Leach 2003.
Study characteristics | ||
Methods |
Study design: split‐body, randomised study Method of randomisation: coin toss to determine which leg was assigned each treatment Blinding: participant ‐ no, doctor ‐ no Power calculation: not mentioned Total number of participants randomised: 13 participants had each lower limb randomised to receive 1 of 2 sclerosing agents Total number of procedures: 26 Treatment localisation: leg veins Exclusions post‐randomisation: none Number of withdrawals and reasons: none |
|
Participants |
Setting: outpatient site Country: USA Gender: women Age: mean 57 years (range 41 ‐ 70) Inclusion criteria: presence of leg veins 0.2 to 0.4 mm in diameter without evidence of feeding reticular veins Exclusion criteria: incompetence at the saphenofemoral or saphenopopliteal junctions |
|
Interventions |
Treatment 1: STS 0.25% Treatment 2: chromated glycerin 72% 1 leg of each participant was randomised to receive either STS 0.25% or chromated glycerin 72%, and the other leg received the other agent Duration of follow‐up: ranged from 2 to 6 months Use of compression: not mentioned |
|
Outcomes | Efficacy: vessel clearance (yes, no) assessed by treating physician at follow‐up Adverse events: bruising, swelling, hyperpigmentation (yes, no) assessed by treating physician at follow‐up Pain: assessed by participant at time of injection (yes, no) |
|
Funding sources | No funding source stated | |
Declarations of interest | No details provided | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | A coin toss |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding mentioned. STS and CG have different viscosities that are visible at time of injection |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | 2 independent experts who were not involved in the treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no incomplete data |
Selective reporting (reporting bias) | Low risk | All specified outcomes were reported |
Other bias | Unclear risk | No details given |