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. 2016 Oct 20;2016(10):CD009682. doi: 10.1002/14651858.CD009682.pub2

Zesiewicz 2007a.

Study characteristics
Methods Double‐blind, placebo controlled, parallel study
Participants 22 patients randomised (11 to pregabalin, 11 to placebo)
Mean age 57 years (SD 13)
Male 40%
Baseline TRS 39 (SD 20)
Interventions Group 1: pregabalin 50 mg‐600 mg (titration 75 mg every 4 days)
Group 2: placebo
Follow‐up: 42 days
Outcomes TRS total score (0 to 100) and subscales: severity (16 points), motor tasks (36 points) and functional disability (32 points), CGI (seven‐point scale)
Notes Trial setting: out‐patients (Parkinson’s Disease and Movement Disorders Center)
Country: University of South Florida, Tampa, Florida, USA
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Computer generated randomization schedule"
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias)
All outcomes Low risk "PGB and placebo were supplied in identical containers"; "both patients and raters were blind to randomization"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk "Tremor measurements were conducted by a blinded rater"
Incomplete outcome data (attrition bias)
All outcomes High risk "Last observation carried forward was used for analysis for patients who prematurely withdrew the study"
Selective reporting (reporting bias) Low risk Free
Other bias Low risk Free

CGI: clinical global impression;PGB: pregabalin; RCT: randomised controlled trial; TRS: Fahn‐Tolosa‐Marin Tremor Rating Scale.