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. |
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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. |
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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. |