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. 2021 Jul 5;2021(7):CD011301. doi: 10.1002/14651858.CD011301.pub2

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)
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
  • Both men and women between the ages of 20 and 90 with glabellar and/or periorbital wrinkles (crow’s feet)


Exclusion criteria
  • Pregnancy or plans to become pregnant

  • Known cardiovascular or neuromuscular disorders, dysphasia

  • History of recent facial infections, allergies to milk proteins or albumin, or current aminoglycoside therapy

  • Patients who had undergone BontA‐ONA or BontA‐ABO treatments within the previous six months

  • Patients on any blood‐thinning medications were excluded to minimise injection site bleeding complications


Severity of disease‐ glabella, crow's feet, forehead lines.
Ethnicity‐ no information
Interventions Duration of study‐ 20 weeks
Intervention
  • OnabotulinumtoxinA (2 5U) in one side (N = 53)


Comparator
  • AbobotulinumtoxinA (62.5 U) in the other side.(N = 53)


Ratio‐ 1:2.5 (OnabotulinumtoxinAOna:AbobotulinumtoxinA)
Outcomes Primary outcome
  • Fitzpatrick Wrinkle Scale, eyebrow height


Secondary outcomes
  • Percentage of patients with continued aesthetic effect

  • Adverse events

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