| Background:Type 2 diabetes mellitus(T2DM)is a disease associated with relative insulin deficiency,and symptoms like thirst,hunger,polyuria,and weight loss,etc.It is also a risk factor for many complications such as cardiovascular disease,diabetic nephropathy,neuropathy and retinopathy among others.T2DM is one of the most common health problems today,and its prevention and control still face huge challenges both in terms of research and treatment.Classical formulas(Jing Fang)are an essential part of Traditional Chinese Medicine(TCM).These herbal combinations were first recorded in the ancient books Shanghanlun and Jinguiyaolue by the Chinese Han dynasty physician Zhang Zhong Jing.Jing Fang have been used in the management of T2DM symptoms with good results for thousands of years.At present,there have been many studies on the efficacy and safety of Jing Fang in the treatment of T2DM and its complications.However,current research trials still need to be systematically examined and evaluated according to stern criteria in order to ascertain and improve their methodological qualities and reporting standards,and consequently,the reliability of their findings.The present paper is divided into two parts,both focusing on recent research of Jing Fang treatments for T2DM:? an evaluation of the methodological quality of recently published systematic reviews and meta-analyses;? a systematic review and meta-analysis of recently published randomized controlled trials(RCT).Study 1:Methodological quality evaluation of recently published systematic reviews and meta-analyses of Jing Fang treating T2D.Objective:To evaluate the methodological quality and reporting standards of recently published systematic reviews and meta-analyses of Jing Fang in the treatment of T2D,as well as the progress and characteristics of evidence-based medicine.Methods:Systematic reviews and meta-analyses of Jing Fang for the treatment of T2DM were retrieved from Chinese and English Internet databases.The retrieval time limit was set to twenty years,up until October 2019.The following information was extracted from the included studies:research paper title,first author's name,year of publication,included clinical trials,intervention measures,bias risk evaluation tools,AMSTAR methodological quality evaluation results,PRISMA statement evaluation results,as well as homogeneity and risk of publication bias.All obtained information and variables were entered in Excel 2010,where a radar chart was created to compare the different entries' dimensions.Results:A total of 4 systematic reviews and 2 meta-analyses on the treatment of T2DM and its complications were included in this evaluation paper.All of the acquired studies were published in Chinese.The publication year of the included literature was 2015-2018,and altogether included four prescriptions:Banxia Xiexin Tang,Baihujia Ginseng Tang,Gegen Qinlian Tang and Shenqi Wan.All the papers included RCTs for evaluation,and all of them tested for heterogeneity and publication bias.In this literature quality evaluation,AMSTAR2 was used to evaluate the methodological quality of the 6 included systematic reviews/meta analyses.When comparing the key items proposed by AMSTAR2,it was found that there were reporting standard issues related to items 2,4,7,and 13,suggesting that the credibility of the included systematic review articles on the whole was low.The main issues with the papers were:? lack of registration of the research proposals;? failure to provide a complete search strategy;?failure to provide a complete list of inclusion/exclusion criteria;?failure to provide information for funding support;?failure to include details about risk of bias.The literature quality evaluation also examined the quality of the included systematic reviews using PRISMA.The main problems found were:? insufficiently structured summary of abstracts;? lack of or insufficient registration information;? lack of or insufficiently detailed retrieval methods;?incomplete research data;?incompletely reported results.The multidimensional evaluation of the studies,combined with the radar chart indications showed that among the six included articles,only one was considered to have good credibility and reliability of findings.Five of the papers had various methodological flaws,making their findings largely' unreliable.Study 2:Systematic review and meta-analysis of recently published RCTs of Jing Fang treating T2DM.Objective:To systematically evaluate recently published clinical trials of classical prescriptions in the treatment of T2DM in order to provide evidence base for their clinical use.Methods:Chinese and English internet databases,and two international clinical trial registration platforms were searched.The retrieval time limit was set to twenty years,up until October 2019.Only RCTs of Jing Fang treating T2DM were collected and selected according to a set of inclusion and exclusion criteria.The included studies were assessed for risk of bias using the Cochrane assessment manual,version 5.3.Meta-analysis was performed using the Revman 5.3 software.Systematic Review Results:A total of 24 RCT studies were included in this meta-analysis and systematic review.One of those was published in English and the rest were published in Chinese.Three of the research papers were multicentre clinical trials and the rest were single centre clinical studies.All were conducted in mainland China.A total of 2243 patients with T2DM were included.There were 9 prescriptions in total used in the trials,all originating from Shanghanlun and Jinguiyaolue.These included:one Chinese patent medicine(Jinguishenqi Wan),and 8 raw herb prescriptions(Dachaihu Tang,Xiaochaihu Tang,Xiaoxianxiong Tang,Banxia Xiexin Tang,Baihujiarenshen Tang,Gegen Qinlian Tang,Wumei Wan/Tang and Lingguizhugan Tang).14 studies reported the method of random sequence generation,4 used assignment concealment,and 3 conducted other blinding methods on their participants.One study did not fully report baseline information,and one study had inconsistent sample size,the rest of the research papers were low-risk in terms of data integrity,selective reporting and bias.Meta-analysis results:1.In the meta-analysis of each control group,there were statistically significant effects in the improvement of FPG and 2hPG in the three main groups:Jing Fang combined with lifestyle intervention compared with only lifestyle intervention,Jing Fang compared with traditional Chinese medicine decoction placebo and Jing Fang compared with western medicine interventions.HbA1c' levels were reported in all but two of the included studies.The meta-analysis of three of the included studies showed that the Jing Fang formulas Dachaihu Tang,Banxia Xiexin Tang and Chaihu Guizhi Ganjiang Tang,combined with lifestyle intervention showed better results in reducing HbAlc than only lifestyle intervention;the meta-analysis of 17 studies showed that Jing Fang were better than the western medicine control group in reducing HbA1c.2.The subgroup analysis showed that in the studies comparing Jing Fang with western medicine treatments,the subgroups where Jing Fang were used to treat the formula pattern syndromes Wumei Tang pattern syndrome,Gegen Qinlian Tang pattern syndrome,Baihu Tang pattern syndrome and Chaihu Tang pattern syndrome,there was significant effectivenes in FPG outcome.Jing Fang treatments in the subgroups of Gegen Qinlian Tang pattern syndrome and Chaihu Tang pattern syndrome were significantly effective in the 2hPG outcome;Jing Fang treatments for Wumei Tang pattern syndrome and Chaihu Tang pattern syndrome were significantly effective in the subgroups testing HbA1.Conclusion:1.The evaluation of the systematic reviews found that the overall quality of the included literature was low,the main deficiencies lying in the papers' methodological qualities,which did not strictly conform to certain reporting standards.Consequently it is considered that this factor affected the evidence strength and credibility of the studies' conclusions.It is suggested that updated systematic reviews that include a larger number of included studies as well as a larger number of classical formulas should be conducted in order to achieve more comprehensive and reliable findings.2.The results of the clinical trials' systematic review and meta-analysis indicate that Jing Fang prescriptions are effective for managing glucose metabolism,lipid metabolism and various TCM syndromes in patients with type 2 diabetes mellitus.The obtained data suggests that patients diagnosed with Chaihu Decoction pattern syndrome,Wumei Decoction pattern syndrome,Baihu Decoction pattern syndrome and Gegen Qinlian Decoction pattern syndrome can obtain good curative effect when they receive their corresponding Jing Fang treatments.It also suggests that clinicians should be experienced in TCM syndrome differentiation and diagnosis,and flexibly use classical prescriptions that fully match their corresponding clinical syndromes.However,the results of this research paper indicate that there are still large methodological limitations in the currently available clinical research of Jing Fang for the treatment of T2DM.It is suggested that future studies on Jing Fang should incorporate better methodological frameworks,higher sample rates and improved blinding methods,as well as reduce risk of bias and conflict of interest. |
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