Skip to main content
. 2018 Feb 25;2018(2):CD004982. doi: 10.1002/14651858.CD004982.pub6

Incandela 2001.

Methods Multicentre, placebo‐controlled RCT.
Participants 30 participants with ST confirmed by colour duplex ultrasonography and varices; 14 males, 16 females; mean age 54 years. 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 8 weeks.
Outcomes Analogue clinical/symptomatic score including pain, tenderness, disability, local swelling, erythema, presence of thrombosis.
Notes All participants received LMWH (enoxaparin 0.1 mL/10 kg of bodyweight od) for initial 4 weeks of study and elastic compression stockings for study period.
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 Unclear method of random sequence generation: "randomisation process was controlled by an external statistical controller."
Allocation concealment (selection bias) Unclear risk Method of allocation concealment not reported.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blinded. "Placebo comparable to Essaven gel was used," "operators were unaware of the contents of the tube."
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear if all participants included were analysed.
Selective reporting (reporting bias) Low risk All prespecified outcomes are reported.