The Role of Antidepressants in the Management of Fibromyalgia Syndrome: A Systematic Review and Meta-Analysis

• Published in: CNS drugs 2012-04, Vol.26 (4), p.297-307
• Main Authors: Häuser, Winfried, Wolfe, Frederick, Tölle, Thomas, Üçeyler, Nurcan, Sommer, Claudia
• Format: Article
• Language: English
• Subjects: Adult; Antidepressive Agents - adverse effects; Antidepressive Agents - pharmacology; Antidepressive Agents - therapeutic use; Biological and medical sciences; Diseases of the osteoarticular system; Fibromyalgia - drug therapy; Fibromyalgia - physiopathology; Humans; Medical sciences; Medicine; Medicine & Public Health; Miscellaneous. Osteoarticular involvement in other diseases; Neurology; Neuropharmacology; Neurosciences; Patient Dropouts; Pharmacology. Drug treatments; Pharmacotherapy; Psychiatry; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease); Psychology. Psychoanalysis. Psychiatry; Psychopharmacology; Quality of Life; Randomized Controlled Trials as Topic; Systematic Review; Treatment Outcome
• ISSN: 1172-7047; 1179-1934
• DOI: 10.2165/11598970-000000000-00000

Background: The role of antidepressants in the management of fibromyalgia syndrome (FMS) still needs to be determined. Objective: The objective of this study was to provide a quantitative analysis (meta-analysis) of the efficacy and harms of antidepressants in the management of adult FMS patients. Data sources: The data sources used were the databases MEDLINE, SCOPUS and the Cochrane Central Register of Controlled Trials (until December 30, 2010), the reference lists of included articles, and the websites of the US National Institutes of Health (NIH) and the Pharmaceutical Research and Manufacturers of America (PhRMA). Study selection: Studies with a randomized controlled trial (RCT) design comparing any types of antidepressants with pharmacological placebo or head-to-head comparisons of different types of antidepressants in FMS patients were included. RCTs in which antidepressants were combined with any other defined treatment or antidepressants were tested against anything but drug placebo were excluded. Patients diagnosed with FMS according to predefined criteria of any age were included. To be included, studies had to assess at least one key domain of FMS (pain, sleep, fatigue, health-related quality of life [HRQOL]) as outcomes of efficacy and report total treatment discontinuation rates and/or dropout rates due to adverse events as outcomes for harms. Data extraction: Data were extracted according to protocols of previous systematic reviews on antidepressants in FMS. Methodology quality was assessed by the van Tulder score. Data synthesis: Standardized mean differences (SMD) were calculated for continuous outcomes by means and standard deviations and relative risks (RR) for 30% pain reduction and total dropout rate for comparisons of antidepressants with placebo. Examination of the combined results was performed by a random effects model. We used Cohen’s categories to evaluate the magnitude of the effect size, calculated by SMD. Heterogeneity was tested by the I 2 statistic. Thirty-five studies were included in the meta-analysis. The SMDs of serotonin noradrenaline (norepinephrine) reuptake inhibitors (SNRIs) on pain, sleep, fatigue, depression and HRQOL were significant. Based on Cohen’s categories, the effect size on pain was small and the ones on sleep, fatigue, depression and HRQOL were not substantial. 1481/3528 (42.0%) patients with SNRIs and 737/2304 (32.0%) patients with placebo reported a 30% pain reduction (number needed to treat [NNT] 10.0