Compression stockings for the initial treatment of varicose veins in patients without venous ulceration

  • Review
  • Intervention

Authors


Abstract

Background

Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. This is an update of a review first published in 2011.

Objectives

To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in patients without healed or active venous ulceration.

Search methods

For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched August 2013) and CENTRAL (2013, Issue 5).

Selection criteria

Randomised controlled trials (RCTs) were included if they involved participants diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment, compression versus placebo stockings, or compression stockings plus drug intervention versus drug intervention alone. Trials comparing different lengths and pressures of stockings were also included. Trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery, were excluded.

Data collection and analysis

Two authors assessed the trials for inclusion and quality (SS and LR). SS extracted the data, which were checked by LR. Attempts were made to contact trial authors where missing or unclear data were present.

Main results

Seven studies involving 356 participants with varicose veins without healed or active venous ulceration were included. Different levels of pressure were exerted by the stockings in the studies, ranging from 10 to 50 mmHg. One study assessed compression hosiery versus no compression hosiery. The other six compared different types or pressures of stockings. The methodological quality of all included trials was unclear, mainly because of inadequate reporting.

The symptoms subjectively improved with the wearing of stockings across trials that assessed this outcome, but these assessments were not made by comparing one randomised arm of a trial with a control arm and are therefore subject to bias.

Meta-analyses were not undertaken due to inadequate reporting and actual or suspected high levels of heterogeneity.

Authors' conclusions

There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of a large RCT of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place.

Résumé scientifique

Bas de contention pour le traitement initial des varices chez les patients sans ulcération veineuse

Contexte

Les chaussettes ou bas de contention servent fréquemment de traitement de première ligne des varices chez les personnes sans ulcère veineux cicatrisé ou actif. Des preuves doivent être établies afin de déterminer si l’utilisation de bas de contention permet de soulager et de traiter les premiers symptômes des varices. Mise à jour d'une revue initialement publiée en 2011.

Objectifs

Évaluer l’efficacité des bas de contention pour le traitement initial des varices chez des patients sans aucun ulcère veineux cicatrisé ou actif.

Stratégie de recherche documentaire

Pour cette mise à jour, le groupe Cochrane Maladies vasculaires périphériques a effectué des recherches dans son registre spécialisé (dernière recherche effectuée en août 2013) et CENTRAL (2013, numéro 5). 

Critères de sélection

Des essais contrôlés randomisés (ECR) ont été inclus lorsque les participants étaient diagnostiqués avec des varices tronculaires sans ulcère veineux cicatrisé ou actif (classification clinique, étiologique, anatomique, physiopathologique (CEAP) C2 à C4). Les essais inclus ont comparé des bas de contention à l’absence de traitement, des bas de contention à des bas placebo, ou des bas de contention combinés à une intervention médicamenteuse à une intervention médicamenteuse seule. Les essais comparant des longueurs et pressions de bas de contention différentes ont également été inclus. Les essais concernant d’autres types de traitement des varices (que ce soient comparateurs de bas ou traitement initial non randomisé), notamment la sclérothérapie et la chirurgie, ont été exclus.

Recueil et analyse des données

Deux auteurs ont évalué l’inclusion et la qualité des essais (SS et LR). SS a procédé à l’extraction des données qui ont été vérifiées par LR. En cas de données manquantes ou imprécises, les auteurs des essais ont été contactés.

Résultats principaux

Sept études ont été incluses concernant 356 participants avec des varices et sans ulcère veineux cicatrisé ou actif. Dans ces études, différents niveaux de pression des bas, allant de 10 à 50 mmHg, ont été appliqués. Une étude a comparé l’utilisation de chaussettes de contention à l’absence de chaussettes de contention. Les six autres études ont comparé différents types ou pressions de bas. La qualité méthodologique de tous les essais inclus était imprécise, principalement en raison de rapports inadaptés.

Les symptômes se sont subjectivement améliorés grâce au port de bas lors des essais qui ont évalués ce résultat, mais ces évaluations n’ont pas comparé un bras randomisé d’une étude à un bras témoin et sont donc sujettes au biais.

Aucune méta-analyse n’a été réalisée en raison de rapports inadaptés et d’une hétérogénéité affichant des niveaux élevés, réels ou suspects.

Conclusions des auteurs

Il n’existe pas assez de preuves de bonne qualité pour déterminer si les bas de contention sont ou non efficaces dans le traitement unique et initial des varices chez les personnes sans ulcère veineux cicatrisé ou actif ou si un type est supérieur à un autre. Les recherches futures doivent avoir recours à un large ECR composé de participants présentant des varices tronculaires portant ou pas des bas de contention, afin d’évaluer l’efficacité de cette intervention. Si le port de bas de contention se révèle être bénéfique, d’autres études comparant la longueur et la pression les plus efficaces doivent alors être réalisées.

Plain language summary

Wearing stockings to provide compression for the treatment of varicose veins

Evidence from randomised controlled trials is not sufficient to determine if compression stockings as the only and initial treatment are effective in managing and treating varicose veins in the early stages. Varicose veins are widened veins that twist and turn and are visible under the skin of the leg. They generally do not cause medical problems although many sufferers seek medical advice. Symptoms that may occur include pain, ankle swelling, tired legs, restless legs, night cramps, heaviness, itching and distress from their cosmetic appearance. Complications such as oedema, pigmentation, inflammation and ulceration can also develop. Compression stockings are often the first line of treatment and come in a variety of lengths, knee length to full tights, and apply different pressures to support the flow of blood in the veins.

Seven studies involving 356 participants with varicose veins and who had not experienced venous ulceration were included in this review. One study assessed compression hosiery versus no compression hosiery. The other six compared different types or pressures of stockings, ranging from 10 to 50 mmHg. The methodological quality of the included trials was unclear and not all studies assessed the same outcomes. One study included only pregnant women whilst other studies included participants who were on surgical waiting lists, that is, people who had sought medical intervention for their varicose veins.

The participants' subjective symptoms, and foot swelling and blood flow (physiological measures) improved in all of the studies that assessed these outcomes when stockings were worn, but these assessments were not made by comparing one randomised arm of the trial with a control arm in the same study. Conclusions from the individual studies regarding the optimum pressure provided by stockings were conflicting, although the results of one study suggested that lower pressured stockings (20 mmHg) may be as effective as higher pressured stockings (30 to 40 mmHg) for relieving symptoms. Conclusions regarding the optimum length of the stockings were inconclusive. No severe or long lasting side effects were noted.

Résumé simplifié

Port de bas de contention pour le traitement des varices

Les preuves obtenues à l’issue d’essais contrôlés randomisés sont insuffisantes pour déterminer si les bas de contention, utilisés comme traitement unique et initial, sont efficaces pour traiter les premiers signes des varices. Les varices sont des veines dilatées et tortueuses qui sont visibles à la surface de la peau des jambes. Elles ne sont généralement pas la source de problèmes médicaux, bien que de nombreuses personnes atteintes de varices demandent conseil à leur médecin. Les symptômes éventuels se caractérisent par des douleurs, un gonflement des chevilles, des jambes lourdes, des fourmillements, des crampes nocturnes, des sensations de lourdeur, des démangeaisons et un aspect esthétique disgracieux. Des complications (œdème, pigmentation, inflammation et ulcération) peuvent également se développer. Les bas de contention sont fréquemment utilisés comme première ligne de traitement et sont disponibles en plusieurs longueurs, demi-jambes ou jambes entières, et appliquent des pressions variables afin de permettre la circulation du flux sanguin.

Cette revue se compose de sept études regroupant 356 participants atteints de varices sans ulcère veineux. Une étude a comparé l’utilisation de chaussettes de contention à l’absence de chaussettes de contention. Les six autres ont comparé différents types ou pressions de bas allant de 10 à 50 mmHg. La qualité méthodologique des essais inclus était imprécise et seules quelques études ont comparé les mêmes critères de jugement. Une étude n’incluait que des femmes enceintes alors que d’autres incluaient des patients figurant sur des listes d’attente afin de subir une intervention chirurgicale, c’est-à-dire des patients ayant sollicité une intervention médicale pour le traitement de leurs varices.

Les symptômes subjectifs des patients, le gonflement des pieds et le flux sanguin (mesures physiologiques), se sont améliorés dans l’ensemble des études ayant évalué ces résultats lorsque des bas de contention étaient portés. Mais ces évaluations n’ont pas comparé un bras randomisé à un bras témoin dans la même étude. Les conclusions tirées des études individuelles concernant la pression optimale fournie par des bas de contention étaient contradictoires, bien que les résultats d’une étude aient révélé que des bas de contention exerçant une pression inférieure (20 mmHg) peuvent être aussi efficaces que des bas de contention exerçant une pression supérieure (30 à 40 mmHg) pour atténuer les symptômes. Les conclusions concernant la longueur optimale des bas de contention n’étaient pas probantes. Aucun effet secondaire grave ou prolongé n’a été signalé.

Notes de traduction

Traduit par: French Cochrane Centre 1st December, 2011
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

Background

Description of the condition

Varicose veins are tortuous, widened veins in the subcutaneous tissue of the lower limb (Campbell 2006). Varicose veins that have arisen as a result of a known cause, such as a previous deep vein thrombosis, are known as secondary varicose veins (Golledge 2003). Theories on the cause of primary varicose veins range from initial structural weakness within the vein wall, which leads to vein dilation, to valve incompetence leading to pooling of the blood and vein dilation (Golledge 2003; London 2000). The Clinical, Etiology, Anatomy, Pathophysiology (CEAP) classification for chronic venous disorders was developed in 1994 by the American Venous Forum and was revised and disseminated in 2004 (Eklöf 2004). It serves as a systematic guide to the diagnosis and classification of chronic venous disorders, which was previously lacking. Today, most published papers on chronic venous disorders will use all or some of the CEAP classification (Eklöf 2004). There are six categories, ranging from small superficial thread like veins (C1) to active venous ulcers (C6). A classification of C0 is given where no clinical findings of venous disease are found. The CEAP classification is therefore used to classify and diagnose varicose veins, which if uncomplicated are classed as grade C2. A classification of C3 indicates varicose veins with oedema and a classification of C4 indicates varicose veins with skin changes due to venous disorders (Padberg 2005). In 2004, it was also decided to define a varicose vein as greater than 3 mm in diameter, to differentiate from reticular veins (Eklöf 2004).

Although varicose veins are associated with low morbidity and mortality, many sufferers seek medical advice and there is some evidence that quality of life can be improved following treatment. Approximately 2% of NHS resources in the UK are spent on managing venous disease, with an estimated £20 to 25 million (excluding non-hospital costs) spent on operations for varicose veins in the year 2001 (Beale 2005). Many patients with varicose veins are asymptomatic, but some experience aching, dullness in the lower limbs, itching, throbbing, distress about the cosmetic appearance and swelling (Metcalfe 2008). Around 5% will develop complications including haemorrhage, thrombophlebitis, oedema, skin pigmentation, atrophie blanche, varicose eczema, lipodermatosclerosis and ulceration (Beale 2005). Prevalence of the condition varies widely between studies from different countries (up to 56% in men and 60% in women) and few studies have measured the incidence within the general population (Robertson 2008). Currently there is geographical variation within the UK as to whether varicose veins (CEAP classification C2 to C4) are treated on the NHS, which is often dependent on financial restrictions (Edwards 2009).

Description of the intervention

Lower limb compression has been used to treat varicose veins since biblical times (Pierson 1983). Nowadays, compression hosiery or stockings (knee and thigh length and full tights) are often first line treatment for varicose veins, especially in primary care, even though evidence supporting their use is limited (Ramelet 2002; Tisi 2007). Although compression may be achieved by different modalities, this review is restricted to compression stockings. There are currently five classifications of compression stockings based on the different manufacturers, who apply different thresholds of pressure as measured at the ankle for different classes: the British Standard, German Standard, French Standard, draft European standard and USA Standard. The draft European standard was developed to try and ensure consistency within the European Union but, due to lack of consensus, this has not occurred (Rajendran 2007). Each classification has between three and four classes according to differing levels of pressure as set by the manufacturer (Palfreyman 2009). This sub-bandage pressure range varies greatly between different countries, leading to variation in the different norms for stockings internationally. For example, for class one alone, the British Standard bandage pressure can be between 14 and 17 mmHg whereas the German Standard can be between 18 and 21 mmHg. Stockings come in a variety of lengths, knee length, thigh length and full tights. The optimum length and pressure are not known, but studies suggest that a lower compression pressure (20 to 30 mmHg) is tolerated better than are higher levels (Beale 2005).

How the intervention might work

Optimum management of varicose veins requires accurate diagnosis and identification of the source of venous incompetence, and treatment should aim to abolish venous reflux and relieve symptoms (Beale 2005). Graded compression works by applying a controlled pressure to the skin. This supports the superficial venous system by exerting an external pressure that is greatest at the ankle (minimum of 14 mmHg) and decreases up the leg (Johnson 2002). By reducing venous capacity and increasing venous velocity in the deeper veins, venous stasis and reflux are reduced helping to reduce the severity of varicose veins and the associated symptoms (Walker 2007). It is, however, important to be aware that the effect of compression stockings is influenced by many factors. For example, the material (both compression class and elasticity) of the stocking, the size and shape of the leg, and the activity of the wearer can all influence the compression applied (Rabe 2008).

Why it is important to do this review

Although compression therapy is widely used in the management of varicose veins, there is still conflicting, poor quality evidence on its effectiveness. There is evidence that patients with varicose veins without healed or active venous ulceration can go on to develop severe complications and consume a large amount of NHS resources. If treatments such as compression stockings can be used to treat varicose veins in the early stages, morbidity and resource use may ultimately be reduced. This review is important to assess the efficacy of compression stockings in the treatment of varicose veins in people without healed or active venous ulceration, including the optimum length and pressure of stockings and whether the use of stockings has any effect on the symptoms related to varicose veins.

Objectives

To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in patients without healed or active venous ulceration.

Methods

Criteria for considering studies for this review

Types of studies

We considered all randomised controlled trials (RCTs) in people with varicose veins and without healed or active venous ulceration (CEAP classification C2 to C4) that assessed:

  • compression stockings versus no treatment,

  • compression stockings versus placebo compression stocking (Tubigrip, for example, which does not provide graduated pressure), or

  • compression plus a drug intervention versus the drug intervention alone.

We also included studies that compared different lengths and pressures of compression stockings. We included parallel group and cross-over trials. There were no language restrictions.

Trials in which compression stockings were compared with interventions other than no treatment, placebo compression stockings or stockings of another length or pressure (for example sclerotherapy, surgery, laser therapy, exercise, balneotherapy or hydrotherapy) were excluded.

Existing Cochrane reviews have assessed the treatment of varicose veins using surgical techniques including sclerotherapy (Rigby 2004; Tisi 2006) as well as assessing the best form of prevention and management of venous disease in certain subsets of the population such as pregnant women (Bamigboye 2007) and those travelling by air (Clarke 2006).

Trials in which compression stockings were assessed against no treatment or a placebo stocking as an adjuvant to primary (initial) treatment with surgery, sclerotherapy or laser therapy were also excluded, as were those assessing other methods of compression such as pneumatic compression techniques.

Studies of participants with a CEAP classification of C5 or C6, indicating venous ulcers, were also excluded due to overlap with an existing Cochrane review (Kolbach 2003).

Types of participants

We included adults (aged 18 years and above) of both sexes who suffered from varicose veins without having healed or active venous ulceration in the lower limb(s). The classification of varicose veins was performed according to CEAP. If methods such as duplex scanning were used to assist in the diagnosis, a clinical diagnosis of trunk or stem varicose veins (CEAP C2) was also required, with or without ankle oedema or minor skin changes (CEAP C3 & C4). Where venous leg ulcers (CEAP C5 and C6) or other severe complications were present, the participants were not included. In studies where the CEAP classification was not used, in early studies for example, a diagnosis by a clinician of trunk varices or varicose veins was sufficient.

Co-morbidity or pregnancy did not influence the decision to include or exclude a trial. Trials including participants who had bilateral varicose veins but where compression was only applied unilaterally were included.

Types of interventions

Interventions included compression from any type of hosiery that exerted a graduated pressure on the lower limb(s). We included any length (knee, thigh, full tights) and grade of pressure. Compression had to be from a graduated pressure stocking and not from a more general support bandage such as Tubigrip.

We compared the intervention with no intervention at all, a placebo stocking such as Tubigrip, or both.

We also included trials that involved participants taking a drug intervention when the drug alone was compared against drug plus compression stocking, allowing the effect of the compression stocking to be assessed.

We assessed comparisons between different lengths or different grades of pressure, or both, where trials compared stockings in two arms of the same trial.

Types of outcome measures

Primary outcomes
  • Change in symptoms such as aching and itching, reported by participants

  • Physiological measures used to monitor the impact of the intervention on varicose vein status, such as venous pressure at the ankle

Secondary outcomes
  • Complications: these included direct complications or side effects from wearing the stockings, e.g. itching, increase in temperature

  • Compliance: this included ensuring the patient was wearing the stockings and that they were being worn correctly, measured subjectively e.g. a report from the patient that they had stopped wearing the stockings

  • Quality of life: where this was measured using a standard questionnaire

Search methods for identification of studies

Electronic searches

For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched August 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) 2013, Issue 5, part of The Cochrane Library, (www.thecochranelibrary.com). See Appendix 1 for details of the search strategy used to search CENTRAL. The Specialised Register is maintained by the TSC and is constructed from weekly electronic searches of MEDLINE, EMBASE, CINAHL, AMED, and through handsearching relevant journals. The full list of the databases, journals and conference proceedings which have been searched, as well as the search strategies used are described in the Specialised Register section of the Cochrane Peripheral Vascular Diseases Group module in The Cochrane Library (www.thecochranelibrary.com).

Searching other resources

For the original version of the review (Shingler 2011) we contacted companies, specialists in the field and journal article authors in order to obtain information regarding unpublished data, or to clarify information where needed. We checked reference lists of appropriate cited studies and reviewed conference proceedings and abstracts from relevant organisations.

Data collection and analysis

Selection of studies

We used the search strategy described to obtain titles and abstracts of studies that were potentially relevant to this review. Two review authors (SS and LR) independently screened the titles and abstracts to identify studies and select trials for possible inclusion in the review. Full text articles were obtained where the above inclusion criteria were met, where further clarification was required, or if translation was necessary. Any disagreements were resolved first by discussion between review authors and, where required, through consultation with the third author (SB).

One review author (SS) attempted to contact three trial authors or co-authors for additional information in order to allow a decision regarding inclusion or exclusion of their studies in this review. This included not being able to tell if all participants had varicose veins or whether subgroup analysis had been performed. Only one study author provided additional information to permit a judgment to be made (Benigni 2003).

Data extraction and management

Two review authors (SS and LR) independently reviewed, extracted and summarised information from the studies using standardised data extraction forms specific to the Cochrane Peripheral Vascular Disease Group. The studies were checked for accuracy by a third review author (SB) where required.

The following information was collected:

1) methods (study design, method of randomisation, concealment of allocation, blinding, power calculations, and source of funding);

2) participants (number, age, sex, inclusion and exclusion criteria);

3) interventions (treatment, control or placebo, duration);

4) outcomes (primary and secondary).

Assessment of risk of bias in included studies

Risk of bias tables were completed for each included study along with narrative in the text to assess the quality of the included studies. Tables were completed independently by two review authors (SS and LR) with a third (SB) available to resolve disagreements, in accordance with the Cochrane Handbook for Systematic Reviews of Interventions version 5.0.2, Chapter 8 (Higgins 2009). The minimum level of study quality included in this review was a RCT. Where this level of quality was not met, the trials were excluded. If enough high quality studies were found, sensitivity analysis was planned.

The 'Risk of bias' tables included six domains: adequate sequence generation, allocation concealment, blinding, incomplete outcome data addressed, free of selective reporting and free of other bias. Each study was independently reviewed by SS and LR and given a judgement of low risk of bias, high risk of bias, or unclear for each domain, along with a description as to why the judgement was made.

Measures of treatment effect

In line with the Cochrane Handbook for Systematic Reviews of Interventions, for dichotomous outcomes, results were expressed as risk ratio (RR) with 95% confidence interval (CI). For continuous scales of measurement, the mean difference (MD) was used, or the standardised mean difference (SMD) if different scales were used (Higgins 2009).

Unit of analysis issues

All types of randomised controlled trials were included.

In the case of a cross-over trial, data from all periods were included.

Dealing with missing data

Where data were missing or unclear, attempts were made to contact the author of the study to obtain the information.

Where we were unable to obtain missing data, assumptions such as assuming normal distribution to use the median value as a mean value were used. Any assumptions made were described with the relevant analysis.

Assessment of heterogeneity

Where applicable, meta-analyses were considered for studies that showed sufficient homogeneity in terms of participants, interventions and outcomes. Where appropriate, assessment of heterogeneity between trials was assessed in the meta-analysis by the Chi² test and the I² statistic. Results for each study were expressed as MD with 95% CI and combined for meta-analysis with RevMan software (version 5.0.25) (RevMan 2008).

Assessment of reporting biases

Where applicable, it was planned to assess publication bias via a funnel plot of outcomes. These can show publication bias by an asymmetrical output (Higgins 2009). Ultimately, a funnel plot was not carried out in this review due to the very small number of studies included in the statistical analysis.

Data synthesis

Meta-analyses were planned where appropriate data were available. Ultimately, no studies were entered into meta-analyses due to the lack of compatible data from the different studies. If meta-analyses had been completed, many assumptions would have had to be made due to the poor levels of reporting.

Subgroup analysis and investigation of heterogeneity

No subgroup analyses were pre-planned.

Sensitivity analysis

If sufficient high quality trials were available, sensitivity analysis was planned to determine the robustness of the review findings.

Results

Description of studies

Results of the search

See Figure 1.

Figure 1.

Study flow diagram.

For this update there was one additional study identified from the Specialised Register and 194 records from CENTRAL. Following screening of titles one additional study was identified for possible inclusion (Mosti 2011).

Included studies

(See also the Characteristics of included studies tables)

A total of nine reports of seven studies were included. The seven included studies were published between 1980 and 2001 and in total involved 356 participants with varicose veins without healed or active venous ulceration. All the studies were set in Europe: five of the seven studies were in the United Kingdom (Anderson 1990; Chant 1985; Chant 1989; Coughlin 2001; Jones 1980), the study by (Jungbeck 1997) was set in Sweden, and the study by (Chauveau 2000) was set in France. All included studies were randomised controlled trials but three had a cross-over design (Anderson 1990; Chauveau 2000; Jones 1980).

Types of participants

All participants were diagnosed with primary varicose veins without healed or active venous ulceration as specified in the inclusion criteria. None of the studies used the CEAP classification; mostly this was because they were conducted prior to the development of the classification. The studies varied in the amount of detail provided to describe their exclusion and inclusion criteria, from providing no detail at all to being very specific.

In six of the studies all participants had varicose veins and were randomised into different groups either to compare types of stocking or different pressures, or to compare wearing stockings versus not wearing stockings. Only one trial (Jones 1980) included other groups of participants who were not diagnosed with varicose veins. This trial was included because the groups were clearly distinguished at entry and in the results, so those participants with varicose veins could be identified for inclusion in our analyses.

Four of the studies recruited patients from surgical waiting lists (Anderson 1990; Chant 1985; Chant 1989; Jones 1980), two from outpatient departments (Chauveau 2000; Jungbeck 1997) and one from a maternity setting as they were pregnant (Coughlin 2001). All included participants were outpatients.

Five of the studies included both men and women; the other two included only female participants (Chauveau 2000; Coughlin 2001), one because the study was on pregnant women. Only two of the studies stated the numbers of male and female participants (Jones 1980; Jungbeck 1997), with the others stating that randomised groups were evenly matched for sex. In the two studies where the participants' sex was stated, there were more women (87) than men (10), possibly reflecting a greater prevalence of symptomatic varicose veins in women or that women seek medical help for varicose veins more readily than men. The age range also varied between studies. Some studies did not specify age (Chant 1985; Chant 1989; Coughlin 2001; Jones 1980) and in the others the age ranged from 20 to 82 years, with mean ages of 40 years (Anderson 1990) and 52 years (Chauveau 2000) in two of the studies.

Interventions

Five of the studies used knee length graduated compression stockings (Chant 1985; Chant 1989; Chauveau 2000; Jones 1980; Jungbeck 1997). Coughlin 2001 used compression tights and Anderson 1990 used full length stockings. Anderson 1990 also used other treatments in the trial, including Paroven and a placebo tablet. This trial assessed the effect of compression stockings and Paroven, alone and in combination, and the groups were identifiable for analyses. A majority of the other studies assessed one type or pressure of stocking against another (Chant 1985; Chant 1989; Chauveau 2000; Jones 1980; Jungbeck 1997), or both. Only one study (Coughlin 2001) randomised participants to wear one type of compression tights or not and then followed up participants to assess compliance.

The following compression stockings or tights were used in the studies: class 1 compression tights (Coughlin 2001), full length hosiery giving a pressure of 30 to 40 mm Hg at the ankle (Anderson 1990), Sigvaris stockings giving a pressure of 30 to 40 mmHg at the ankle or 40 to 50 mmHg at the ankle (Chant 1985), an Eesiness NHS two-way stocking (20 mmHg at the ankle) and Sigvaris medium stocking (30 to 40 mmHg at the ankle) (Jones 1980), French class 1 (10 to 15 mmHg) and French class 2 (15 to 20 mmHg) below-knee stockings (Chauveau 2000), Jobst Medical Leg wear knee-hi class 1 (20 mmHg at the ankle) and Jobst Medical Leg wear knee-hi class 2 (30 mmHg at the ankle) (Jungbeck 1997), and Sigvaris and Medi Plus support hose (Chant 1989). Some of the studies did not provide the amount of pressure provided by the hosiery or the class of stocking. It was therefore difficult to make comparisons between the types of stocking.

Outcomes

Some studies assessed more than one outcome.

Four of the included studies used the change in symptoms as an outcome measure (Anderson 1990; Chant 1985; Jones 1980; Jungbeck 1997). Two of these used a visual analogue scale (VAS) to determine change in symptoms before and after wearing stockings (Anderson 1990; Jungbeck 1997). Only Anderson 1990 reported the results of the VAS at the level of individual symptoms. Jungbeck 1997 grouped all symptoms together and reported the results before and after intervention for the two different classes of stocking used in the trial. The other two studies used self-reporting of symptoms as their outcome measure (Chant 1985; Jones 1980). Although Jones 1980 reported on symptoms, it was not the study's primary outcome and no data were reported, just a line stating "patients with varicose veins were relieved of aching symptoms by both sorts of stocking". Chant 1985 stated the number of participants in each stocking group who reported an improvement in symptoms, as well as the number of participants that were removed from the surgical waiting list.

Three studies reported the change in physiological measures (Chauveau 2000; Jones 1980; Jungbeck 1997). Jungbeck 1997 and Jones 1980 used foot volumetry before and after wearing stockings. Chauveau 2000 used air plethysmography to look for a tourniquet effect of stockings.

The only study to assess complications of wearing compression stockings as their main outcome was Chauveau 2000. This study determined whether below-knee stockings (class 1 (10 to 15 mmHg) and class 2 (15 to 20 mmHg)) impeded venous return by a tourniquet effect using air plethysmography with venous occlusion. Anderson 1990 described side effects of headache, abdominal pain and nausea, which occurred throughout the trial, but these could have been caused by the other interventions that were given, which included Paroven and a placebo tablet. Chant 1989 assessed compliance with compression stockings and also recorded the reasons why participants did not wear them. These included "caused irritation", which affected four of the 40 participants. No trials revealed severe side effects.

Two studies assessed the outcome measure of compliance (Chant 1989; Coughlin 2001). Coughlin 2001 investigated the acceptability and usage of compression tights in pregnant women at various time points up to six weeks post partum via self-reporting by the participants. Chant 1989 assessed the compliance of two different types of stocking (Sigvaris and Medi Plus) by prescribing participants the stockings and then visiting them at home on a random basis, on average six weeks later, to determine whether or not they were wearing the stockings.

No study assessed the outcome measure of quality of life.

Length of studies

Studies varied in length from one day (wearing each of the two types of stocking for 15 minutes) (Chauveau 2000) to throughout pregnancy and up to six weeks post partum (Coughlin 2001). For a majority of the studies, it was difficult to tell for how long participants actually wore the stockings, and in his review we used the time period taken at when the assessors reviewed participants. However, this relied on the participants actually wearing the stockings between assessments.

Excluded studies

(See also the Characteristics of excluded studies tables)

For this update one additional study (Mosti 2011) was identified for possible inclusion and subsequently excluded.

In total forty-three articles of 40 studies were identified as excluded, some for more than one reason. Seventeen of the articles included participants who had a surgical intervention or sclerotherapy, either as a randomised alternative to stockings or as an initial treatment prior to adjuvant therapy with compression (Abramowitz 1973; Biswas 2007; Bond 1997; Bond 1999; Hamel-Desnos 2008; Hamel-Desnos 2010; Houtermans-Auckel 2009; Isiklar 2003; Kline 1972; Makin 1982; Mariani 2011; Melrose 1979; Mosti 2009; O'Hare 2010; Perhoniemi 1983; Raraty 1999; Weiss 1999). Of the 40 excluded studies, 15 were not randomised controlled trials (RCTs) (Acsady 1996; Hirai 2002; Horvath 1983; Ibegbuna 1997; Isiklar 2003; Kakkos 2001; Kline 1972; Lascasas 2009; Leon 1993; Mauss 1969; Norgren 1988; Pierson 1983; Raju 2007; Szendro 1992; Zhang 2004). Six of the articles (Austrell 1995; Derman 1989; Guest 2003; Rabe 2010; Schul 2009; Thaler 2001) did not include participants with diagnosed varicose veins at recruitment; generally, the participants in these articles were either healthy or were diagnosed with other forms of venous disease, such as ulceration. Some of the excluded articles did not use hosiery as their method of compression, Griffin 2007 and Kakkos 2001 used pneumatic compression as their intervention, and Acsady 1996 did not use compression at all.

The study by Benigni 2003 would have met the inclusion criteria of this review but the trial included participants with CEAP classification C1 to 3. The author was contacted but reported no subgroup analysis of participants with a CEAP classification of C2 or above. Therefore, this study had to be excluded. This was the same for the study by Gandhi 1984 in which participants included people with varicose veins and clinical gravitational disease. Those with varicose veins could not be separated in the results, thereby precluding inclusion of the study in this review. The final study which could potentially have been included was by Mosti 2011. However, this study included participants with CEAP classification C2 to C5 and no subgroup analysis of participants with a CEAP classification of C2 to C4 was reported. The study author was contacted to see if this analysis had been undertaken, but no reply was received.

Risk of bias in included studies

See also 'Risk of bias' tables and Figure 2

Figure 2.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Allocation

None of the included studies described the allocation sequence or the concealment of allocation sufficiently to make a clear judgement and were therefore marked as 'unclear'.

Only the study by Chant 1985 described how allocation was decided: "Patients were selected sequentially from a surgical waiting list, starting with those added most recently". However, no other information on the type of sequence or how the sequence was produced was provided and, therefore, it was unclear as to whether it was adequate or not.

Blinding

It is difficult to blind participants when using compression stockings as an intervention. It is obvious to the participant whether they are wearing a compression stocking or not. It is likely that it was for this reason that blinding of the participants was rarely stated in the studies. If a study compared different types of stocking, blinding of the participants was not assumed unless stated. If a study used only one type and pressure of stocking, and participants had been randomised to wear or not wear stockings, it was assumed that the participants were not blinded.

Only one study stated that the participants were assessed blind (Chant 1985). However, the study did not state whether participants were also blinded, and as participants were randomised to two different pressures of stocking it cannot be assumed that they were or were not blinded. In all other included studies there was no discussion around blinding and, therefore, all the studies were marked as unclear.

Incomplete outcome data

For nearly all of the included studies there were insufficient data available to make a low or high risk of bias judgement on the completeness of outcome data. Therefore, six out of the seven included studies were marked as unclear. In some of the studies, although reasons for drop-outs or withdrawals were given, it was not possible to tell from the results whether all participants were included or had completed the course of treatment. For example, in the studies by Chauveau 2000 and Anderson 1990 the results tables provided mean measures, not permitting the reader to tell if all participants' results were included.

The only study that allowed the reader to determine that all outcome data were accounted for was Chant 1989. This study provided results for the outcome compliance by providing the actual number of participants who were wearing stockings after six weeks. Data for this outcome were complete.

Selective reporting

None of the included studies provided sufficient information to permit a low or high risk of bias judgement on selective reporting and were therefore classed as unclear. None of the study protocols were available and text reporting pre-specified outcomes was not clear.

Other potential sources of bias

All studies were marked as unclear. Although none appeared to have major risks of bias, due to insufficient reporting there was not enough information to permit a judgement of low risk of bias. Nearly all the included studies gave acknowledgement to companies providing stockings: Chant 1985 thanked Sigvaris Company; Jones 1980 thanked Ganzoni and Cie AG, Switzerland; Anderson 1990 thanked Zyma (UK) and Ganzoni (Switzerland) for providing Sigvaris stockings, Paroven and placebo capsules; and Jungbeck 1997 thanked Beiersdorf for supplying stockings and their contribution to the study.

The participants in Chant 1989 were prescribed stockings tailored to their degree of venous insufficiency, which could mean people were given different types and pressures of stocking. This may have had an impact on their compliance. In studies by Chant 1985 and Coughlin 2001, there were high drop-out rates following the initial prescription of stockings (33% and 32% respectively), which may have affected the results.

All the included studies were relatively small. The largest study (Chant 1985) included only 104 participants. Two studies (Chauveau 2000; Jones 1980) had very small numbers of participants with varicose veins (both n = 10).

Effects of interventions

The main objective of this review was to assess the effectiveness of compression stockings in the initial treatment of varicose veins in individuals without venous ulceration. Seven studies assessed effectiveness using one or more of the pre-specified outcomes for this review.

Primary outcomes

Change in symptoms

Four studies assessed this outcome (Anderson 1990; Chant 1985; Jones 1980; Jungbeck 1997). Two used a visual analogue scale (VAS) to report and evaluate symptoms including pain, ankle swelling, tired legs, restless legs, night cramps, heaviness, itching and distress from the cosmetic appearance. One study combined their results, providing only a median percentage change in all symptoms before and after wearing stockings (Jungbeck 1997), while the other study provided VAS results for change in each of the individual symptoms using means and standard errors (Anderson 1990). The other two studies (Chant 1985; Jones 1980) used self-reporting of symptoms and gave a more general result as to whether symptoms had improved or not at different time points in each study. No objective measure was used. Therefore, the results of the studies could not be combined. Individually, all studies reported a subjective improvement in symptoms by the end of the trial, but these were not analysed comparing the two randomised arms of the trials and were therefore subject to bias.

Jungbeck 1997 provided limited reporting of symptom change (all subjective symptoms) combined in participants wearing class 1 (20 mmHg) versus class 2 (30 mmHg) stockings. Results were given as patients' assessments of subjective symptoms expressed as median of VAS (in per cent). For class 1 stockings, there was a reduction of 28.2%, and for class 2 stockings there was a reduction of 31.3%. There was no significant difference between the two groups.

Anderson 1990 found no statistically significant differences in VAS scores after any of the four treatments. However, the use of Paroven and compression hosiery on their own appeared to reduce symptoms more than the placebo, as seen in the VAS scores. For example, for the symptom of swelling the mean VAS score for the placebo was 35.3; the mean score for hosiery plus placebo was 28.2; the mean score for Paroven was 31.5; and the mean score for hosiery plus Paroven was 32.4. These observed improvements were true for all symptoms with the exception of distress from cosmetic appearance.

Chant 1985 provided limited information and data, reporting only the number of participants who experienced improved symptoms with wearing 30 to 40 mmHg stockings (42 out of 53 participants) and 40 to 50 mmHg stockings (40 out of 51 participants).

Jones 1980 provided no data for changes in symptoms comparing the different intervention groups of the trial.

Physiological measures

Three studies assessed this outcome (Chauveau 2000; Jones 1980; Jungbeck 1997).

Two studies used foot volumetry to measure expelled volume (EV), the relative expelled volume related to 100 ml of foot volume (EVR or EVrel), rate of refilling of the foot after exercise (Q), and the quotient combining both aspects of functional assessment (Q/EVR or Q/EVrel). This quotient is a measure of the blood expelled by the musculovenous pump in the leg and the prevention of reflux by venous valves, both of which are important for the prevention of varicose veins. Other measures were taken but only these four were consistent between the two studies (Jones 1980; Jungbeck 1997). Both studies investigated differences between stockings providing 20 mmHg pressure and those providing 30 to 40 mmHg pressure. One study was a cross-over trial (Jones 1980) where participants wore each type of stocking for three weeks, with a week of not wearing stockings in between. The other trial (Jungbeck 1997) was a parallel group study, where participants were randomised to one of two different types of stocking for eight weeks. Because there were only two studies that assessed these measures, and they were of different methodology, it was decided not to combine them in a comparison table or meta-analysis. Both studies also had poor levels of reporting: Jungbeck 1997 used only medians (and 95% confidence intervals (CI)) to report initial values and values at eight weeks for both class 1 (20 mmHg) and class 2 (30 mmHg) stockings. The results in Jones 1980 required the reader to read values off a graph for each physiological measure. These results would have to be used very cautiously if a meta-analysis had been produced.

Jones 1980 reported in their varicose vein group (n = 10) an improved performance for EV (20% (20 mmHg) and 8% (30 to 40 mmHg)), EVR (30% and 15%), Q (50% and 20%) and Q/EVR (20% and 35%) compared with the baseline values. Jungbeck 1997 reported significant improvement in EV and EVrel after wearing class 1 (20 mmHg) stockings for eight weeks compared with the baseline values (EV: baseline median 12.4, 95% CI 10.5 to 12.7 versus median 14.7, 95% CI 12.8 to 16.4, P < 0.05; EVrel: median 1.09, 95% CI 0.87 to 1.23 versus median 1.38, 95% CI 1.10 to 1.56, P < 0.01). Jungbeck 1997 reported no significant differences for Q and Q/EVrel or for EV, EVrel, Q and Q/EVrel in class 2 (30 mmHg) stockings.

One study used air plethysmography to measure arterial inflow (AI), venous volume (V50) and maximum venous outflow (MVO) as part of the assessment for a tourniquet effect whilst wearing stockings (Chauveau 2000). No significant changes were found in any of these measures whilst wearing class 1 (10 to 15 mmHg) stockings. Significant reductions were found for arterial inflow (mean value of 1.22 mL/s to 0.93 mL/s) and venous volume (98 mL to 80 mL) whilst wearing class 2 (15 to 20 mmHg) stockings. However, this study was not designed to compare the effectiveness of the stocking.

Secondary outcomes

Complications

Only one small study (n = 10) assessed this as a main outcome (Chauveau 2000). Two different pressures of stocking (class 1 (10 to 15 mmHg) and class 2 (15 to 20 mmHg)) were tested to assess if there was any difference in producing a tourniquet effect whilst they were being worn. A tourniquet effect is a possible side effect of wearing compression stockings, which could impede venous return (Chauveau 2000). For people who already suffer from arteriopathy such a side effect could potentially lead to ischaemia of the surrounding tissues. No tourniquet effect of class 1 or 2 below-knee stockings was found.

Two other studies reported on side effects. Anderson 1990 reported the side effects of abdominal pain, headache and nausea; however this was a four-arm cross-over trial that also included taking Paroven and a placebo tablet, which may have caused the reported side effects. The study reported that the side effects were similar in all four arms and none were severe or long lasting, but no results were presented. In Coughlin 2001, in which compliance was the main outcome, irritation was given as a reason why some participants stopped wearing stockings but no information regarding the severity was given. The authors stated that abdomen size was likely to be the cause of the discomfort because the participants were pregnant women and compression tights were provided as the intervention.

Compliance

Two studies reported on compliance (Chant 1989; Coughlin 2001).

Both studies had a high initial drop-out rate. In Coughlin 2001, 33% of participants (pregnant women with varicose veins) did not want to take part in the study once randomised to wearing compression tights. In Chant 1989, 30% of randomised participants (22 out of 66 patients wanting symptomatic relief of varicose veins prior to elective surgery for the condition) did not collect the compression stockings they were randomised to.

Compliance was assessed differently in the two trials, with Coughlin 2001 relying on self-reports from the women as to when they stopped wearing the tights. As their pregnancies progressed, increasing numbers of women rejected the compression tights: 7 women wore them up to 20 weeks, 4 to 28 weeks, 14 to 34 weeks, 2 to term and 4 to 6 weeks post partum. No statistical calculations were performed. Chant 1989 completed random visits to participants' houses approximately six weeks after the stockings had been prescribed to assess whether participants were wearing the stockings. Overall compliance with treatment for the 66 patients entered into the trial was 32%. Both studies found a general low compliance, but in the study by Chant 1989 neither type of stocking studied produced significantly more or less compliance than the other (Chi2 = 1.70). Generally, non-compliance appeared to be greatest when the hosiery was initially prescribed, and reasons given by participants for not wearing them included discomfort, application, appearance, not effective and that they caused irritation. Coughlin 2001 concluded that tights were unacceptable in pregnant women due to their abdominal size. Meta-analysis was not carried out because of the described differences in compliance assessments between the studies.

Quality of life

No studies assessed or reported on this outcome directly.

All the included studies had an insufficient level of reporting and relatively small sample sizes. Therefore this review is unable to make comment with regards to the effect of compression stockings for varicose veins in people without healed or active venous ulceration for the outcomes assessed: change in symptoms, change in physiological measures, complications, compliance and quality of life.

Discussion

Summary of main results

This review has summarised the evidence for the use of graduated compression hosiery or stockings for the treatment of primary varicose veins in patients without venous ulceration. Of the 79 articles identified, only seven studies were eventually included, with a total of 356 participants with varicose veins without healed or active venous ulceration. All but one of the outcomes of the review (quality of life) were assessed in one or more of the included studies. No severe or long lasting side effects were noted.

Subjectively, participants' symptoms and physiological measures improved in all of the studies that assessed these outcomes when stockings were worn, but these assessments were not made by comparing one randomised arm of the trial with a control arm, and so are subject to bias. No conclusions regarding the optimum length of compression stocking can be made as there were no conclusive results from the included studies. Conclusions from individual studies regarding the optimum pressure provided by stockings are conflicting, although the results of one study (Jungbeck 1997) suggest that lower pressured stockings (20 mmHg) may be as effective for relieving symptoms as higher pressured stockings (30 to 40 mmHg).

Overall completeness and applicability of evidence

No studies assessed symptom change when wearing stockings compared to not wearing stockings. All the studies that assessed the outcome of symptom change included participants in whom two different types of stocking were compared. There is insufficient, high quality evidence to determine whether or not compression stockings are effective in the sole and initial treatment of varicose veins in people without healed or active venous ulceration or whether any type of stocking is superior to any other type. To answer the objective of this review, adequately powered trials that compare wearing stockings versus not wearing stockings would be required. Only one included study randomised participants to wearing hosiery or not wearing hosiery (Coughlin 2001). However, there were no data for the group that did not wear hosiery and the outcome of this study was compliance in pregnant women, not improvement of symptoms or physiological measures.

Although all the participants were diagnosed with varicose veins, as stated in the inclusion criteria, there was some variation in the type of participant. One study included only pregnant women, whilst other studies included participants who were on surgical waiting lists. Such groups of participants may bias towards participants who have sought medical intervention for their varicose veins.

The lack of conclusive results from this review means that its potential impact on clinical practice is very limited. Current clinical practice varies internationally. In the UK, compression stockings are often given as a first line of treatment and management for varicose veins without healed or active venous ulceration. Although stockings are generally not found to completely reverse or eradicate the disease, observational findings (as mentioned in this review) suggest that they may subjectively improve symptoms. However, as other treatments that could help remove varicose veins completely and improve cosmetic appearance become more viable and common in everyday practice patients may prefer these to wearing compression stockings for long periods of time. Compression stockings may remain important options for the elderly and those at risk from or not wanting a surgical or invasive procedure. They are also a cheap treatment with very few side effects, so some health professionals may still see them as the most efficient treatment in the first instance; the health professionals need to remember that initial compliance remains an issue though.

Quality of the evidence

Only seven studies with a total of 356 participants with varicose veins without healed or active venous ulceration were included in this review. Studies varied in sample size from 10 to 104. However, even the largest study was still relatively small. The methodological quality for included studies was unclear as inadequate reporting did not permitting a low risk or high risk of bias judgement (see 'Risk of bias' tables and Figure 2). This, combined with the small sample sizes, means the included studies were graded as relatively poor quality. Not all included studies assessed the same outcomes. Compliance generally appeared to be poor in the studies that assessed this outcome. The greatest number of drop-outs appeared to be when the hosiery was initially prescribed.

The included studies were conducted between nine and 30 years ago. The age of some studies is likely to be the cause of the inadequate reporting. The current standard for reporting clinical trials, the CONSORT statement, was not developed until 1996 and earlier studies did not have such specific guidelines. This made it difficult to assess the risk of bias for the included studies, all of which had inadequate reporting. A judgement of low risk or high risk of bias could not be given to items that were not described, as they may have taken place but were not reported. This led to most of the items for each of the studies being judged as unclear in the risk of bias tables.

Potential biases in the review process

This review followed a structured protocol that had been agreed by the Cochrane Peripheral Vascular Disease Group. At least two authors were involved in selecting relevant studies, assessing trial quality and extracting data.

Where necessary, authors were contacted to gather further information. Not all the authors replied, meaning these studies had to be excluded as it was not clear if participants met the inclusion criteria or not. However, relevant data may have been missed by excluding these studies, if participants did actually meet the inclusion criteria, leading to bias. Only by receiving a reply from the author could this be resolved.

Statistical analyses in the form of meta-analyses were not performed for any outcome. This was primarily due to the poor levels of reporting of the data from the included trials.

Agreements and disagreements with other studies or reviews

A recent systematic review by Palfreyman 2009 examined the current evidence regarding the effectiveness of compression hosiery in the treatment of varicose veins. The review included 25 studies, including RCTs, systematic reviews, non-randomised studies and guidelines. This review also found methodological flaws in the included studies and came to the conclusion that the evidence for the benefit of compression hosiery for varicose veins was equivocal. No conclusion regarding the class or length of compression hosiery for effective management of varicose veins was made. Therefore, the results of the present systematic review would appear to agree with the review by Palfreyman 2009. They do state, however, that the incorrect application of compression hosiery can have serious consequences, including necrosis. This review did not find any evidence to support or disagree with this statement. Even though the outcomes and methods of this review were slightly different to Palfreyman 2009, the results show that more research is required in this area, especially a large scale RCT. Currently the quality of evidence that is available does not permit a conclusive result.

Consensus papers, such as that by Partsch 2008, have shown the efficacy of compression therapy in phlebologic treatments. However, the present Cochrane review only looked at compression stockings for initial treatment of varicose veins without healed or active venous ulceration and not at the use of compression stockings in other situations, such as the use of stockings after varicose vein surgery or in combination with other varicose vein treatments, or other situations in which compression stockings are used. Although other Cochrane reviews have assessed the topic of varicose veins and compression therapy, no Cochrane review on this specific title has been produced previously.

There also appears to be a lack of current research investigating the effects of compression hosiery on varicose veins without healed or active venous ulceration. Therefore, although some trials do suggest a subjective improvement in symptoms, no statistically significant results are available either to support the use of compression hosiery or to show which level of compression or length is most effective.

Authors' conclusions

Implications for practice

From this review, there is insufficient, high quality evidence to determine whether or not compression hosiery or stockings are effective in the sole and initial treatment of varicose veins without healed or active venous ulceration or whether any type of stockings is superior to any other type. This could be because there was insufficient evidence available and the studies that were included had poor levels of reporting. However, where symptoms were assessed, many studies appeared to show a subjective improvement in participants wearing stockings but these assessments were not made by comparing one randomised arm of a trial with a control arm, and therefore are subject to bias. To provide hard evidence as to whether compression stockings are effective in the initial treatment and management of varicose veins in people without healed or active venous ulceration, a large scale RCT needs to be completed. Until this is done, no evidence-based implications for practice can be made.

Compliance with compression stockings appears to be initially poor when they are prescribed, with relatively high drop-out rates (around 30% from the two trials that assessed this outcome). However, it could also be suggested that a compliance rate in the long term of around 70% is relatively good for a treatment, but this is only relying upon the subjective evidence from the two small studies included in this review.

No severe or long lasting side effects were found in this review. However, stockings can have adverse effects if incorrectly applied or used in patients with peripheral vascular disease, and those fitting them should have received appropriate training.

Implications for research

During this review, no high quality studies were found assessing the effectiveness of compression hosiery or stockings in treating varicose veins compared to a control group (either with no treatment or with a placebo or non-compression stockings). This made it difficult to answer the specific research question. Many of the included studies compared pressures or makes of stocking, which therefore makes the assumption that some kind of improvement will be found in wearing stockings. This review could not find any significant evidence to suggest that stockings are effective in the initial treatment of varicose veins in people without healed or active venous ulceration. Therefore, a large scale, good quality RCT is required on this topic.

The reporting of all the included studies in this review was insufficient. Therefore, future research in this subject area should use up to date reporting guidelines such as CONSORT.

If significant evidence is found that suggests compression stockings are effective in the initial treatment and management of varicose veins in people without healed or active venous ulceration, trials into which is the optimum pressure and length of stocking to use would help guide clinical practice. It may also help standardise the classification of compression hosiery, making provision of stockings easier for healthcare professionals.

Acknowledgements

Editorial staff at the Peripheral Vascular Disease Group
Professor G Fowkes for his advice and guidance
Professor G Murray for his statistical input

Data and analyses

Download statistical data

This review has no analyses.

Appendices

Appendix 1. CENTRAL search strategy

 

#1MeSH descriptor: [Varicose Veins] explode all trees768
#2varicos*1224
#3(tortu* near/3 (vein* or veno* or saphenous))19
#4(incomp* near/3 (vein* or veno* or saphenous or valv*))144
#5(insuffic* near/3 (vein* or veno* or saphenous))742
#6((saphenous or vein* or veno*) near/3 reflux)105
#7(dilated near/3 (vein* or veno* or saphenous))33
#8MeSH descriptor: [Saphenous Vein] explode all trees554
#9GSV80
#10MeSH descriptor: [Venous Insufficiency] explode all trees355
#11(#1 or #2 or #3 or #4 or #5 or #6 or #8 or #9 or #10)2213
#12MeSH descriptor: [Bandages] explode all trees2047
#13stocking* or hosier* or tight* or sock* or bandag*:ti,ab,kw (Word variations have been searched)3858
#14jobst or surepress or activa or kendall or elbeo or levante or lloveras or cette or sigvaris or solidea or medilast or VenoTrain* or Soleg* or Ulcertec or ComfortPro or Comfort-Pro or "Ulcer Kit":ti,ab,kw (Word variations have been searched)144
#15#12 or #13 or #144342
#16#11 and #15 in Trials321
#17sr-pvd9869
#18#16 not #17194

What's new

Last assessed as up-to-date: 20 August 2013.

DateEventDescription
14 October 2013New citation required but conclusions have not changedSearches rerun, one new excluded study identified. Review updated accordingly, minor copy edits made. Conclusions not changed
14 October 2013New search has been performedSearches rerun, one new excluded study.

Contributions of authors

Sarah Shingler (SS) selected relevant trials, assessed trial quality, extracted data, carried out statistical analyses and wrote the review.
Lindsay Robertson (LR) selected relevant trials, assessed trial quality and extracted data.
Sheila Boghossian (SB) was consulted where disagreements occurred and checked data for accuracy.
Marlene Stewart (MS) was consulted for advice regarding the review process and contributed to the writing of the review.

Declarations of interest

None known

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Chief Scientist Office, Scottish Government Health Directorates, The Scottish Government, UK.

    The PVD Group editorial base is supported by the Chief Scientst Office.

Differences between protocol and review

In order to reflect the objective of this review more closely, the title of this review was changed from 'Compression stockings for varicose veins' to 'Compression stockings for the initial treatment of varicose veins in patients without venous ulceration'.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Anderson 1990

Methods

Study was a prospective, randomised, cross-over trial with a factorial design

Method of randomisation: Not stated

Concealment of allocation: Not stated

Details of blinding: Not stated

No intention-to-treat analysis or sample size calculation is provided

Exclusions post randomisation: Six

Sources of funding: Not stated

Participants

Country: Scotland, UK

Setting: The Glasgow Royal Infirmary (for initial assessment and data collection)

No: 72 participants were randomised

Age: Between 20 and 61 (average age 40 years).

Sex: Both

Inclusion Criteria: All patients on the waiting list for varicose vein surgery, who were interviewed to determine the presence of lower limb pain, heaviness, itching, night cramps, swelling or cosmetic distress. To be included, patients had to have two or more of these symptoms (excluding cosmetic distress).

Exclusion Criteria: Patients were excluded if their only complaint was embarrassment from vein appearance; aged over 65; had clinical evidence of peripheral arterial disease; concurrent treatment with diuretic, calcium antagonist, non steroidal anti-inflammatory, vasodilator or corticosteroid drugs; a history of deep vein thrombosis.

Interventions

Treatment: There were four possible treatment arms:

1) Placebo capsules alone, 2) Paroven alone, 3) Hosiery + placebo 4) Hosiery + Paroven.

Paroven was taken for 28 days at a dose of 250mg, four times a day.

Hosiery was full length and fitted to give a pressure of 30 - 40 mmHg at the ankle.

Control: Each patient acted as their own control. Placebo was also used.

Duration: Each of these treatments were taken for successive four week periods and treatment sequence was balanced within groups of 12 in three Latin squares to minimise carry-over effect.

Outcomes

Primary outcome measure: Subjective symptoms, including pain, heaviness, itching, swelling and cramp measured by visual analogue scale (VAS) following each treatment.

Secondary outcomes: Compliance was assessed by counting the number of capsules left at each return visit and by asking the patient how long they wore the stockings for each day.

The aim of the study was to assess efficacy of graduated compression hosiery and Paroven, both singly and in combination, when treating varicose veins.

Notes

No washout period between treatments.

Acknowledgement is given to companies for providing Paroven, placebo capsules and Sigvaris 503 graduated compression hosiery.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information provided
Allocation concealment (selection bias)Unclear riskInsufficient information provided
Blinding (performance bias and detection bias)
All outcomes
Unclear riskInsufficient information provided. Patients will have known if they were provided with a stocking, but no information on whether assessors were blind.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAll drop-outs/withdrawals accounted for, but unclear when reporting clinic attendance.
Selective reporting (reporting bias)Unclear riskPrimary outcome reported. Little information or analyses on compliance.
Other biasUnclear risk

Acknowledgements to "Zyma (UK) Ltd and Ganzoni (Switzerland) for providing Paroven and placebo capsules and Sigvaris 503 graduated compression hosiery."

No wash out periods given between treatments.

Chant 1985

Methods

Study was a randomised controlled trial

Method of Randomisation: Patients were selected sequentially from a surgical waiting list, no further information is provided.

Method of concealment: Not stated

Details of blinding: Results were "reviewed blind", no information on whether patients or other personnel were blinded.

There is no power calculation or intention-to-treat analysis provided

Exclusions post randomisation: 163 initially asked to take part, but 104 actually entered the trial and were randomised. "25 did not reply because they had moved from the area, 4 had undergone operations elsewhere and 30 declined to participate".

Source of funding: Not stated

Participants

Country: Southampton, England, UK

Setting: Department of vascular surgery

No: 104 participants

Age: Not stated

Sex: Not stated

Inclusion and exclusion criteria: No clear criteria stated. "Groups were evenly matched for age, symptomatology, and extent of varicose veins". Patients were selected from a varicose vein surgical waiting list, "starting with those added most recently".

Interventions

Treatment: Participants were randomised into two groups:

- 53 to wear below-knee stockings providing 30 - 40 mmHg pressure at the ankle

- 51 to wear below-knee stockings providing 40 - 50 mmHg pressure at the ankle

Control: Not stated

Duration: Six weeks

Outcomes

Primary outcome: Leg symptoms (self-reported)

Secondary outcome: Tolerance of the stocking was also assessed

The aim of this study was to investigate the acceptability of the stocking, Sigvaris. When reviewed, "particular attention was paid to tolerance of the stockings and whether symptoms were better, worse or unchanged".

NotesSigvaris Company provided the stockings
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk

"Patients were selected sequentially from a surgical waiting list"

No information on how the sequence was generated is provided however

Allocation concealment (selection bias)Unclear riskInsufficient information provided
Blinding (performance bias and detection bias)
All outcomes
Unclear riskReviewers were blinded: "They were then reviewed blind", but no information on whether the participants or any other personnel were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information to permit judgement
Selective reporting (reporting bias)Unclear risk

The primary outcome of leg symptoms are reported on. However, tolerance is not clearly reported: "Of the 104 patients who took part in the trial, 80 claimed the stockings were comfortable....the main cause of discomfort was not simply that they were too tight".

The main focus in the comment section is the fact that they were able to reduce their waiting list by 51 patients, who wanted to be removed from the surgical waiting list due to symptom improvement. This was not one of the aims or outcomes stated in the methods.

Other biasUnclear risk

Acknowledgement given to Sigvaris Company for providing the stockings.

Authors state "we accept that the study was biased towards surgery because patients were taken from the waiting list..."

Chant 1989

Methods

Study was a randomised controlled trial

Method of randomisation:Not stated

Concealment of allocation: Not stated

Details of blinding: None stated

No power calculation and no intention-to-treat analysis

Exclusions/loses post randomisation: 26. 22 failed to collect the prescribed stockings. A further four underwent elective surgery before having a chance to assess the stocking effects.

Source of funding: Not stated

Participants

Country: Southampton, England, UK

Setting: Royal South Hants Hospital outpatient dept and patients homes

No: 40 participants

Age: Not stated

Sex: Not stated

Inclusion criteria: Not clear, patients awaiting surgery for varicose veins were included

Exclusion criteria: Not stated

Interventions

Treatments: Of those who collected the stockings:

- 18 participants wore Medi Plus stockings

- 22 participants wore Sigvaris stockings

"The exact prescription was tailored to the patients' degree of venous insufficiency as specified in the manufacturer's guidelines".

Control: Not stated

Duration: Not clearly stated. Data was collected "on average 6 weeks following collection of stockings".

Outcomes

Primary outcome: Participant compliance with wearing stockings

The study also explores "the patients physical ability to put the stockings on".

Notes

No information as to the level of pressure provided by the stockings is provided. Patients appear to have been given varying degrees of compression stocking depending on their symptoms: "The exact prescription was tailored to the patients' degree of venous insufficiency as specified in the manufacturer's guidelines".

High withdrawal rate from beginning of the study (39%).

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information reported
Allocation concealment (selection bias)Unclear riskInsufficient information reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskInsufficient information reported
Incomplete outcome data (attrition bias)
All outcomes
Low riskReasons provided for all drop outs and no missing outcome data. Results written to allow actual number of participants to be seen and accounted for.
Selective reporting (reporting bias)Unclear riskCompliance is reported, but little information regarding grip strength data is provided (chi square) only. No results are given or discussed regarding symptomatic relief.
Other biasUnclear risk

Pressure of stocking not known, possibly varied depending on individuals' symptoms/venous insufficiency: "prescription was tailored to the individual".

High withdrawal/drop-out rate.

Chauveau 2000

Methods

Study was a randomised cross-over trial

Method of randomisation: Not stated

Concealment of allocation: Not stated

Details of blinding: Not stated

No information is provided regarding intention-to-treat analysis or a power calculation

Exclusions post randomisation: None

Source of funding: Not stated

Participants

Country: France

Setting: Outpatients at the Phlebology Department of Notre Dame de Bon Secours Hospital, Paris

No: 10

Age: Mean age 52 years (range 27 - 77 years)

Sex: All female

Inclusion criteria: Mild to moderate primary varicose veins, with or without skin trophic disorder.

Some also complained of other symptoms: Eight of them complained of leg heaviness, four of leg pain and three of night cramps.

Exclusion criteria: No clear exclusion criteria is stated, but none of the participants had a history of deep vein thrombosis, sclerotherapy within the last 6 months, clinical evidence of lower limb obstructive arteriopathy, or acute or severe illness. All had normal deep veins.

Interventions

Treatments: French class 1 (10 - 15 mmHg) and class 2 (15 - 20 mmHg) below-knee stockings were worn by all participants allocated in a random order.

Control: Measures taken before stockings were worn.

Duration: Not clear. Study followed a protocol, which included starting at 9am and wearing each stocking for a period of 15 minutes, between control measures (15 minutes without wearing a stocking).

OutcomesPrimary outcome: Calf volume changes (via air plethysmography). Air plethysmography with venous occlusion (50 mmHg) was used to measure arterial inflow (AI), venous volume (V50) and maximum venous outflow (MVO).
NotesSmall sample size
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo information provided. "Each patient was examined with both stocking classes, allocated in a random order".
Allocation concealment (selection bias)Unclear riskInsufficient information reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskInsufficient information reported
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskUnclear as results table only gives mean value with standard deviation
Selective reporting (reporting bias)Unclear riskResults report outcome that maximum venous outflow was unchanged by class 1 and class 2 below-knee stockings. Requires further information to permit judgement.
Other biasUnclear risk

Sample size was small (n = 10).

Participants only wore stockings for 15 minutes.

Coughlin 2001

Methods

Study was a randomised controlled trial

Method of randomisation: Not stated

Concealment of allocation: Not stated

Details of blinding: Not stated. Patients were obviously aware if they were provided with a stocking or not

There is no power calculation or intention-to-treat analysis

Exclusions/drop-outs post-randomisation: Of the 46 randomised to wear tights, an initial 15 wished not to wear them

Source of funding: Not stated

Participants

Country: UK

Setting: Antenatal clinic of Countess of Chester Hospital

No: 83 identified, 46 randomised to wear tights

Age: Not stated

Sex: All female (all pregnant)

Inclusion criteria: Not clearly stated. All were pregnant, diagnosed with superficial reflux from a scan, and varicose veins and normal deep veins.

Exclusion criteria: Not stated

Interventions

Treatment: Randomised to wear class 1 compression tights or not.

Control: It is presumed those not randomised to wear tights (n = 37) acted as the control, but no further information is given on this group.

Duration: Not clearly stated. Initial booking visit, up until 6 weeks post partum. It is unclear if this was the pre-identified time to stop wearing tights or the women just stopped wearing them at this time.

OutcomesPrimary outcome: Acceptability and therefore compliance/usage of compression tights in pregnant women.
Notes

No information on the classification of the stocking and therefore the pressure exerted is provided.

High drop-out rate

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information reported, "46 women were randomised to wear tights..."
Allocation concealment (selection bias)Unclear riskInsufficient information reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskParticipants were obviously not blinded as they were either given tights or not, but no information is given as to whether assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot known where the other 37 possible control women were assessed or not
Selective reporting (reporting bias)Unclear riskInsufficient information reported
Other biasUnclear riskHigh withdrawal rate at baseline (n = 15, 32%), may make conclusion less robust.

Jones 1980

Methods

Study was a randomised cross-over trial

Method of randomisation: Not stated

Concealment of allocation: Not stated

Details of blinding: Not stated

There is no power calculation or intention-to-treat.

Exclusions post randomisation: None

Source of funding: Acknowledgement for support is given to the MRC Programme Grant No. G973/756

Participants

Country: London, UK

Setting: Thrombosis Research Unit, King's College Hospital.

No: 30 (in three groups, one being varicose veins n = 10)

Age: Not stated

Sex: 26 female, 4 male

Inclusion criteria:

Group 1: normal deep veins and no varicose veins (n = 10 female)

Group 2: superficial varicose veins (n = 9 female, 1 male)

Group 3: post-phlebitic limb (n = 7 female, 3 male)

Exclusion criteria: Not stated

Interventions

Treatment: Participants wore: Eesiness NHS 2-way stretch stockings (20 mmHg) or Sigvaris graduated pressure stockings (30 - 40 mmHg) in a random order.

Control: The 30 patients all had control measures taken at the initial visit via foot volumetry and sodium clearance. Group 1 were also used as a control group, but were recruited after a suspected deep vein thrombosis or aching legs.

Duration: Three weeks in one stocking, one week with no stocking, then 3 weeks in the other stocking.

Outcomes

Primary outcome: The competence of superficial and deep venous system measured by foot volumetry (EV, EVR, Q, Q/EVR and T1/2) and sodium subcutaneous tissue clearance.

Secondary outcome: Patient acceptability of stockings

NotesAcknowledgements given to Ganzoni and Cie AG, St Gallen, Switzerland for supplying the Sigvaris stockings.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information reported
Allocation concealment (selection bias)Unclear riskInsufficient information reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNo mention of whether measures were in place to blind participants from the type of stocking they were wearing. There is no mention of whether assessors were blind when collecting or analysing data.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo missing data obvious, but results given as means and standard deviations.
Selective reporting (reporting bias)Unclear riskInsufficient information reported
Other biasUnclear riskAcknowledgement given to Ganzani and Cie AG, St Gallen, Switzerland for supplying Sigvaris stockings.

Jungbeck 1997

Methods

Study was randomised

Method of randomisation: Not stated

Concealment of allocation: Not stated

Details of blinding: Not stated

There is no power calculation or intention-to-treat analysis.

Exclusions post randomisation: 6 withdrew from the study

Source of funding: Not stated

Participants

Country: Lund, Sweden

Setting: Department of vascular surgery and vascular laboratory, University Hospital, Lund.

No: 37

Age: Ranging from 27 to 82 years of age

Sex: 21 female, 9 male

Inclusion criteria: Seeking advice for symptomatic varicose veins with (or without) minor skin changes. Patients could have bilateral venous insufficiency, classified as grade 2 (varicose veins) and recurrent varicose veins.

Exclusion criteria: Not stated

Interventions

Treatment: Low grade (class 1, 20 mmHg) or medium grade (class 2, 30 mmHg) Jobst Medical Leg wear knee-hi graduated stockings.

Control: None stated. Baseline values of foot volumetry taken.

Duration: eight weeks.

OutcomesPrimary outcomes: Foot volumetry measures (EV, EVrel, Q and Q/EVrel) and Visual analogue scale (VAS) used to evaluate pain, ankle swelling, tired legs, restless legs and night cramps according to the individual. VAS was repeated after the eight weeks of compression treatment.
NotesAcknowledgement is given to Beiersdorf AG, Germany for the supply of stockings and contribution.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskInsufficient information reported
Allocation concealment (selection bias)Unclear riskInsufficient information reported
Blinding (performance bias and detection bias)
All outcomes
Unclear riskInsufficient information reported
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNo missing data stated, but unclear as results given as percentages
Selective reporting (reporting bias)Unclear riskFoot volumetry outcomes reported. However, VAS results are expressed as median percentages for each class of stocking, making it impossible to distinguish differences in individual symptoms.
Other biasUnclear riskAcknowledgement given: "The supply of stockings and the contribution by Beiersdorf AG, Germany, is greatly appreciated."

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Abramowitz 1973The trial examined sclerotherapy versus compression. The trial had no control group to compare the compression group to.
Acsady 1996Study was not an RCT, and intervention is not compression.
Austrell 1995Participants did not meet inclusion criteria as they are not diagnosed with varicose veins.
Benigni 2003Includes patients with chronic venous disease CEAP classification C1 - 3. No subgroup analysis for those participants with CEAP 2 and above, which could be included in this review. Liaised with author who has no further results for this sub group of patients only, therefore unable to include.
Biswas 2007Participants underwent vascular surgery followed by randomisation to compression stockings.
Bond 1997Participants underwent surgical intervention followed by randomisation to compression.
Bond 1999Participants underwent surgery followed by randomisation to compression.
Derman 1989Participants were healthy women, not diagnosed with varicose veins.
Gandhi 1984Unable to distinguish participants with varicose veins (contact with author attempted). Garments used were anti-embolism, general support garments and bandages.
Griffin 2007Trial compares pneumatic compression systems, not meeting inclusion criteria.
Guest 2003Participants were diagnosed with venous ulceration, not meeting inclusion criteria.
Hamel-Desnos 2008Participants underwent sclerotherapy followed by compression stockings.
Hamel-Desnos 2010Participants underwent sclerotherapy followed by randomisation to compression or no compression.
Hirai 2002Study was not an RCT.
Horvath 1983Study was not an RCT.
Houtermans-Auckel 2009Participants underwent surgical intervention followed by randomisation to compression stockings.
Ibegbuna 1997Study was not an RCT.
Isiklar 2003Study was not an RCT, participants underwent sclerotherapy followed by compression.
Kakkos 2001Study was not an RCT, compression used was pneumatic compression.
Kline 1972Study was not an RCT, participants underwent sclerotherapy followed by compression.
Lascasas 2009Trial was not an RCT, participants were randomised by entrance order. Therefore, study did not meet the inclusion criteria.
Leon 1993This study was not randomised, therefore did not meet this study's inclusion criteria.
Makin 1982Participants underwent sclerotherapy followed by compression.
Mariani 2011Participants underwent surgical intervention followed by randomisation to compression.
Mauss 1969Study was not an RCT.
Melrose 1979Participants underwent surgical intervention followed by randomisation to compression.
Mosti 2009Participants underwent surgery followed by randomisation to compression.
Mosti 2011Includes participants with chronic venous disease CEAP classification C2 to C5. No subgroup analysis reported for those participants with CEAP C2 to C4, which could be included in this review. Attempted to contact study author but no reply received, therefore unable to include.
Norgren 1988Study was not randomised, and therefore not an RCT.
O'Hare 2010Participants underwent sclerotherapy followed by randomisation for compression.
Perhoniemi 1983Participants underwent varicose vein surgery then allocated to compression stockings or bandages.
Pierson 1983Study was not randomised.
Rabe 2010Participants were diagnosed with phlebitis, not varicose veins.
Raju 2007Study was retrospective and non-randomised.
Raraty 1999Participants underwent surgery followed by bandages or stockings.
Schul 2009Participants had isolated reticular veins and telangiectasia therefore not meeting inclusion criteria.
Szendro 1992Study not randomised, outcomes not among those evaluated in this review.
Thaler 2001Participants did not meet inclusion criteria for this study as varicose veins were not present at the start of the trial.
Weiss 1999Participants underwent sclerotherapy followed by compression therapy.
Zhang 2004Study was not an RCT, participants underwent invasive procedure as well as compression.

Characteristics of ongoing studies [ordered by study ID]

NCT00766974

Trial name or titleCompression aided management of edema in patients with C3 venous disease
MethodsPatients with venous disease and edema and non-venous edema will be evaluated by clinical exam and venous duplex ultrasound. Patients eligible for the study will be randomised to knee-high 20 - 30 mmHg graded compression stockings or anti-embolism (13 - 18 mmHg) compression stockings. Patients will have limb quantitative edema assessment, a severity score and quality of life determination. Compression will be assigned to each treatment group with instruction on proper wear and duration, and the interface pressure of compression at the skin surface at the ankle level determined. Following 4 weeks of compression, patients will return for evaluation in the following areas: quantify limb edema, quantify compression at the ankle, venous clinical severity score, and venous disease specific quality of life.
ParticipantsPatients of both sexes aged 18 - 80 will be included. Participants must have varicose veins or lower leg edema (bilaterally or unilaterally) or both.
InterventionsPatients eligible for the study will be randomised to knee-high 20 - 30 mmHg graded compression stockings or anti-embolism (13 - 18 mmHg) compression stockings to wear for four weeks.
OutcomesOutcomes include amount of limb edema, quantify compression at the ankle, venous clinical severity score, and venous disease specific quality of life. Data are analysed using ANOVA followed by Scheffe's F test for comparison of multiple means. Student's t-test for unpaired and paired data will be used for comparison of two means.
Starting dateOctober 2008
Contact informationPrinciple Investigator: Joseph Raffetto, MDBoston VA Healthcare, West Roxbury, Massachusettes, United States 857-203-5572
NotesJoseph Raffetto contacted in November 2013. The study is still ongoing. Plan to publish the results possibly in 2014.

Ancillary