| According to epidemiological studies,there were approximately 451 million people with diabetes worldwide in 2017,accounting for 8.4%of the total population.About half of them were undiagnosed with additional 374 million patients were pre-diabetic.Globally,diabetes attributed medical expenses was $85 billion in 2017,representing 11.6%of all medical expenses and diabetes led to 9.9%mortality in general population.Diabetic nephropathy is one of the most common and devastating diabetic complications for patients and health systems.It affects about 25-40%of the total diabetic population,accounting for 2%-3%of the general population.Chinese medicine is extensively used in Asia.Cluster analyses among different research groups accross different regions during the same period showed that patients with different locality have different combinations of signs and symptoms.However,most of the current literature reviews were narrative which lacked systematic search stragtegy and rarely included non-Chinese literature.Also,these reviews did not compare the natural clusterisation of diabetes syndrome.There are numerous guidelines of diabetes based on syndromic diagnosis.Among different clinical guidelines or studies,the enlisted syndromes are different.Even for the same syndrome,the diagnostic criteria also varied across the guidelines.In addition,the syndromic diagnosis of diabetes lacks the support of objective and transparent methodology,which led to uncertainty to the clinical treatment and research of diabetes.One of the advantages of Chinese medicine is the established system of syndromic diagnosis and treatment through repeated clinical trials and adjustment.In theory,patients with different pathogeneses and clinical presentations should be stratified to provide a more individualized disease treatment.However,there are continous criticisms from some scholars on Chinese medicine theory including syndromic diagnosis and they proposed to abolish the theory and only keep the Chinese medicines.They did not recognise the unique diagnostic system based on the differentiation of clinical presentation.In addition,regarding to the specific management of diabetes,the adavantages of using Chinese medicine syndromic diagnosis on top of conventional medicine is unclear.Studies on the effectiveness of syndromic diagnosis is warranted.Objective:This study aims to summarise the syndromic classification of diabetes,to obtain the expert consensus of diabetes syndromic diagnosis with local(southern China)representation based on consensus methodologies to census diabetes syndromes in Hong Kong;and to provide evidence support for the Chinese Medicine syndromic diagnosis.Methods:1.Systematic Literature Review-Systematic review1.1 All studies containing Chinese medicine syndromic diagnosis of diabetes were extracted from 6 Chinese and English databases with unlimited research methodologies.1.2 In the initial phase,a set of search strategy was used to extract the title and abstract of the studies in the six databases.The title and of the studies were independently screened by two investigators and studies not related to Chinese medicine or diabetes were filtered.1.3 In the second stage,the full text of the remaining literature were extracted and reviewed by two researchers,and studies not related to Chinese Medicine or diabetes were removed with detail justification.1.4 All the syndromes related to diabetes were extracted from the included literature.Studies were classified according to the methodology and discussed in narrative manner;literature with objective statistical analysis on clustering of syndromes were separately analysed.2.Expert consensus-Delphi expert consensus2.1 Ten experts from different regions,with outstanding background in traditional Chinese medicine classics,Chinese medicine formulation,diabetes specialists,and internists were invited to join the expert panel.2.2 In the initial phase,all the signs and symtpms related to diabetes were extracted from the current commonly used clinical guidelines and literature.All signs or symptoms writtern in compound form were broken into single form to establish the baseline questionnaire.2.3 In the first round of interview,each of the 10 experts assessed the importance of different sign.s and symptoms for the diagnosis of the specific syndrome with a score of 1-9(Likert scale)and supplemented with additional items for each syndrome.2.4 In the second round,experts were invited to re-assess the signs and symptoms that did not reach consensus together with new items proposed in the first round.2.5 Signs and symptoms that reached consensus in the first round and the second round became the primary diagnostic criteria of the respecitve syndrome.Items that failed to reach consensus and had an average score of over 6.7 or had reached consensus in the sensitivity analyses became secondary diagnostic criteria.3.Cross-sectional study3.1 The Chinese medicine syndrome distribution of 1087 diabetic patients in Hong Kong was surveyed by collecting the presence of signs and symptoms of each patient.The presence of syndrome was determined based on the results of expert consensus.3.2 Statistical models for the Chinese medicine syndromic diagnosis and conventional medical diagnosis were developed based on the clinical presentation and biochemitry of 302 diabetic patients.3.3 Four models were built with regression analyses(Traditional Chinese Medicine Syndromic Diagnosis Model,Traditional Western Medicine Biochemistry cum Epidemiological Diagnostic Model,Traditional Chinese Medicine cum Epidemiological Syndromic Diagnostic Model and Traditional Chinese Medicine-Traditional Western Medicine Biochemistry-Epidemiology Combined Diagnostic Model)to observe the ability to explain the variance of kidney function.Results:1.Literature review results1.1 A total of 171 articles were included in the literature reivew for data extraction,including 1 systematic review,41 clinical trials,1 cohort study,9 case series discussions,6 data-mining research,37 narrative literature review studies,44 cross-sectional studies,5 research protocol and 1 dissertation.1.2 The literatures involved a total of 74 syndromes.According to the studies with clustering analyses,the natural clustering of signs and symptoms of diabetes included spleen and kidney qi deficiency,liver and kidney yin deficiency,yang deficiency and blood stasis syndrome,stomach heat blazing,stomach heat stagnation,qi and yin deficiency,lung heat with loss of fluid,yin deficiency with blood stasis and yin and yang deficiency.1.3 Diabetic nephropathy is the most common complication of diabetes with Chinese medicine syndromic diagnosis research.1.4 The.syndromic clustering and presentation of diabetes in the north and the south were different,with the northern patients slightly more with qi and yin deficiency.Southern patietns had more clustering of gastric heat with dampness and heat.Similarly,the syndromic clustering of diabetic nephropathy in the south tended to be related to dampness and in the north is more related to yin deficiency.The clustering and distribution of diabetes syndromes varies among different regions.2.Expert consensus results2.1 Ten experts from different regions with outstanding background in traditional Chinese medicine classics,Chinese medicine formulation,diabetes specialists,and internists joined the expert panel.2.2 From "Guidelines for the Prevention and Treatment of Diabetes in Traditional Chinese Medicine","Clinical Diagnosis and Treatment Program for Traditional Chinese Medicine","Guidelines for Clinical Research and Research of New Drugs for Traditional Chinese Medicine","Traditional Chinese Medicine Clinical Treatment Terminology","Traditional Clinical Practice Guide for Traditional Chinese Medicine","Traditional Chinese Medicine Symptoms" eleven syndomes were extracted,namely phlegm-dampness-heat stagnation,dampness and heat in spleen,heat from liver and stomach stagnation,gastrointestinal dampness,spleen weak and stomach heat,upper heat and lower cold,yin deficiency with heat,qi and yin deficiency,liver and kidney Yin deficiency,yin and yang deficiency and blood stasis.2.3 The primary and secondary diagnostic criteria were developed for 11 syndromes3.Cross-sectional study3.1 Blood stasis was the most common Chinese medicine syndrome in Hong Kong(63.7%),followed by liver and kidney yin deficiency(43.5%),Qi and yin deficiency(27.6%),and dampness and spleen heat(20.4%).3.2 Simple traditional Western Medicine Biochemistry cum Epidemiological Diagnostic Model could only explain 37.1%variation of renal function among diabetic patients.Traditional Chinese Medicine Syndromic Diagnostic Model had a similar explanatory ability.The Traditional Chinese Medicine-Traditional Western Medicine Biochemistry-Epidemiology Combined Diagnostic Model can provide the best interpretation(67.3%)for the variation of renal function among diabetic patients.Conclusion:The literature review summarised the key literatures related to the diabetes syndromic diagnosis,established the foundation for the subsequent related research;analysed the distribution of the key naturally clusterised syndromes,showed the difference between the north and the south;revealed the diversity of syndrome differentiation,guided the optimization of the syndrome differentiation of diabetes,analysed the limitations of the current epidemiological research,and provided the basis for the individualised treatment based on syndrome differentiation.The expert consensus inherited the existing clinical guidelines and research,deepened and broadened the depth and breadth of diabetes syndromic diagnosis of various clinical guidelines,and comprehend Chinese medicine syndrome differentiation of diabetes,provided an internationally recognized methodology for diabetes Chinese medicine syndrome differentiation based on expert consensus;set up the primary and secondary diagnostic criteria,provided a more detailed,hierarchical,targeted and practical framework for syndromic diagnosis.Cross-sectional study for the first time documented the distribution of syndromes of diabetes in Hong Kong which reconciled with previous researches and Chinese medicine theory;used a simple regression model to demonstrate that Chinese medicine syndrome differentiation can effectively explain the variance of renal function in addition to Western medicine diagnosis.The evidence supported the use of Chinese medicine syndrome differentiation. |
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