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      Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial

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          Abstract

          Introduction

          Fatigue is one of the most disabling symptoms associated with fibromyalgia that greatly impacts quality of life. Fatigue was assessed as a secondary objective in a 2-phase, 24-week study in outpatients with American College of Rheumatology-defined fibromyalgia.

          Methods

          Patients were randomized to duloxetine 60-120 mg/d ( N = 263) or placebo ( N = 267) for the 12-week acute phase. At Week 12, all placebo-treated patients were switched to double-blind treatment with duloxetine for the extension phase. Fatigue was assessed at baseline and every 4 weeks with the Multidimensional Fatigue Inventory (MFI) scales: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Activity, and Reduced Motivation. Other assessments that may be associated with fatigue included Brief Pain Inventory (BPI) average pain, numerical scales to rate anxiety, depressed mood, bothered by sleep difficulties, and musculoskeletal stiffness. Treatment-emergent fatigue-related events were also assessed. Changes from baseline to Week 12, and from Week 12 to Week 24, were analyzed by mixed-effects model repeated measures analysis.

          Results

          At Week 12, duloxetine versus placebo significantly (all p < .05) reduced ratings on each MFI scale, BPI pain, anxiety, depressed mood, and stiffness. Improvement in ratings of being bothered by sleep difficulties was significant only at Weeks 4 and 8. At Week 24, mean changes in all measures indicated improvement was maintained for patients who received duloxetine for all 24 weeks ( n = 176). Placebo-treated patients switched to duloxetine ( n = 187) had significant within-group improvement in Physical Fatigue (Weeks 16, 20, and 24); General Fatigue (Weeks 20 and 24); Mental Fatigue (Week 20); and Reduced Activity (Weeks 20 and 24). These patients also experienced significant within-group improvement in BPI pain, anxiety, depressed mood, bothered by sleep difficulties, and stiffness. Overall, the most common (> 5% incidence) fatigue-related treatment-emergent adverse events were fatigue, somnolence, and insomnia.

          Conclusions

          Treatment with duloxetine significantly improved multiple dimensions of fatigue in patients with fibromyalgia, and improvement was maintained for up to 24 weeks.

          Trial registration

          ClinicalTrials.gov registry NCT00673452.

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          Most cited references20

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          The fibromyalgia impact questionnaire: development and validation.

          An instrument has been developed to assess the current health status of women with the fibromyalgia syndrome. The Fibromyalgia Impact Questionnaire (FIQ) is a brief 10-item, self-administered instrument that measures physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. We describe its development and validation. This initial assessment indicates that the FIQ has sufficient evidence of reliability and validity to warrant further testing in both research and clinical situations.
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            Patient perspectives on the impact of fibromyalgia.

            The objective of this study was to elicit and assess important symptom domains and the impact of fibromyalgia on patients' quality of life and functioning from a patient's perspective. The intention was to collect this information as part of an overall effort to overcome shortcomings of existing outcome measures in fibromyalgia. This was a qualitative study in which six focus group sessions with 48 women diagnosed with fibromyalgia were conducted to elicit concepts and ideas to assess the impact of fibromyalgia on their lives. The focus groups conducted with fibromyalgia patients identified symptom domains that had the greatest impact on their quality of life including pain, sleep disturbance, fatigue, depression, anxiety, and cognitive impairment. Fibromyalgia had a substantial negative impact on social and occupational function. Patients reported disrupted relationships with family and friends, social isolation, reduced activities of daily living and leisure activities, avoidance of physical activity, and loss of career or inability to advance in careers or education. The findings from the focus groups revealed that fibromyalgia has a substantial negative impact on patients' lives. A comprehensive assessment of the multiple symptoms domains associated with fibromyalgia and the impact of fibromyalgia on multidimensional aspects of function should be a routine part of the care of fibromyalgia patients.
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              Application of the multidimensional fatigue inventory (MFI-20) in cancer patients receiving radiotherapy.

              In this paper the psychometric properties of the multidimensional fatigue inventory (MFI-20) are established further in cancer patients. The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation and mental fatigue. The instrument was used in a Dutch and Scottish sample of cancer patients receiving radiotherapy. The dimensional structure was assessed using confirmatory factor analyses (Lisrel's unweighted least-squares method). The hypothesised five-factor model appeared to fit the data in both samples (adjusted goodness of fit; AGFI: 0.97 and 0.98). Internal consistency of the separate scales was good in both the Dutch and Scottish samples with Cronbach's alpha coefficients ranging from 0.79 to 0.93. Construct validity was assessed by correlating the MFI-20 to activities of daily living, anxiety and depression. Significant relations were assumed. Convergent validity was investigated by correlating the MFI scales with a visual analogue scale measuring fatigue and with a fatigue-scale derived from the Rotterdam Symptom Checklist. Results support the validity of the MFI-20. The highly similar results in the Dutch and Scottish sample suggest that the portrayal of fatigue using the MFI-20 is quite robust.
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                Author and article information

                Journal
                Arthritis Res Ther
                Arthritis Research & Therapy
                BioMed Central
                1478-6354
                1478-6362
                2011
                13 June 2011
                : 13
                : 3
                : R86
                Affiliations
                [1 ]Women's Health Research Program, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, 222 Piedmont Avenue, Suite 8200, Cincinnati, OH 45219, USA
                [2 ]Statistics, MedImmune, LLC, 35 W. Watkins Mill Road, Gaithersburg, MD 20878, USA
                [3 ]Scientific Communications, Lilly USA, LLC, Drop Code 4125, Indianapolis, IN 46285, USA
                [4 ]Clinical Research, Lilly USA, LLC, Drop Code 4125, Indianapolis, IN 46285, USA
                Article
                ar3359
                10.1186/ar3359
                3218901
                21668963
                190ee5c9-2223-444b-854c-39453d30db6d
                Copyright ©2011 Arnold et al.; licensee BioMed Central Ltd.

                This is an open access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 15 December 2010
                : 22 April 2011
                : 13 June 2011
                Categories
                Research Article

                Orthopedics
                Orthopedics

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