scholarly journals PUK36 - COMPARISON OF PATIENT-REPORTED OUTCOMES IN RANDOMIZED CONTROLLED TRIALS AND IN OBSERVATIONAL STUDIES FOR OVERACTIVE BLADDER: A SYSTEMATIC LITERATURE REVIEW

2018 ◽  
Vol 21 ◽  
pp. S481
Author(s):  
K. Borkowska ◽  
V. Taieb ◽  
N. Germain ◽  
A. Mejri ◽  
A. Jakubowska ◽  
...  
Toxins ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 470
Author(s):  
Alfonso Fasano ◽  
Vijayashankar Paramanandam ◽  
Mandar Jog

Cervical dystonia (CD) is a neurological movement disorder characterized by sustained involuntary muscle contractions. First-line therapy for CD is intramuscular injections of botulinum neurotoxin (e.g., abobotulinumtoxinA) into the affected muscles. The objective of this systematic literature review is to assess the clinical evidence regarding the effects of abobotulinumtoxinA for treatment of CD in studies of safety, efficacy, patient-reported outcomes, and economic outcomes. Using comprehensive electronic medical literature databases, a search strategy was developed using a combination of Medical Subject Heading terms and keywords. Results were reviewed by two independent reviewers who rated the level of evidence. The search yielded 263 publications, of which 232 were excluded for being duplicate publications, not meeting the selection criteria, or failing to meet predefined eligibility criteria, leaving a total of 31 articles. Clinical efficacy, patient-reported outcomes, and safety data were in 6 placebo-controlled trials (8 articles), 6 active-controlled trials, and 16 observational studies (17 articles). Data on health economic outcomes were provided in one of the clinical trials, in two of the observational studies, and in one specific cost-analysis publication. This review demonstrated that the routine use of abobotulinumtoxinA in CD is well-established, effective, and generally well-tolerated, with a relatively low cost of treatment.


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