McCoy 1999.
Study characteristics | ||
Methods |
Study design: randomised, controlled, blinded trial Method of randomisation: not mentioned Blinding: participants ‐ yes, physician ‐ yes and outcomes assessment ‐ yes Power calculation: not mentioned Total number of participants: 81 Total number of procedures: 162 Treatment localisation: leg veins Number of exclusions post‐randomisation: none Number of withdrawals and reasons: none |
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Participants |
Setting: outpatient site Country: Australia Gender: women Age: range: 21 ‐ 76 years (mean 44.3 years) Inclusion criteria: women with primary idiopathic telangiectasia on the legs were eligible to participate in the trial if they demonstrated symmetrical areas of vessels on both legs and identifiable reticular feeding veins. Gave informed consent Exclusion criteria: telangiectasia around the ankles or clusters of microvessels arising secondary to surgical scars were excluded because they are rarely symmetrical, in the authors' experience results of treatment are unpredictable in these instances. Other exclusion criteria included previous sclerotherapy (although patients who had undergone previous venous surgery were included), clinical or duplex doppler evidence of major saphenous or large perforator incompetence, history of ischaemic heart disease, vasculitis of any aetiology, diabetes mellitus, current pregnancy or the regular use of anticoagulants |
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Interventions |
Treatment 1: POL (POL 1% was derived by diluting POL 3% with normal saline) Treatment 2: hypertonic saline (hypertonic saline 20% was derived by combing 2 mL of 30% saline with 1 mL of 2% lignocaine hydrochloride to constitute 3 mL of sclerosant) For each participant, 1 leg was randomly assigned POL and the other hypertonic saline as the sclerosant. Participants were unaware of the choice of sclerosant for each leg until after the 2‐month assessment. However, the treating physician was aware at the time of treatment. All treatments were undertaken with the participant in the supine position. Becton‐Dickison needles #30 gauge and 3 mL disposable syringes were used. Sufficient solution to completely blanch a reticular feeding system and all of its visible blanches and telangiectasia was infused. 1 treatment only was performed per leg. Compression was not employed, and no specific restrictions were placed on participants by activities or exercise following the treatment Duration of follow‐up: 2 months Use of compression: not used |
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Outcomes | Clinical assessment: the treating physician: Rated improvement on a scale of 0 (no improvement) to 10 (complete disappearance). Photographic assessment rated improvement based on before‐and‐after photographs using the same 0 to 10 scale method. Side effects of treatment were also assessed. Participants rated pain of injection for each leg from 0 (not painful) to 10 (extremely painful) | |
Funding sources | No details provided | |
Declarations of interest | No details provided | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "For each participant, one leg was randomly assigned polidocanol and the other hypertonic saline as the sclerosant" Comment: states "randomised", no further details given |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were unaware of the choice of sclerosant for each leg until after the 2‐month assessment. However, the treating physician was aware at the time of treatment |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | A non‐treating physician, blinded to sclerosants used for each leg, rated improvement based on before‐and‐after photographs using the same 0 to 10 scale method |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details given |
Selective reporting (reporting bias) | Unclear risk | No details given |
Other bias | Unclear risk | No details given |