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. 2011 Dec 7;2011(12):CD008826. doi: 10.1002/14651858.CD008826.pub2

Leach 2003.

Study characteristics
Methods Study design: split‐body, randomised study comparing sodium tetradecyl sulfate and glycerin
Method of randomisation: coin toss to determine which leg was assigned each treatment (confirmed through correspondence with trial co‐author Mitchell P Goldman, MD)
Blinding: patient ‐ no, doctor ‐ no
Power calculation: no
Number randomised: 13 patients had each lower limb randomised to receive one of two sclerosing agents
Exclusions post‐randomisation: none
Losses to follow up: none
Source of funding: "No significant interest with commercial supporters." No funding source stated
Participants Setting: outpatient location
Country: USA
Total number: 13 patients
Age: mean age 57 years (range of 41 to 70)
Sex: female
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: one leg of each patient was randomised to receive either sodium tetradecyl sulfate (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
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 patient at time of injection (yes, no)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A coin toss (method confirmed through correspondence with study co‐author Mitchell P Goldman, MD).
Allocation concealment (selection bias) Unclear risk Not mentioned
Blinding (performance bias and detection bias)
All outcomes High risk No blinding mentioned. STS and CG have different viscosities that are visible at time of injection.
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 Low risk The study appears to be free of other sources of bias.