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) |
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Interventions | Group 1: pregabalin 50 mg‐600 mg (titration 75 mg every 4 days) Group 2: placebo Follow‐up: 42 days |
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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 |
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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.