Kahle 2006.
Study characteristics | ||
Methods | Study design: randomised, double‐blinded, placebo‐controlled study comparing polidocanol and normal saline Method of randomisation: randomised into 4 blocks with the randomisation program of Microsoft Excel Blinding: patient ‐ yes, treating doctor ‐ unclear, photo evaluator ‐ yes Power calculation: not mentioned Number of patients randomised: 48 Number of patients analysed: 48 Number of exclusions post‐randomisation: 0 Number of withdrawals post‐randomisation: 0 Source of funding: not stated |
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Participants | Setting: outpatient site Country: Germany Total number: 48 Age: Not mentioned Sex: Not mentioned Inclusion criteria: presence of spider veins Exclusion criteria: not stated |
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Interventions | Treatment: injection with polidocanol 0.25% or normal saline placebo followed by compression bandages for 24 hours and then compression stockings for 1 week Duration: 4 weeks |
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Outcomes | 1) evaluation of photos by blinded consultants (scale of 0 to 100) 2) evaluation of veins by treating doctor (scale of 0 to 3) 3) Patient satisfaction: scale of 0 to 3 |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated program using Microsoft Excel in 4 random blocks. |
Allocation concealment (selection bias) | Unclear risk | Method not stated |
Blinding (performance bias and detection bias) All outcomes | Low risk | Examining doctor and patients were blinded to allocation. Photos from visits one and two were sent twice to blinded external consultants using different numbering. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete data |
Selective reporting (reporting bias) | High risk | The efficacy data on ratings of the treating physician, and the patient satisfaction data were not statistically analysed or presented in a manner that allows for inclusion in a meta‐analysis. |
Other bias | Low risk | The study appears to be free of other sources of bias. |