scholarly journals Methodological Considerations in N-of-1 Trials of Traditional Chinese Medicine

2021 ◽  
Vol 2021 ◽  
pp. 1-11
Author(s):  
Haiyin Huang ◽  
Jiaqi An ◽  
Lizhi Lu ◽  
Mingli Wang ◽  
Huijia Chen ◽  
...  

More and more scholars choose N-of-1 trials for TCM clinical research. However, the quality of the experimental designs was uneven. Accumulating more than eight years of experience in exploring the N-of-1 trials of TCM, the authors and their team searched the related literature in main Chinese and English databases, referenced to relevant Chinese and international guidelines. The design, implementation, and data analysis of N-of-1 trials of TCM are still in in-depth exploration and practice. “Carryover effect” may affect the design and quality of the trials. Individualized treatment should be guided by the classic theories of TCM. It is expected to formulate reasonable observation periods and pairs and closely integrate individual and group statistical analysis.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.


Author(s):  
Qinghui Qu ◽  
Xinyang Zhang

The purpose of this paper is to retrieve and study the highly cited papers as well as the correlation between the citation frequency and the download frequency of the 20 traditional Chinese medicine journals in China, in order to provide the guidance for improving the influence and academic quality of these journals. Bibliometric analyses were conducted on 1103 papers of 20 traditional Chinese medicine journals from 2011 to 2020 by retrieving for the China Academic Journal Network Publishing Database (CAJD) in China National Knowledge Infrastructure (CNKI). SPSS 17.0 software was used to analyze the correlation between the citation frequency and the download frequency via conducting regression fitting and establishing the mathematical models. The results showed that the total citations of the 1103 papers were 93051 times and the average citations were 84.36 times per paper. The total downloads of the 1103 papers were 2058442 times, and the average downloads were 1866.22 times per paper. China Journal of Chinese Materia Medica ranked first according to the number of papers, total citations and total downloads. The citations of Journal of Chinese Medicinal Materials ranked first based on the number of citations per paper. One of Li’s paper had been cited the most (983 times). There were 629 (57.03%) papers whose first author was from universities. The scopes of the first authors were distributed in 29 regions and 2 special administrative regions (Macao, Hong Kong) in China. The authors from Beijing published 283 (25.66%) papers, ranking number one. The number of papers supported by funds was 882 (79.96%). The research results of correlation showed that the citation frequency and the download frequency of the highly cited papers had a highly positive correlation from both journal and paper level for whether the sample data of journals was normally distributed or nonnormally distributed. The correlation coefficients of the 20 journals at journal level and that at paper level were 0.9765 and 0.6677, respectively. The correlation was better at journal level than that at paper level, while the optimal regression fitting was all cubic polynomial. Among the 1103 papers, there were 684 (62.01%) research papers and 419 (37.99%) review papers. The main citation period of the top 15 papers was from the 2nd year to the 6th year after publication, accounting for 78.39%. Papers on clinical therapeutics research, papers on the pharmacological effects and its mechanism of traditional Chinese medicine, and papers on traditional Chinese medicine and natural medicine were the main source of the highly cited papers of the traditional Chinese medicine journals. Editors of the journals should focus on the above-mentioned research areas to select manuscripts for exploiting the excellent sources extensively, while paying attention to review papers, focusing on national major or key projects, paying attention to network spreading, stabilizing authors with quality services, in order to improve the influence and the academic quality of journals.


2020 ◽  
Vol 4 (3) ◽  
Author(s):  
Ying Yao ◽  
Li Liu

Oral ulcer is a kind of ulcerative injury that occurs in the oral mucosa and is very common in clinic. In severe case, it can affect the quality of life of the patients. Western medicine treatment of oral ulcer is often prone to relapse, while the effect of traditional Chinese medicine treatment is remarkable.


2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Guoqiang Yang ◽  
Jin Zhang

Objective: To analyze the clinical effect and value of oral administration and external therapy of traditional Chinese medicine for treatment of cervical tuberculous lymphadenopathy. Methods: A total of 56 patients with cervical tuberculous lymphadenopathy admitted to our hospital from January 1 to January 2018 were recruited. By using double-blind method, the patients were divided into control group (n=28) and experimental group (n=28). Control group comprised of patients with conventional anti-tuberculosis treatment, while the experimental group comprised of patients treated with oral administration and external therapy of traditional Chinese medicine. Total effective rate, incidence of complication and level of T lymphocyte subsets were compared between the two groups of cervical tuberculous lymphadenopathy patients. Results: Post-treatment data of total effective rate, complication rate, CD3+, CD4+, CD8+, CD4+/CD8+ of the experimental group were compared with the control group. P<0.05; statistical analysis showed statistical significance. Post-treatment data of CD3+, CD4+, CD8+, CD4+/CD8+ of both control and experimental groups were compared with pre-treatment data. P<0.05; statistical analysis showed statistical significance. Conclusion: Oral administration and external therapy of traditional Chinese medicine possesses significant effect in treatment of cervical tuberculous lymphadenopathy.


2020 ◽  
Author(s):  
Ying Wang ◽  
Chang Liu ◽  
Xuan Wang ◽  
Mengpei Zhang ◽  
Zhiheng Wang ◽  
...  

Abstract Background Traditional Chinese medicine (TCM) liver depression infertility quality of life scale is developed to provide a scientific and reliable tool for TCM treatment and intervention in the treatment of liver depression patients with infertility, as well as basis and assistance for clinical decision-making.Methods Literature research method: Through the retrieval of Chinese knowledge network (CNKI), Wanfang (WANFANG), Vip (VIP), Springer, PubMed database of existing Chinese life quality scale and infertility dedicated quality of life scale, an entry pool is built with symptoms, emotional state, social function state and satisfaction as dimensions. Using the Delphi method to screen the entries. Screening entries according to the results of expert review, and evaluating the positive degree coefficient, authority degree and coordination coefficient by the experts. Using the clinical questionnaire method to screen the entries further. To form the Chinese medicine liver depression infertility life of quality scale. Scale evaluation: the reliability and validity of the scale were evaluated based on the results of the clinical questionnaire. Results After two rounds of Delphi method, there are 33 entries remained. The clinical questionnaire rescreened entries, formed the traditional Chinese medicine liver depression infertility quality of life scale containing 4 dimensions of symptoms, emotional states, social function states and satisfaction, with total of 29 entries and VAS score scale. Evaluation results: the Kronbach alpha coefficients performed well in total and each aspect. The validity of the scale: the structural efficiency evaluation results are in good agreement with the scale structure envisioned at the time of design. The relationship between the quality of life scale and the standard scale (FertiQoL International2008) showed a high absolute value.Conclusion In this study, the quality of life scale of Chinese medicine liver depression type infertility was developed by literature research, Delphi method and clinical questionnaire, with good reliability and validity of the scale evaluated. It could be used as a tool for efficacy judgment tool or quality of life evaluation in Chinese medicine treatment or intervention for patients with liver depression infertility.


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