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. |