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      The efficacy of the traditional Chinese medicine Jia Wei Niu Bang Zi granule combined with methotrexate in treating active rheumatoid arthritis : A multicenter, randomized, double-blinded controlled clinical trial

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          Rheumatoid arthritis (RA) is a chronic systemic and autoimmune inflammatory disease ending with the destruction of joints. Current therapies can relieve RA symptoms, but some also bring severe adverse events. Therefore, an effective and safe therapeutic strategy remains to be created to benefit patients with RA by large. Jia Wei Niu Bang Zi granule (NBZG) consisting of RA-fighting Chinese herbals has been used in Longhua Hospital in the last several decades. NBZG has potential therapeutic effect on RA, which should be evaluated by larger sample clinical trial.


          A multicenter, randomized, double-blind, placebo-controlled clinical trials will be conducted to determine the efficiency of NBZG in pain relief and joint protection. A total of 120 patients with active RA will be enrolled, and treated with NBZG or placebo for 12 weeks. The primary outcome measurements include rate of American College of Rheumatology (ACR) 50 at 12 weeks’ treatment. The 2nd outcome measurements include rate change of ACR20, ACR70, the disease activity score (DAS) 28, 36-item Short-Form Health Survey Questionnaire, Health Assessment Questionnaire - Disability Index, score changes of Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, and the Athens insomnia scale at the same time points.


          Although NBZG has shown efficacy in treating RA in Longhua Hospital for decades, the universality of this efficacy needs evaluated. The results of this trial will provide a convincing evidence about NBZG's efficacy in treating active RA in a large population.

          Trial registration:

 ID: NCT03173040 (registered on May 30, 2017)

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          Most cited references 28

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          Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations.

          The primary objectives of this research were to translate, validate, and generate normative data on the SF-36 Health Survey for use among Dutch-speaking residents of the Netherlands. Translation of the SF-36 into Dutch followed the stepwise, iterative procedures developed by the IQOLA Project. Following extensive pilot testing, the SF-36 was administered to: (1) a random sample of adult residents of Amsterdam (n = 4172); (2) a random, nationwide sample of adults (n = 1742); (3) a sample of migraine sufferers (n = 423); and (4) a sample of cancer patients undergoing active anti-neoplastic treatment (n = 485). Data quality across the four studies was consistently high. The rates of missing data ranged from 1% to 5% at the item level, and from 1.2% to 2.6% at the scale level. Multitrait scaling analysis confirmed the hypothesized scale structure of the SF-36 and associated scale scoring in all four samples. Cronbach's alpha coefficients surpassed the 0.70 criterion for group comparisons in all but one case (the Social Functioning scale in the cancer sample), with a mean alpha coefficient across all scales and samples of 0.84. Known-group comparisons yielded consistent support for the validity of the SF-36. In the two community samples, statistically significant differences in SF-36 mean scale scores were observed as a function of age, gender, and the prevalence of chronic health conditions. In the migraine and cancer samples, mean SF-36 scale scores varied significantly as a function of various indicators of disease severity. The SF-36 profiles for the two community samples were highly similar. The cancer sample yielded the lowest SF-36 scores, with the migraine sample holding an intermediate position. On-going studies will generate data on the responsiveness of the SF-36 to within-group changes in health over time. Efforts are underway to translate and validate the questionnaire for use among ethnic minority groups in the Netherlands.
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            Cytokine pathways and joint inflammation in rheumatoid arthritis.

             G Panayi,  Hyon Choy (2001)
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              American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis.

              Trials of rheumatoid arthritis (RA) treatments report the average response in multiple outcome measures for treated patients. It is more clinically relevant to test whether individual patients improve with treatment, and this identifies a single primary efficacy measure. Multiple definitions of improvement are currently in use in different trials. The goal of this study was to promulgate a single definition for use in RA trials. Using the American College of Rheumatology (ACR) core set of outcome measures for RA trials, we tested 40 different definitions of improvement, using a 3-step process. First, we performed a survey of rheumatologists, using actual patient cases from trials, to evaluate which definitions corresponded best to rheumatologists' impressions of improvement, eliminating most candidate definitions of improvement. Second, we tested 20 remaining definitions to determine which maximally discriminated effective treatment from placebo treatment and also minimized placebo response rates. With 8 candidate definitions of improvement remaining, we tested to see which were easiest to use and were best in accord with rheumatologists' impressions of improvement. The following definition of improvement was selected: 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. Additional validation of this definition was carried out in a comparative trial, and the results suggest that the definition is statistically powerful and does not identify a large percentage of placebo-treated patients as being improved. We present a definition of improvement which we hope will be used widely in RA trials.

                Author and article information

                [a ]Longhua Hospital, Shanghai University of Traditional Chinese Medicine
                [b ]Institute of Spine, Shanghai University of Traditional Chinese Medicine
                [c ]Key Laboratory of Theory and Therapy of Muscles and Bones, Ministry of Education (Shanghai University of Traditional Chinese Medicine)
                [d ]Department of Rheumatology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
                [e ]Department of Rheumatology, The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei
                [f ]Department of Orthopaedics, Shanghai Seventh People's Hospital, Shanghai
                [g ]Department of Rheumatology, The Bengbu Hospital of Chinese Medicine, Bengbu
                [h ]Rehabilitation Medicine College, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
                Author notes
                []Correspondence: Qi Shi, Qian-Qian Liang, Institute of Spine, Shanghai University of Traditional Chinese Medicine, 725 Wan-Ping South Road, Shanghai 200032, China (e-mails: shiqish@ , liangqianqiantcm@ ); Yong-Jun Wang, School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China (e-mail: yjwang8888@ ).
                Medicine (Baltimore)
                Medicine (Baltimore)
                Wolters Kluwer Health
                February 2019
                08 February 2019
                : 98
                : 6
                MD-D-19-00238 14424
                Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Research Article
                Study Protocol Clinical Trial
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