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. 2015 Oct 19;2015(10):CD001066. doi: 10.1002/14651858.CD001066.pub3

Bergstein 1975.

Methods Randomised controlled trial comparing O ‐ (B‐hydroxyethyl) rutoside (HR) with matching placebo.
Participants Inclusion criteria: 28 weeks' gestation with visible varicose veins on legs and vulva and subjective complaints, no sign of internal disease or arterial or orthopaedic abnormality of the legs.
Exclusion criteria: women on salt‐free diet or taking diuretics or wearing bandages or supportive stockings.
Interventions A double‐blind trial that used 300 mg rutoside (O‐Beta‐hydroxylethyl rutoside) 3 times daily in capsule form, for 8 weeks versus placebo from 28 weeks of gestation. Women were assessed by interview at 28 weeks, 32 weeks and 36 weeks' gestation. Leg circumference also taken at these times.
Participants were asked to take no other drugs, particularly analgesics.
Outcomes Subjective response to treatment judged by reduction in pains and paraesthesiae and reduction in ankle circumference.
Neonatal outcomes: live birth, Apgar scores.
Notes Women were asked to take the bottles back so that the remaining capsules could be counted and a check made that the dosage had been taken correctly.
All women gave birth to healthy babies with good Apgar scores, no further information provided.
Sample size: 69 women.
Country: The Netherlands.
Study years: not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation sequence generation not fully described: "two groups randomly allocated".
Allocation concealment (selection bias) Unclear risk Allocation concealment not described.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Study described as double blind. Active drug (rutoside) and placebo capsules were identical in appearance, scent or taste. There was blinding of participants and personnel. Bottles were labelled with randomly‐selected numbers not revealed to the investigator until the end of the trial.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk There was blinding of participants and personnel/investigator.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 69 women randomised. 3 women lost to follow‐up. 1 woman in the intervention group moved, and 2 women in the placebo group developed deep vein thrombosis.
Selective reporting (reporting bias) Low risk Outcomes stated of interest have been reported.
Other bias Low risk None noted.