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ObjectiveTo systematically evaluate the distribution of traditional Chinese medicine（TCM） syndromes of primary osteoporosis（POP） in China by using evidence-based medicine methods， and to understand the distribution law of the syndromes. MethodChina National Knowledge Infrastructure（CNKI）， VIP Chinese Science and Technology Journal Database（VIP）， WanFang Data Knowledge Service Platform（WanFang） and China Biology Medicine（CBM） were searched to obtain representative literature， and each database was searched from the 1994 World Health Organization defined diagnostic criteria for osteoporosis until May 1， 2023. Two researchers independently screened literature according to the criteria， extracted data， and cross-checked them. Meta analysis was conducted using R4.1.3， and subgroup analysis was performed. ResultA total of 56 Chinese papers were included， involving 14 415 patients. After standardized classification of syndromes， 11 articles were excluded， and Meta analysis results of the ultimately included 45 Chinese articles showed that the distribution frequencies of liver-kidney Yin deficiency syndrome， spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome in 12 723 patients were 27%［95% confidence interval（CI） 0.24-0.31］， 32%（95% CI 0.29-0.36）， 36%（95% CI 0.30-0.42）. Subgroup analysis showed that there was a statistically significant difference in the distribution of the three TCM syndromes in the north and south（P<0.05）. In addition， the incidence of TCM syndrome fractures in different types of POP was 15%（95% CI 0.09-0.24） for liver-kidney Yin deficiency syndrome， 20%（95% CI 0.12-0.30） for spleen-kidney Yang deficiency syndrome， and 31%（95% CI 0.25-0.39） for kidney deficiency and blood stasis syndrome. ConclusionThe distribution of syndromes in POP patients is mainly kidney deficiency， accompanied by liver and spleen dysfunction. Liver-kidney Yin deficiency syndrome， spleen-kidney Yang deficiency syndrome and kidney deficiency and blood stasis syndrome are all the main syndromes of POP and osteoporotic fractures， and kidney deficiency and blood stasis syndrome is most closely related to the development of osteoporotic fractures. The reference standards for syndrome determination among the included studies are inconsistent， and in the future， it is necessary to focus on their determination standards to obtain consensus research results， at the same time， conduct large-scale syndrome research to obtain representative research results， providing a basis for clinical practice and research.
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Objective To standardize the selection of clinical research outcome indicators,which can objectively evaluate the clinical efficacy or effect of traditional Chinese medicine in the treatment of myasthenia gravis.This study aims to standardize the construction of the core outcome set of clinical research of traditional Chinese medicine in the treatment of myasthenia gravis.Methods We followed the core outcome set development specification(COS-STAD)to carry out research,established a research working group,which set up a Delphi-method advisory group.Two graduate students of working group conducted a document research and meetings of patients to establishe an outcome set item pool of myasthenia gravis in clinical trials of Chinese medicine under the instruction of other members.With the questionnaire based on the content of item pool,we then carried out Delphi-method expert consultations and a consensus meeting.Results The core outcome set of clinical research on myasthenia gravis treated with traditional Chinese medicine included five outcome domains:endpoint outcome,myasthenia gravis symptom evaluation,medication evaluation,quality of life evaluation and safety outcome;Nine outcome measures:recurrence rate,incidence of hormone complications,incidence of crisis,QMGS scale(MGFA quantitative myasthenia gravis score),daily activity scale of MG patients(ADL),analysis of immunosuppressant dosage,analysis of glucocorticoid dosage,analysis of cholinesterase inhibitor dosage,and incidence of adverse events.Conclusion The five outcome domains and nine outcome measures included in the core outcome set can be used as outcome options for the efficacy evaluation of myasthenia gravis clinical research.
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ObjectiveTo review the drug information and research progress on oral Chinese patent medicines in the treatment of cardiac arrhythmia to identify existing problems and provide references for follow-up research. MethodChinese patent medicines against cardiac arrhythmia were retrieved from the three major drug catalogues，Yaozh.com，and relevant guidelines with arrhythmia as the retrieval term. The instructions for included Chinese patent medicines were retrieved through Yaozh.com and specific information was extracted. The research articles on Chinese patent medicines included were retrieved from the five databases，and the information meeting the inclusion and exclusion criteria was extracted and displayed in the form of text description and graphs after statistical analysis. ResultSixty-five oral Chinese patent medicines were included in this study，with the main functions of activating the blood and resolving stasis. The average daily cost of medicines was 8.17 yuan，and there were 42 medicines with an average daily cost of less than 10 yuan，showing a moderate medicine cost. A total of 351 research articles on Chinese patent medicines were screened out，including 259 randomized controlled trials （RCTs），16 non-RCTs，eight non-controlled trials，62 systematic reviews，two guidelines，and two expert consensuses. Eighteen types of Chinese patent medicines were involved，whose clinical trials had been conducted in 28 provinces，cities，autonomous regions，and municipalities in China. Wenxin granules and Shensong Yangxin capsules were the top medicines under investigation，accounting for 75.21% of all research articles. Among the included studies，the most common comparison design was Chinese patent medicine combined with western medicine vs western medicine （64.25%）. The outcome evaluation was mainly based on clinical efficacy，symptom efficacy，arrhythmia efficacy，adverse reactions，and heart rate changes. ConclusionThe number of clinical studies of oral Chinese patent medicines against cardiac arrhythmia varies greatly，but traditional Chinese medicine （TCM） syndrome differentiation thinking is less considered in practical application. Due to unstandardized clinical research and low-quality literature，further advancement is required in the future.
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Objective: To evaluate the therapeutic effect and security of Buyang Huanwu decoction in treatment of the ischemic stroke recovery. Methods: We retrieved the relevant articles of random and semi- random control trials in treating ischemic stroke recovery using Buyang Huanwu decoction, published in China National Knowledge Infrastructure (CNKI), the Wanfang Data, the Weipu Information Resources System, the Chinese Biomedical Literature Database (CBM), Cochrane Library, PUBMED and MEDLINE from the date of establishment until to March 2018. The quality of studies was evaluated according to the Cochrane Reviewers?? handbook 5.1, and the study was carried out using Cochrane system assessment methods. Statistical analysis was performed with Rev Man 5.3. Results: Altogether 39 studies and 3539 cases of ischemic stroke recovery were enrolled. In terms of clinical efficacy, the difference between Buyang Huanwu Decoction and Western Medicine conventional therapy in the treatment of ischemic stroke was significantly different from that of conventional western medicine therapy [RR =1.26, 95％CI (1.20, 1.31), Z =10.05, P ＜ 0.00001], and the difference between Buyang Huanwu Decoction and other Chinese patent medicines was statistically significant [RR =1.12, 95％CI(1.06, 1.19), Z =3.82, P =0.0001]; neurological deficit NIHSS score [MD =-2.55, 95％CI (-3.10, -2.01), Z =9.20, P ＜ 0.00001]; clinical neurological deficit score (CSS) [MD =-3.85, 95％CI (-5.21, -2.50), Z =5.56, P ＜ 0.00001]; limb motor function score (FMA) [MD =6.10, 95％CI (1.19, 11.01), Z =2.43, P =0.01]; Barthel Index of Daily Living Activity Scale [MD =9.09, 95％CI (6.95, 11.23), Z =8.33, P ＜ 0.00001]; In terms of improving blood rheology index, serum peroxide lipid (LPO), serum superoxide dismutase (SOD) and other biochemical indicators, due to the small number of studies, it may have a certain effect. Most studies did not report adverse reactions. Conclusion: Based on the existing clinical evidence, combination of Buyang Huanwu decoction and western medicine has higher clinical efficacy than western medicine alone for the ischemic stroke recovery. Due to the limited methodological quality of the included studies, more high- quality RCTs with large scale are needed to increase the strength of the above evidence.