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Alprazolam para el temblor esencial

Información

DOI:
https://doi.org/10.1002/14651858.CD009681.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 06 diciembre 2015see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Trastornos del movimiento

Copyright:
  1. Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Elisa Bruno

    Correspondencia a: Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK

    [email protected]

  • Alessandra Nicoletti

    Department GF Ingrassia, Section of Neurosciences, University of Catania, Catania, Italy

  • Graziella Quattrocchi

    Department GF Ingrassia, Section of Neurosciences, University of Catania, Catania, Italy

  • Graziella Filippini

    Scientific Director’s Office, Carlo Besta Foundation and Neurological Institute, Milan, Italy

  • Mario Zappia

    Department GF Ingrassia, Section of Neurosciences, University of Catania, Catania, Italy

  • Carlo Colosimo

    Department of Neurology, Terni University Hospital, Terni, Italy

Contributions of authors

EB: protocol and review editing, literature searching, study selection, quality assessment, data extraction.

AN: protocol and review editing.

GQ: literature searching, quality assessment, data extraction.

CC: protocol editing, quality assessment, study selection.

GF: protocol editing, editing and revising of the review.

MZ: protocol editing, revising of the review.

Sources of support

Internal sources

  • None, Other

External sources

  • None, Other

Declarations of interest

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.

Conversely, 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.

Acknowledgements

The review authors would like to express their gratitude to Cristina Sampaio and to Ricardo M. Fernandes for precious comments and guidance provided during development of the final version of this review.

Version history

Published

Title

Stage

Authors

Version

2015 Dec 06

Alprazolam for essential tremor

Review

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

https://doi.org/10.1002/14651858.CD009681.pub2

2012 Mar 14

Alprazolam for essential tremor

Protocol

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

https://doi.org/10.1002/14651858.CD009681

Differences between protocol and review

In an attempt to provide a standardised and reliable assessment of the quality of the evidence on study outcomes, we decided to use the GRADE evidence profile, a systematic and explicit system for grading the evidence according to four quality categories. We reported results obtained through this approach in summary of findings Table 1.

Methods for future updates

We did not perform two preplanned analysis because data were insufficient. These analyses will be eventually implemented, if possible, in future updates of the review.

Methods for analysing continuous data: Scales used to assess tremor in most studies are continuous. We will transform ordinal scales with enough categories to continuous scales by assigning a score to each grade, so that we can express the intervention effect as a difference in means, or as a standardised mean difference (SMD). In the case of an ordinal scale with few categories, we will combine data from adjacent categories into two categories, and will use methods for binary data such as odds ratios (ORs) or risk differences (RDs) to evaluate intervention effects.

Sensitivity analysis: We will undertake sensitivity analyses to assess the robustness of results to fixed‐effect versus random‐effects assumptions, and inclusion or exclusion of studies at high risk of bias (i.e. inadequate allocation concealment and lack of a blinded outcome assessor). We will use best‐ and worst‐case scenarios when taking missing data into account.

Keywords

MeSH

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Flowchart of the literature search on alprazolam and essential tremor.

Figuras y tablas -
Figure 1

Flowchart of the literature search on alprazolam and essential tremor.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1: Comparison for efficacy, Outcome 1: Clinical rating scale

Figuras y tablas -
Analysis 1.1

Comparison 1: Comparison for efficacy, Outcome 1: Clinical rating scale

Summary of findings 1. Alprazolam for essential tremor

Alprazolam for essential tremor

Patient or population: patients with essential tremor
Settings: outpatients
Intervention: alprazolam

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Alprazolam

Tremor severity
Clinical rating scale. Scale from 0 to 4
Follow‐up: 2 weeks

Mean tremor severity in control groups was
2.13 points

Mean tremor severity in intervention group was
0.75 lower
(0.67 to 0.83 lower)

24
(1 study)

⊕⊝⊝⊝
Very lowa,b

Withdrawals due to adverse events

Follow‐up: 2 weeks

None

None

24

(1 study)

⊕⊝⊝⊝
Very lowa,b

Quality of life

Investigator global assessment

Scale from 1 to 7

Follow‐up: 2 weeks

Mean score in the control group was

3.83 points

Mean score in the intervention group was

1.16 lower

(0.17 to 2.15 lower)

24

(1 study)

⊕⊝⊝⊝
Very lowa,b

Quality of life

Investigator global assessment

Scale from 1 to 7

Follow‐up: 2 weeks

Mean score in the control group was

3.5points

Mean score in the intervention group was

0.67 lower

(0.27 to 1.61 lower)

24

(1 study)

⊕⊝⊝⊝
Very lowa,b

*The basis for the assumed risk (e.g. median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: Confidence interval

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate
Very low quality: We are very uncertain about the estimate

aDowngraded by 2 levels for very serious risk of bias: allocation and blinding methods not described (selection bias); number of adverse events in the placebo group not reported (reporting bias); essential tremor diagnostic criteria applied to participants not reported; patient exclusion and inclusion criteria not specified. An arbitrary, not validated, clinical rating scale for tremor severity was used for assessment of tremor.
bDowngraded by 2 levels for very serious imprecision: small sample size; uncertainty of clinical relevance of results reported and of effects measured.

Figuras y tablas -
Summary of findings 1. Alprazolam for essential tremor
Comparison 1. Comparison for efficacy

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1.1 Clinical rating scale Show forest plot

1

24

Mean Difference (IV, Fixed, 95% CI)

‐0.75 [‐0.83, ‐0.67]

Figuras y tablas -
Comparison 1. Comparison for efficacy