Abstract | IMPORTANCE: OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: In this single-blind, 3-arm comparison randomized clinical trial, 28 patients at the Facial Nerve Center, University of Utah, Salt Lake City, were randomized to onabotulinumtoxinA, abobotulinumtoxinA, or incobotulinumtoxinA treatment. Each patient was given the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis before treatment and 1, 2, and 4 weeks after treatment, and improvements were compared among the groups. Data were collected from July 3, 2012, to March 31, 2015. INTERVENTIONS: MAIN OUTCOMES AND MEASURES: RESULTS: A total of 28 patients (mean [SD] age, 49.1 [18.5] years; 8 [28.6%] male and 20 [71.4%] female), with 6 patients enrolled multiple times, received 38 treatments (15 onabotulinumtoxinA, 13 abobotulinumtoxinA, and 10 incobotulinumtoxinA). No significant difference existed in baseline pretreatment SAQ scores among the 3 groups. Mean (SD) SAQ score improvement at 4 weeks was 41% (31%) for the onabotulinumtoxinA, 42% (20%) for the abobotulinumtoxinA, and 17% (18%) for the incobotulinumtoxinA groups. No significant differences were noted in SAQ score improvements among the 3 groups at weeks 1 and 2 after treatment (week 1 mean improvements of 42% in the onabotulinumtoxinA, 45% in the abobotulinumtoxinA, and 26% in the incobotulinumtoxinA groups; P = .19; week 2 mean improvements of 43% in the onabotulinumtoxinA, 46% in the abobotulinumtoxinA, and 28% in the incobotulinumtoxinA groups; P = .20). The difference in mean SAQ score improvement for abobotulinumtoxinA vs incobotulinumtoxinA from pretreatment to 4 weeks after treatment was not significant (30 vs 12 points; P = .11) despite a significant difference in mean total SAQ score for abobotulinumtoxinA vs incobotulinumtoxinA (40.34 vs 58.00; P = .02). CONCLUSIONS AND RELEVANCE: TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT03048383. LEVEL OF EVIDENCE: 1.
|
Authors | Andrew J Thomas, Michael O Larson, Samuel Braden, Richard B Cannon, P Daniel Ward |
Journal | JAMA facial plastic surgery
(JAMA Facial Plast Surg)
Vol. 20
Issue 2
Pg. 141-147
(Mar 01 2018)
ISSN: 2168-6092 [Electronic] United States |
PMID | 28973094
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
|
Chemical References |
- Neuromuscular Agents
- Botulinum Toxins, Type A
- abobotulinumtoxinA
- incobotulinumtoxinA
- onabotulinum toxin A
|
Topics |
- Adolescent
- Adult
- Aged
- Aged, 80 and over
- Botulinum Toxins, Type A
(therapeutic use)
- Drug Administration Schedule
- Face
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Neuromuscular Agents
(therapeutic use)
- Patient Reported Outcome Measures
- Prospective Studies
- Severity of Illness Index
- Single-Blind Method
- Synkinesis
(diagnosis, drug therapy)
- Treatment Outcome
- Young Adult
|