Arnold LM, Rosen A, Pritchett YL, et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder

Indiana University-Purdue University Indianapolis, Indianapolis, Indiana, United States
Pain (Impact Factor: 5.21). 12/2005; 119(1-3):5-15. DOI: 10.1016/j.pain.2005.06.031
Source: PubMed


This was a 12-week, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of duloxetine, a selective serotonin and norepinephrine reuptake inhibitor, in 354 female patients with primary fibromyalgia, with or without current major depressive disorder. Patients (90% Caucasian; mean age, 49.6 years; 26% with current major depressive disorder) received duloxetine 60 mg once daily (QD) (N=118), duloxetine 60 mg twice daily (BID) (N=116), or placebo (N=120). The primary outcome was the Brief Pain Inventory average pain severity score. Response to treatment was defined as >or=30% reduction in this score. Compared with placebo, both duloxetine-treated groups improved significantly more (P<0.001) on the Brief Pain Inventory average pain severity score. A significantly higher percentage of duloxetine-treated patients had a decrease of >or=30% in this score (duloxetine 60 mg QD (55%; P<0.001); duloxetine 60 mg BID (54%; P=0.002); placebo (33%)). The treatment effect of duloxetine on pain reduction was independent of the effect on mood and the presence of major depressive disorder. Compared with patients on placebo, patients treated with duloxetine 60 mg QD or duloxetine 60 mg BID had significantly greater improvement in remaining Brief Pain Inventory pain severity and interference scores, Fibromyalgia Impact Questionnaire, Clinical Global Impression of Severity, Patient Global Impression of Improvement, and several quality-of-life measures. Both doses of duloxetine were safely administered and well tolerated. In conclusion, both duloxetine 60 mg QD and duloxetine 60 mg BID were effective and safe in the treatment of fibromyalgia in female patients with or without major depressive disorder.

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Available from: Smriti Iyengar, Jul 18, 2014
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    • "Review (Arnold et al. 2005 [11]: 5, Chappell et al. 2008 [20] "
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    ABSTRACT: Background Chronic painful conditions have an important influence on the ability to work. Work-related outcomes, however, are not commonly reported in publications on trials investigating the treatment of chronic painful conditions. We aim to provide an overview of the reporting of work-related outcomes in such trials and investigate the relationship between work-related outcomes and pain outcomes. Methods We conducted a systematic literature search in PubMed with the aim of identifying randomised placebo-controlled clinical trials investigating treatments for chronic painful conditions or rheumatic diseases that also reported on work-related outcomes. Methodological study quality was assessed with the Oxford Quality Scale (OQS). Meta-analyses were conducted for the outcomes of interference with work and number of patients with at least 30% reduction in pain intensity (30% pain responders). The correlation between work-related and pain outcomes was investigated with regression analyses. Results We included 31 publications reporting on 27 datasets from randomised placebo-controlled trials (with a total of 11,434 study participants) conducted in chronic painful or rheumatic diseases and reporting on work-related outcomes. These 31 publications make up only about 0.2% of all publications on randomised placebo-controlled trials in such conditions. The methodological quality of the included studies was high; only nine studies scored less than four (out of a maximum five) points on the OQS. Sixteen different work-related outcomes were reported on in the studies. Of 25 studies testing for the statistical significance of changes in work-related outcomes over the course of the trials, 14 (56%) reported a significant improvement; the others reported non-significant changes. Eight studies reported data on both interference with work and 30% pain responders: meta-analyses demonstrated similar, statistically significant improvements in both these outcomes with active therapy compared to placebo and regression analysis showed that these outcomes were correlated. Conclusions Despite the importance of pain as a reason for decreased ability to work, work-related outcomes are reported in substantially less than 1% of publications on placebo-controlled trials in chronic painful and rheumatic diseases. Work-related outcomes and pain responder outcomes are closely related.
    Full-text · Article · Jul 2014 · Journal of Occupational Medicine and Toxicology
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    • "Duloxetine was approved in 2008 and milnacipran in 2009. Double-blind RCTs evaluating duloxetine doses ranging between 60 and 120 mg per day have typically shown greater improvement in pain reports and self-report functioning than those in the placebo arm [60–62]. Analysis of pooled data from the 4 RCTs [63] indicates that 48% of treated patients and 32% of patients receiving placebo reported >30% pain reduction. "
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    ABSTRACT: Fibromyalgia syndrome (FMS) is a common chronic musculoskeletal pain disorder of unknown etiology and characterized by generalized body pain, hyperalgesia, and other functional and emotional comorbidities. Despite extensive research, no treatment modality is effective for all FMS patients. In this paper, we briefly review the history of FMS and diagnostic criteria, and potential pathophysiological mechanisms including central pain modulation, neurotransmitters, sympatho-adrenal and hypothalamic-pituitary-adrenal systems and peripheral muscle issues. The primary focus of the paper is to review treatment options for managing fibromyalgia symptoms. We will discuss FDA-approved medications and other pharmacologic agents, and non-pharmacologic treatments that have shown promising effects.
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    • "Pain interference items include sleep, work, walking ability, and enjoyment of life (0 = does not interfere to 10 = completely interferes). The BPI has been widely used to assess chronic pain across a variety of conditions, including low back pain [12] [13], arthritis [13], neuropathy [14], and fibromyalgia [15]. Good reliability (coefficient α > 0.70) and validity have been demonstrated across multiple pain conditions [13]. "
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    ABSTRACT: Chronic pain and obesity are significant public health concerns in the United States associated with significant levels of health-care expenses and lost productivity. Previous research suggests that obesity is a risk factor for chronic pain, mainly due to excessive weight placed on the joints. However, the obesity-pain relationship appears to be complex and reciprocal. Little work to date has focused on the relationship between weight and pain among patients undergoing gastric bypass surgery for weight loss. Patients scheduled to undergo bariatric surgery for weight loss at a large southeastern academic medical center (N = 115) completed the Brief Pain Inventory (BPI), the Center for Epidemiological Studies 10-item Depression scale (CESD-10), and the Beck Anxiety Inventory (BAI). Higher presurgical weight was associated with higher pain-on-average ratings, higher functional impairment due to pain across the domains of physical activity, mood, walking ability, relationships, and enjoyment of life. Higher presurgical weight was associated with higher BAI scores, but weight was not related to depression. Findings suggest that bariatric surgery candidates report a moderate amount of pain prior to surgery and that presurgical weight is associated with higher pain, increased functional impairment due to pain, and increased anxiety. Anxiety was found to mediate the relationship between increased weight and pain.
    Full-text · Article · Oct 2012 · Pain Research and Treatment
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