Combination pharmacotherapy for the treatment of fibromyalgia in adults

Joelle Thorpe; Bonnie Shum; R Andrew Moore; Philip J Wiffen; Ian Gilron

doi:10.1002/14651858.CD010585.pub2

Cochrane Database of Systematic Reviews

Combination pharmacotherapy for the treatment of fibromyalgia in adults

Information

DOI:

https://doi.org/10.1002/14651858.CD010585.pub2 Copy DOI

Database:

Cochrane Database of Systematic Reviews

Version published:

19 February 2018see what's new

Type:

Intervention

Stage:

Review

Cochrane Editorial Group:

Cochrane Pain, Palliative and Supportive Care Group

Copyright:

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

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Authors

Joelle Thorpe

Anesthesiology & Perioperative Medicine, Queen's University, Kingston, Canada
Bonnie Shum

Anesthesiology & Perioperative Medicine, Queen's University, Kingston, Canada
R Andrew Moore

Plymouth, UK
Philip J Wiffen

Thame, UK
Ian Gilron

Correspondence to: Departments of Anesthesiology & Perioperative Medicine & Biomedical & Molecular Sciences, Queen's University, Kingston, Canada

[email protected]

Contributions of authors

The title was registered by IG. The protocol was written by IG, BS, RAM and PW. JBT and IG assessed inclusion of papers and extracted data. JBT took on lead authorship for the full review and wrote up the review. IG, JBT, RAM and PW contributed to the final draft and approved the published version. IG will be responsible for the update.

Sources of support

Internal sources

Queen's University Department of Anesthesiology & Perioperative Medicine, Canada

Research time support

External sources

Canadian Institutes of Health Research ‐ Industry‐Partnered (Pfizer) Investigator Award to IG, Canada

Salary support

Declarations of interest

JT: none known.

BS: 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 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.

PW: none known.

IG is an anaesthesiologist and conducts clinical trials in acute and chronic pain conditions. He has received lecture/consultancy fees from Biogen (2016) and Adynxx (2015). IG, who is the lead and corresponding author on one of the included studies in this review, did not participate in data extraction or assessments pertaining to that study.

This review was identified in a 2019 audit as not meeting the current definition of the Cochrane Commercial Sponsorship policy. At the time of its publication it was compliant with the interpretation of the existing policy. As with all reviews, new and updated, at update this review will be revised according to 2020 policy update.

Acknowledgements

This work was funded, in part, by research funding from the Canadian Institutes of Health Research.

Cochrane Review Group funding acknowledgement: this project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to Cochrane Pain, Palliative and Supportive Care (PaPaS). The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.

Version history

Published

Title

Stage

Authors

Version

2018 Feb 19

Combination pharmacotherapy for the treatment of fibromyalgia in adults

Review

Joelle Thorpe, Bonnie Shum, R Andrew Moore, Philip J Wiffen, Ian Gilron

https://doi.org/10.1002/14651858.CD010585.pub2

2013 Jun 13

Combination pharmacotherapy for the treatment of fibromyalgia

Protocol

Ian Gilron, Bonnie Shum, R Andrew Moore, Philip J Wiffen

https://doi.org/10.1002/14651858.CD010585

Differences between protocol and review

We added a description of how we evaluated the quality of the evidence using GRADE, and we added a description of the criteria we used for rating the risk of bias as low, unclear, or high. We did not apply Oxford Quality Scores (Jadad 1996) to the studies assessed for inclusion due to redundancies with the 'Risk of bias' assessments used (Higgins 2011a; Higgins 2011b).

We also refined our data analysis section to describe in detail methods we planned to use in the event of there being adequate data, and provided a justification and references for making judgements of very low quality evidence in the event of there being little or no data available.

Notes

At October 2020 we did not identify any new potentially relevant studies likely to change the conclusions. Therefore, this review has now been stabilised following discussion with the authors and editors. The review will be reassessed for updating in two years. If appropriate, we will update the review before this date if new evidence likely to change the conclusions is published, or if standards change substantially which necessitate major revisions.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Humans;

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.

Figure 1

Flow diagram

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Figure 2

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

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Figure 3

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

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Summary of findings 1. Any combination of two or more drugs compared with placebo or other comparators, or both, for fibromyalgia

Outcome	Result	GRADE
Any combination of two or more drugs compared with placebo or other comparators, or both, for fibromyalgia
Patient or population: adults with fibromyalgia Settings: community Intervention: any combination of two or more drugs (note: our searches found nine combinations of drugs) Comparison: placebo and/or other comparators
Patient‐reported pain relief of 30% or greater	No or insufficient data for analysis for any combination of drugs	Very low quality, as no data for analysis
Patient‐reported pain relief of 50% or greater	No or insufficient data for analysis for any combination of drugs	Very low quality, as no data for analysis
Patient‐reported global impression of clinical change much or very much improved (moderate improvement)	No or insufficient data for analysis for any combination of drugs	Very low quality, as no data for analysis
Any pain‐related outcome indicating some improvement	No or insufficient data for analysis for any combination of drugs	Very low quality, as no data for analysis
Participants experiencing any adverse event	No or insufficient data for analysis for any combination of drugs	Very low quality, as no data for analysis
Participants experiencing any serious adverse event	No or insufficient data for analysis for any combination of drugs	Very low quality, as no data for analysis
Withdrawals due to adverse events	No or insufficient data for analysis for any combination of drugs	Very low quality, as no data for analysis
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of effect, but there is a possibility that it is substantially different Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect

Summary of findings 1. Any combination of two or more drugs compared with placebo or other comparators, or both, for fibromyalgia

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Table 1. Methodology of included trials

First author, year	Trial comparisons
First author, year	Placebo‐controlled	Combination vs. only 1 component	Combination vs. both components	Combination vs. other
Albertoni Giraldes 2016	+	+
Bennett 2003	+
de Zanette 2014			+
Gilron 2016	+		+
Goldenberg 1986	+		+
Goldenberg 1996	+		+
Hussain 2011			+
Kravitz 1994	+		+
Nicolodi 1996			+	+^a
Pridgen 2017	+			+
Quijada‐Carrera 1996	+		+
Russell 1991	+		+
Russell 1995	+
Vaeroy 1989	+
Vlainich 2010		+
Zucker 2006		+
^aNicolodi 1996 compared a monoamine oxidase inhibitor, 5‐hydroxytryptophan, their combination, and amitriptyline.

Table 1. Methodology of included trials

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Combination pharmacotherapy for the treatment of fibromyalgia in adults

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