Lowe 2006.
Study characteristics | ||
Methods |
Study design‐ single centre, double‐blind, randomised study, active‐controlled, parallel‐design Study date‐ start (March 2003), end (March 2005) Study setting‐ outpatients from one private clinic |
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Participants |
Randomised 62 participants, with mean age of 41 years (range 27‐60 years) total population; 44 ± 7.3 years in BontA1 group; 39 ± 6.6 years in BontA2 group. Gender‐ 90% female, 10% male Inclusion criteria
Exclusion criteria
Severity of disease‐ moderate or severe glabellar lines at maximum contraction. BontA group comprised 15 of 31 patients (48%) with moderate glabellar lines and 16 patients (52%) with severe glabellar lines. In the BontA2 group, 17 of 31 patients (55%) had moderate glabellar lines and 14 (45%) had severe glabellar lines at baseline. Ethnicity‐ 97% Caucasian |
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Interventions |
Duration of study‐ 16 weeks Intervention
Comparator
Ratio‐ 1:2.5 (OnabotulinumtoxinA: AbobotulinumtoxinA) |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | "Drs P. Lowe and R. Patnaik have received research grants from Allergan, Inc. Dr N. Lowe owns stock in Allergan, Inc, and has received research grants, consulting payments, and educational grants from Allergan, Inc. He has also received research grants and consulting payments from Medicis. Gill Shears, PhD (of Gill Shears, Inc), provided assistance with the writing of the manuscript." | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a computer‐generated randomisation code, in block sizes of 6, that determined treatment assignments for each individual. "Randomization cards" were prepared" page 976 Comment: we considered this low risk of bias |
Allocation concealment (selection bias) | Low risk | Quote: "randomisation number and contained the treatment assignment. These were kept in a secure location and neither the investigator nor the patients had access to them or their contents. The treatment assigned to each patient was determined at the baseline visit by a pharmacist who opened the card with the lowest available randomisation number in order to discover the treatment assignment and then prepared the appropriate syringe" page 976 Comment: we considered this low risk of bias |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The investigator and the patients were masked as to which product was being used—the syringes were identical in appearance and the volume to be injected was the same regardless of the product" page 976 Comment: we considered this low risk of bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The investigator and the patients were masked as to which product was being used—the syringes were identical in appearance and the volume to be injected was the same regardless of the product." page 976 Comment: we considered this low risk of bias |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "A total of 62 patients were enrolled, of whom 59 (95%) completed the study (Fig 1). No patient discontinued because of lack of efficacy or adverse effects and one each discontinued for personal reasons, withdrawal of consent, and need for surgery." page 977 Comment: we considered this low risk of bias |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported. Comment: we considered this low risk of bias |
Other bias | Unclear risk | Dr N. Lowe owns stock in Allergan, Inc. Comment: we considered this unclear risk of bias |