Ochoa 2021.
| Study characteristics | ||
| Methods |
Study design: randomised clinical trial Method of randomisation: not mentioned Blinding: participant ‐ no; treating doctor ‐ yes; outcome assessors ‐ yes Power calculation: sample size was calculated to give a statistical power of 80% Total number of participants: 720 Total number of procedures: 720 Treatment localisation: leg veins Number of exclusions post‐randomisation: 111 Number of withdrawals and reasons: 111 lost to follow‐up |
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| Participants |
Setting: outpatient site Country: Mexico Gender: men and women Age: mean 41 years group A and 42 years group B Inclusion criteria: varicose, reticular or telangiectatic leg veins, or both Exclusion criteria: incompetence at the saphenofemoral or saphenopopliteal junctions; history of DVT; general poor health |
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| Interventions |
Group A: received 250 lipoprotein‐lipase release unit of sulodexide twice a day for 7 days before scheduled sclerotherapy and this continued for 3 months after the initial procedure Group B: control group, underwent sclerotherapy without sulodexide treatment Duration of follow‐up: 16 weeks Use of compression: not mentioned |
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| Outcomes | Incidence of hyperpigmentation Degree of hyperpigmentation Vein disappearance rate Major bleeding |
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| Funding sources | Union Internationale de Phlébologie 2018 Research Fellowship Kreussler Young Scientists' Sclerotherapy Grant award | |
| Declarations of interest | Quote: "A.J.G.O. has previously been paid consulting fees and for speaking in a meeting organized by Alfasigma." | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details given |
| Allocation concealment (selection bias) | Unclear risk | No details given |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details given |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | The photographs were evaluated by 2 independent physicians blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details given |
| Selective reporting (reporting bias) | Unclear risk | No details given |
| Other bias | Unclear risk | No details given |