Michaels 2012.
Study characteristics | ||
Methods |
Study design‐ single centre, randomised, double‐ blind, active ‐controlled, split‐face design in glabellar lines, forehead lines, and crow's feet lines Study date‐ no information Study setting‐ outpatients from one private clinic (USA) |
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Participants |
Randomised‐ 53 participants, with mean of age of 50 years (range 34‐65 years). Gender: 52 female, one male. Other demographic data: eight were smokers, and 26 had undergone treatment with BoNT‐ONA in the past Inclusion criteria
Exclusion criteria
Severity of disease‐ glabella, crow's feet, forehead lines. Ethnicity‐ no information |
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Interventions |
Duration of study‐ 20 weeks Intervention
Comparator
Ratio‐ 1:2.5 (OnabotulinumtoxinAOna:AbobotulinumtoxinA) |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | "The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article." | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A coin toss was used to randomly assign the side of the face to receive BoNT‐ONA as follows: “heads” meant that BoNT‐ONA was injected on the right side, whereas “tails” meant that BoNT‐ONA was injected on the left" page 98 Comment: we considered this low risk of bias |
Allocation concealment (selection bias) | Unclear risk | Quote: "A coin toss was used to randomly assign the side of the face to receive BoNT‐ONA as follows: “heads” meant that BoNT‐ONA was injected on the right side, whereas “tails” meant that BoNT‐ONA was injected on the left" page 98 Comment: we considered this unclear risk of bias due to the authors did not reported methods of allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Patients were blinded to the laterality of treatments" page 97 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 97 Comment: we considered this unclear risk of bias because the authors did not explain how they blinded the investigators |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information about losses Comment: we considered this unclear risk of bias |
Selective reporting (reporting bias) | High risk | Only P value, no data were showed Comment: we considered this a high risk of bias. We sent an e‐mail to authors on 23 November 2015. No answer to date |
Other bias | Low risk | We considered this study at low risk of other bias |