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

  1. Sarah Shingler1,*,
  2. Lindsay Robertson2,
  3. Sheila Boghossian3,
  4. Marlene Stewart4

Editorial Group: Cochrane Vascular Group

Published Online: 9 DEC 2013

Assessed as up-to-date: 20 AUG 2013

DOI: 10.1002/14651858.CD008819.pub3


How to Cite

Shingler S, Robertson L, Boghossian S, Stewart M. Compression stockings for the initial treatment of varicose veins in patients without venous ulceration. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD008819. DOI: 10.1002/14651858.CD008819.pub3.

Author Information

  1. 1

    Oxford Outcomes, Oxford, UK

  2. 2

    The Freeman Hospital, Department of Vascular Surgery, Newcastle upon Tyne, UK

  3. 3

    The University of Edinburgh, Public Health Sciences, The Medical School, Edinburgh, UK

  4. 4

    University of Edinburgh, Centre for Population Health Sciences, Edinburgh, UK

*Sarah Shingler, Oxford Outcomes, Seacourt Tower, West Way, Oxford, OX2 0JJ, UK. shinglersl@hotmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 9 DEC 2013

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Characteristics of included studies [ordered by study ID]
Anderson 1990

MethodsStudy 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


ParticipantsCountry: 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.


InterventionsTreatment: 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.


OutcomesPrimary 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.


NotesNo 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 riskAcknowledgements 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

MethodsStudy 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


ParticipantsCountry: 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".


InterventionsTreatment: 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


OutcomesPrimary 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 riskThe 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 riskAcknowledgement 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

MethodsStudy 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


ParticipantsCountry: 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


InterventionsTreatments: 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".


OutcomesPrimary outcome: Participant compliance with wearing stockings

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


NotesNo 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 riskPressure 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

MethodsStudy 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


ParticipantsCountry: 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.


InterventionsTreatments: 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 riskSample size was small (n = 10).

Participants only wore stockings for 15 minutes.

Coughlin 2001

MethodsStudy 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


ParticipantsCountry: 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


InterventionsTreatment: 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.


NotesNo 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

MethodsStudy 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


ParticipantsCountry: 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


InterventionsTreatment: 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.


OutcomesPrimary 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

MethodsStudy 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


ParticipantsCountry: 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


InterventionsTreatment: 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.