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Drug Class Review: Drugs for Fibromyalgia

Final Original Report

Drug Class Reviews

, DO, , MS, , PhD, , PharmD, and , MPA:HA.

Portland (OR): Oregon Health & Science University; .

Structured Abstract


We compared the effectiveness and harms of tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, selective serotonin reuptake inhibitors, selective serotonin and norepinephrine reuptake inhibitors, noradrenergic and specific serotonergic reuptake inhibitor, norepinephrine and dopamine reuptake inhibitor, serotonin receptor antagonist, antiepileptic drugs, and skeletal muscle relaxants in adults with fibromyalgia.

Data Sources:

We searched Ovid MEDLINE®, the Cochrane Database of Systematic Reviews®, and the Cochrane Central Register of Controlled Trials® and Database of Abstracts of Reviews of Effects through October 2010. For additional data we also hand searched reference lists, US Food and Drug Administration medical and statistical reviews and dossiers submitted by pharmaceutical companies.

Review Methods:

Study selection, data abstraction, validity assessment, grading the strength of the evidence, and data synthesis were all carried out according to standard Drug Effectiveness Review Project review methods.

Results and Conclusions:

We found eligible studies of treatment for fibromyalgia with amitriptyline, nortriptyline, citalopram, fluoxetine, paroxetine, cyclobenzaprine, pregabalin, gabapentin, milnacipran, and duloxetine. We found no eligible studies with the other included drugs and no eligible studies of included interventions when used as adjunctive therapy. Head-to-head trials were few, and provided low-strength evidence that short-term treatment with immediate-release paroxetine is superior to amitriptyline in reducing pain and sleep disturbance and provided low-strength evidence there are no significant differences between amitriptyline as compared with cyclobenzaprine and nortriptyline. Although there were some significant differences between drugs in overall adverse events, they did not produce any differences in withdrawals due to adverse events. Additionally, based on indirect comparison meta-analysis, we found low evidence that duloxetine was superior to milnacipran on outcomes of pain, sleep disturbance, depressed mood, and health-related quality of life. We found low evidence that both duloxetine and milnacipran were superior to pregabalin on improvement in depressed mood, whereas pregabalin was superior to milnacipran on improvement in sleep disturbance. Amitriptyline was similar to duloxetine, milnacipran, and pregabalin on outcomes of pain and fatigue, with insufficient data on the other outcomes. Although there were some significant differences between duloxetine, milnacipran, and pregabalin in specific adverse events, they did not produce any differences in overall withdrawals, overall adverse events, and withdrawals due to adverse events. For the remaining drugs, there was only evidence of significant improvements in pain over placebo in 1 trial for gabapentin, in 1 of 3 trials for cyclobenzaprine, and in 1 trial of fluoxetine. But, no conclusions can be drawn about comparative effectiveness or harms among these drugs because the numbers of trials/patients in placebo-controlled trials were too few to provide meaningful results in indirect comparisons. Duloxetine was not effective on pain reduction in male, nonwhite, and older patients based on a small sample size that was underpowered to detect a difference. Compared with placebo, duloxetine, fluoxetine, controlled-release paroxetine, and pregabalin significantly improved fibromyalgia symptoms regardless of baseline depression but milnacipran was only effective in nondepressed patients. Controlled -release paroxetine and pregabalin significantly improved fibromyalgia symptoms regardless of baseline anxiety.


Drug Effectiveness Review Project: Marian McDonagh, PharmD, Principal Investigator
Oregon Evidence-based Practice Center: Mark Helfand, MD, MPH, Director

Acknowledgments: We thank Leah Williams, our publications editor, for putting this report into its present form for you to read and Allison Low for assistance with data abstraction and retrieval of articles and assistance with editing and formatting.

Clinical Advisory Group: We extend our appreciation to the clinical advisors listed below for their thoughtful advice and input during our research process.
Manfred Harth, MD, Professor Emeritus, Medicine, University of Western Ontario, Canadian Rheumatology Association.
Mary-Ann Fitzcharles, Associate Professor, McGill University, Director Fibromyalgia Clinic McGill Pain Center, Montreal General Hospital, Quebec Pain Society Executive Committee, Arthritis Society of Canada, medical Advisory Committee.

Funding: The Drug Effectiveness Review Project, composed of 12 organizations including 11 state Medicaid agencies, and the Canadian Agency for Drugs and Technology in Health commissioned and funded for this report. These organizations selected the topic of the report and had input into its Key Questions. The content and conclusions of the report were entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed

Suggested citation:

Smith B, Peterson K, Fu R, McDonagh M, Thakurta S. Drugs for fibromyalgia. Final original report.

The purpose of Drug Effectiveness Review Project reports is to make available information regarding the comparative clinical effectiveness and harms of different drugs. Reports are not usage guidelines, nor should they be read as an endorsement of or recommendation for any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports.

Copyright © 2011, Oregon Health & Science University.
Bookshelf ID: NBK55552PMID: 21678632
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