Lee 2013.
Study characteristics | ||
Methods |
Study design‐ double‐blinded, randomised, active‐controlled, parallel‐design, phase III study in glabellar lines (Poster) Study date‐ no information Study setting‐ no information |
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Participants |
Randomised 314 participants. Age‐ no information. Gender ‐ no information Inclusion criteria‐ no information Exclusion criteria‐ no information Severity of disease‐ moderate to severe glabellar lines at maximal contraction Ethnicity‐ no information |
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Interventions |
Duration of study‐ 16 weeks Intervention
Comparator
Ratio‐ 1:1 (New BontA[Medytox®]: OnabotulinumtoxinA) |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | WS Lee worked in the Medical Department of Medytox Inc., Ochang, South Korea | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients was randomised at a 1:1 ratio to receive 20U of toxin" page 116 Comment: we considered unclear risk of bias because the authors did not explain how they randomised the participants |
Allocation concealment (selection bias) | Unclear risk | Quote: "patients was randomised at a 1:1 ratio to receive 20U of toxin" page 116 Comment: we considered unclear risk of bias because the authors did not explain the methods used for maintain the allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blinded" page 116 Comment: we considered this unclear risk of bias because the authors did not explain how they blinded the participants |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blinded" page 116 Comment: we considered this unclear risk of bias because the authors did not explain how they blinded the outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information about losses Comment: we considered unclear risk of bias |
Selective reporting (reporting bias) | High risk | Incomplete data. The authors reported only the outcomes assessed at week 4 Comment: we considered this high risk of bias We e‐mailed authors on June 21, 2018, but the electronic address was wrong and we could not find a valid e‐mail. |
Other bias | Unclear risk | The author worked for Medy‐tox Comment: we considered this a unclear risk of bias |