Study protocol: Traditional Chinese Medicine (TCM) syndrome differentiation for heart failure patients and its implication for long-term therapeutic outcomes of the Qiliqiangxin capsules
Background: Syndrome differentiation is a commonly used methodology and practice in Traditional Chinese Medicine (TCM) guiding the diagnosis and treatment of diseases including heart failure (HF). However, previous clinical trials seldom consider the impact of syndrome patterns on the outcome evalua...
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| description | Background: Syndrome differentiation is a commonly used methodology and practice in Traditional Chinese Medicine (TCM) guiding the diagnosis and treatment of diseases including heart failure (HF). However, previous clinical trials seldom consider the impact of syndrome patterns on the outcome evaluation of TCM formulae. Qiliqiangxin (QLQX) capsule is a TCM formula with cardiotonic effect to improve the cardiovascular function for heart failure with proven efficacy from well-designed clinical trials. Though, there is no clinical trial with a large sample size and long assessment period that considers the relationship between TCM syndrome differentiation and the treatment efficacy of QLQX. In the present study, we design a study protocol to evaluate the relationship between TCM syndrome differentiation and the severity of heart failure as well as its progression. Furthermore, we will evaluate the impact of the TCM syndrome patterns on the efficacy of QLQX in the outcome of heart failure.
Methods: This is a clinical study conducted in conjunction with an ongoing clinical trial (QUEST Study) by sharing the parent patient populations but with different aims and independent designed roadmaps to investigate the TCM syndrome pattern distributions and the impacts of syndrome pattern types on the efficacy of QLQX in HF treatment. The clinical trial involves over 100 hospitals in mainland China and Hong Kong SAR with 3080 HF patients. By assessing the morbidity and re-hospitalization, we will verify and apply a modified TCM Questionnaire to collect the clinical manifestations of HF and acquire the tongue images of the patients to facilitate the syndrome differentiation. We will base on the "2014 Consensus from TCM experts on diagnosis and treatment of chronic heart failure" to evaluate the TCM syndromes for the patients. A pilot study with at least 600 patients will be conducted to evaluate the reliability, feasibility and validity of the modified TCM questionnaire for syndrome differentiation of HF and the sample size is calculated based on the confidence level of 95%, population size of 3080 and 5% margin of error. Secondly, we will investigate the characteristic of TCM syndrome distribution of HF patients and its correlation with the functional and biochemical data. Furthermore, we will evaluate the relationship between the TCM syndrome patterns and the efficacy of QLQX in the treatment of heart failure. Lastly, we will investigate the implication of tongue diagno |
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Methods: This is a clinical study conducted in conjunction with an ongoing clinical trial (QUEST Study) by sharing the parent patient populations but with different aims and independent designed roadmaps to investigate the TCM syndrome pattern distributions and the impacts of syndrome pattern types on the efficacy of QLQX in HF treatment. The clinical trial involves over 100 hospitals in mainland China and Hong Kong SAR with 3080 HF patients. By assessing the morbidity and re-hospitalization, we will verify and apply a modified TCM Questionnaire to collect the clinical manifestations of HF and acquire the tongue images of the patients to facilitate the syndrome differentiation. We will base on the "2014 Consensus from TCM experts on diagnosis and treatment of chronic heart failure" to evaluate the TCM syndromes for the patients. A pilot study with at least 600 patients will be conducted to evaluate the reliability, feasibility and validity of the modified TCM questionnaire for syndrome differentiation of HF and the sample size is calculated based on the confidence level of 95%, population size of 3080 and 5% margin of error. Secondly, we will investigate the characteristic of TCM syndrome distribution of HF patients and its correlation with the functional and biochemical data. Furthermore, we will evaluate the relationship between the TCM syndrome patterns and the efficacy of QLQX in the treatment of heart failure. Lastly, we will investigate the implication of tongue diagnosis in the severity and therapeutic outcome of HF.
Expect outcomes: To our knowledge, this is the first large scale clinical trial to evaluate the impacts of TCM syndrome differentiation on the progression and therapeutic outcome of HF patients and explore the diagnostic value of TCM Tongue Diagnosis in HF patients. We expect to obtain direct clinical evidence to verify the importance of TCM syndrome differentiation for the diagnosis and treatment of HF.</description><identifier>ISSN: 1749-8546</identifier><identifier>EISSN: 1749-8546</identifier><identifier>DOI: 10.1186/s13020-021-00515-1</identifier><identifier>PMID: 34656145</identifier><language>eng</language><publisher>LONDON: Springer Nature</publisher><subject>Cardiac arrhythmia ; Cardiac patients ; Cardiomyocytes ; Care and treatment ; Chinese medicine ; Clinical trials ; Congestive heart failure ; Coronary artery disease ; Diagnosis ; Disease ; Drug dosages ; Edema ; Ejection fraction ; Heart ; Heart failure ; Homeopathy ; Hospitalization ; Hospitals ; Integrative & Complementary Medicine ; Life Sciences & Biomedicine ; Materia medica and therapeutics ; Medical research ; Medicine, Chinese ; Medicine, Experimental ; Morbidity ; Mortality ; Patient outcomes ; Patients ; Pharmacology & Pharmacy ; Qiliqiangxin (QLQX) capsule ; Recruitment ; Science & Technology ; Syndrome ; Syndrome element ; TCM syndrome differentiation ; Therapeutics ; Tongue ; Tongue diagnosis ; Traditional Chinese medicine ; Traditional Chinese Medicine (TCM)</subject><ispartof>Chinese medicine, 2021-10, Vol.16 (1), p.1-103, Article 103</ispartof><rights>COPYRIGHT 2021 BioMed Central Ltd.</rights><rights>2021. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2021</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>13</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000707704300001</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c571t-5695151301224f56302674b313d58b9c5576dde7e07d6b6859dc3f4691d48f763</citedby><cites>FETCH-LOGICAL-c571t-5695151301224f56302674b313d58b9c5576dde7e07d6b6859dc3f4691d48f763</cites><orcidid>0000-0003-4772-5300</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8520188/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8520188/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2103,2115,27929,27930,39263,53796,53798</link.rule.ids></links><search><creatorcontrib>Leung, Alice Yeuk Lan</creatorcontrib><creatorcontrib>Chen, Hoiyong</creatorcontrib><creatorcontrib>Jia, Zhenhua</creatorcontrib><creatorcontrib>Li, Xinli</creatorcontrib><creatorcontrib>Shen, Jiangang</creatorcontrib><title>Study protocol: Traditional Chinese Medicine (TCM) syndrome differentiation for heart failure patients and its implication for long-term therapeutic outcomes of the Qiliqiangxin capsules</title><title>Chinese medicine</title><addtitle>CHIN MED-UK</addtitle><description>Background: Syndrome differentiation is a commonly used methodology and practice in Traditional Chinese Medicine (TCM) guiding the diagnosis and treatment of diseases including heart failure (HF). However, previous clinical trials seldom consider the impact of syndrome patterns on the outcome evaluation of TCM formulae. Qiliqiangxin (QLQX) capsule is a TCM formula with cardiotonic effect to improve the cardiovascular function for heart failure with proven efficacy from well-designed clinical trials. Though, there is no clinical trial with a large sample size and long assessment period that considers the relationship between TCM syndrome differentiation and the treatment efficacy of QLQX. In the present study, we design a study protocol to evaluate the relationship between TCM syndrome differentiation and the severity of heart failure as well as its progression. Furthermore, we will evaluate the impact of the TCM syndrome patterns on the efficacy of QLQX in the outcome of heart failure.
Methods: This is a clinical study conducted in conjunction with an ongoing clinical trial (QUEST Study) by sharing the parent patient populations but with different aims and independent designed roadmaps to investigate the TCM syndrome pattern distributions and the impacts of syndrome pattern types on the efficacy of QLQX in HF treatment. The clinical trial involves over 100 hospitals in mainland China and Hong Kong SAR with 3080 HF patients. By assessing the morbidity and re-hospitalization, we will verify and apply a modified TCM Questionnaire to collect the clinical manifestations of HF and acquire the tongue images of the patients to facilitate the syndrome differentiation. We will base on the "2014 Consensus from TCM experts on diagnosis and treatment of chronic heart failure" to evaluate the TCM syndromes for the patients. A pilot study with at least 600 patients will be conducted to evaluate the reliability, feasibility and validity of the modified TCM questionnaire for syndrome differentiation of HF and the sample size is calculated based on the confidence level of 95%, population size of 3080 and 5% margin of error. Secondly, we will investigate the characteristic of TCM syndrome distribution of HF patients and its correlation with the functional and biochemical data. Furthermore, we will evaluate the relationship between the TCM syndrome patterns and the efficacy of QLQX in the treatment of heart failure. Lastly, we will investigate the implication of tongue diagnosis in the severity and therapeutic outcome of HF.
Expect outcomes: To our knowledge, this is the first large scale clinical trial to evaluate the impacts of TCM syndrome differentiation on the progression and therapeutic outcome of HF patients and explore the diagnostic value of TCM Tongue Diagnosis in HF patients. We expect to obtain direct clinical evidence to verify the importance of TCM syndrome differentiation for the diagnosis and treatment of HF.</description><subject>Cardiac arrhythmia</subject><subject>Cardiac patients</subject><subject>Cardiomyocytes</subject><subject>Care and treatment</subject><subject>Chinese medicine</subject><subject>Clinical trials</subject><subject>Congestive heart failure</subject><subject>Coronary artery disease</subject><subject>Diagnosis</subject><subject>Disease</subject><subject>Drug dosages</subject><subject>Edema</subject><subject>Ejection fraction</subject><subject>Heart</subject><subject>Heart failure</subject><subject>Homeopathy</subject><subject>Hospitalization</subject><subject>Hospitals</subject><subject>Integrative & Complementary Medicine</subject><subject>Life Sciences & Biomedicine</subject><subject>Materia medica and therapeutics</subject><subject>Medical research</subject><subject>Medicine, Chinese</subject><subject>Medicine, Experimental</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Patient outcomes</subject><subject>Patients</subject><subject>Pharmacology & Pharmacy</subject><subject>Qiliqiangxin (QLQX) capsule</subject><subject>Recruitment</subject><subject>Science & Technology</subject><subject>Syndrome</subject><subject>Syndrome element</subject><subject>TCM syndrome differentiation</subject><subject>Therapeutics</subject><subject>Tongue</subject><subject>Tongue diagnosis</subject><subject>Traditional Chinese medicine</subject><subject>Traditional Chinese Medicine (TCM)</subject><issn>1749-8546</issn><issn>1749-8546</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>HGBXW</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNqNUl1rFDEUHUSxWv0DPgUEqcjUZPIxMz4IZfGj0CJifQ7Z5GY3JTPZJhm1f81fZ2a3tF3xQfKQy73nnJt7c6rqBcHHhHTibSIUN7jGDakx5oTX5EH1hLSsrzvOxMN78UH1NKXLAqKcdo-rA8oEF4TxJ9Xvb3ky12gTQw46-HfoIirjsguj8mixdiMkQOdgnC4hOrpYnL9G6Xo0MQyAjLMWIozZqZmBbIhoDSpmZJXzUwS0KYVST0iNBrlyu2Hjnb6D-zCu6gxxQHkNUW1gyk6jMGVdGiQU7JxHX513V06Nq19uRFpt0uQhPaseWeUTPL-5D6vvHz9cLD7XZ18-nS5OzmrNW5JrLvqym7Iq0jTMclF2Jlq2pIQa3i17zXkrjIEWcGvEUnS8N5paJnpiWGdbQQ-r052uCepSbqIbVLyWQTm5TYS4kmVkpz1IUJzjnuNGCcoIb3vDGDCseUftkhFVtN7vtDbTcgCjy26i8nui-5XRreUq_JAdbzDpuiJwdCMQw9UEKcvBJQ3eqxHClGRTWtFGNHR-98u_oJdhiuVft6imxy0jzR1qpcoAbrSh9NWzqDwRHZnnKIqH1fE_UOUYGJwOI1hX8nuEV_cIxRQ-r1Pw0_zxaR_Y7IA6hpQi2NtlECxnm8udzWWxudzaXJJCerMj_YRlsEkXj2m4JWKMW9y2mNES4Rnd_T964fLWnYswjZn-AaYuD2k</recordid><startdate>20211016</startdate><enddate>20211016</enddate><creator>Leung, Alice Yeuk Lan</creator><creator>Chen, Hoiyong</creator><creator>Jia, Zhenhua</creator><creator>Li, Xinli</creator><creator>Shen, Jiangang</creator><general>Springer Nature</general><general>BioMed Central Ltd</general><general>BioMed Central</general><general>BMC</general><scope>BLEPL</scope><scope>DTL</scope><scope>HGBXW</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7TM</scope><scope>7X7</scope><scope>7XB</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>P64</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0003-4772-5300</orcidid></search><sort><creationdate>20211016</creationdate><title>Study protocol: Traditional Chinese Medicine (TCM) syndrome differentiation for heart failure patients and its implication for long-term therapeutic outcomes of the Qiliqiangxin capsules</title><author>Leung, Alice Yeuk Lan ; Chen, Hoiyong ; Jia, Zhenhua ; Li, Xinli ; Shen, Jiangang</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c571t-5695151301224f56302674b313d58b9c5576dde7e07d6b6859dc3f4691d48f763</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Cardiac arrhythmia</topic><topic>Cardiac patients</topic><topic>Cardiomyocytes</topic><topic>Care and treatment</topic><topic>Chinese medicine</topic><topic>Clinical trials</topic><topic>Congestive heart failure</topic><topic>Coronary artery disease</topic><topic>Diagnosis</topic><topic>Disease</topic><topic>Drug dosages</topic><topic>Edema</topic><topic>Ejection fraction</topic><topic>Heart</topic><topic>Heart failure</topic><topic>Homeopathy</topic><topic>Hospitalization</topic><topic>Hospitals</topic><topic>Integrative & Complementary Medicine</topic><topic>Life Sciences & Biomedicine</topic><topic>Materia medica and therapeutics</topic><topic>Medical research</topic><topic>Medicine, Chinese</topic><topic>Medicine, Experimental</topic><topic>Morbidity</topic><topic>Mortality</topic><topic>Patient outcomes</topic><topic>Patients</topic><topic>Pharmacology & Pharmacy</topic><topic>Qiliqiangxin (QLQX) capsule</topic><topic>Recruitment</topic><topic>Science & Technology</topic><topic>Syndrome</topic><topic>Syndrome element</topic><topic>TCM syndrome differentiation</topic><topic>Therapeutics</topic><topic>Tongue</topic><topic>Tongue diagnosis</topic><topic>Traditional Chinese medicine</topic><topic>Traditional Chinese Medicine (TCM)</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Leung, Alice Yeuk Lan</creatorcontrib><creatorcontrib>Chen, Hoiyong</creatorcontrib><creatorcontrib>Jia, Zhenhua</creatorcontrib><creatorcontrib>Li, Xinli</creatorcontrib><creatorcontrib>Shen, Jiangang</creatorcontrib><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Web of Science - Science Citation Index Expanded - 2021</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Chinese medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Leung, Alice Yeuk Lan</au><au>Chen, Hoiyong</au><au>Jia, Zhenhua</au><au>Li, Xinli</au><au>Shen, Jiangang</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Study protocol: Traditional Chinese Medicine (TCM) syndrome differentiation for heart failure patients and its implication for long-term therapeutic outcomes of the Qiliqiangxin capsules</atitle><jtitle>Chinese medicine</jtitle><stitle>CHIN MED-UK</stitle><date>2021-10-16</date><risdate>2021</risdate><volume>16</volume><issue>1</issue><spage>1</spage><epage>103</epage><pages>1-103</pages><artnum>103</artnum><issn>1749-8546</issn><eissn>1749-8546</eissn><abstract>Background: Syndrome differentiation is a commonly used methodology and practice in Traditional Chinese Medicine (TCM) guiding the diagnosis and treatment of diseases including heart failure (HF). However, previous clinical trials seldom consider the impact of syndrome patterns on the outcome evaluation of TCM formulae. Qiliqiangxin (QLQX) capsule is a TCM formula with cardiotonic effect to improve the cardiovascular function for heart failure with proven efficacy from well-designed clinical trials. Though, there is no clinical trial with a large sample size and long assessment period that considers the relationship between TCM syndrome differentiation and the treatment efficacy of QLQX. In the present study, we design a study protocol to evaluate the relationship between TCM syndrome differentiation and the severity of heart failure as well as its progression. Furthermore, we will evaluate the impact of the TCM syndrome patterns on the efficacy of QLQX in the outcome of heart failure.
Methods: This is a clinical study conducted in conjunction with an ongoing clinical trial (QUEST Study) by sharing the parent patient populations but with different aims and independent designed roadmaps to investigate the TCM syndrome pattern distributions and the impacts of syndrome pattern types on the efficacy of QLQX in HF treatment. The clinical trial involves over 100 hospitals in mainland China and Hong Kong SAR with 3080 HF patients. By assessing the morbidity and re-hospitalization, we will verify and apply a modified TCM Questionnaire to collect the clinical manifestations of HF and acquire the tongue images of the patients to facilitate the syndrome differentiation. We will base on the "2014 Consensus from TCM experts on diagnosis and treatment of chronic heart failure" to evaluate the TCM syndromes for the patients. A pilot study with at least 600 patients will be conducted to evaluate the reliability, feasibility and validity of the modified TCM questionnaire for syndrome differentiation of HF and the sample size is calculated based on the confidence level of 95%, population size of 3080 and 5% margin of error. Secondly, we will investigate the characteristic of TCM syndrome distribution of HF patients and its correlation with the functional and biochemical data. Furthermore, we will evaluate the relationship between the TCM syndrome patterns and the efficacy of QLQX in the treatment of heart failure. Lastly, we will investigate the implication of tongue diagnosis in the severity and therapeutic outcome of HF.
Expect outcomes: To our knowledge, this is the first large scale clinical trial to evaluate the impacts of TCM syndrome differentiation on the progression and therapeutic outcome of HF patients and explore the diagnostic value of TCM Tongue Diagnosis in HF patients. We expect to obtain direct clinical evidence to verify the importance of TCM syndrome differentiation for the diagnosis and treatment of HF.</abstract><cop>LONDON</cop><pub>Springer Nature</pub><pmid>34656145</pmid><doi>10.1186/s13020-021-00515-1</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-4772-5300</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Cardiac arrhythmia Cardiac patients Cardiomyocytes Care and treatment Chinese medicine Clinical trials Congestive heart failure Coronary artery disease Diagnosis Disease Drug dosages Edema Ejection fraction Heart Heart failure Homeopathy Hospitalization Hospitals Integrative & Complementary Medicine Life Sciences & Biomedicine Materia medica and therapeutics Medical research Medicine, Chinese Medicine, Experimental Morbidity Mortality Patient outcomes Patients Pharmacology & Pharmacy Qiliqiangxin (QLQX) capsule Recruitment Science & Technology Syndrome Syndrome element TCM syndrome differentiation Therapeutics Tongue Tongue diagnosis Traditional Chinese medicine Traditional Chinese Medicine (TCM) |
| title | Study protocol: Traditional Chinese Medicine (TCM) syndrome differentiation for heart failure patients and its implication for long-term therapeutic outcomes of the Qiliqiangxin capsules |
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