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      Effects of external application of compound Qingbi granules on acute gouty arthritis with dampness-heat syndrome: a randomized controlled trial

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          Abstract

          Background and aim

          The use of anti-inflammatory and analgesic drugs such as nonsteroidal anti-inflammatory drugs(NSAIDs) for treating acute gout has limitations, such as adverse reactions in the gastrointestinal tract and toxicity in the liver, kidney, and heart. Hence, a new safe and effective treatment approach needs to be explored to reduce the use of anti-inflammatory and analgesic drugs, incidence of adverse reactions, and patients’ burden. This randomized controlled clinical trial aimed to investigate the clinical efficacy and safety of the external application of compound Qingbi granules (CQBG) in treating acute gouty arthritis(AGA), providing evidence for designing a safe, effective, and optimized protocol for AGA comprehensive treatment.

          Methods

          A total of 90 patients in line with the diagnostic standard of AGA were recruited and randomly divided into control, T1, and T2 groups (30 in each group). All the participators in the three groups all received Western-medicine-basic treatment (low-purine diet, drinking water more than 2000 mL/days, oral loxoprofen, and NAHCO 3). Besides, the T1 group received an external application of diclofenac diethylamine emulgel, while the T2 group received an external application of CQBG. The participants in the control group received single-use Western-medicine-basic treatment. With a treatment course of 7 days and a follow-up of 7 days, the three groups were compared in terms of primary outcome indicators, including swelling, pain improvement, and change in pain duration and secondary outcome indicators, including serum C-reactive protein (CRP) level, uric acid (UA) level, and change in the thickness of the inflammatory synovium of joints under ultrasound. Meanwhile, the safety of the protocol was evaluated.

          Results

          The three groups of patients had no apparent differences in age, body mass index, history of gout, complications, and so on before recruitment. A comparison between pretreatment and post-treatment revealed remarkable reductions in the arthralgia visual analog scale score(VAS) and the swelling score in the three groups after the treatment and the improvements in the T2 group were more significant than those in the T1 and control groups ( P < 0.05). Regarding the onset time of pain improvement and pain duration, the T2 group had more significant efficacy compared with the other two groups ( P < 0.05). The serum CRP and blood UA levels in the three groups significantly decreased after the treatment, but with no significant intergroup difference. The improvement in the thickness of the inflammatory synovium in joints tested by ultrasound was more significant in the T2 group than in the control group ( P < 0.05). For safety evaluations, no significant difference in the incidence of adverse events was found.

          Conclusions

          The external application of CQBG combined with Western-medicine-basic treatment in patients with AGA improved arthralgia and swelling, shortened the period of taking NSAIDs, and reduced the levels of CRP and serum UA. Its therapeutic effect was significantly better than the effect of single-use Western-medicine-basic treatment. The study provided evidence for the clinical application of CQBG combined with Western medicine in treating AGA.

          Trial registration: ChiCTR, ChiCTR1800018020. Registered 27 August 2018, https://www.chictr.org.cn/showproj.aspx?proj=27138

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          Most cited references 41

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          Prevalence of Hyperuricemia and Gout in Mainland China from 2000 to 2014: A Systematic Review and Meta-Analysis

          We systematically identified the prevalence of hyperuricemia and gout in mainland China and provided informative data that can be used to create appropriate local public health policies. Relevant articles from 2000 to 2014 were identified by searching 5 electronic databases: PubMed, Google Scholar, Chinese Wanfang, CNKI, and Chongqing VIP. All of the calculations were performed using the Stata 11.0 and SPSS 20.0 software. The eligible articles (n = 36; 3 in English and 33 in Chinese) included 44 studies (38 regarding hyperuricemia and 6 regarding gout). The pooled prevalence of hyperuricemia and gout was 13.3% (95% CI: 11.9%, 14.6%) and 1.1% (95% CI: 0.7%, 1.5%), respectively. Although publication bias was observed, the results did not change after a trim and fill test, indicating that that impact of this bias was likely insignificant. The prevalence of hyperuricemia and gout was high in mainland China. The subgroup analysis suggested that the geographical region, whether the residents dwell in urban or rural and coastal or inland areas, the economic level, and sex may be associated with prevalence.
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            Prevalence of the metabolic syndrome in patients with gout: the Third National Health and Nutrition Examination Survey.

            To determine the prevalence of metabolic syndrome among patients with gout and to examine the association between the 2 conditions in a nationally representative sample of US adults. Using data from 8,807 participants age >or=20 years in the Third National Health and Nutrition Examination Survey (1988-1994), we determined the prevalence of metabolic syndrome among individuals with gout and quantified the magnitude of association between the 2 conditions. We used both the revised and original National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP III) criteria to define metabolic syndrome. The prevalence (95% confidence interval [95% CI]) of metabolic syndrome according to revised NCEP/ATP III criteria was 62.8% (51.9-73.6) among individuals with gout and 25.4% (23.5-27.3) among individuals without gout. Using 2002 census data, approximately 3.5 million US adults with a history of gout have metabolic syndrome. The unadjusted and age- and sex-adjusted odds ratios (95% CI) of metabolic syndrome for individuals with gout were 4.96 (3.17-7.75) and 3.05 (2.01-4.61), respectively. With the original NCEP/ATP criteria, the corresponding prevalences were slightly lower, whereas the corresponding odds ratios were slightly higher. The stratified prevalences of metabolic syndrome by major associated factors of gout (i.e., body mass index, hypertension, and diabetes) remained substantially and significantly higher among those with gout than those without gout (all P values <0.05). These findings indicate that the prevalence of metabolic syndrome is remarkably high among individuals with gout. Given the serious complications associated with metabolic syndrome, this frequent comorbidity should be recognized and taken into account in long-term treatment and overall health of individuals with gout.
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              Gout and the risk of type 2 diabetes among men with a high cardiovascular risk profile.

              Our objective was to evaluate the independent relation between a history of gout and the future risk of type 2 diabetes among men with a high cardiovascular risk profile. We prospectively examined over a 6-yr period the relation between gout and the risk of incident type 2 diabetes in 11 351 male participants from the Multiple Risk Factor Intervention Trial (MRFIT). Incident diabetes was defined based on the American Diabetes Association (ADA) criteria for epidemiological studies. Cox proportional hazards regression was used to adjust for potential confounders. We documented 1215 new cases of type 2 diabetes. After adjusting for age, BMI, smoking, family history of type 2 diabetes, alcohol intake, dietary factors and presence of individual components of the metabolic syndrome, the multivariate relative risk (RR) for incident type 2 diabetes among men with gout at baseline, as compared with men without gout, was 1.34 (95% CI 1.09, 1.64). When we further adjusted for serum uric acid levels, the association remained significant (RR 1.26; 95% CI 1.02, 1.54). When we updated the status of gout annually during follow-up as a time-varying covariate, the association remained similar. The association also remained similar in our subgroup analyses by major covariates (P-values for interaction >0.16). These findings from men with a high cardiovascular risk profile suggest that men with gout are at a higher future risk of type 2 diabetes independent of other known risk factors. These data expand on well-established, cross-sectional associations between hyperuricaemia, gout and the metabolic syndrome, and extend the link to the future risk of type 2 diabetes.
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                Author and article information

                Contributors
                zhangjie945@outlook.com
                Journal
                Chin Med
                Chin Med
                Chinese Medicine
                BioMed Central (London )
                1749-8546
                7 November 2020
                7 November 2020
                2020
                : 15
                Affiliations
                [1 ]GRID grid.412636.4, Department of Traditional Chinese Medicine, , The First Hospital of China Medical University, ; Shenyang, 110001 China
                [2 ]Key Laboratory of Ministry of Education for TCM Viscera-State Theory and Applications, Ministry of Education of China (Province-Ministry Co-Construct), Shenyang, China
                Article
                398
                10.1186/s13020-020-00398-8
                7648992
                © The Author(s) 2020

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001809, National Natural Science Foundation of China;
                Award ID: No.81973661
                Award Recipient :
                Funded by: Evidence based capacity building project of traditional Chinese Medicine
                Award ID: (2019)-130
                Award Recipient :
                Funded by: National key talents training project of TCM clinical characteristic technology inheritance
                Award ID: (2018)-224
                Award Recipient :
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                © The Author(s) 2020

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