Formulation of international standards of Chinese medicine technology: clinical practice guide of Chinese medicine for cough.

OBJECTIVE: To formulate the first clinical practice guideline for the treatment of cough using Chinese medicine based on the grading of recommendations assessment, development, and evaluation (GRADE) systematic approach, including clinical evidence, evaluation of ancient literature, and expert consensus. METHODS: In the process of development, the regulation of "evidence-based, consensus-assisted, and empirical" was followed, and a comprehensive systematic approach of recommendation assessment, GRADE, evidence-based evaluation, expert consensus, and the Delphi method was used. In the process of guideline development, evidence-based evaluation of ancient literature was included for the first time, and clinical evidence was fully integrated with clinical expert consensus. RESULTS: The clinical practice guidelines for the treatment of cough with Chinese herbal medicine were developed after a comprehensive consideration of evidence-based evaluation and expert opinions. The guideline recommendations focused on recommending herbal compound decoctions and Chinese patent medicines for cough in different conditions. Based on the GRADE systematic approach, we conducted an evidence-based evaluation of the recommended Chinese patent medicines one by one; meanwhile, the expert consensus method was used to unify the recommendations of both. CONCLUSION: Based on clinical evidence, ancient literature evaluation, and expert consensus, a clinical practice guideline for Traditional Chinese Medicine (TCM) in the treatment of cough was developed, providing the first current clinical practice guideline for domestic and foreign TCM and Western medicine practitioners, especially respiratory professionals at home and abroad.

Bioactivity-based ultra-performance liquid chromatography-coupled quadrupole time-of-flight mass spectrometry for NF-κB inhibitors identification in Chinese Medicinal Preparation Bufei Granule.

Traditional Chinese medicine (TCM) preparations have become effective treatments for many diseases. However, their active ingredients are still uncertain and difficult to identify. In this study, we propose a strategy that integrates ultra-performance liquid chromatography/quadrupole-time-of-flight mass spectrometry (UPLC/Q-TOF-MS) and bioactive (NF-κB inhibitor) luciferase reporter assay systems for the rapid determination of various anti-inflammatory compounds of TCM preparations. In this way, Bufei Granule (BFG), a TCM preparation used for the clinical therapy of asthma, was analyzed by the two ways of component identification and activity detection. Potential anti-inflammatory constituents were screened by NF-κB activity assay systems and simultaneously identified according to the mass spectrometry data. Three structural types of NF-κB inhibitors (caffeic acid derivatives, flavonoids and Pentacyclic triterpenes) were characterized. Further cytokine detection confirmed the anti-inflammatory effects of the potential NF-κB inhibitors. Compared with conventional chromatographic separation and inhibitory activity detection, integrating UPLC/Q-TOF-MS identification and virtual validation was more convenient and more reliable. This strategy clearly demonstrates that MS data-based fingerprinting is a meaningful tool not only in identifying constituents in complex matrix but also in directly screening for powerful trace ingredients in TCM preparations. Copyright © 2016 John Wiley & Sons, Ltd.

Concept and significance of a subjective and multiple index system of clinical evaluation for traditional Chinese medicine / 中西医结合学报

Traditional Chinese medicine (TCM) has its own system of diagnosis and treatment theory, and its methods for evaluating clinical efficacy are different from those of Western medicine. Applying evaluation techniques and methods that are used in Western medicine mechanically to TCM will not work. So building evaluation techniques, which adhere to regulations and characteristics of TCM, is necessary and imperative. As the quality of life and patient-reported outcome instruments were brought into practice and developed, clinical evaluation ideas and methods for TCM are provided with an opportunity for development. This article puts forward the concept of subjective complex outcomes (SCOs), which constitutes subjective feelings gained from the patient, doctor and caregiver, different from laboratory parameters. SCOs provide a multidimensional and complex health-related quality of life (HRQL) assessment and focus on the source of assessment information of diseases. This article also introduces a case study building SCO methods of TCM treatment for chronic obstructive pulmonary diseases, in order to promote discussion and provide a platform for future research.