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Cochrane Database of Systematic Reviews

Amitriptyline for fibromyalgia in adults

Information

DOI:
https://doi.org/10.1002/14651858.CD011824Copy DOI
Database:
  1. Cochrane Database of Systematic Reviews
Version published:
  1. 31 July 2015see what's new
Type:
  1. Intervention
Stage:
  1. Review
Cochrane Editorial Group:
  1. Cochrane Pain, Palliative and Supportive Care Group

Copyright:
  1. Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Authors

  • R Andrew Moore

    Correspondence to: Plymouth, UK

    [email protected]

  • Sheena Derry

    Oxford, UK

  • Dominic Aldington

    Royal Hampshire County Hospital, Winchester, UK

  • Peter Cole

    Oxford Pain Relief Unit, Churchill Hospital, Oxford University Hospitals NHS Trust, Oxford, UK

  • Philip J Wiffen

    Thame, UK

Contributions of authors

PW, RAM, and SD wrote the protocol.

For the original review, and again for this update, RAM and SD carried out searches, assessed studies for inclusion, and extracted data. RAM acted as arbitrator. All authors were involved in writing the review.

RAM will be responsible for updating the review.

Sources of support

Internal sources

  • Oxford Pain Relief Trust, UK.

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

SD has no conflicts relating to this review or any similar product.

PW has no conflicts relating to this review or any similar product.

RAM has no conflicts relating to this review or any similar product.

DA has no conflicts relating to this review or any similar product.

PC has received research support from industry sources at various times but none related to this review.

For transparency SD, PW and RAM have received research support from charities, government, and industry sources at various times, but none relate to this review. We are funded by the NIHR for work on a series of reviews informing the unmet need of chronic pain and providing the evidence for treatments of pain.

Acknowledgements

Support for this review came from the Oxford Pain Relief Trust.

The protocol for this review was written with funding support from the NHS Cochrane Collaboration Programme Grant Scheme (UK) and European Union Biomed 2 Grant no. BMH4 CT95 0172 (UK). We are grateful to the peer reviewers for some very useful comments relating to that protocol, and the earlier review.

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

Version history

Published

Title

Stage

Authors

Version

2015 Jul 31

Amitriptyline for fibromyalgia in adults

Review

R Andrew Moore, Sheena Derry, Dominic Aldington, Peter Cole, Philip J Wiffen

https://doi.org/10.1002/14651858.CD011824

Differences between protocol and review

This update considers fibromyalgia only. Neuropathic pain conditions are the subject of a separate review. It is based on a template for reviews of drugs used to relieve fibromyalgia. The aim is for all reviews to use the same methods, based on new criteria for what constitutes reliable evidence in chronic pain (Moore 2010a; Appendix 1).

We have used three‐tiers of evidence, not two, to better distinguish the strength of evidence and in line with other reviews of interventions for neuropathic pain. We assessed the data according to different neuropathic pain conditions, and planned no further subgroup analysis because the amount of data was expected to be small.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Flow diagram.
Figures and Tables -
Figure 1

Flow diagram.

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figures and Tables -
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.
Figures and Tables -
Figure 3

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

Forest plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Third‐tier efficacy.
Figures and Tables -
Figure 4

Forest plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Third‐tier efficacy.

Third‐tier evidence: substantial pain relief
Figures and Tables -
Figure 5

Third‐tier evidence: substantial pain relief

Comparison 1 Amitriptyline versus placebo, Outcome 1 Third‐tier efficacy.
Figures and Tables -
Analysis 1.1

Comparison 1 Amitriptyline versus placebo, Outcome 1 Third‐tier efficacy.

Comparison 1 Amitriptyline versus placebo, Outcome 2 At least 1 adverse event.
Figures and Tables -
Analysis 1.2

Comparison 1 Amitriptyline versus placebo, Outcome 2 At least 1 adverse event.

Comparison 1 Amitriptyline versus placebo, Outcome 3 All‐cause withdrawal.
Figures and Tables -
Analysis 1.3

Comparison 1 Amitriptyline versus placebo, Outcome 3 All‐cause withdrawal.

Comparison 1 Amitriptyline versus placebo, Outcome 4 Adverse event withdrawal.
Figures and Tables -
Analysis 1.4

Comparison 1 Amitriptyline versus placebo, Outcome 4 Adverse event withdrawal.

Comparison 1 Amitriptyline versus placebo, Outcome 5 Lack of efficacy withdrawal.
Figures and Tables -
Analysis 1.5

Comparison 1 Amitriptyline versus placebo, Outcome 5 Lack of efficacy withdrawal.

Amitriptyline compared with placebo for fibromyalgia

Patient or population: adults with fibromyalgia

Settings: community

Intervention: amitriptyline 25 to 50 mg daily

Comparison: placebo

Outcomes

Probable outcome with intervention

Probable outcome with placebo

NNT or NNH and/or relative effect (95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

At least 50% reduction in pain or equivalent (substantial)

360 in 1000

110 in 1000

RR 2.9 (1.7 to 4.9)

NNT 4.1 (2.9 to 6.7)

4 studies, 275 participants

Very low

Small number of studies and participants

At least 30% reduction in pain or equivalent (moderate)

no data

Adverse event withdrawals

80 in 1000

90 in 1000

RR 1.03 (0.49 to 2.2)

NNTp not calculated

4 studies, 298 participants

Very low

Small number of studies and participants

Serious adverse events

none reported

Death

none reported

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.

Figures and Tables -
Comparison 1. Amitriptyline versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Third‐tier efficacy Show forest plot

4

275

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [1.69, 4.91]

1.1 Fibromyalgia

4

275

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [1.69, 4.91]

2 At least 1 adverse event Show forest plot

4

318

Risk Ratio (M‐H, Fixed, 95% CI)

1.54 [1.29, 1.84]

3 All‐cause withdrawal Show forest plot

7

418

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.53, 1.11]

4 Adverse event withdrawal Show forest plot

4

298

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.49, 2.16]

5 Lack of efficacy withdrawal Show forest plot

3

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.42 [0.19, 0.95]

Figures and Tables -
Comparison 1. Amitriptyline versus placebo