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. 2018 Feb 25;2018(2):CD004982. doi: 10.1002/14651858.CD004982.pub6

De Sanctis 2001.

Methods Placebo‐controlled RCT.
Participants 30 participants with ST confirmed by colour duplex ultrasonography and varicose veins; mean age 51 years; 17 males, 13 females. Not reported if participants were hospitalised or non‐hospitalised.
Interventions Essaven gel (5 cm of gel).
Placebo (5 cm of gel).
Study treatment given for 4 weeks.
Outcomes Mean decrease in temperature, mean symptomatic score (local pain, disability, swelling).
Notes All participants received LMWH (clexane 0.1 mL/10 kg of bodyweight od) for 4 weeks and elastic compression stockings.
Funding: not reported.
Disclosure of potential COI: not reported, no COI forms available.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Method of random sequence generation not reported. "the randomization process was controlled by an external statistical controller according to GCP rules."
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blind study. "Placebo comparable to Essaven gel was used," "operators were unaware of the contents of the tube."
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data.
Selective reporting (reporting bias) Low risk All prespecified outcomes reported.