Research On Development Of Application Guidelines Of Chinese Medicine For Chronic Heart Failure

The guidelines have been registered on the international practice guidelines registration platform(http://www.guidelines-registry.cn/)(No.IPGRP-2020CN083).Objective To construct the clinical problems of traditional Chinese medicine(TCM)in treatment of chronic heart failure(CHF),retrieve and evaluate the clinical research evidence,and formulate corresponding recommendations to complete the first draft of the Research on development of Application Guidelines of Chinese Medicine for Chronic Heart Failure.Methods1 Construction of clinical problemsBased on the principles of PICO,we organized existing expert consensus,practice guidelines and related literature,formulate a list of clinical problems,determine research objects and intervention measures through expert surveys,screen outcome indicators and rank their importance,thereby constructing clinical questions.2 Comprehensive evaluation of evidence-based evidence2.1 Literature retrieval and screeningDevelop a search strategy based on the list of research questions.Conduct an electronic search of CNKI,Wanfang,VIP,Sino Med,Pub Med,Embase,Cochrane Library databases for clinical randomized controlled trials of TCM in the treatment of CHF.The search time is from the inception to November 30,2020.Supplementary search strategies are carried out at the same time.According to the inclusion and exclusion criteria,the literature was screened and relevant data were extracted.2.2 Methodological quality evaluationThe methodological quality evaluation of clinical randomized controlled trials was carried out using the Cochrane Collaboration’s tool for assessing risk of bias(ROB).2.3 Evidence synthesis and analysisRev Man 5.3 software was used for the meta-analysis of efficacy indicators.Egger test was used to evaluate publication bias using Stata 15.0 software.Perform descriptive analysis to evaluate safety.2.4 Grading of the quality of evidence bodyBased on the Grade of Recommendation,Assessment,Development,and Evaluation(GRADE)system,the quality of the evidence body is evaluated and graded,including high(A),medium(B),and low(C),extremely low(D)levels.3 Formation of recommendationsBy organizing an expert consensus meeting,clinical experts are invited to evaluate the strength of the evidence body’s recommendation by weighing pros and cons,costs,patient values and willingness based on the level of evidence-based evidence quality.The results include strong recommendation(I),weak recommendation(II),and temporary not recommended(O),weakly not recommended(-II),and strongly not recommended(-I).Any one vote >50% or two total votes under the same recommendation direction >70% is considered to be a consensus.The agreed-upon items will eventually become guidelines recommendations.4 Completion of the draft guidelineComplete the drafting of the first draft of the guidelines following regulations of developing guideline.Results1 List of clinical questionsThis guide divides the research population(P)into heart failure with reduced ejection fraction(HFr EF)and heart failure with preserved ejection fraction(HFp EF),involving three TCM syndrome types: Qi deficiency and blood stasis syndrome(QDBSS),Yang Qi deficiency and blood stasis syndrome(Yang-QDBSS),Qi and Yin deficiency and blood stasis syndrome(Yin-QDBSS).According to the results of the expert consultation questionnaire on clinical issues,a total of 4 types of intervention measures(I),including Chinese patent medicine(oral Chinese patent medicine and TCM injection),Chinese medicine decoction,TCM rehabilitation exercise,and meridian and acupoint therapy are included.The comparison measures(C)are all conventional western medicine treatments,and 13 outcomes(O).The summary of clinical questions based on the PICO principle is as follows:P: HFr EF and HFpEF patients;I: TCM combined with international standard therapy.TCM includes Chinese patent medicine(oral Chinese patent medicine and TCM injection),TCM decoction,TCM rehabilitation exercise,meridian and acupoint therapy(acupuncture,moxibustion,acupoint application);C: international standard therapy;O: The ranking of the importance of outcomes is the Minnesota living with heart failure questionnaire(MLHFQ)> TCM syndrome > 6-minute walk distance(6MWD)> New York Heart Association(HYHA)cardiac function efficacy ≈ heart failure rehospitalization rate > B-type natriuretic peptide(BNP)or N-terminal pro-brain natriuretic peptide(NT-proBNP)> all-cause death rate ≈ cardiogenic death rate > left ventricular ejection fraction(LVEF)> the ratio of peak mitral valve blood flow velocity in early left ventricular diastole to peak mitral valve blood flow velocity in atrial systole(E/A)or the ratio of peak mitral valve blood flow velocity in early diastole to peak mitral valve annulus velocity in early diastole(E/e’);outcomes also include the incidence of adverse events..2 Overview of clinical evidence and quality classification274 related articles were included.Among them,there are 11 kinds of Chinese patent medicines(Qili Qiangxin capsule,Qishen Yiqi dropping pill,Xinbao pill,Shenfu Qiangxin pill,Buyi Qiangxin tablet,Shenfu injection,Xinmailong injection,Shengmai injection,Huangqi injection,Yiqifumai lyophilized injection,Shenmai injection),9 kinds of TCM decoctions(Buyang Huanwu decoction,Zhigancao decoction,Shengmai powder combined with Xuefu Zhuyu decoction,Zhigancao decoction combined with Xuefu Zhuyu decoction,Zhenwu decoction,Linggui Shugan decoction,Wuling power,Zhenwu decoction combined with Xuefu Zhuyu decoction,Zhenwu decoction combined with Taohong Siwu decoction),and 2 kinds of TCM rehabilitation exercise(Tai Chi,Baduanjin)for the treatment of HFr EF.There are 5 kinds of Chinese patent medicines(Qiliqiangxin capsule,Qishen Yiqi dropping pill,Shenfu injection,Xinmailong injection,Shenmai injection),5 kinds of TCM decoctions(Yangyin Shuxin recipe,Zhenwu decoction,Linggui Zhugan decoction,modified Wuling power,Linggui Zhugan decoction combined with Xuefu Zhuyu decoction),and 2 kinds of TCM rehabilitation exercise(Tai Chi,Baduanjin)for the treatment of HFp EF.There are 14 types of meridian and acupoint therapies(acupuncture,moxibustion,acupoint application)for CHF.The quality classification results of 48 evidence bodies were 5 pieces of medium-quality evidence bodies(B),33 pieces of low-quality evidence bodies(C),and 10 pieces of extremely low-quality evidence bodies(D).3 RecommendationsFinally,33 recommendations reached a consensus,of which 6 were strong recommendations(I)and 27 were weak recommendations(II).4 Draft GuidelinesThe criteria for disease differentiation and syndrome differentiation of CHF refer to the Expert Consensus on Chinese Medicine Diagnosis and Treatment of Chronic Heart Failure.4.1 Recommendations on TCM for HFr EF1)QDBSSTCM decoctions: Buyang Huanwu decoction(II C);Oral Chinese patent medicines: Qishen Yiqi dropping pill(I B);TCM injections: Huangqi injection(II C);TCM rehabilitation exercise: Baduanjin(II C)or Tai Chi(II D).2)Yang-QDBSS TCM decoctions: Zhenwu decoction(II D)or Linggui Zhugan decoction(II C)or Zhenwu decoction combined with Xuefu Zhuyu decoction(II C)or Wuling power(II C)or Zhenwu decoction combined with Taohong Siwu soup(II D);Oral Chinese patent medicines: Qili Qiangxin capsule(I B)or Xinbao pill(II B)or Shenfu Qiangxin pill(II C);TCM injections: Shenfu injection(I C)or Xinmailong injection(I B);TCM rehabilitation exercise: Baduanjin(II C)or Tai Chi(II D);Other TCM therapies: Acupoint application on dog days(II C).3)Yin-QDBSSTCM decoctions: Shengmai powder combined with Xuefu Zhuyu decoction(II C);Oral Chinese patent medicines: Buyiqiangxin tablet(II C);TCM injections: Shenmai injection(II B)or Shengmai injection(II C)or Yiqifumai lyophilized injection(II C);TCM rehabilitation exercise: Baduanjin(II C)or Tai Chi(II D).4.2 Recommendations on TCM for HFp EF1)QDBSS Oral Chinese patent medicines: Qishen Yiqi dropping pill(I C);TCM rehabilitation exercise: Tai Chi(II C)or Baduanjin(II C).2)Yang-QDBSSTCM decoctions: Zhenwu decoction(II C)or Linggui Zhugan decoction(II D)or Linggui Zhugan decoction combined with Xuefu Zhuyu decoction(II C)or modified Wuling powder(II C);Oral Chinese patent medicines: Qili Qiangxin capsule(I C);TCM injections: Shenfu injection(II D)or Xinmailong injection(II C);TCM rehabilitation exercise: Tai Chi(II C)or Baduanjin(II C);Other TCM therapies: Acupoint application on dog days(II C).3)Yin-QDBSSTCM decoctions: Yangyin Shuxin recipe(II C);TCM injections: Shenmai injection(II C);TCM rehabilitation exercise: Tai Chi(II C)or Baduanjin(II C).Conclusion1.There is a wide range of traditional Chinese medicine therapies for the treatment of CHF.Drug therapies including oral Chinese patent medicines,TCM injections,and TCM decoctions are the mainstay;non-drug therapies include Tai Chi,Baduan Jin,acupuncture,moxibustion,and acupoint application are supplemented.Among them,the evidence-based evidence related to Chinese patent medicine in the treatment of HFr EF is the most abundant.2.When evaluating the efficacy of TCM,clinical experts pay more attention to the outcome indicators of quality of life,TCM syndromes,exercise tolerance,and cardiac function.However,they pay less attention to other alternative outcome indicators and long-term prognosis-related outcome indicators.The combination of TCM and conventional western medicine is more effective than conventional western medicine and has better safety,but the advantages of each medicine are different.3.By organizing an expert consensus meeting on the basis of comprehensively collecting and sorting out clinical research evidence for the treatment of CHF with TCM,the formulation of the Research on development of Application Guidelines of Chinese Medicine for Chronic Heart Failure was completed.In the end,this study formed a total of 6 strong recommendations and 27 weak recommendations.Although the quality of the evidence is generally low,the recognition by experts and patient acceptance is high.The formulation of this guideline can further standardize the rational application of TCM in the treatment of CHF.4.With the emergence of more high-quality clinical research evidence of TCM treatment of CHF,the Application Guidelines of Chinese Medicine for Chronic Heart Failure still need to be continuously updated and improved.