Benigni 1999.
Study characteristics | ||
Methods | Study design: multicentre, split‐body, randomised comparative trial (a pilot study) comparing aetoxisclerol in foam and liquid solution Method of randomisation: drawing of lots Blinding: patient ‐ no, treating doctor ‐ no Power calculation: no Number of patients randomised: 24 Number of patients analysed: 20 Number of exclusions post‐randomisation: 4 (information obtained through personal correspondence with Jean‐Patrick Benigni, MD) Number of withdrawals and reasons: none Source of funding: not stated |
|
Participants | Setting: 4 outpatient centres (information obtained through personal correspondence with Jean‐Patrick Benigni, MD) Country: France Total number: 20 Age: mean age 37.7 (range of ages 18 to 65) Sex: female Weight: mean weight 58.1kg Height: mean height 162.7cm Body mass index (BMI): mean 22.0 History of pregnancy: mean 0.75 Employed: 17/20 Sports: 7/20 Smoking: 2/20 Family history of venous disease: 17/20 Oral contraceptive use: 5/20 Inclusion criteria: "clear phototype" (classifications I to III on the Fitzpatrick classification scale), "roughly symmetrical reticular veins and telangiectases of the lateral thigh surface", reflux of reticular varices of at least 1 point on continuous Doppler Exclusion criteria: incompetence of the large saphenous veins or their collaterals, incompetence of the deep veins, perineal varices, skin condition of the lateral face of the thigh, obesity (BMI > 30), pregnancy, psychiatric trouble, a contraindication to sclerotherapy, hormonal treatment within 6 months of enrolment |
|
Interventions | After randomisation, one thigh was treated with polidocanol foam 0.25% by the Monfreux method, and the other was treated with polidocanol solution 0.25%. Duration of follow up: 5 sessions every 15 ± 2 days, and a control visit 15 days after the last session |
|
Outcomes | Efficacy: appearance of telangiectasias on visual analogue scales (0 to 10) as assessed by the treating doctors (days 0, 15, 30, 45, 60 & 75) and by patients (days 0 and 75). Four criteria were assessed: colour, density, relief and surface Adverse effects: as assessed by the treating physician: ecchymosis, thrombi, microthrombi, matting, pigmentation, necrosis Number of points of injection The quantity of sclerosant injected |
|
Notes | Outcomes were not presented separately for telangiectasias for: patient assessment of efficacy on visual analogue scale, adverse reactions, number of injection points, and quantity of sclerosant injected. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Drawing of lots |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | High risk | Blinding is not mentioned for patients or treating doctors. Foam and liquid sclerosants have distinct appearances on injection. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 4 people were "lost of view" as per personal communication with Dr. Benigni. No explanation was provided in the published article. |
Selective reporting (reporting bias) | High risk | The only outcome data separated for telangiectasias is appearance on visual analogue scales as rated by the treating doctors. No statistical analysis was performed, and no standard deviations were presented, thereby preventing inclusion of the data in a meta‐analysis. |
Other bias | Low risk | No additional contributors to bias. |