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

McCoy 1999.

Study characteristics
Methods Study design: split‐body, randomised, blinded, controlled study comparing polidocanol and hypertonic saline
Method of randomisation: unclear
Blinding: patient ‐ yes, treating doctor ‐ no, photo assessor ‐ yes
Power calculation: no
Number of patients randomised: 81
Number of patients analysed: 81
Number of exclusions post randomisation: 0
Number of withdrawals and reasons: 0
Source of funding: not stated
Participants Setting: outpatient setting
Country: Australia
Total number: 81
Age: average 44.3 years (range from 21 to 76)
Sex: female
Inclusion criteria: patients with primary idiopathic telangiectasia with "symmetric areas of vessels on both legs and identifiable reticular feeding veins"
Exclusion criteria: "telangiectasia around the ankles or clusters of microvessels arising secondary to surgical scars", previous sclerotherapy, clinical or duplex doppler evidence of incompetence of major saphenous or large perforator, history of Ischaemic heart disease, vasculitis of any aetiology, diabetes mellitus, current pregnancy, regular us of anticoagulants
Interventions Treatment: one leg treated with Hypertonic saline (HS) 20% (2 mL of 30% saline with 1 mL of 2% lignocaine hydrochloride). The other leg treated with polidocanol (POL) 1%
Duration: 2 months
Outcomes 1) Patient satisfaction: scale of 0 to 10
2) Clinically assessed efficacy: physician rated improvement on scale of 0 to 10 comparing baseline photographs to clinical assessment at 2 month follow‐up visit
3) Blinded photo assessment: non‐treating physician rated improvement on scale of 0 to 10 based on before and after photos
4) Adverse events: 1) telangiectatic matting: treating physician rated on scale of 0 to 3 (not present, mild, moderate, severe) at 2 month follow‐up visit. 2) haemosiderin staining: rated by same method as telangiectatic matting
5) Pain of injection: patients rated pain of each leg on scale of 0 to 10
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not mentioned. Unsuccessful attempt at contacting authors.
Allocation concealment (selection bias) Unclear risk Not mentioned. Unsuccessful attempt at contacting authors.
Blinding (performance bias and detection bias)
All outcomes Low risk Patient was blinded to treatment although treating physician was not. External assessor of photographs was blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk No incomplete outcome 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.