Quality Assessment of Clinical Practice Guidelines for Integrative Medicine in China: A Systematic Review

Objective: To assess the quality of integrative medicine clinical practice guidelines(CPGs) published before 2014. Methods: A systematic search of the scientific literature published before 2014 was conducted to select integrative medicine CPGs. Four major Chinese integrated databases and one guideline database were searched: the Chinese Biomedical Literature Database(CBM), the China National Knowledge Infrastructure(CNKI), China Science and Technology Journal Database(VIP), Wanfang Data, and the China Guideline Clearinghouse(CGC). Four reviewers independently assessed the quality of the included guidelines using the Appraisal of Guidelines for Research and Evaluation(AGREE) Ⅱ Instrument. Overall consensus among the reviewers was assessed using the intra-class correlation coefficient(ICC). Results: A total of 41 guidelines published from 2003 to 2014 were included. The overall consensus among the reviewers was good [ICC: 0.928; 95% confidence interval(CI): 0.920 to 0.935]. The scores on the 6 AGREE domains were: 17% for scope and purpose(range: 6% to 32%), 11% for stakeholder involvement(range: 0 to 24%), 10% for rigor of development(range: 3% to 22%), 39% for clarity and presentation(range: 25% to 64%), 11% for applicability(range: 4% to 24%), and 1% for editorial independence(range: 0 to 15%). Conclusions: The quality of integrative medicine CPGs was low, the development of integrative medicine CPGs should be guided by systematic methodology. More emphasis should be placed on multi-disciplinary guideline development groups, quality of evidence, management of funding and conflicts of interest, and guideline updates in the process of developing integrative medicine CPGs in China.     

Quality assessment of clinical guidelines in China: 1993–2010

Background  Clinical practice guidelines (CPGs) play an important role in healthcare in China as well as in the world. However, the current status and trends of Chinese CPGs are unknown. The aim of this study was to systematically review the present situation and the quality of Chinese CPGs published in the peer-reviewed medical literature.

Methods  To identify Chinese CPGs, a systematic search of relevant literature databases (CBM, WANFANG, VIP, and CNKI) was performed for the period January 1978 to December 2010. We used the AGREE II instrument to assess the quality of the included guidelines.

Results  We evaluated 269 guidelines published in 115 medical journals from 1993 to 2010 and produced by 256 different developers. Only four guidelines (1%) described the systematic methods for searching and selecting the evidence, 14 (5%) guidelines indicated an explicit link between the supporting evidence and the recommendations, only one guideline used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Thirty-one guidelines (12%) mentioned updates and the average frequency of update was 5.5 years; none described a procedure for updating the guideline. From the assessment with the Appraisal of Guidelines for Research and Ecaluation II (AGREE II), the mean scores were low for the domains “scope and purpose” (19%) and “clarity of presentation” (26%) and very low for the other domains (“rigour of development” 7%, “stakeholder involvement” 8%, “applicability” 6% and “editorial independence” 2%).

Conclusions  Compared with other studies on the quality of guidelines assessed with the AGREE instrument in other countries, Chinese CPGs received lower scores, which indicates a relatively poor quality of the guidelines. However, there was some increase over time.

     

Status Quo and Analysis of the Cardiovascular Clinical Practice Guidelines/Expert Consensuses of Chinese and Integrative Medicine:A Systematic

Objective:To describe and analyze the status quo of cardiovascular clinical practice guidelines or expert consensuses including both Chinese medicine(CM)and integrative medicine,through systematic literatures searching and quality assessment.Methods:Data bases including Chinese Biomedical Literature Database,the China National Knowledge Infrastructure,Wanfang Data,China Science and Technology Journal Database were searched for published CM or integrative cardiovascular clinical practice guidelines or expert consensuses.The website www.medlive.cn was also retrieved as supplementary.The clinical practice evaluation tool AGREEⅡwas used to assess the quality of included guidelines or consensuses.Results:A total of 31 relevant clinical practice guidelines or expert consensuses were included,covering diagnosis,treatment,Chinese patent and patient fields.Common cardiovascular diseases like coronary heart diseases,heart failure and arrhythmia were also involved.Through analysis it was found that both the quantity and quality of included guidelines have been improved year by year.A total of 4 evidence-based clinical practice guideline has been found,one of which was a guideline project plan.Except that,the remaining 27 reports were all consensusbased guidelines.The scores of each field,from highest to lowest,were clarity of presentation(58%),scope and purpose(54%),stakeholder involvement(28%),rigor of development(21%),applicability(13%)and editorial independence(8%).Conclusions:Although clinical practice guidelines in cardiovascular domain of Chinese have gained increasing concern,with both quantity and quality improved,there is still huge gap in methodology and reporting standards between CM guidelines and international ones.On the one hand,it is essential to improve and standardize the methodology of developing CM guidelines.On the other hands,the evaluation system of evidence and recommendation with CM characters should be developed urgently.     

Status Quo and Analysis of the Cardiovascular Clinical Practice Guidelines/Expert Consensuses of Chinese and Integrative Medicine: A Systematic Review

Objective: To describe and analyze the status quo of cardiovascular clinical practice guidelines or expert consensuses including both Chinese medicine (CM) and integrative medicine, through systematic literatures searching and quality assessment. Methods: Data bases including Chinese Biomedical Literature Database, the China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database were searched for published CM or integrative cardiovascular clinical practice guidelines or expert consensuses. The website www. medlive.cn was also retrieved as supplementary. The clinical practice evaluation tool AGREE Ⅱ was used to assess the quality of included guidelines or consensuses. Results: A total of 31 relevant clinical practice guidelines or expert consensuses were included, covering diagnosis, treatment, Chinese patent and patient fields. Common cardiovascular diseases like coronary heart diseases, heart failure and arrhythmia were also involved. Through analysis it was found that both the quantity and quality of included guidelines have been improved year by year. A total of 4 evidence-based clinical practice guideline has been found, one of which was a guideline project plan. Except that, the remaining 27 reports were all consensus based guidelines. The scores of each field, from highest to lowest, were clarity of presentation (58%), scope and purpose (54%), stakeholder involvement (28%), rigor of development (21%), applicability (13%) and editorial independence (8%). Conclusions: Although clinical practice guidelines in cardiovascular domain of Chinese have gained increasing concern, with both quantity and quality improved, there is still huge gap in methodology and reporting standards between CM guidelines and international ones. On the one hand, it is essential to improve and standardize the methodology of developing CM guidelines. On the other hands, the evaluation system of evidence and recommendation with CM characters should be developed urgently.     

Appraisal of Clinical Practice Guidelines for Ischemic Stroke Management in Chinese Medicine with Appraisal of Guidelines for Research and Evaluation Instrument: A Systematic Review

Objective: To systematically review the clinical practice guidelines (CPGs) for ischemic stroke in Chinese medicine (CM) with the Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) instrument. Methods: CM CPGs for ischemic stroke were searched in 5 online databases and hand-searches in CPG-related handbooks published from January 1990 to December 2012. The CPGs were categorized into evidence based (EB) guideline, consensus based with no explicit consideration of evidence based (CB-EB) guideline and consensus based (CB) guideline according to the development method. Three reviewers independently appraised the CPGs based on AGREE Ⅱ instrument, and compared the CPGs'' recommendations on CM pattern classification and treatment. Results: Five CM CPGs for ischemic stroke were identified and included. Among them, one CPG was EB guideline, two were CB guidelines and two were CB-EB guidelines. The quality score of the EB guideline was higher than those of the CB-EB and CB guidelines. Five CM patterns in the CPGs were recommended in the EB CPG. The comprehensive protocol of integrative Chinese and Western medicine recommended in the EB CPG was mostly recommended for ischemic stroke in the CPGs. The recommendations varied based on the CM patterns. Conclusion: The quality of EB CPG was higher than those of CB and CB-EB CPGs in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions.     

Appraisal of the Quality and Contents of Clinical Practice Guidelines for Hypertension Management in Chinese Medicine: A Systematic Review

Objective: To evaluate the quality and consistency of recommendations in the clinical practice guidelines(CPGs) for hypertension in Chinese medicine(CM). Methods: CM CPGs were identified from 5 electronic databases and hand searches through related handbooks published from January 1990 to December 2013. Three reviewers independently appraised the CPGs based on the Appraisal of Guidelines for Research and Evaluation(AGREE Ⅱ) instrument, and compared the CPGs' recommendations on CM syndrome pattern classification and treatment. Results: Five CM CPGs for hypertension were included. The quality score of the evidence-based(EB) guideline was higher than those of the consensus-based with no explicit consideration of evidence-based(CB-EB) and the consensus-based(CB) guidelines. Three out of five patterns in the CPGs were recommended by the EB guideline. Tianma Gouteng Formula(天麻钩藤复方) in the EB guideline was recommended mostly for hypertension patients with pattern of ascendant hyperactivity of Gan(Liver)-yang and pattern of yin deficiency with yang hyperactivity in the CPGs. Acupuncture and massage were recommended for Grade Ⅰ and Grade Ⅱ hypertension with severe symptoms weakening the quality of life in the EB guideline. For Grade Ⅰ and Grade Ⅱ hypertension, CM could be used alone, while for Grade Ⅲ hypertension, they should be used in combination with Western medicines. Conclusion: The quality of EB guideline was higher than those of CB and CB-EB CPGs in CM for hypertension and CM should be prescribed alone or combined with Western medicines based on the grade of hypertension.     

Development of clinical practice guidelines in 11 common diseases with Chinese medicine interventions in China

Objective:To analyze the clinical practice guideline(CPG) development on 11 common diseases with Chinese medicine(CM) interventions in China.Methods:The CPGs of 11 common diseases which could be treated effectively with CM had been published between 1980 and 2010 in China.The 11 diseases include coronary heart disease(angina pectoris),hypertension,chronic gastritis,rheumatoid arthritis,cerebral infarction,migraine,diabetes,primary osteoporosis,insomnia,common cold,and IgA nephropathy.The issuing organization,date of publication,development methods,and citation rate of the CPGs were analyzed.According to the development method,each guideline was categorized as consensus-based(CB),evidence-based(EB), or consensus based with no explicit consideration of evidence-based(CB-EB).Results:Thirty-three CPGs on the 11 common diseases were found:20 guidelines were classified as CB,13 as CB-EB and none as EB.Fifteen CPGs were issued by the China Association of Chinese Medicine,8 by professional working groups,and 4 by the State Administration of Traditional Chinese Medicine.Six guidelines were published between 1980 and 1990,9 between 1991 and 2000,and 18 between 2001 and 2010.Fifty-eight percent of these guidelines have not been amended timely.Only 54.5%(18/33) of the 33 guidelines were cited by other researchers and 45.5% (15/33) percent had never been cited.Conclusions:Most CPGs developed for 11 common diseases with CM approaches in China are consensus,and their citation rates are relatively low.The results suggest that more EB CPG or CPG strictly based on expert consensus could be developed,and great efforts should be made for future CM CPG application.     

Regional Variations in Medication Usage for Cardiovascular Diseases at the Community Level in China (PURE-China Study)

We investigated the usage of secondary prevention drugs and traditional Chinese medicine (TCM) products in individuals with cardiovascular diseases (CVDs) at the community level in China. Among 2,407 participants with self-reported coronary heart disease (CHD) and 872 with stroke, nearly 80% of individuals with CHD and 73% of individuals with stroke were not taking any proven secondary prevention drug. However, 32.9% of them took TCM products. Patients with CVDs in rural areas used less secondary prevention treatment, but more TCM products than their counterparts in the urban regions. After adjusting for confounding factors, lower rates of secondary prevention treatment were evident in Western China compared with Eastern China, which was more developed. Systematic change is needed to promote the development of evidence-based medicine at the community level in China.     

WHO西太区与世界中医药学会联合会中医名词术语国际标准比较研究：卫气营血辨证（一）（英文）

Syndrome differentiation of defense,qi,nutrient and blood aspects is a method developed by Ye Tian-shi,a celebrated traditional Chinese medicine （TCM）physician in the Qing Dynasty,for the treatment of warm disease of external contraction,which is a further development of syndrome differentiation of the six meridians.According to the theory of TCM,     

Clinical Practice Guidelines and Experts'' Consensuses for Treatment of Coronavirus Disease 2019 (COVID-19) Patients with Chinese Herbal Medicine: A Systematic Review

Objective: To systematically review the clinical practice guidelines for the treatment of coronavirus disease 2019(COVID-19) patients with Chinese herbal medicine(CHM), summarize their recommendations and evaluate their qualities. Methods: Electronic databases, websites of governments, academic associations or organizations for eligible guidelines were searched up to April 2020. Information were extracted to summarize recommendations for the use of Chinese herbal formulae and Chinese patent medicine(CPM) for COVID-19 patients. The methodological quality and reporting quality of the included guidelines were independently evaluated, using the Appraisal of Guidelines for REsearch and Evaluation(AGREE) Ⅱ tool and Reporting Items for Practice Guidelines in healthcare(RIGHT) statement, respectively. Results: Totally 45 guidelines were identified: 42(93%) suggested specific CM formulae for treating COVID-19 patients; and 35(78%) assigned patients diagnosed with COVID-19 to 4 stages(early, development, critical and recovery). The recommended formulae and CPMs for each stage with diverse syndrome types have been summarized. Most of the included guidelines were of low methodological quality, with only one achieving moderate quality of AGREE Ⅱ. The frequency with which the 35 items in the Reporting Items for Practice Guidelines in Healthcare(RIGHT) checklist were reported averaged 36.5% across the 45 guidelines. Conclusions: This systematic review has summarized current recommendations for treating COVID-19 patients with CHM and shows that the general quality of present guidelines is quite low. The development of future guidelines should include increased awareness of the features of good quality guidelines.     

美沙拉嗪肠溶片联合中药灌肠方治疗湿热内蕴型溃疡性结肠炎疗效评价

目的:探讨美沙拉嗪肠溶片联合中药灌肠方治疗湿热内蕴型溃疡性结肠炎(UC)的临床疗效.方法:选取80例湿热内蕴型UC病人,随机分为对照组40例(单纯给予美沙拉嗪肠溶片口服)和观察组40例(美沙拉嗪肠溶片口服+中药灌肠方),疗程结束后进行中医证候疗效评价及改良UC Mayo评分.结果:治疗后,观察组中医证候积分、中医证候疗效、改良UC Mayo评分及白细胞介素-6水平均明显优于对照组(P<0.01).结论:美沙拉嗪肠溶片联合中药灌肠方在湿热内蕴型UC病人中的疗效肯定,值得临床推广.     

145名远洋航海人员中医体质类型与晕动病关系探讨

目的：探讨中医体质类型与晕动病发生之间的关系。方法：采用北京中医药大学王琦等编制的《中医体质分类与判定》标准判定某远洋船队远洋航海人员体质类型的分布情况,对发生晕动病的远洋航海人员采用格瑞比尔（Graybiel）评分法评定晕动病的程度,分析不同体质类型远洋航海人员的晕动病发生情况。结果：出航前145名远洋航海人员体质类型主要以平和质为主,占50.3%,其他体质类型分布为湿热质占14.5%,气郁质占10.3%,气虚质占6.2%,阳虚质占7.6%,阴虚质占6.2%,血瘀质占4.1%,特禀质占0.7%,无痰湿质。经过176d远洋航行后,145名远洋航海人员返航时的体质分布情况有所改变,其中平和质占33.8%,湿热质占13.8%,气郁质占13.1%,气虚质占11.0%,阳虚质占6.9%,阴虚质占9.7%,血瘀质占4.1%,特禀质占0.7%,痰湿质占6.9%。航行中远洋航海人员晕动病发生率为69.7%（101人）,不同体质的远洋航海人员晕动病发生率存在差异（P〈0.001）,湿热质远洋航海人员的晕动病发生率明显高于平和质远洋航海人员（P〈0.000714）。结论：人体体质类型可能与远洋航海过程中晕动病的发生存在一定的联系。远洋航海环境对人的体质的影响尚须进一步研讨。     

乳腺增生病中医体质类型调查分析

目的：探讨乳腺增生病及其证候与中医体质的相关性。方法：采用非匹配病例对照研究方法,运用中医体质量表进行中医体质调查。调查对象472例,其中乳腺增生病例组336例,非乳腺增生对照组136例。结果：病例组中医体质类型分布依次为气郁质（31．85％）、平和质（22．32％）、气虚质（12．2‰）、阴虚质（11．01％）、阳虚质（9．52％）、瘀血质（4．76％）、湿热质（3．27％）、特禀质（2．68%）、痰湿质（2．38％）,与对照组比较,差异有统计学意义（P〈0．01）。336例乳腺增生病中．肝郁气滞证、痰瘀互结证和冲任失调证分别为195（58．04％）,87（25．89％）,54（16．07％）例。不同证型的中医体质分布差异有统计学意义（P〈0．01）。肝郁气滞证和痰瘀互结证患者均以气郁质为主．气郁质比例分别为37．95％和29．89％;冲任失调证患者则以平和质和气虚质为主,分别占22．22%和20．37%。结论：乳腺增生病发病及其发病后的证候类型与体质相关。     

中药与西药对照治疗偏头痛的Meta分析

目的评价中药治疗偏头痛的临床疗效和安全性。方法计算机检索中国期刊全文数据库、维普中文期刊数据库、万方学术期刊全文数据库、中国生物医学文献服务系统(CBM)、中国生物医学期刊引文数据库(CMCI/CMCC整合版)、中医药在线数据库,检索2000年1月—2009年12月10年间的相关文献,收集中药治疗偏头痛的随机对照试验(RCTs)。按纳入排除标准筛选试验、评价研究质量、提取有效数据,并采用RevMan5.0进行统计分析。结果最终纳入20个RCT评价中药与西药在偏头痛疗效方面的差异,Meta分析显示:有效率[RR=1.22,95%CI(1.15,1.29),P<0.01],差异有统计学意义。敏感性分析表明评价结果稳定。漏斗图显示不对称,提示纳入评价的文献存在发表性偏倚。结论中药治疗偏头痛有效,但由于本系统评价纳入研究的方法学质量较低,尚需开展更多设计合理、执行严格的多中心大样本且随访时间足够长的随机对照试验验证其疗效及安全性。     

中药小包装饮片的历史源流及其调剂规范化操作的思考

目的传承历代中药调剂操作经验,规范现代中药小包装饮片调剂操作技术。方法通过查阅历代古籍和现代文献,系统整理和分析中药饮片小包装的历史渊源、使用利弊、包装选择、使用现状及调剂规程等五方面情况,回顾小包装饮片的发展历程,总结调剂操作经验,编排现代调剂操作规程。结果中药小包装饮片调剂具有独特的优势,"审、摆、看、对、拿、掂、分、核、包、发"的"十字口诀"是其主要操作要点。结论中药小包装饮片调剂"十字口诀"易记、易懂、易操作,提高临床调剂质量、规范调剂技能具有指导意义。     

473例艾滋病毒感染者和艾滋病患者中医临床症状和证候分布规律初探

目的:对皖北地区艾滋病毒(human immunodeficiency virus, HIV)感染者和艾滋病(acquired immunodeficiency syndrome, AIDS)患者的中医临床症状和证候特点进行初步探讨.方法:采用中医临床流行病学调查方法,制定统一的临床观察表与调查方法,用Excel建立相关数据库,对症状、体征和证型的频数分布进行统计.结果:皖北地区HIV感染者和AIDS患者的感染途径主要为经血感染;临床症状以乏力、气短为最多见;HIV期以气血两亏型为最多见,AIDS期以气阴两虚、肺肾不足型,肝经风火、湿毒蕴结型,脾肾亏虚、湿邪阻滞型和气虚血瘀、邪毒壅滞型为前4位复合证型.结论:AIDS中医临床症状特征是"以虚为主,虚实夹杂,气血津液俱亏,湿毒瘀虚同在",证型特征是"复杂多变,以虚为本,多脏腑受累",病情呈现渐行性发展、渐进性加重之特点.