Review question
What is the effectiveness of compression stockings as the only and initial treatment of varicose veins in people without healed or active venous ulceration (leg ulcers)?
Background
Varicose veins are widened veins that twist and turn and are visible under the skin of the legs. They generally do not cause medical problems, although many people seek medical advice. Symptoms may include pain, ankle swelling, tired legs, restless legs, night cramps, heaviness, itching and distress from their cosmetic appearance. Complications such as oedema (build-up of fluid), pigmentation, inflammation (swelling, redness and pain) and ulceration (sores) can also develop. Compression stockings are often the first line of treatment and come in a variety of lengths from knee-length to full tights, and apply different pressures to support the flow of blood in the veins.
Study characteristics
We included 13 studies involving 1021 participants with varicose veins who had not experienced venous ulceration in this review (search run May 2020). Five studies assessed compression stocking versus no compression stocking (for example no treatment or placebo stocking with no graduated elastic). Three of these studies used knee-length stockings, one used full-length stockings and one used full tights. Eight studies compared different types or pressures of knee-length stockings. The stockings used in the studies exerted different levels of pressure. One study included only pregnant women, while other studies included people who had sought medical intervention for their varicose veins by being on surgical waiting lists, or attending vascular surgery or dermatology (skin care) clinics or outpatient departments.
Key results
Participants considered their symptoms had improved when stockings were worn in the nine studies that assessed this outcome, but these assessments were not always made by comparing one treatment group of the trial with a control group in the same study and was therefore subject to bias.
Two studies comparing stockings with placebo stockings measured physical signs; there was no clear difference between baseline and follow-up for ankle circumference, while oedema was reduced in the stocking group compared with the placebo stocking group. Generally there were no clear differences between studies comparing two types of stockings for volume reduction and change in diameter (ways to measure oedema).
Complications or side effects ranged from sweating, itching, irritation, skin dryness and a feeling of tightness. There were no severe or long-lasting side effects.
Two studies comparing stockings with different stockings, and four studies comparing stockings with placebo/no treatment assessed compliance (whether the person used the stockings as directed). In the stocking versus different stocking studies, there was no clear difference between the stockings, with generally low levels of compliance reported. In the stocking versus placebo/no treatment group, three studies reported results. Of these, one study reported a high initial dropout rate with generally low levels of compliance. The other two studies reported generally good compliance in the stocking group. Some reasons provided for non-compliance included discomfort, difficulty in putting the stockings on, appearance, not being effective and causing irritation.
Four studies that compared stockings with different stockings and two studies that compared stockings with placebo/no treatment assessed comfort, tolerance and acceptability of stockings. Comparing stockings with placebo/no treatment, comfort, tolerance and acceptability was affected by the study population. Compression tights were increasingly rejected by pregnant women as their pregnancy progressed, while in a study of non-pregnant women, the stockings group showed no more hindrance of normal activities and daytime discomfort when compared with placebo stockings. In the stocking versus different stockings studies, two studies reported similar levels of tolerance and discomfort between the types of stocking. Discomfort was the main reason for indicating a preference for one type of stocking over another.
One study assessed quality of life, showing no clear differences between the stocking and no stocking groups.
No conclusions regarding the optimum length or pressure of compression stockings could be made as there were no conclusive results from the included studies.
Certainty of the evidence
The certainty of the evidence was low or very low because of risk of bias due to poor reporting, not all studies assessed the same outcomes, they assessed them in different ways, or reported them in a way that they could be combined and analysed with other studies. Evidence from available 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.
There is insufficient high-certainty 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 large RCTs 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.
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 the second update of a review first published in 2011.
To assess the effectiveness of compression stockings for the only and initial treatment of varicose veins in people without healed or active venous ulceration.
For this update, the Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and AMED databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 May 2020. We also checked references of studies identified from the literature searches.
We included randomised controlled trials (RCTs) involving people 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 or placebo stockings, or compression stockings plus drug intervention versus drug intervention alone. We also included trials comparing different lengths and pressures of stockings. We excluded 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.
We followed standard Cochrane methodology. Two review authors independently assessed trials for inclusion, extracted data, assessed risk of bias and assessed the certainty of the evidence using GRADE. Outcomes of interest were change in symptoms; physiological measures; complications; compliance; comfort, tolerance and acceptability of wearing stockings; and quality of life.
We included 13 studies with 1021 participants with varicose veins without healed or active venous ulceration. One study included pregnant women while other studies included participants who had sought medical intervention for their varicose veins by being on surgical waiting lists, or attending vascular surgery or dermatology clinics or outpatient departments. The stockings used in the studies exerted different levels of pressure, ranging from 10 mmHg to 50 mmHg. Five studies assessed compression stockings versus no compression stockings or placebo stockings. Three of these studies used knee-length stockings, one used full-length stockings and one used full tights. Eight studies compared different types or pressures of knee-length stockings. The risk of bias of many included trials was unclear, mainly because of inadequate reporting. We were unable to pool studies as they did not report the same outcomes or used different ways to assess them. Many studies were small and there were differences in the populations studied. The certainty of the evidence was therefore low to very low.
Compression stockings compared with no treatment or placebo stockings
All four studies that reported change in symptoms found a subjective improvement by the end of the study. However, change in symptoms was not always analysed by comparing the randomised arms of the studies and was therefore subject to bias. Two studies assessed physiological measures using either ankle circumference or duplex sonography to measure oedema. Ankle circumference showed no clear difference between baseline and follow-up while oedema was reduced in the stocking group compared with the placebo stocking group. Three studies reported complications or side effects with itching and irritation the main side effects reported. None of the trials reported severe side effects. Reports of compliance varied between studies. One study reported a high dropout rate with low levels of compliance due to discomfort, application and appearance; two studies reported generally good levels of compliance in the stocking group compared to placebo/no treatment. Two studies reported comfort, tolerance and acceptability with outcomes affected by the study population. Compression tights were increasingly rejected by pregnant women as their pregnancy progressed, while in one study of non-pregnant women, the stockings group showed no more hindrance of normal activities and daytime discomfort when compared with placebo stockings. One study reported quality of life showing no clear differences between the stocking and placebo stocking groups.
Compression stockings compared with different compression stockings
All five studies that reported change in symptoms found a subjective improvement in symptoms by the end of the study. Change in symptoms was not always analysed comparing the randomised arms of the trials and was therefore subject to bias. Five studies reported a variety of physiological measures such as foot volumetry, volume reduction and change in diameter. Generally, there were no clear differences between study arms. Four studies reported complications or side effects, including sweating, itching, skin dryness, and constriction and tightness. None of the trials reported severe side effects. Two studies reported compliance showing no difference in compliance rates between stockings groups, although one study reported high initial levels of dropout due to discomfort, appearance, non-effectiveness and irritation. Four studies reported comfort, tolerance and acceptability. Two studies reported similar levels of tolerance and discomfort between groups. Discomfort was the main reason for indicating a preference for one type of stocking over another. None of the studies assessed quality of life.
No conclusions regarding the optimum length or pressure of compression stockings could be made as there were no conclusive results from the included studies.