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

Pregabalin for essential tremor

Elisa Bruno  1 , Alessandra Nicoletti, Graziella Quattrocchi, Graziella Filippini, Carlo Colosimo, Mario Zappia
Affiliations

Pregabalin for essential tremor

Elisa Bruno et al. Cochrane Database Syst Rev. .

Abstract

Background: Essential tremor is one of the most common movement disorders. Treatment primarily consists of pharmacological agents. While primidone and propranolol are well-established treatments in clinical practice, they may be ineffective in 25% to 55% of patients and can produce serious adverse events in a large percentage of them. For these reasons, it is worth evaluating the treatment alternatives for essential tremor. Some specialists have suggested that pregabalin could be a potentially useful agent, but there is uncertainty about its efficacy and safety.

Objectives: To assess the effects of pregabalin versus placebo or other treatment for essential tremor in adults.

Search methods: We performed a systematic search without language restrictions to identify all relevant trials up to December 2015. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, NICE, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (ICTRP). We handsearched grey literature and examined the reference lists of identified studies and reviews.

Selection criteria: We included all randomised controlled trials (RCTs) of pregabalin versus placebo or any other treatments. We included studies in which the diagnosis of ET was made according to accepted and validated diagnostic criteria. We excluded studies conducted in patients presenting secondary forms of tremor or reporting only neurophysiological parameters to assess outcomes.

Data collection and analysis: Two reviewers independently collected and extracted data using a data collection form. We assessed the risk of bias of the body of evidence, and we used inverse variance methods to analyse continuous outcomes and measurement scales. We compared the mean difference between treatment groups, and we combined results for dichotomous outcomes using Mantel-Haenszel methods and risk differences We used Review Manager software for data management and analysis.

Main results: We only found one study eligible for this review (22 participants). We assessed the risk of bias for most domains as unclear. We graded the overall quality of evidence as very low. Compared to placebo, patients treated with pregabalin showed no significant improvement of motor tasks on the 36-point subscale of the Fahn-Tolosa-Marin Tremor Rating Scale (TRS) (MD -2.15 points; 95% CI -9.16 to 4.86) or on the 32-point functional abilities subscale of the TRS (MD -0.66 points; 95% CI -2.90 to 1.58).The limited evidence showed no difference in study withdrawal (Mantel-Haenszel RD -0.09; 95% CI -0.48 to 0.30) and presentation of adverse events between pregabalin and placebo (Mantel-Haenszel RD 0.18; 95% CI -0.13 to 0.50).

Authors' conclusions: The effects of pregabalin for treating essential tremor are uncertain because the quality of the evidence is very low. One small study did not highlight any effect of this treatment; however, the high risk of bias and the lack of other studies on this topic limit further conclusion.

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Conflict of interest statement

The original review was not compliant with Cochrane Commercial Sponsorship policy for the following reasons:

CC received financial support from Merz (manufacturer of Botulinum toxin), Teva (manufacturer of propranolol) and other pharma companies. AN received financial support from Lundbeck (manufacturer of benzodiazepine clobazam) and UCB (manufacturer of levetiracetam). MZ received financial support from Novartis (manufacturer of propranolol [Sandoz]), UCB, Lundbeck and other pharma companies.

However, the current update have a majority of authors and lead author free of conflicts as the lead author and all the other authors have not received payments from manufacturers or marketers of the interventions of interest or potential comparators within the 3 years of the decision to update and none of the authors are/were employed by a company who has a real or potential financial interest in the findings of the review and/or have a relevant patent.

Figures

1
1
Flowchart of the literature search on pregabalin and essential tremor
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Pregabalin versus placebo: efficacy, Outcome 1: Change in TRS part B score (motor function) between baseline and end of follow‐up
1.2
1.2. Analysis
Comparison 1: Pregabalin versus placebo: efficacy, Outcome 2: Change in TRS part C score (functional abilities) between baseline and end of follow‐up
1.3
1.3. Analysis
Comparison 1: Pregabalin versus placebo: efficacy, Outcome 3: Change in TRS part A score (tremor severity) between baseline and end of follow‐up
2.1
2.1. Analysis
Comparison 2: Pregabalin versus placebo: safety, Outcome 1: Withdrawals
2.2
2.2. Analysis
Comparison 2: Pregabalin versus placebo: safety, Outcome 2: Adverse events
See this image and copyright information in PMC

Update of

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