s life. Finally it could
also be discussed that for therapy by MCS ‘‘adherence’’
(defined as Yes or No wearing, how is wearing, and why
no wearing) would be a more appropriate term than
‘‘compliance’’.
Disclosure of interest
The author declares that he has no conflicts of interest concerning this article.
Acknowledgements
Dr Lun and Mrs Jodie-Léon for the correction of the text.
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