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      Effects of qiming granule for diabetic macular edema : A protocol for systematic review and meta-analysis

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          Abstract

          Background:

          Diabetic macular edema is a further complication of diabetes. It is an important type of diabetic eye disease and the main cause of blindness of diabetic patients. Qiming granule is a Chinese patent medicine widely used in the treatment of diabetic macular edema. There are some reports about this medicine for macular edema. At present, there is only 1 systematic review on qiming granule in the treatment of diabetic macular edema. However, there are many defects in this article, so it is necessary to re-summarize and evaluate the existing evidence.

          Methods and analysis:

          Three English database and 4 Chinese databases other sources will be searched. Two methodological trained researchers will read the title, abstract and full texts, and independently select the qualified literature according to inclusion and exclusion criteria. After assessment of the risk of bias and data extraction, we will conduct meta-analyses for outcomes including central macular thickness, optimum corrected vision, overall effect rates, and adverse effects. The heterogeneity of data will be investigated by Cochrane χ 2 and I 2 tests. We build 3 hypotheses for subgroup analysis according to the guidance for a credible subgroup effect: Disease status at baseline, duration of intervention, type of concomitant medication. Sensitivity analysis will be conducted to evaluate the stability of the results. Then publication bias assessment will be conducted by funnel plot analysis and Egger test. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluate system to evaluate the quality of evidence.

          Results:

          The results of our research will be published in a peer-reviewed journal.

          Conclusion:

          In our study, the evidence of qiming granule in the treatment of macular edema was comprehensively summarized and carefully evaluated. It will provide more options for clinical treatment of the disease.

          PROSPERO registration number:

          CRD42018108626.

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          Most cited references23

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          Is a subgroup effect believable? Updating criteria to evaluate the credibility of subgroup analyses.

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            A consumer's guide to subgroup analyses.

            The extent to which a clinician should believe and act on the results of subgroup analyses of data from randomized trials or meta-analyses is controversial. Guidelines are provided in this paper for making these decisions. The strength of inference regarding a proposed difference in treatment effect among subgroups is dependent on the magnitude of the difference, the statistical significance of the difference, whether the hypothesis preceded or followed the analysis, whether the subgroup analysis was one of a small number of hypotheses tested, whether the difference was suggested by comparisons within or between studies, the consistency of the difference, and the existence of indirect evidence that supports the difference. Application of these guidelines will assist clinicians in making decisions regarding whether to base a treatment decision on overall results or on the results of a subgroup analysis.
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              Diabetic macular oedema.

              Diabetic macular oedema, characterised by exudative fluid accumulation in the macula, is the most common form of sight-threatening retinopathy in people with diabetes. It affects one in 15 people with diabetes resulting in more than 20 million cases worldwide. Few epidemiological studies have been done to specifically investigate risk factors for diabetic macular oedema, although poor glycaemic and blood pressure control are associated with the presence and development of the disorder. The pathophysiological processes begin with chronic hyperglycaemia, and interplay between vascular endothelial growth factor (VEGF) and inflammatory mediators. Non-invasive imaging using optical coherence tomography has allowed clinicians to detect mild levels of diabetic macular oedema in order to monitor progress and guide treatment. Although focal or grid laser photocoagulation was the traditional mode of treatment, intraocular pharmacotherapy with anti-VEGF agents is now the standard of care. However, these therapies are expensive and resource intensive. Emerging therapeutic strategies include improving efficacy and duration of VEGF suppression, targeting alternative pathways such as inflammation, the kallikrein-kinin system, the angiopoietin-Tie2 system, and neurodegeneration, and using subthreshold and targeted laser therapy. Ongoing research should lead to improvements in screening, diagnosis, and management of diabetic macular oedema.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Wolters Kluwer Health
                0025-7974
                1536-5964
                October 2019
                18 October 2019
                : 98
                : 42
                : e17496
                Affiliations
                Hospital of Chengdu University of Traditional Chinese Medicine, PR China.
                Author notes
                []Correspondence: Chunguang Xie, Hospital of Chengdu University of Traditional Chinese Medicine, No.39 Shi-er-qiao Road, Chengdu 610072, Sichuan Province, PR China (e-mail: xiecg@ 123456cdutcm.edu.cn ).
                Article
                MD-D-19-07223 17496
                10.1097/MD.0000000000017496
                6824701
                31626104
                c0defd47-8c1c-4103-a853-1242e7afccca
                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. http://creativecommons.org/licenses/by/4.0

                History
                : 13 September 2019
                : 16 September 2019
                Categories
                3800
                Research Article
                Study Protocol Systematic Review
                Custom metadata
                TRUE

                diabetic macular edema,protocol,qiming granule,systematic review and meta-analysis

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