Sclerotherapy

Patients and methods

Foam polidocanol sclerotherapy versus liquid

polidocanol sclerotherapy in management of varicose

veins in lower limbs

AbstractBackground: Varicose veins treatment with liquid sclerosing drugs has been performed for almost 100 years.

The first foam sclerosant were described 60 years ago (Goldman et al, 2002). On contact of the sclerosant with the

vein endothelium, the treated veins will be transformed into fibrous cords that cannot recanalize with a functional

result corresponds to the surgical removal of varicose veins (Malouf, 2000).

Patients and methods: One hundred patients complaining of varicose vein lower limbs less than 4mm in

diameter with competent sapheno-femoral and sapheno-popliteal junctions undergone sclerotherapy; 50 patients

were injected by liquid polidocanol And 50 patients were injected by foam polidocanol in the outpatient Clinic of

Suez Canal University Hospital at Ismailia-Egypt. We followed our patients for 6 months in which they were

evaluated for disappearance of varicose veins, side effects and satisfaction with chosen regimen.

Results: Most of the studied patients in both groups were females (56% in foamy POL group and 64% in liquid

POL group). Most of the studied patients were in age group ranging from 30 – 50 years (76% in foamy POL group

and 80% in liquid POL group). Both groups were matched as regarding age and sex. After 4 weeks of

sclerotherapy, total disappearance was more evident among patients treated with the foamy form of POL (84%

versus 52% in liquid POL group). Resolution and fading in pigmentation was significant in both groups, however

it was significantly better with the use of foam group. Post-sclerosis pain was significantly more with the use of

Liquid form of POL with median visual analogue scale 3 versus 1 with the use of Foamy form of POL. There was

no statistically significant difference between both groups regarding the incidence of different side effects.

Discussion and conclusion: Improvement occurred with the use of foamy form of POL was significantly better

than what was recorded with the use of liquid form of POL.

Key words: Foam POL, Liquid POL, Sclerotherapy.

Introduction

Varicose veins treatment with liquid sclerosing drugs has been performed

for almost 100 years. The first foam sclerosant was described 60 years

ago, and was demonstrated that it is hard to tell who has really invented

the technique. However, it remains obvious that two authors –Cabrera in

Spain and Monfreux in France- have boosted its use in the past 10 years

(Goldman et al., 2002).

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The aim of sclerotherapy is the elimination of intracutaneous,

subcutaneous, and/or transfascial varicose veins (perforating veins). The

contact of the sclerosant with the endothelium leads to changes in the

venous wall. In the long term, successfully treated veins will be

transformed into fibrous cords that cannot recanalize. The functional

result corresponds to the surgical removal of varicose veins (Malouf,

2000).

The first advantage of foam is that it does not mix much with blood,

and, therefore, mechanisms of dilution do not happen. Foam sclerosant

also offer the advantage of being an excellent contrast medium for B-

mode echography since ultrasounds are scattered by the multiple

air/liquid interfaces and foam is recognized by its white cloud aspect and

dark shade cone (Guex, 2005).

Many different types of foams have been used and presented, using

different sclerosing agents. The approved technique is a double-syringe

system technique which has been manufactured and standardized but is

still undergoing complete evaluation. The method of this technique is to

mix gas and liquid through either a three-way stopcock or double-syringe

system technique (Guex, 2005).

The ideal sclerosing solution should be painless to inject, free of

adverse effects, and specific for damaged (varicose) veins. The two most

widely used sclerosing solutions worldwide are sodium tetradecyl sulfate

(STS) and polidocanol (POL). These sclerosing agents have a well-

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documented history of safety and efficacy spanning 40 to 50 years (Breu

et al., 2004).


The study is a clinical comparative study between foam polidocanol

sclerotherapy versus liquid polidocanol sclerotherapy in management of

varicose veins in lower limbs.

It included one hundred patients undergone sclerotherpy; 50 patients were

injected by liquid polidocanol And 50 patients were injected by foam

polidocanol in the outpatient Clinic of Suez Canal University Hospital in

Ismailia-Egypt. We followed our patients for 6 months, in the first 2

months at two weeks interval and after that every month.

In our study, we included:

1. Patient with Varicose veins who were proved by duplex ultrasound to have varicose veins with competent sapheno-femoral and sapheno-popliteal junction.

2. Varicose veins that less than 4 mm in diameter.3. Both sexes4. Age range from 18 to 60 years.

We assessed our patients before the procedure by: Full history taking,

thorough clinical examination, duplex Ultrasound and pelvi-abdominal

ultrasound.

Data collection

A total of 100 patients were enrolled in the study and were randomly allocated to one of two groups: Foamy POL group and liquid POL group. Sample size was taken as all patients with varicose veins in any age, both sexes, varicose vein diameter less than 4 mm without

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incompetence in the sapheno-femoral and sapheno-popliteal junctions in a leg with healthy skin including the sites of injection without any contraindication for sclerotherapy. Fifty Patients were injected in the outpatient clinic by liquid polidocanol sclerotherapy 0.5% and 1% concentration and the other group (50 patients) was injected by foam polidocanol sclerotherapy 0.5% and 1% concentration. The optimal concentration was determined

according to the diameter of vein .

Data management

Gathered data were processed using SPSS version 15 (SPSS Inc.,

Chicago, IL, USA). Quantitative data were expressed as means ± SD

while qualitative data were expressed as numbers and percentages (%).

Chi Square and Fisher's exact tests were used to test significance of

difference for qualitative variables. A probability value (p-value) < 0.05

was considered statistically significant.

Method of injection and preparation of Sclerotherapy :

1. Selection of the concentration and formulation (liquid or Foam) of

Sclerosing agent was based on protocol outlined and presented in

Table (1). The vein diameter was measured by duplex ultrasound,

while the patient is standing. If foam was necessary, it is

formulated from 1 ml of sclerosing solution and 4ml of air mixed

at ratio of 1:4, using The Tessari method which uses a three-way

stopcock and two 5 ml syringe to mix sclerosant. Appropriate post

procedure care was being conducted, and patients will be asked to

keep a record of any adverse events resulting from treatment.

Sclerotherapy will be performed by standard technique on only one leg in

single treatment session. The dose of sclerotherapy is 2ml in each session.

All patients will require elastic stocking compress to the treated leg for 7

days following treatment, and ask the patient to walk directly after

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injection. After having first leg treated, subjects returned 1week later for

treatment of contra lateral leg. Patient`s will be seen every 2 weeks

thereafter for follow-up.

Digital photographs were taken prior to treatment and at 4 weeks post-

treatment.

Table (1) Concentrations of polidocanol according to the diameter of

varicose vein and quantities used per injection

___________________________________________________________

Diameter Liquid Foam

___________________________________________________________

1-2mm 1% 0.5%

2.1-3mm 1.25% 0.65%

3.1-4mm 1.5% 0.75%

4.1-5mm 2% 1%

5.1-6mm 2.5% 1.25%

Volume per injection 0.5 ml 2 ml

Quantity (Polidocanol) per injection 0.5 ml 0.5 ml

___________________________________________________________

(Hamel-Desnos et al., 2003).

Ethical consideration

Written consents will be obtained from all patients before getting

them involved in this study.

The steps of the study; the aims , the potential benefits will be

discussed with each individual patient ,

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Patient will be informed about any abnormal results of procedure

and tests performed and will be instructed and treated accordingly.

The patient has the right for withdrawal from the study at any time

with neither jeopardizing the right of the patient to be treated nor

affecting the relationship between the patient and the care provider.

Results

The aim of the present study was to assess the efficacy of polidocanol

(POL) in the foamy and liquid form in sclerotherapy of varicose veins of

the lower limb. A total of 100 patients with varicose veins were enrolled

in the study and were then randomly allocated to one of two treatment

groups; foam POL group (n= 50) and liquid POL group (n = 50). The

patients were evaluated for disappearance of varicose veins, side effects

and satisfaction with each of liquid and foamy form.

Table 1: - Patient characteristics among both groups of the study: -

Foamy POL(n=50)

Liquid POL(n=50)

Total(n=100)

p-value

Age (years)

20 – 8 (16%) 6 (12%) 14 (14%)

0.7 (NS)30 – 22 (44%) 18 (36%) 40 (40%)

40 – 16(32%) 20(40%) 36 (36%)

50 – 55 4 (8%) 6 (12%) 10 (10%)

SexMale 22 (44%) 18 (36%) 40 (40%)

0.8 (NS)Female 28 (56%) 32 (64%) 60 (60%)

NS: no statistically significant difference (p-value > 0.05).

Table (1): Shows that both groups were matched as regarding age and

sex. Most of the studied patients in both groups were females (56% in the

foamy POL group and 64% in the liquid POL group). Most of the studied

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44%

36%

66% 64%

0%

10%

20%

30%

40%

50%

60%

70%

% o

f p

atie

nts

Male Female

Foamy POL Liquid POL

16%

12%

44%

36%

32%

40%

8%

12%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

% o

f p

atie

nts

20 – 30 – 40 – 50 – 55



patients were in age group ranging from 30 – 50 years (76% in foamy

POL group and 80% in liquid POL group).

Graph 1: - Age distribution among both groups of the study: -

Graph 2: - Sex distribution among both groups of the study: -

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16%

48%

84%

52%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

% o

f p

atie

nts

Partial disappearance Total disappearance



Table 2: - Disappearance of varicose veins in both groups of the study: -

DisappearanceFoamy POL

(n=50)Liquid POL

(n=50)Total

(n=100)p-value

Partial disappearance 8 (16%) 24 (48%) 32 (32%)0.03*

Total disappearance 42 (84%) 26 (52%) 68 (68%)

*Statistically significant difference

Table (2): Shows that there was statistically significant difference

between both groups as regarding degree of disappearance of varicose

veins after 4 weeks of sclerotherapy. Total disappearance was more

evident among patients treated with the foamy form of POL (84% versus

52% in liquid POL group).

Graph 3: - Disappearance in both groups of the study: -

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Table 3: - Percentage of pigmentation pre and post-sclerosis in both groups of the study: -

% of pigmentationFoamy POL

(n=50)Liquid POL

(n=50)p-value

Pre-sclerosis 75% 78% 0.6 (NS)

Post-sclerosis 14% 47% 0.001*

p-value 0.001* 0.01*

*Statistically significant difference (p-value < 0.05)NS: no statistically significant difference

Table (3): illustrates the change in the percentage of pigmentation

after 4 weeks of sclerotic therapy in both groups. Improvement in the

percentage of pigmentation was significant in both groups, however the

improvement occurred with the use of foamy form of POL was

significantly better than what was recorded with the use of liquid form of

POL.

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Table 4: - Degree of post-sclerosis pain and use of analgesia: -

Post-sclerosis painFoamy POL

(n=50)Liquid POL

(n=50)Total

(n=100)p-value

VAS

No pain 24 (48%) 12(24%) 36 (36%)

0.03*Mild 26 (52%) 28 (56%) 54(54%)

Moderate 0 (0%) 10 (20%) 10(10%)

median (range) 2(0 - 2) 6 (0 – 4) 4 (0 – 4)

Use of analgesia 4 (8%) 8(16%) 12 (12%) 0.7 (NS)

*Statistically significant difference (p-value < 0.05)NS: no statistically significant difference

Table (4): Shows that post-sclerosis pain was significantly more with

the use of Liquid form of POL with median visual analogue scale 3

versus 1 with the use of Foamy form of POL. Use of post-sclerosis

analgesia was higher in Liquid POL group but with no statistically

significant difference.

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Table 5: - Side effects distribution among both groups of the study: -

Side effectsFoamy POL

(n=50)Liquid POL

(n=50)Total

(n=100)p-value

Ecchymosis 21 (42%) 19 (38%) 40 (40%) 0.8 (NS)

Hyper pigmentation 10 (20%) 6 (12%) 16 (16%) 0.7 (NS)

Itching 10 (20%) 8 (16%) 18 (18%) 0.9 (NS)

Telangiectatic matting 4 (8%) 2 (4%) 6 (6%) 0.9 (NS)

Marked swelling 6 (12%) 2(4%) 8 (8%) 0.6 (NS)

Superficial thrombophlebitis

0 (0%) 0 (0%) 0 (0%) 1 (NS)

DVT 0 (0%) 0 (0%) 0 (0%) 1 (NS)

Pulmonary embolism 0 (0%) 0 (0%) 0 (0%) 1 (NS)

Stroke 0 (0%) 0 (0%) 0 (0%) 1 (NS)

Skin necrosis 0 (0%) 0 (0%) 0 (0%) 1 (NS)

Allergic Reaction 0 (0%) 0 (0%) 0 (0%) 1 (NS)

NS: no statistically significant difference

Table (5): Shows the reported side effects among patients in both

groups of the study. Ecchymosis was estimated to be the most common

reported side effect in patients of both groups (42% in foamy POL group

and 38% in liquid POL group). These minor side effects were estimated

to be more common among patients treated with foam POL form but with

no statistically significant difference. Other reported side effects were

hyper pigmentation, Itching, telangiectatic matting and marked swelling.

There was no statistically significant difference between both groups

regarding the incidence of different side effects.

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Graph 4: - Side effects distribution among both groups of the study: -

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92%

80%

8%

20%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

% o

f p

atie

nts

Satisfied Unsatisfied



Table 6: - Patients' satisfaction among both groups of the study: -

Foamy POL(n50)

Liquid POL(n=50)

Total(n=100)

p-value

Satisfied 46 (92%) 43 (86%) 89 (89%)

0.5 (NS)Unsatisfied 4 (8%) 7 (14%) 11 (11%)

Total 50 50 100(100%)

NS: no statistically significant difference

As regarding, the patient satisfaction with the form used in the

treatment, there was no significant difference between both groups. Only

11 patients were unsatisfied by the treatment; four patients in the foam

group and 7 in the liquid groups.

Graph 5: - Patients' satisfaction among both groups of the study: -

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Discussion

The present study was aiming to assess the efficacy of polidocanol

(POL) in the foamy form and the liquid form in sclerotherapy of varicose

veins of the lower limb. A total of 50 patients with varicose veins were

enrolled in the study and were then randomly allocated to one of two

treatment groups; foam POL group (n= 25) and liquid POL group (n =

25). The patients were evaluated for clearance of varicose veins, side

effects and satisfaction with each of liquid and foamy form.

Polidocanol was reported by Goldman et al., (1987), Sadick (1994),

Weiss (1994) and Noel (2004) as an effective safe sclerosing solution

with distinct advantages of being forgiving with extravasation and having

extremely low risk of allergic reaction. The incidence of post sclerosis

pigmentation and telangiectatic matting in different sclerosing solutions

including polidocanol with different concentration was conducted in a

study done by Weiss and Weiss (1990). They stated that these

complications were related to both vessel size and to sclerosing

concentration.

Polidocanol at concentrations of 0.25%, 0.5% and 1% was injected in

the dorsal rabbit ear model by Goldman et al., (1987). They reported that

POL at concentration of 0.5% and 1% produced histologic and clinical

vein disappearance, whereas POL at 0.25% concentration didn't produce

clinical vein resolution. In addition, they noted recanalization at the low

concentration of 0.25%. In the present study we used both 0.5% and 1%

concentrations

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Numerous studies were performed to compare the effect of different

sclerosing agents in the management of telangiectasia and reticular veins.

They used polidocanol in different concentration in their comparison. In

1987 Carlin and Ratz used polidocanol 0.25% in liquid form on 20

patients. The patients were injected every 4 weeks until all vessels had

disappeared or for a maximum of six visits. They reported that 13 patients

had good to excellent disappearance of veins and two had poor results.

They stated that the level of overall improvement was good. However,

they believed that the concentration of polidocanol that they used may

have been too low, resulting in slower disappearance of the vessels.

Another study used polidocanol 0.25% was presented by Kern et al.,

(2004). They used POL in both forms either as liquid or foam. A single

sclerosing session was performed in each patient. They proved that

polidocanol concentration of 0.25% had a lower efficacy in clearing the

telangiectatic and reticular veins in either forms.

Polidocanol at a concentration of 0.5% was used by Sadick (1994) to

treat reticular veins of 2 – 3 mm in diameter in 20 patients. A single

sclerosing session was performed in each patient. He stated that

polidocanol at this concentration was successful in the treatment of

reticular vessels. In 2005, another study was presented by Rao et al.,

using polidocanol in both forms, foamed and liquid. Their study was

carried on twenty patients. They emphasized that POL in both forms was

found to be effective in causing the disappearance of veins in all size

categories. Ecchymosis and reversible hyperpigmentation being the most

common adverse events occurred. Of note, no skin necrosis, no

recanalization was observed in any patient treated either form. All

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subjects tolerated POL very well and were pleased with their treatments.

Their study confirms that POL, in both liquid and foamy forms have

similar efficacy, tolerability and patient satisfaction.

The results of this study show that for the same concentration of

polidocanol, the efficacy of sclerotherapy with foam is greater than with

liquid, although risks of minor adverse effects such as pain,

inflammation, and skin pigmentation are also more frequent. Other

authors have published similar results when using duplex-guided

sclerotherapy (Hamel-Desnos et al., 2003; Yamaki et al., 2004).

The specific characteristics of foam sclerosants may explain their

greater capacity and irritant nature. Foam sclerosants are compact

solutions that displace the blood column rather than dissolving in the

circulating blood. Foam adheres better to the walls of the vein, a feature

that, together with the capacity to provoke spasm, allows greater contact

with the endothelium, conferring greater efficacy at lower concentrations

and lower total quantity of sclerosant (Frullini et al., 2002).

The durability of the foam sclerosant combined with a greater capacity

to penetrate collaterals results in sclerosis over a larger region. The foam

is highly echogenic which facilitates ultrasound guided sclerotherapy,

increasing the safety of sclerosis of saphenous axes (Cavezzi and

Frullini, 1999; Frullini et al., 2000).

The greater efficacy seen in the foam group confirms the advantages

of this type of sclerosis and confirmation of efficacy by Duplex

ultrasound added value to the study. From the practical point of view,

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foam sclerosis involves cheap, readily available, and easy to use products

in daily practice, not unduly lengthening the medical process and

probably reducing the number of sessions needed to treat each patient

(Alos et al., 2006).

Regarding the safety of the treatment, Harkins and Harmon in 1934

and Richardson in 1937 demonstrated the safety of injecting animals

with small doses of endovenous air for short periods. Based on these

experiments, Henriet (1997) analyzed the passage of this air to the

circulation system under several conditions of extracorporeal circulation

or during echocardiograms using air, confirming the safety of the

procedure. These results are consistent with several later clinical studies

using foam produced by various techniques (Garcia, 2001; Cavezzi et

al., 2002) proving that small doses of air injected intravenously do not

produce major systemic changes and are well tolerated by patients. The

presentation of major complications (deep vein thrombosis or lung

thromboembolism) is unusual with this technique and is probably related

to the dose used and the sclerosis region, occurring considerably more

often with truncal saphenous sclerosis, incompetent perforator veins, and

when large doses of foam are used (Varcoe, 2001). None of these

complications occurred in our study or in similar studies, mainly due to

the type of veins treated (reticular and postoperative) and the low doses

and concentrations used.

The minor complications recorded (local inflammation and

hyperpigmentation), which in our study were very similar to the study

published by Benigni and Sadoun (1999), present widely divergent

percentages in the literature, attributable to several possible factors: the

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method of foam production, as non-industrial methods do not produce a

completely standardized microfoam; and the relatively low

concentrations and quantities used in each session (higher concentrations

of sclerosant produce smaller size bubbles). The larger bubble size could

be directly related to the appearance of inflammation beyond the

endothelium, involving the whole venous wall and the perivenous tissue

with the consequent clinical signs and anti-aesthetic secondary effects

such as skin pigmentation (Breu and Guggenbichler, 2004).

However, there is a clear tendency towards the reduction of foam

concentrations in order to achieve better results and avoid the secondary

effects characteristic of this technique. The use of postsclerosis, elastic

compression for only 48 h could have been another possible influential

factor as longer term compression has been shown to be effective in

reducing inflammation and its consequences (Vin and Benigni, 2003).

Skin pigmentation can also be reduced by performing drainage micro-

thrombectomy on the thrombosis of the treated vein (Scultetus et al.,

2003).

Other minor complications that have been described in the literature

(dizziness and blurred vision) derive from the passing of air from the

foam to the circulation system, are related to the total quantity of injected

foam, and are prevented by the patient gradually sitting up and previous

elevation of the treated limb (Frullini et al., 2002).

No incident of this kind was recorded in our study due probably to the

low doses administrated to all patients. There was a significant relation

between presentation of pigmentation and the concentration of sclerosant

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used. but the sample size was small and statistical power limited, so care

must be used in the interpretation of this result.

An important feature of the design of this study and one which made

the two groups more homogeneous and easier to compare, was use of the

two techniques simultaneously on the same patient, each of whom acted

as his/her own control. Assessment of the differences between the

procedures was thus, more valid and precise with regard to both efficacy

and complications as any possible confounding factors that depended on

the patients were automatically corrected and variability was greatly

reduced. Likewise, the use of the duplex ultrasound allowed for greater

accuracy and objectivity in determining the percentages of sclerosant for

each venous caliber and enabled accurate measurement of partial and

complete efficacy.

In conclusion, the results of this study demonstrate that foam

polidocanol has greater sclerosant efficacy compared to liquid

polidocanol in the treatment of telangiectatic varices not involving the

saphenofemoral junction. A larger percentage of total sclerosis as well as

the extent of the obliterated region was observed. Despite this, foam

sclerosant also showed a greater tendency to provoke inflammation and

consequently mild adverse effects including pain, signs of inflammation

and skin pigmentation.

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