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 |
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| 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 |
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| 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 |
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| 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 |
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| 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. |