Interventions for varicose veins and leg oedema in pregnancy New search for studies and content updated (no change to conclusions)

Abstract

Background

Pregnancy is presumed to be a major contributory factor in the increased incidence of varicose veins in women, which can in turn lead to venous insufficiency and leg oedema. The most common symptom of varicose veins and oedema is the substantial pain experienced, as well as night cramps, numbness, tingling, the legs may feel heavy, achy, and possibly be unsightly. Treatments for varicose veins are usually divided into three main groups: surgery, pharmacological and non‐pharmacological treatments. Treatments of leg oedema comprise mostly symptom reduction rather than cure and use of pharmacological and non‐pharmacological approaches.

Objectives

To assess any form of intervention used to relieve the symptoms associated with varicose veins and leg oedema in pregnancy.

Search methods

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies.

Selection criteria

Randomised trials of treatments for varicose veins or leg oedema, or both, in pregnancy.

Data collection and analysis

Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.

Main results

We included seven trials (involving 326 women). The trials were largely unclear for selection bias and high risk for performance and detection bias.

Two studies were placebo‐controlled trials. The first one compared a phlebotonic (rutoside) with placebo for the reduction in symptoms of varicose veins; the second study evaluated the efficacy of troxerutin in comparison to placebo among 30 pregnant women in their second trimester with symptomatic vulvar varicosities and venous insufficiency in their lower extremities. Data from this study were not in useable format, so were not included in the analysis. Two trials compared either compression stockings with resting in left lateral position or reflexology with rest for 15 minutes for the reduction of leg oedema. One trial compared standing water immersion for 20 minutes with sitting upright in a chair with legs elevated for 20 minutes. Women standing in water were allowed to stand or walk in place. One trial compared 20 minutes of daily foot massage for five consecutive days and usual prenatal care versus usual prenatal care. The final trial compared three treatment groups for treating leg oedema in pregnancy. The first group was assigned to lateral supine bed rest at room temperature, women in the second group were asked to sit in a bathtub of waist‐deep water at 32 ± 0.5 C with their legs horizontal and the third group included the women who were randomised to sitting immersed in shoulder‐deep water at 32 ± 0.5 C with legs extended downward. We did not include this study in the analysis as outcomes reported in the paper were not pre‐specified outcomes of this review.

We planned to use GRADE methods to assess outcomes for two different comparisons and assign a quality rating. However, only two out of three outcomes for one comparison were reported and could be assessed. Evidence from one trial (rutoside versus placebo) for the outcomes of reduction in symptoms and incidence of complications associated with varicose veins and oedema was assessed as of moderate quality.

Rutoside versus placebo 

One trial involving 69 women, reported that rutoside significantly reduced the symptoms associated with varicose veins (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.11 to 3.22; moderate quality evidence). The incidence of complications (deep vein thrombosis) did not differ significantly between the two groups (risk ratio (RR) 0.17, 95% CI 0.01 to 3.49; moderate quality evidence). There were no significant differences in side‐effects (RR 1.30, 95% CI 0.23 to 7.28). Women's perception of pain was not reported in this trial.

External pneumatic intermittent compression versus rest 

One trial, involving 35 women, reported no significant difference in lower leg volume when compression stockings were compared against rest (mean difference (MD) ‐258.80, 95% CI ‐566.91 to 49.31).

Reflexology versus resting 

Another trial, involving 55 women, compared reflexology with rest. Reflexology significantly reduced the symptoms associated with oedema (reduction in symptoms: RR 9.09, 95% CI 1.41 to 58.54). The same study showed a trend towards satisfaction and acceptability with the intervention (RR 6.00, 95% CI 0.92 to 39.11).

Water immersion versus leg elevation 

There was evidence from one trial, involving 32 women, to suggest that water immersion for 20 minutes in a swimming pool reduces leg volume (RR 0.43, 95% CI 0.22 to 0.83).

Foot massage versus routine care 

One trial, involving 80 women reported no significant difference in lower leg circumference when foot massage was compared against routine care (MD ‐0.11, 95% CI ‐1.02 to 0.80).

No other primary or secondary outcomes were reported in the trials.

Authors' conclusions

There is moderate quality evidence to suggest that rutosides appear to help relieve the symptoms of varicose veins in late pregnancy. However, this finding is based on one study (69 women) and there are not enough data presented in the study to assess its safety in pregnancy. Reflexology or water immersion appears to help improve symptoms for women with leg oedema, but again this is based on two small studies (43 and 32 women, respectively).

Author(s)

Rebecca MD Smyth, Nasreen Aflaifel, Anthony A Bamigboye

Abstract

Plain language summary

Interventions for varicose veins and leg oedema in pregnancy 

There is not enough evidence on treatments for varicose veins and leg oedema in pregnancy.

Varicose veins, sometimes called varicosity, occur when a valve in the blood vessel walls weakens and the blood stagnates. This in turn leads to problems with the circulation in the veins and to oedema or swelling. The vein then becomes distended, its walls stretch and sag, allowing the vein to swell into a tiny balloon near the surface of the skin. The veins in the legs are most commonly affected as they are working against gravity, but the vulva (vaginal opening) or rectum, resulting in haemorrhoids (piles), can be affected too. Pregnancy seems to increase the risk of varicose veins and they cause considerable pain, night cramps, numbness, tingling, the legs may feel heavy, achy, and they are rather ugly. Treatments for varicose veins are usually divided into three main groups: pharmacological treatments, non‐pharmacological and surgery. The review identified seven trials involving 326 women. Although there was a moderate quality evidence to suggest that the drug rutoside seemed to be effective in reducing symptoms, the study was too small to be able to say this with real confidence. Similarly, with reflexology and water immersion, there were insufficient data to be able to assess benefits and harms, but they looked promising. Compression stockings do not appear to have any advantages. More research is needed.

Author(s)

Rebecca MD Smyth, Nasreen Aflaifel, Anthony A Bamigboye

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

Rutosides appear to help relieve the symptoms of varicose veins in late pregnancy. However, this finding is based on one study (69 women) and there are not enough data presented in the study to assess its safety in pregnancy.

Reflexology and water immersion appears to help improve symptoms for women with leg oedema, but again, the findings are based on single studies.

Implications for research 

We are unable to provide clear guidance regarding any form of intervention used to relieve the symptoms associated with varicose veins and leg oedema in pregnancy. We have identified that there is a need for large, well‐designed multicentre randomised controlled trials with clear allocation concealment, which will allow for robust conclusions to be drawn. It is of note that the largest trial included in this review involved only 69 women.

As a result of the findings of this Cochrane review, we make the following suggestions for the design and conduct of future trials investigating the use of any form of intervention used to relieve the symptoms associated with varicose veins and leg oedema in pregnancy.

Large multicentre trials are needed, which look at clinically relevant outcomes; neonatal outcomes, adverse effects and maternal satisfaction.

Data on economic outcomes should be obtained, to allow for allocation of resources and service planning.

It is difficult to blind women and caregivers to their randomised allocation because of the invasive nature of the interventions. It is possible to blind the outcome assessor to treatment allocation, which is strongly recommended. Any blinding should be clearly stated in the trial report.

Trial protocols should be made publicly available in order to allow comparison of the reported outcomes with prespecified outcomes. This will allow outcome reporting bias to be kept to a minimum.

It is essential to involve consumers in any future trials at all stages, and most significantly during the planning stages, in order to identify those outcomes which are deemed of most relevance and importance.

There was no information in any of the included trials regarding long‐term outcomes for women and babies. We propose that future trialists should consider instituting some form of long‐term follow‐up which is feasible and appropriate for the study population in question.

If interventions such as those identified in this review are shown to do more good than harm, the next step would be to establish the optimum dosage, timing of intervention, and which are acceptable to women.

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