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

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
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
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)
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)
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.