Carlin 1987.
Study characteristics | ||
Methods | Study design: split‐body, randomised, double‐blinded, double‐paired, placebo‐controlled
study comparing polidocanol (aetoxisclerol), sodium tetradecyl sulfate, heparsal, and normal saline. Method of randomisation: not mentioned. Author contacted, but no reply received. Blinding: patient ‐ yes, treating doctor ‐ yes Power calculation: No Number of patients randomised: 20 (4 quadrants of legs on each patient) Number of patients analysed: 20 Number of exclusions post‐randomisation: 0 Number of withdrawals and reasons: 0 Source of funding: not stated |
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Participants | Setting: outpatient site Country: USA Total number: 20 Age: range from 29 to 55 Sex: female Inclusion criteria: "bilaterally symmetrical telangiectasias of the lower extremities" Exclusion criteria: patients taking hormonal therapy, anticoagulants or disulfiram |
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Interventions | Each patient's legs were divided into 4 quadrants: 1) treated with sodium tetradecyl sulfate (STS) 0.5% 2) treated with polidocanol (POL) 0.5% 3) heparsal (saline 20% with heparin 100 units/mL) 4) placebo ‐ normal saline 0.9% Patients wore gradient support hose for 48 hours after each sclerotherapy procedure Duration: treated every 4 weeks until resolution or up to a maximum of 6 visits (maximum of 24 weeks) |
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Outcomes | 1) efficacy: clinical assessment of improvement: scale of 1 to 5 (poor, fair, moderate, good, excellent) 2) adverse events: a) itching: scale of 1 to 4 (none, mild, moderate, severe) b) hyperpigmentation: scale of 1 to 3 (mild, moderate, severe) c) neovascularisation: scale of 1 to 3 (mild, moderate, severe) 3) patient satisfaction (dissatisfied, neither, satisfied, very satisfied) 4) pain: scale of 1 to 4 (none, mild, moderate, severe) 5) number of treatments required for clearance (from 1 to >6) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not mentioned. Unsuccessful in attempt to contact authors. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. Unsuccessful in attempt to contact authors. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | States double‐blind, but no further details provided. Sclerosants used are identifiable by differing viscosities. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | High risk | Some of the adverse reactions were not statistically analysed by sclerosing agent used. Patient satisfaction data was not separated based on sclerosing agent used. |
Other bias | High risk | The study design divides each person's legs into four quadrants to receive separate simultaneous treatments and analysis, and thereby risks bias by carry‐across effect. |