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. 2021 Oct 12;2021(10):CD012723. doi: 10.1002/14651858.CD012723.pub2

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