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Research on the development methodology for clinical practice guidelines for organic integration of traditional Chinese medicine and Western medicine

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Military Medical Research 2024年第3期11卷 313-322页

作者： Ying-Hui Jin Yan-Ping Wang Ying-Lan Xie Gui-Hua Tian Xiao-Yu Zhang Nan-Nan Shi Ke-Hu Yang Xin Sun Yao-Long Chen Da-Rong Wu Xin-Feng Guo Long Ge Chen Zhao Cheng Lu Yin Jiang Jing Guo Si-Yu Yan Yong-Bo Wang Qiao Huang Xiang-Ying Ren Ying-Yue Rao Yun-Yun Wang Meng-Qian Yuan Xian-Tao Zeng Hong-Cai Shang Center for evidence-based and Translational medicine Zhongnan Hospital of Wuhan UniversityWuhan 430071China Institute of Basic Research in Clinical medicine China Academy of Chinese Medical SciencesBeijing 100700China China Center for evidence based Traditional Chinese medicine Beijing 100029China Hubei Provincial Hospital of Traditional Chinese medicine Wuhan 430074China Key Laboratory of Chinese Internal medicine of Ministry of Education and Beijing Dongzhimen HospitalBeijing University of Chinese MedicineBeijing 100700China evidence-based medicine Center School of Basic Medical SciencesLanzhou UniversityLanzhou 730000China China Center for evidence-based medicine West China Hospital of Sichuan UniversityChengdu 610041China State Key Laboratory of Dampness Syndrome of Chinese medicine the Second Affliated Hospital of Guangzhou University of Chinese MedicineGuangzhou 510120China evidence-based medicine Team Guangdong Provincial Hospital of Traditional Chinese MedicineGuangzhou 510120China Nanjing University of Chinese medicine Nanjing 210023China Jiangsu Province Hospital of Chinese medicine Nanjing 210029China

Integrated traditional Chinese medicine(TCM)and Western medicine(WM)is a new medical science grounded in the knowledge bases of both TCM and WM,which then forms a unique modern medical system in China.Integrated TCM and WM has a long history in China,and has made important achievements in the process of clinical diagnosis and treatment.However,the methodological defects in currently published clinical practice guidelines(CPGs)limit its development.The organic integration of TCM and WM is a deeper integration of TCM and WM.To realize the progression of"integration"to"organic integration",a targeted and standardized guideline development methodology is needed.Therefore,the purpose of this study is to establish a standardized development procedure for clinical practice guidelines for the organic integration of TCM and WM to promote the systematic integration of TCM and WM research results into clinical practice guidelines in order to achieve optimal results as the whole is greater than the sum of the parts.

关键词： Methodology Traditional Chinese medicine Western medicine Organic integration Clinical practice guidelines(CPGs)

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Efficacy and safety of extracorporeal shock wave therapy combined with sodium hyaluronate in treatment of knee osteoarthritis:a systematic review and Meta-analysis

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Journal of Traditional Chinese medicine 2024年第2期44卷 243-250页

作者： ZHOU Mingwang DONG Zhuanli WEI Changhao FENG Lufang WANG Xiaoping LIU Haiping JI Xing YANG Kehu LI Shenghua department of Orthopaedics Gansu Provincial Hospital of Traditional Chinese MedicineLanzhou 730050China department of Quality Management Lanzhou Petrochemical General HospitalLanzhou 730050China department of Orthopaedics Lanzhou Petrochemical General HospitalLanzhou 730050China evidence-based Social Science Research Center School of Public HealthLanzhou UniversityLanzhou730000China evidence-based medicine Center School of Basic Medical SciencesLanzhou UniversityLanzhou 730000China Key Laboratory of evidence based medicine and Knowledge Translation of Gansu Province Lanzhou 730000China Center for Translational medicine Gansu Provincial Hospital of Traditional Chinese MedicineLanzhou 730050China department of Orthopaedics Gansu Provincial Hospital of Traditional Chinese MedicineLanzhou 730000China

OBJECTIVE:To assess the efficacy and safety of extracorporeal shockwave therapy(ESWT)combined with sodium hyaluronate(HA)for the treatment of knee osteoarthritis(KOA).METHODS:PubM ed,Embase,the Cochrane Library,Web of Science,China National Knowledge Infrastructure,Wanfang database,China Science and Technology Journal Database,and SinoMed were searched from inception to July 2020.The quality of the randomized controlled trials was evaluated independently by two reviewers according to the criteria in the Cochrane Collaboration for Systematic Reviews.The identified articles were then screened individually using EndnoteX9 for eligibility in this Meta-analysis.The heterogeneity among the articles was evaluated using I2.RESULTS:A total of 17 studies,comprising 2000 individuals,were included in this Meta-analysis.The results showed that a significant improvement was observed in knee pain and function based on the clinical efficacy of ESWT combined with HA.Statistical analysis of clinical efficacy showed that[relative risk(RR)=1.21,95%confidence interval(CI)(1.12,1.30),Pevidence showed that ESWT combined with HA offers an inexpensive,welltolerated,safe,and effective method to improve pain and functionality in patients with KOA.However,tightly controlled,randomized,large multicenter trials are warranted to validate the current findings.

关键词： osteoarthritis knee randomized controlled trial extracorporeal shockwave therapy hyaluronic acid Meta-analysis

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Characteristics and quality of clinical practice guidelines for diabetic kidney disease: a systematic review

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Journal of Traditional Chinese medicine 2024年第3期44卷 609-619页

作者： WANG Yuhuang ZHANG Le ZHANG Zhengshan YAO Zhi LI Xiyao SUN Luying LIAO Xing department of Nephropathy and Endocrine Dongzhimen HospitalBeijing University of Chinese Medicine Centre for evidence-based Chinese medicine Institute of Basic Research in Clinical MedicineChina Academy of Chinese Medical Sciences department of Endocrine One Zone Fangshan HospitalBeijing University of Chinese Medicine

OBJECTIVE: To assess the quality of Clinical practice guidelines(CPGs) in the context of diabetic kidney disease(DKD) and determine whether any factors affect the quality. METHODS: We searched eight databases along with five international and national organizations to develop or archive guidelines from their inception to July 2023, with an additional search of ***. And the authoritative organizations related to nephrology. CPGs and consensus statements created using direct differential diagnosis or therapy for DKD were included without language restrictions. Their quality was evaluated by four reviewers using the Appraisal of Guidelines for Research and Evaluation Ⅱ(AGREE Ⅱ) instrument. Along with the item and domain scores, the guideline was also allocated an overall quality score, which ranged from 1(lowest possible quality) to 7(highest possible quality). Moreover, an overall recommendation for use was also assigned(“recommended”, “recommended with modifications” or “not recommended”). RESULTS: A total of 16 CPGs were included, of which 14 were from Asia and the remaining two from Europe. These two CPGs were updated in the third version. Six CPGs were recommended for use because their primary domains scored in the medium or high category. Furthermore, five CPGs were recommended with modifications as the stakeholder involvement, applicability, and editorial independence domains were evaluated as low categories. In all domains, the lowest average score was for rigour of development(33%), followed by application(36%), and stakeholder involvement(51%). The highest average score was for scope and purpose(79%), followed by clarity of presentation(75%). None of the CPGs considered the patient's viewpoint, and six of 16 CPGs did not use any grading system to translate the evidence into recommendations. Additionally, only three of 16 CPGs shared search strategy, and eight of 16 CPGs did not declare a funding source. CONCLUSIONS: According to the AGREE II evaluation, more than one in four CPGs for DKD had poor methodolo

关键词： appraisal of guidelines for research and evaluation II diabetic nephropathies practice guideline quality assessment systematic review

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Factors and Their Impact on Treatment Effect of Acupuncture in Different Outcomes:A Meta-Regression of Acupuncture Randomized Controlled Trials

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Chinese Journal of Integrative medicine 2024年第3期30卷 260-266页

作者： XIU Wen-cui GANG Wei-juan ZHOU Qi SHI Lan-jun HU Xiang-yu MING Tian-yu LUO Zhen ZHANG Yu-qing JING Xiang-hong Institute of Acupuncture and Moxibustion China Academy of Chinese Medical SciencesBeijing100700China China Center for evidence-based Traditional Chinese medicine China Academy of Chinese Medical SciencesBeijing100700China department of Health Research Methods Evidenceand ImpactMcMaster UniversityHamiltonOntarioL8S 4L8Canada Center for evidence-based Integrative medicine-Clarity Collaboration Guang’anmen HospitalChina Academy of Chinese Medical SciencesBeijing100053China

Background:The effects of acupuncture have varied in different randomized controlled trials(RCTs),and there are many factors that influence treatment effect of acupuncture in different outcomes,with conflicting results.Objective:To identify factors and their impact on the treatment effect of acupuncture in different outcomes.Methods:Acupuncture RCTs were searched from 7 databases including Medline(Pub Med),Embase,Cochrane Central Register of Controlled Trials,China National Knowledge Infrastructure,Wanfang Database,VIP Database,and China Biology medicine disc between January 1st,2015 and December 31st,2019.Eligible studies must compare acupuncture to no acupuncture,sham acupuncture,or waiting lists,and report at least 1patient-important outcome.A multi-level meta-regression was conducted using a 3-level robust mixed model and univariate analyses were performed for all independent variables,even those excluded from the multivariable model due to collinearities.We used thresholds of 0.2 and 0.4 for the difference of standardized mean differences(SMDs),categorising them as small(0.4) effects.Results:The pain construct analysis involved 211 effect estimates from 153 studies and 14 independent variables.High-frequency acupuncture treatment sessions produced larger effects compared to low-frequency sessions [large magnitude,the difference of adjusted SMDs 0.46,95% confidence interval(CI) 0.07 to 0.84;P=0.02].The non-pain symptoms construct analysis comprised 323 effect estimates from 231 studies and 15 independent variables.Penetrating acupuncture showed moderately larger effects when compared to non-penetrating acupuncture(0.30,95% CI 0.06 to 0.53;P=0.01).The function construct analysis included 495 effect estimates from 274 studies and 14 independent variables.Penetrating acupuncture and the flexible acupuncture regimen showed moderately larger effects,compared to non-penetrating acupuncture and fixed regimen,respectively(0.40,95% CI 0 to 0.80;P=0.05;0.29,95% CI 0.06 to 0.53;P=0.01).

关键词： acupuncture randomized controlled trial patient-important outcome meta-regression

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Efficacy of electroacupuncture on myocardial protection and postoperative rehabilitation in patients undergoing cardiac surgery with cardiopulmonary bypass:a systematic review and Meta-analysis

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Journal of Traditional Chinese medicine 2024年第1期44卷 1-15页

作者： QIN Xiaoyu WANG Chunai XUE Jianjun ZHANG Jie LU Xiaoting DING Shengshuang GE Long WANG Minzhen the First Clinical Medical College Gansu University of Chinese MedicineLanzhou 730030China department of Anesthesiology Gansu Provincial Hospital of Traditional Chinese MedicineLanzhou 730050China evidence-based medicine Center Lanzhou UniversityLanzhou 730030China Institute of Epidemiology and Statistics School of Public HealthLanzhou UniversityLanzhou 730030China

OBJECTIVE:To evaluate the efficacy of electroacupuncture(EA)intervention on myocardial protection and postoperative rehabilitation in patients undergoing cardiac surgery with cardiopulmonary bypass(CPB).METHODS:Eight databases,including Pub Med,Embase,the Cochrane Library,Web of Science,Chinese Bio Medical Literature Database,China National Knowledge Infrastructure Database,Wanfang Data,China Science and Technology Journal Database,and two clinical trial registries,were searched.All randomized controlled trials(RCTs)related to EA intervention in cardiac surgery with CPB were collected.based on the inclusion and exclusion criteria,two researchers independently screened articles and extracted data.After the quality evaluation,RevMan 5.3 software was used for analysis.RESULTS:Fourteen RCTs involving 836 patients were included.Compared with the control treatment,EA significantly increased the incidence of cardiac automatic rebeat after aortic unclamping[relative risk(RR)=1.15,95%confidence interval(CI)(1.01,1.31),P<0.05;moderate].Twenty-four hours after aortic unclamping,EA significantly increased the superoxide dismutase[standardized mean difference(SMD)=0.96,95%CI(0.32,1.61),P<0.05;low],and interleukin(IL)-2[SMD=1.33,95%CI(0.19,2.47),P<0.05;very low]expression levels and decreased the malondialdehyde[SMD=-1.62,95%CI(-2.15,-1.09),P<0.05;moderate],tumour necrosis factor-α[SMD=-1.28,95%CI(-2.37,-0.19),P<0.05;moderate],and cardiac troponin I[SMD=-1.09,95%CI(-1.85,-0.32),P<0.05;low]expression levels as well as the inotrope scores[SMD=-0.77,95%CI(-1.22,-0.31),P<0.05;high].There was no difference in IL-6 and IL-10 expression levels.The amount of intraoperative sedative[SMD=-0.31,95%CI(-0.54,-0.09),P<0.05;moderate]and opioid analgesic[SMD=-0.96,95%CI(-1.53,-0.38),P<0.05;low]medication was significantly lower in the EA group than in the control group.Moreover,the postoperative tracheal intubation time[SMD=-0.92,95%CI(-1.40,-0.45),P<0.05;low]and intensive care unit stay[SMD=-1.71,95%CI(-3.06,-0.36),P<0.05;low]were significan

关键词： electroacupuncture cardiopulmonary bypass thoracic surgery myocardial ischaemia-reperfusion injury myocardial protection postoperative rehabilitation Meta-analysis randomized controlled trial

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Prognosis value of heat-shock proteins in esophageal and esophagogastric cancer:A systematic review and meta-analysis

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World Journal of Gastrointestinal Oncology 2024年第4期16卷 1578-1595页

作者： Eric Toshiyuki Nakamura Amanda Park Marina Alessandra Pereira Daniel Kikawa Francisco Tustumi department of Gastroenterology Instituto do CâncerHospital das Clínicas da Universidade de São PauloFaculdade de MedicinaUniversidade de São PauloSão Paulo 01246000Brazil department of Scientific Initiation Universidade Mogi das CruzesSão Paulo 08780911Brazil department of evidence-based medicine Centro Universitário LusíadaCentre for Evidence-Based MedicineCentro Universitário Lusíada(UNILUS)SantosBrazil department of Surgery Hospital Israelita Albert EinsteinSão Paulo 05652900Brazil

BACKGROUND Heat shock proteins(HSPs)are molecular chaperones that play an important role in cellular protection against stress events and have been reported to be overex-pressed in many cancers.The prognostic significance of HSPs and their regulatory factors,such as heat shock factor 1(HSF1)and CHIP,are poorly understood.AIM To investigate the relationship between HSP expression and prognosis in esophageal and esophagogastric cancer.METHODS A systematic review was conducted in accordance with PRISMA recommend-ations(PROSPERO:CRD42022370653),on Embase,PubMed,Cochrane,and LILACS.Cohort,case-control,and cross-sectional studies of patients with eso-phagus or esophagogastric cancer were included.HSP-positive patients were compared with HSP-negative,and the endpoints analyzed were lymph node metastasis,tumor depth,distant metastasis,and overall survival(OS).HSPs were stratified according to the HSP family,and the summary risk difference(RD)was calculated using a random-effect model.RESULTS The final selection comprised 27 studies,including esophageal squamous cell carcinoma(21),esophagogastric adenocarcinoma(5),and mixed neoplasms(1).The pooled sample size was 3465 patients.HSP40 and 60 were associated with a higher 3-year OS[HSP40:RD=0.22;95%confidence interval(CI):0.09-0.35;HSP60:RD=0.33;95%CI:0.17-0.50],while HSF1 was associated with a poor 3-year OS(RD=-0.22;95%CI:-0.32 to-0.12).The other HSP families were not associated with long-term survival.HSF1 was associated with a higher probability of lymph node metastasis(RD=-0.16;95%CI:-0.29 to-0.04).HSP40 was associated with a lower probability of lymph node dissemination(RD=0.18;95%CI:0.03-0.33).The expression of other HSP families was not significantly related to tumor depth and lymph node or distant metastasis.CONCLUSION The expression levels of certain families of HSP,such as HSP40 and 60 and HSF1,are associated with long-term survival and lymph node dissemination in patients with esophageal and esophagogastric cancer.

关键词： Heat-shock proteins Heat-shock response Prognosis Esophageal neoplasms Meta-analysis

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The Effect of Total Cholesterol on Myocardial Infarction in Chinese Male Hypertension Population

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Biomedical and Environmental Sciences 2010年第1期23卷 37-41页

作者： JIAN-XIN LI JIE CAO XIANG-FENG LU SHU-FENG CHEN DA-HAI YU XIU-FANG DUAN XI-GUI WU DONG-FENG GU department of evidence based medicine Cardiovascular lnstitute and Fuwai Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beo'ing 100037 China

Objective Total cholesterol （TC） is an important risk factor for myocardial infarction （M1）, but the effect of TC on MI in Chinese male hypertension population has not been well documented. We conducted a prospective cohort study to determine the incidence and relative risk for M1 across a wide range of TC levels in Chinese male hypertension population. Methods A cohort of 5 298 male employees aged 18-74 years recruited from Capital Steel and Iron Company in Beijing of China in 1974-1980 was followed up for an average of 20.84 years. A total of 122 incident M1 cases were identified during the period of follow-up. Results The incidence of MI among participants with elevated TC and those with desirable TC in male non-hypertension population was 137.20 and 63.81 per 100 000 person-years, respectively; and the corresponding incidence in male hypertension population was 279.80 and 130.96 per 100 000 person-years, respectively. After adjustment for important covariables, 10.38%, 16.71%, and 23.80% of M1 cases were attributable to hypertension, elevated TC, and hypertension plus elevated TC, respectively. In male hypertension population, the multivariate adjusted hazard ratios of MI were 1.21, 2.39, 3.38, and 3.95 for participants with TC level of 5.17-5.68, 5.69-6.20, 6.21-6.71, and ≥6.72 mmol/L, compared with those with TC〈5.17 mmol/L. The corresponding population attributable risks were 2.92%, 9.20%, 8.87%, and 9.84%, respectively. Conclusion Elevated TC is an important independent risk factor of M1 both in male non-hypertension and hypertension populations. There is a linear association between TC level and M1 incidence in Chinese male hypertension population.

关键词： Hypertension Cholesterol Myocardial infarction Cohort studies

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Management of autoimmune hepatitis induced by hepatitis delta virus

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World Journal of Gastroenterology 2024年第8期30卷 799-805页

作者： Eleni Gigi Vasileios Lagopoulos Aris Liakos Hepatology Unit The Second Internal Medicine DepartmentAristotle University Medical SchoolHippokrateio General HospitalThessaloniki 54642Greece department of Surgical AHEPA General Hospital of ThessalonikiThessaloniki 54636Greece Clinical Research and evidence-based medicine Unit Second Medical DepartmentHippokratio General HospitalAristotle University ThessalonikiThessaloniki 54642Greece

Approximately 12-72 million people worldwide are co-infected with hepatitis B virus(HBV)and hepatitis delta virus(HDV).This concurrent infection can lead to several severe outcomes with hepatic disease,such as cirrhosis,fulminant hepatitis,and hepatocellular carcinoma,being the most common.Over the past few decades,a correlation between viral hepatitis and autoimmune diseases has been reported.Furthermore,autoantibodies have been detected in the serum of patients co-infected with HBV/HDV,and autoimmune features have been reported.However,to date,very few cases of clinically significant autoimmune hepatitis(AIH)have been reported in patients with HDV infection,mainly in those who have received treatment with pegylated interferon.Interestingly,there are some patients with HBV infection and AIH in whom HDV infection is unearthed after receiving treatment with immunosuppressants.Consequently,several questions remain unanswered with the challenge to distinguish whether it is autoimmune or“autoimmune-like”hepatitis being the most crucial.Second,it remains uncertain whether autoimmunity is induced by HBV or delta virus.Finally,we investigated whether the cause of AIH lies in the previous treatment of HDV with pegylated interferon.These pressing issues should be elucidated to clarify whether new antiviral treatments for HDV,such as Bulevirtide or immu-nosuppressive drugs,are more appropriate for the management of patients with HDV and AIH.

关键词： Autoimmune hepatitis Hepatitis delta virus Bulevirtide Prednisolone

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Serum 25-hydroxyvitamin D, genetic susceptibility, and the risk of incident type 2 diabetes: A prospective cohort in East China

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中华医学杂志(英文版) 2024年第8期137卷 972-979页

作者： Sun Ying Zhang Haojie Wang Bin Wang Yuying Chen Chi Chen Yi Lu Yingli Wang Ningjian West China Hospital Sichuan University Chengdu Sichuan 610041 department of Endocrinology Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese medicine Shanghai 201203 Institute and department of Endocrinology and Metabolism Shanghai Ninth People’s Hospital Shanghai JiaoTong University School of medicine Shanghai 200011 China department of Endocrinology and Metabolism and department of Guideline and Rapid Recommendation Cochrane China Center MAGIC China Center Chinese evidence-based medicine Center

Background: The serum vitamin D level varies widely by population, and studies have linked vitamin D levels with the risk of type 2 diabetes mellitus (T2DM). However, the relationship is inconsistent and the impact of vitamin D on T2DM among East Chinese adults is unclear. The study aimed to investigate the association between serum 25-hydroxyvitamin D (25[OH]D) levels and the risk of T2DM and evaluated whether the association is modified by genetic predisposition.Methods: In the Survey on Prevalence in East China for Metabolic Diseases and Risk Factors (SPECT-China) cohort, 1862 participants free of T2DM at baseline were included. A weighted genetic risk score was calculated with 28 variants associated with T2DM. Hierarchical logistic models were used to examine the association of serum 25(OH)D and genetic risk with T2DM.Results: After a 5-year follow-up, 132 cases of T2DM were documented. We observed no significant association between quartiles of serum 25(OH)D and T2DM risk after multivariable adjustment (χ2 = 0.571,Pfor trend = 0.426). Compared to those in the lowest quartile of 25(OH)D, the odds ratios (ORs) (95% confidence interval [CI]) for participants with increased quartiles were 1.29 (0.74-2.25), 1.35 (0.77-2.36), and 1.27 (0.72-2.24), respectively. We observed a positive association of glycated hemoglobin (HbA1c) with 25(OH)D at baseline (β = 1.752,P = 0.001) and after follow-up (β = 1.385,P = 0.003), and a negative association of ln conversion homeostasis model assessment (HOMA)-β with 25(OH)D at baseline (β = -0.982,P = 0.021). There was no significant interaction between 25(OH)D and diabetes genetic predisposition on the risk of T2DM (χ2 = 2.710,Pfor interaction = 0.100). The lowest OR (95% CI) of T2DM was among participants with low genetic risk and the highest quartile of 25(OH)D (0.17 [0.05–0.62]).Conclusion: Serum 25(OH)D may be irrelevant to the risk of incident T2DM among East Chinese adults regardless of genetic predisposition.

关键词： Vitamin D Diabetes mellitus, Type 2 Genetic predisposition to disease Prospective cohort Glycated hemoglobin SPECT-China

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Acupuncture:Effective and Recommended but More Implementation Needed

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Chinese medicine and Culture 2024年第1期7卷 86-93页

作者： Mel Hopper Koppelman evidence based Acupuncture Middletown 02842the United States of America

Acupuncture enjoys a robust evidence base for dozens of clinical conditions and decades of research exploring its mechanisms of action. It has over 9,000 positive recommendations from official government and clinical guidelines. However, it still remains relatively inaccessible in the United States, Europe and elsewhere, especially compared to the strength of evidence-based recommendations for its use. Acupuncture would benefit from robust implementation strategies, utilizing insights and approaches from implementation science. The clinical use of Botox for migraine suffered from weaker evidence of effectiveness and greater evidence of harm, but using a streamlined and robust implementation strategy, Allergan was able to achieve widespread implementation from when it began its efforts around 2010. Such a systematic approach that identifies and overcomes barriers to implementation for acupuncture would benefit millions of people who currently are offered less effective and more invasive treatments, contrary to the recommendations of clinical guidelines.

关键词： Acupuncture Implementation science Accessibility Emergency use Migraine

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