PMID- 28836659
OWN - NLM
STAT- MEDLINE
DCOM- 20170920
LR  - 20220716
IS  - 1469-493X (Electronic)
IS  - 1361-6137 (Linking)
VI  - 8
IP  - 8
DP  - 2017 Aug 24
TI  - Zonisamide for essential tremor.
PG  - CD009684
LID - 10.1002/14651858.CD009684.pub2 [doi]
LID - CD009684
AB  - BACKGROUND: Essential tremor (ET) is one of the most common movement disorders. 
      The treatment is primarily based on pharmacological agents. Although primidone 
      and propranolol are well established treatments in clinical practice, they can be 
      ineffective in 25% to 55% of patients, and can produce serious adverse events in 
      a large percentage of them. For these reasons, it may be worthwhile evaluating 
      the treatment alternatives for ET. Zonisamide has been suggested as a potentially 
      useful agent for the treatment of ET but there is uncertainty about its efficacy 
      and safety. OBJECTIVES: To assess the effect on functional abilities and the 
      safety profile of zonisamide in adults with essential tremor (ET). SEARCH 
      METHODS: We carried out a systematic search, without language restrictions to 
      identify all relevant trials. We searched CENTRAL, MEDLINE, Embase, NICE, 
      ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform 
      (ICTRP) to January 2017. We searched BIOSIS Citation Index (2000 to January 2017) 
      for conference proceedings. We handsearched grey literature and examined the 
      reference lists of identified studies and reviews. SELECTION CRITERIA: We 
      included all randomised controlled trials (RCTs) of zonisamide versus placebo or 
      any other treatment. 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 review authors independently collected and extracted data using a data 
      collection form. We assessed the risk of bias and the quality of evidence.We used 
      inverse variance methods for continuous outcomes and measurement scales. We 
      compared differences between treatment groups as mean differences. We combined 
      results for dichotomous outcomes using Mantel-Haenszel methods and obtained risk 
      differences to compare treatment groups. We used Review Manager 5 software for 
      data management and analysis. MAIN RESULTS: We only considered one study eligible 
      for this review (20 participants). Assessments of risk of bias for most domains 
      were unclear or low. Adverse events were only reported in participants from the 
      zonisamide group, making it possible that they were aware of treatment group 
      assignment. We are uncertain as to the effects of zonisamide on motor tasks (mean 
      difference (MD) -0.00, 95% confidence interval (CI) -1.51 to 1.51, very 
      low-quality evidence) and functional disabilities (MD -0.30, 95% CI -1.23 to 
      0.63, very low-quality evidence) when compared with placebo. Three participants 
      in the zonisamide group (30%) and two participants in the placebo group (20%) 
      discontinued the treatment and withdrew from the study for any reason (very 
      low-quality evidence), however the increased risk of withdrawal in the zonisamide 
      group was statistically non-significant (risk difference (RD) 0.1, 95% CI -0.28 
      to 0.48). Six participants in the zonisamide group (60%) and none of the 
      participants in the placebo group (0%) developed adverse events (AEs), with a RD 
      of 0.60 (95% CI 0.28 to 0.92; very low quality evidence). The most common AEs, 
      experienced with zonisamide treatment, were headache, nausea, fatigue, 
      sleepiness, and diarrhoea. Quality of life was not assessed in the study 
      included. AUTHORS' CONCLUSIONS: Based on currently available data, there is 
      insufficient evidence to assess the efficacy and safety of zonisamide treatment 
      for ET.
FAU - Bruno, Elisa
AU  - Bruno E
AD  - Department GF Ingrassia, Section of Neurosciences, University of Catania, 
      Catania, Italy, 95123.
FAU - Nicoletti, Alessandra
AU  - Nicoletti A
FAU - Filippini, Graziella
AU  - Filippini G
FAU - Quattrocchi, Graziella
AU  - Quattrocchi G
FAU - Colosimo, Carlo
AU  - Colosimo C
FAU - Zappia, Mario
AU  - Zappia M
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20170824
PL  - England
TA  - Cochrane Database Syst Rev
JT  - The Cochrane database of systematic reviews
JID - 100909747
RN  - 0 (Anticonvulsants)
RN  - 0 (Isoxazoles)
RN  - 459384H98V (Zonisamide)
SB  - IM
UOF - doi: 10.1002/14651858.CD009684
MH  - Anticonvulsants/adverse effects/*therapeutic use
MH  - Essential Tremor/*drug therapy
MH  - Humans
MH  - Isoxazoles/adverse effects/*therapeutic use
MH  - Randomized Controlled Trials as Topic
MH  - Zonisamide
PMC - PMC6483684
COIS- EB: none.
 AN: none.
 GQ: none.
 CC: none.
 GF: none.
 MZ: none.
EDAT- 2017/08/25 06:00
MHDA- 2017/09/21 06:00
PMCR- 2018/08/24
CRDT- 2017/08/25 06:00
PHST- 2017/08/25 06:00 [pubmed]
PHST- 2017/09/21 06:00 [medline]
PHST- 2017/08/25 06:00 [entrez]
PHST- 2018/08/24 00:00 [pmc-release]
AID - CD009684.pub2 [pii]
AID - 10.1002/14651858.CD009684.pub2 [doi]
PST - epublish
SO  - Cochrane Database Syst Rev. 2017 Aug 24;8(8):CD009684. doi: 
      10.1002/14651858.CD009684.pub2.