Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,S...Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,Sino Med,Pub Med,Web of Science,Embase,Cochrane library,JBI,CINAHL,Psyc INFO,Clinical Trials Registry Platform portal,Clinical Trials Registry,Australian New Zealand Clinical Trials Registry,Center Watch Registry from inception to May 15,2022 to find randomized controlled trials,non-randomized controlled trials,case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage,with search terms of mastitis,acute mastitis,lactation mastitis,puerperal mastitis,breast problem,breast engorgement,milk stasis,blocked ducked,breast pain,breast massage,and acupoint massage.Outcomes and the measurement schemes(measurement methods,timing of assessing outcome,frequency of assessing outcome,measurers)were extracted from the included studies.We used the Management of Otitis Media with Effusion in Children with Cleft Palate(MOMENT)to assess the quality of each study,then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials(OMERACT)Filter 2.1 framework.Results We identified 85 clinical trials,in which 54 different outcomes were reported.A total of 81.2%(69/85)of studies were assessed as medium quality with a mean score of 2.6,and 18.8%(16/85)as low quality with a mean score of 0.9.These outcomes were organized in three core areas.Lump size(89.4%,76/85)was the most frequently reported outcome,followed by breast pain(69.4%,59/85)and milk excretion(68.2%,58/85).Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous.Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.展开更多
Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for...Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.展开更多
Objective:Nature theory of Chinese medicine (CM) is the core basic theory of Traditional Chinese Medicine (TCM), in which cold-hot nature is the focus of research. Studies have found that CM ingredients are the materi...Objective:Nature theory of Chinese medicine (CM) is the core basic theory of Traditional Chinese Medicine (TCM), in which cold-hot nature is the focus of research. Studies have found that CM ingredients are the material basis for the production of medicine natures. Therefore, it is speculated that CMs with similar composition of substances should have similar medicinal nature. Modern work studies cold-hot medicine of CMs with chemical fingerprinting technology because the chemical fingerprint data of CM can reflect the whole composition of CM ingredients. Methods:To verify the hypothesis above, in this work, we study quantifying the similarity of CM ingredients to fingerprint similarity, and explore the relationship between the composition of CMs and cold-hot nature. Firstly, we utilize ultraviolet (UV) spectrum technology to analyze 61 CMs, which have clear cold-hot nature (including 30 ‘cold’ CMs and 31 ‘hot’ CMs). Secondly, with the constructed fingerprint database of CMs, a distance metric learning algorithm is studied to metric the similarity of UV fingerprints. Finally, a retrieval scheme is proposed to build a predictive identification model to identify cold-hot nature of CMs. Results:By means of numerous experiment analyses, ultraviolet spectrum data of petroleum ether solvent can better represent CMs to distinguish between cold and hot natures. Comparing with existing classical models, the proposed identification scheme has better predictive performance. Conclusion:The experimental results prove our inference that CMs with similar composition of substances should have similar medicinal nature. The proposed prediction model is proved to be effective and feasible.展开更多
Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interview...Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.展开更多
基金supported by Special Funds for Basic Research Business Expenses of Central Universities(2022-JYB-PY-004).
文摘Objective To systematically analyze the current status of outcomes reporting in clinical trials on treating stasis acute mastitis with Traditional Chinese Medicine breast massage.Methods We searched CNKI,Wanfang,VIP,Sino Med,Pub Med,Web of Science,Embase,Cochrane library,JBI,CINAHL,Psyc INFO,Clinical Trials Registry Platform portal,Clinical Trials Registry,Australian New Zealand Clinical Trials Registry,Center Watch Registry from inception to May 15,2022 to find randomized controlled trials,non-randomized controlled trials,case series and cohort studies which reported the outcomes of stasis acute mastitis managed with Traditional Chinese Medicine breast massage,with search terms of mastitis,acute mastitis,lactation mastitis,puerperal mastitis,breast problem,breast engorgement,milk stasis,blocked ducked,breast pain,breast massage,and acupoint massage.Outcomes and the measurement schemes(measurement methods,timing of assessing outcome,frequency of assessing outcome,measurers)were extracted from the included studies.We used the Management of Otitis Media with Effusion in Children with Cleft Palate(MOMENT)to assess the quality of each study,then categorized outcomes derived from the included studies into different domains according to the Outcome Measures in Rheumatology Arthritis Clinic Trials(OMERACT)Filter 2.1 framework.Results We identified 85 clinical trials,in which 54 different outcomes were reported.A total of 81.2%(69/85)of studies were assessed as medium quality with a mean score of 2.6,and 18.8%(16/85)as low quality with a mean score of 0.9.These outcomes were organized in three core areas.Lump size(89.4%,76/85)was the most frequently reported outcome,followed by breast pain(69.4%,59/85)and milk excretion(68.2%,58/85).Five methods were used to assess lump size and four methods to assess breast pain.Conclusions The outcomes reported in clinical trials regarding stasis acute mastitis treated by Traditional Chinese Medicine breast massage are heterogeneous.Developing a core outcome set to achieve consistent standards for reporting outcomes and modalities for validation of the outcomes is clearly warranted.
基金supported by the National Natural Science Foundation Project of China(81473544)Ministry of Education Program for Innovative Research Team(IRT1276)+2 种基金National key research and development projects of modernization of traditional Chinese medicine(2019YFC1710000,2019YFC1710003)Henan Youth Talent Promotion Project(2020HYTP060)the National Basic Research Program of China(2015CB554401).
文摘Objective:This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine(TCM)for patients with stable angina pectoris,and to provide baseline data for the development of core outcome sets(COSs)for relevant clinical trials.Methods:Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris.Outcome measures of each trial were extracted.Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM.Results:94 randomized trials(with 9,111 participants)involving 79 different outcomes were identified.The mean number of outcomes was 5(1-21 per trial).The 5 most commonly reported outcomes were efficacy rate of electrocardiogram,efficacy rate of angina pectoris,efficacy rate of TCM syndrome,fasting lipid indices,and withdrawal rate of nitroglycerin.Several challenges were identified:(1)significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome;(2)transformation of continuous data into categorical data and presented as such in>90% of trials;(3)few trials on the outcomes associated with the advantages and characteristics of TCM;and(4)selective reporting of outcomes.Conclusions:The outcomes used are excessively heterogenous,and the choice of some outcomes(timing and techniques)for measurement is confusing or inappropriate.Hence,developing and implementing a COS is necessary for greater consistency.
基金National key basic research development program (973 Program)(Grant No.:2007CB512600)National Natural Science Foundation of China (Grant No.:81473369)+1 种基金Key research and development plan of Shandong province (Grant No.:2016CYJS08A01-1)Shandong Province TCM science and technology development plan project (2019-0037).
文摘Objective:Nature theory of Chinese medicine (CM) is the core basic theory of Traditional Chinese Medicine (TCM), in which cold-hot nature is the focus of research. Studies have found that CM ingredients are the material basis for the production of medicine natures. Therefore, it is speculated that CMs with similar composition of substances should have similar medicinal nature. Modern work studies cold-hot medicine of CMs with chemical fingerprinting technology because the chemical fingerprint data of CM can reflect the whole composition of CM ingredients. Methods:To verify the hypothesis above, in this work, we study quantifying the similarity of CM ingredients to fingerprint similarity, and explore the relationship between the composition of CMs and cold-hot nature. Firstly, we utilize ultraviolet (UV) spectrum technology to analyze 61 CMs, which have clear cold-hot nature (including 30 ‘cold’ CMs and 31 ‘hot’ CMs). Secondly, with the constructed fingerprint database of CMs, a distance metric learning algorithm is studied to metric the similarity of UV fingerprints. Finally, a retrieval scheme is proposed to build a predictive identification model to identify cold-hot nature of CMs. Results:By means of numerous experiment analyses, ultraviolet spectrum data of petroleum ether solvent can better represent CMs to distinguish between cold and hot natures. Comparing with existing classical models, the proposed identification scheme has better predictive performance. Conclusion:The experimental results prove our inference that CMs with similar composition of substances should have similar medicinal nature. The proposed prediction model is proved to be effective and feasible.
基金supported by the National Natural Science Foundation of China(No.81473544).
文摘Objective:This study aimed to develop a core outcome set(COS)for use in future studies of stable angina pectoris(SAP)in traditional Chinese medicine(TCM).Methods:Systematic literature reviews and qualitative interviews with cardiologists and patients with SAP treated using TCM were conducted to generate a set of outcomes.Outcomes were prioritized by stakeholders via two rounds of an online Delphi survey and face-to-face consensus meetings.Following the final consensus meeting,a final COS was generated.Results:An initial set of 324 outcomes was identified.A preliminary list of 65 outcomes was employed in the Delphi study.In total,223 participants from seven stakeholder groups were invited to score outcomes in the first Delphi round:87 completed round 1 and 47 completed round 2.Thirty-one participants attended the consensus meeting and agreed on a final core set of outcomes comprising six items across four domains:frequency of angina attack,duration of angina attack,Seattle angina questionnaire,total exercise duration in the exercise treadmill test,cardiovascular events,and QT interval on electrocardiography.Conclusions:The COS developed in this study provides the minimum requirements for measurement and reporting in future TCM clinical trials for the treatment of SAP.The employment of this COS may reduce heterogeneity across trials and facilitate evidencebased decision-making for stakeholders.
