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 |
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| 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 |
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| 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 |
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| 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) |
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| 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. |