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Cochrane Database of Systematic Reviews

Gabapentina para el dolor de la fibromialgia en adultos

Información

DOI:
https://doi.org/10.1002/14651858.CD012188.pub2Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 03 enero 2017see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Dolor y cuidados paliativos

Copyright:
  1. Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

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Autores

  • Tess E Cooper

    Correspondencia a: Cochrane Pain, Palliative and Supportive Care Group, Pain Research Unit, Churchill Hospital, Oxford, UK

    [email protected]

  • Sheena Derry

    Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Oxford, UK

  • Philip J Wiffen

    Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Oxford, UK

  • R Andrew Moore

    Pain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics), University of Oxford, Oxford, UK

Contributions of authors

PW registered the title.

TC, RAM, SD, and PW wrote the protocol.

TC and PW performed screening and data extraction.

All authors were involved in writing the full review.

PW will be responsible for updates in the future.

Sources of support

Internal sources

  • Oxford Pain Relief Trust, UK.

    General institutional support

External sources

  • The National Institute for Health Research (NIHR), UK.

    NIHR Cochrane Programme Grant: 13/89/29 ‐ Addressing the unmet need of chronic pain: providing the evidence for treatments of pain

Declarations of interest

TC: none known.

SD: none known.

PW: none known.

RAM has received grant support from Grünenthal relating to individual patient level analyses of trial data regarding tapentadol in osteoarthritis and back pain (2015). He has received honoraria for attending boards with Menarini concerning methods of analgesic trial design (2014), with Novartis (2014) about the design of network meta‐analyses, and RB on understanding pharmacokinetics of drug uptake (2015). He has received honoraria from Omega Pharma (2016) and Futura Pharma (2016) for providing advice on trial and data analysis methods.

Acknowledgements

The Oxford Pain Relief Trust provided institutional support.

Cochrane Review Group funding acknowledgement: the National Institute for Health Research (NIHR) is the largest single funder of the Cochrane Pain, Palliative and Supportive Care (PaPaS) Review Group. Disclaimer: the views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR, National Health Service (NHS) or the Department of Health.

The protocol followed the agreed template for fibromyalgia, which we developed in collaboration with the Cochrane Musculoskeletal Group and Cochrane Neuromuscular Diseases (NMD) Group. The Cochrane PaPaS Group managed the editorial process.

We thank the peer reviewer Mike Lunn, Joint Co‐ordinating Editor of the Cochrane NMD Group, for his useful comments on the protocol.

Version history

Published

Title

Stage

Authors

Version

2017 Jan 03

Gabapentin for fibromyalgia pain in adults

Review

Tess E Cooper, Sheena Derry, Philip J Wiffen, R Andrew Moore

https://doi.org/10.1002/14651858.CD012188.pub2

2016 May 11

Gabapentin for fibromyalgia pain in adults

Protocol

Tess E Cooper, R Andrew Moore, Sheena Derry, Philip J Wiffen

https://doi.org/10.1002/14651858.CD012188

Differences between protocol and review

We have extended the description of the GRADE assessment for exceptional circumstances to explain possible decisions. We have also removed one secondary outcome (any disability‐related or mental health‐related outcome) because, on reflection, this is not usually reported in trials.

Notes

A restricted search in March 2018 did not identify any potentially relevant studies likely to change the conclusions. The authors and editors are confident that further research will not change the conclusions. Therefore, this review has now been stabilised following discussion with the authors and editors. If appropriate, we will update the review if new evidence likely to change the conclusions is published, or if standards change substantially which necessitate major revisions.

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.

History of Earlier Reviews
Figuras y tablas -
Figure 1

History of Earlier Reviews

Study flow diagram.
Figuras y tablas -
Figure 2

Study flow diagram.

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.

Summary of findings for the main comparison. Gabapentin compared with placebo for fibromyalgia

Gabapentin compared with placebo for fibromyalgia

Patient or population: adults with fibromyalgia

Settings: community

Intervention: gabapentin

Comparison: placebo

Outcomes

Assumed risk ‐ probable outcome with intervention

Corresponding risk ‐ probable outcome with control

Relative effect
(95% CI)

Number of
studies, participants

Quality of the evidence
(GRADE)

Comments

gabapentin

placebo

30% pain reduction at 12 weeks

38/75

23/75

Not calculated

1 study, 150 participants

very low

One included study of fewer than 200 participants; LOCF imputation.

Downgraded three levels because of small numbers and study limitations

50% pain reduction at 12 weeks

No data

No data

very low

Outcome not reported

PGIC ‐ any category of "better"

at 12 weeks

68/75

35/75

Not calculated

1 study, 150 participants

very low

One included study of fewer than 200 participants; LOCF imputation;

non‐standard outcome ‐ usually top two categories of better, not top three, used

Downgraded three levels because of small numbers and study limitations

Withdrawals due to adverse events

12/75

7/75

Not calculated

1 study, 150 participants

very low

One included study of fewer than 200 participants; few events

Downgraded three levels because of small numbers

Serious adverse events

"No significant group differences"

1 study, 150 participants

very low

Deaths

None reported

1 study, 150 participants

very low

CI: Confidence interval; LOCF: last observation carried forward; PGIC: Patient Global Impression of Change

Descriptors for levels of evidence (EPOC 2015):
High quality: This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different is low.
Moderate quality: This research provides a good indication of the likely effect. The likelihood that the effect will be substantially different is moderate.
Low quality: This research provides some indication of the likely effect. However, the likelihood that it will be substantially different is high.
Very low quality: This research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different is very high.

Substantially different: a large enough difference that it might affect a decision.

Figuras y tablas -
Summary of findings for the main comparison. Gabapentin compared with placebo for fibromyalgia