Skip to main content
. 2011 Dec 7;2011(12):CD008826. doi: 10.1002/14651858.CD008826.pub2

Rao 2005.

Study characteristics
Methods Study design: split‐body, randomised, double‐blinded study comparing foam and liquid polidocanol and sodium tetradecyl sulfate
Method of randomisation: coin toss (information obtained through personal correspondence with Mitchell P Goldman, MD, one of the study authors)
Blinding: patients ‐ yes, treating doctors ‐ no, assessing doctors ‐ yes
Power calculation: no
Number of patients randomised: 20 (19 with telangiectasias)
Number of patients analysed: For telangiectasias: 19
Number of exclusions post randomisation: 0
Number of withdrawals and reasons: 0
Source of funding: Dr Goldman, one of the authors, received a stipend and the Fibro‐Vein from STD Pharmaceuticals, Ltd
Participants Setting: outpatient location
Country: USA
Total Number: 20 (19 for telangiectasias)
Age: not specified
Sex: 19 female, 1 male
Inclusion criteria: "healthy subjects...with varicose, reticular, and/or telangiectatic leg veins"
Exclusion criteria: Incompetence at the saphenofemoral or saphenopopliteal junctions
Interventions For veins < 1 mm: one leg received STS 0.25%, and the other received POL 0.5% solution. Treatment was followed by 7 days of class III graduated compression stockings
Duration: 12 weeks
Outcomes 1) Efficacy: four independent, blinded physicians, assessed high‐quality digital photographs taken prior to treatment and at 12 weeks post‐treatment for "overall clearance of treatment based on vessel size." Scale of 1 to 5: (worse, no change, minimal disappearance, moderate disappearance, complete disappearance)
2) Adverse events: ecchymosis, hyperpigmentation, coagulum formation, local urticaria, telangiectatic matting, skin necrosis, allergic reaction.
3) Patient‐assessed tolerability at 12 weeks post‐treatment: scale of 0 to 3: no discomfort, mild discomfort, moderate discomfort, severe discomfort
4) Patient satisfaction at 12 weeks post‐treatment: scale of 1 to 5: (worse, no change, minimal disappearance, moderate disappearance, complete disappearance)
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) Low risk Physician was given the solution to inject by nurse (personal communication with Mitchell P Goldman, MD)
Blinding (performance bias and detection bias)
All outcomes Low risk "Treating physician was blinded to the agent being injected. An independent panel of four physicians, blinded to treatment performed randomised photographic evaluations."
Incomplete outcome data (attrition bias)
All outcomes Low risk There were no incomplete outcome data.
Selective reporting (reporting bias) High risk Data for adverse events, subject tolerability, and subject satisfaction were not presented separately by vein size.
No statistical analysis was performed, and the data was presented without standard deviations, thereby preventing future inclusion of study data in a meta‐analysis.
Other bias Unclear risk Dr Goldman, one of the authors, received a stipend and the Fibro‐Vein from STD Pharmaceuticals, Ltd.