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

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          Abstract

          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.

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          The fibromyalgia impact questionnaire: development and validation.

          C Burckhardt, S. Clark, R M Bennett (1991)
          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 L Fields (1984)
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              Psychometric and clinical tests of validity of the Japanese SF-36 Health Survey.

              S Fukuhara, J E Ware, M Kosinski … (1998)
              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

                Journal
                Journal ID (iso-abbrev): Arthritis Res. Ther.
                Title: Arthritis research & therapy
                Publisher: Springer Science and Business Media LLC
                ISSN (Electronic): 1478-6362
                ISSN (Print): 1478-6354
                Publication date (Electronic): Aug 22 2015
                Volume: 17
                Affiliations
                [1 ] Department of Psychosomatic Medicine, Nihon University School of Medicine, 30-1 Oyaguchi Kamicho, Itabashi-ku, Tokyo, 173-8610, Japan. murakami.masato@nihon-u.ac.jp.
                [2 ] Department of Neuropsychiatry, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan. k2osada@marianna-u.ac.jp.
                [3 ] Shionogi & Co. Ltd., 12F, Hankyu Terminal Bldg, 1-4 Shibata 1-chome, Kita-ku, Osaka, 530-0012, Japan. hiromichi.mizuno@shionogi.co.jp.
                [4 ] Shionogi & Co. Ltd., 12F, Hankyu Terminal Bldg, 1-4 Shibata 1-chome, Kita-ku, Osaka, 530-0012, Japan. toshimitsu.ochiai@shionogi.co.jp.
                [5 ] Eli Lilly Japan K.K., Sannomiya Plaza Building, 7-1-5 Isogamidori, Chuo-ku, Kobe, 651-0086, Japan. alev_levent@lilly.com.
                [6 ] Institute of Medical Science, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo, 160-8402, Japan. kusuki-nishioka@bz04.plala.or.jp.
                Article
                Publisher Item ID: 10.1186/s13075-015-0718-y
                DOI: 10.1186/s13075-015-0718-y
                PMC ID: 4546310
                PubMed ID: 26296539
                SO-VID: 5b0f9979-233b-4666-9437-7b1a348bca25
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