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      A randomized, double-blind, placebo-controlled phase III trial of duloxetine in Japanese fibromyalgia patients

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          Abstract

          Introduction

          Fibromyalgia is characterized by widespread pain and is often accompanied by accessory symptoms. There are limited treatment options for this condition in Japan. Therefore, we conducted a phase III study to assess the efficacy and safety of duloxetine in Japanese patients with fibromyalgia.

          Methods

          This randomized, double-blind, placebo-controlled, parallel-group trial was conducted in Japan. Outpatients who met the American College of Rheumatology 1990 criteria for fibromyalgia and whose Brief Pain Inventory (BPI) average pain score was ≥4 were randomized to duloxetine 60 mg or placebo once daily for 14 weeks. The primary efficacy measure was the change in the BPI average pain score from baseline. Secondary efficacy, quality of life (QoL), and safety outcomes were also evaluated. Mixed-effects model repeated-measures (MMRM) analysis and last observation carried forward (LOCF) analysis of covariance were used to evaluate the primary efficacy measure.

          Results

          Overall, 393 patients were randomized to receive either duloxetine (n = 196) or placebo (n = 197). The MMRM analysis revealed no significant difference between duloxetine and placebo regarding the change in BPI average pain scores at week 14. Based on LOCF analysis, a statistically significant improvement in the change in BPI average pain scores at week 14 was observed for patients treated with duloxetine compared with placebo. Duloxetine treatment was associated with improved outcomes in nearly all secondary and post hoc analyses. The treatment was generally well tolerated. Somnolence, nausea, and constipation were the most common treatment-emergent adverse events in the duloxetine group. The discontinuation rates due to treatment-emergent adverse events were similar in both groups.

          Conclusions

          Although the MMRM analysis did not demonstrate superiority of duloxetine over placebo, duloxetine treatment was associated with improved outcomes in secondary and post hoc analyses of the mean change in the BPI average pain score and most of the secondary outcomes, including analgesia and QoL. Duloxetine treatment was safe and well tolerated. These results suggest that duloxetine treatment could be associated with improvements in pain relief and QoL in Japanese patients with fibromyalgia.

          Trial registration

          ClinicalTrials.gov Identifier: NCT01552057. Registered 9 March 2012.

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          Most cited references 27

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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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            Endogenous pain control systems: brainstem spinal pathways and endorphin circuitry.

             A Basbaum,  H Fields (1983)
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              Psychometric and clinical tests of validity of the Japanese SF-36 Health Survey.

              Cross-sectional data from a representative sample of the general population in Japan were analyzed to test the validity of Japanese SF-36 Health Survey scales as measures of physical and mental health. Results from psychometric and clinical tests of validity were compared. Principal components analyses were used to test for the hypothesized physical and mental dimensions of health and the pattern of scale correlations with those components. To test the clinical validity of SF-36 scale scores, self-reports of chronic medical conditions and the Zung Self-Rating Depression Scale were used to create mutually exclusive groups differing in the severity of physical and mental conditions. The pattern of correlations between the SF-36 scales and the two empirically derived components generally confirmed hypotheses for most scales. Results of psychometric and clinical tests of validity were in agreement for the Physical Functioning, Role-Physical, Vitality, Social Functioning, and Mental Health scales. Relatively less agreement between psychometric and clinical tests of validity was observed for the Bodily Pain, General Health, and Role-Emotional scales, and the physical and mental health factor content of those scales was not consistent with hypotheses. In clinical tests of validity, the General Health, Bodily Pain, and Physical Functioning scales were the most valid scales in discriminating between groups with and without a severe physical condition. Scales that correlated highest with mental health in the components analysis (Mental Health and Vitality) also were most valid in discriminating between groups with and without depression. The results of this study provide preliminary interpretation guidelines for all SF-36 scales, although caution is recommended in the interpretation of the Role-Emotional, Bodily Pain, and General Health scales pending further studies in Japan.
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                Author and article information

                Contributors
                murakami.masato@nihon-u.ac.jp
                k2osada@marianna-u.ac.jp
                hiromichi.mizuno@shionogi.co.jp
                toshimitsu.ochiai@shionogi.co.jp
                alev_levent@lilly.com
                +81-(0)3-3580-8531 , kusuki-nishioka@bz04.plala.or.jp
                Journal
                Arthritis Res Ther
                Arthritis Research & Therapy
                BioMed Central (London )
                1478-6354
                1478-6362
                22 August 2015
                22 August 2015
                2015
                : 17
                : 1
                Affiliations
                [ ]Department of Psychosomatic Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kamicho, Itabashi-ku, Tokyo 173-8610 Japan
                [ ]Department of Neuropsychiatry, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511 Japan
                [ ]Shionogi & Co. Ltd., 12F, Hankyu Terminal Bldg, 1-4 Shibata 1-chome, Kita-ku, Osaka 530-0012 Japan
                [ ]Eli Lilly Japan K.K., Sannomiya Plaza Building, 7-1-5 Isogamidori, Chuo-ku, Kobe, 651-0086 Japan
                [ ]Institute of Medical Science, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402 Japan
                Article
                718
                10.1186/s13075-015-0718-y
                4546310
                © Murakami et al. 2015

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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                Orthopedics

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