This study systematically reviewed the randomized controlled trial(RCT) of traditional Chinese medicine(TCM) treatment of post-stroke depression(PSD) and analyzed the clinical study characteristics and outcome indicators, aiming to optimize the design and establish the core outcome set in the future clinical trials of the TCM treatment of PSD. PubMed, Web of Science, Cochrane Library, EMbase, CNKI, VIP, Wanfang, and SinoMed were searched for the relevant RCT published in recent 3 years. The basic characteristics, intervention measures, and outcome indicators of the included RCT were extracted, and the descriptive analysis was carried out. A total of 76 RCTs were eventually included, with the sample size concentrated in 80-100 cases. The most frequent TCM syndromes were liver depression and Qi stagnation(15 times, 31.91%) and phlegm combined with stasis(5 times, 10.63%). The frequency of intervention methods followed a descending trend of TCM decoction(35 times, 46.05%) and TCM decoction + acupuncture(4 times, 5.26%), Chinese patent medicine(3 times, 3.94%), and the intervention mainly lasted for 1 to 3 months(43 times, 60.56%). The adverse reactions of patients were mainly digestive system reaction(150 patients, 39.37%) and nervous system reaction(112 patients, 29.39%). Most of the included studies had unclear risk of bias, involving 84 outcome indicators, which belonged to 8 indicator domains. The RCTs of TCM treatment of PSD showed a variety of problems, such as non-standard TCM syndrome differentiation, inconsistent names of TCM syndrome scores and measurement tools, low quality, unclear risk of bias, neglect of endpoint indicators, unreasonable selection of substitute indicators, lack of differentiation between primary and secondary outcome indicators, non-standard reporting of safety indicators, insufficient attention to economic indicators, and lack of long-term prognosis evaluation. It is suggested that the future research should improve the quality of methodology and build a standardized core outcome set to promote the development of high-quality clinical research in this field.
Humans ; Randomized Controlled Trials as Topic ; Drugs, Chinese Herbal/administration & dosage* ; Stroke/psychology* ; Depression/etiology* ; Treatment Outcome ; Medicine, Chinese Traditional

The efficacy and safety of different Chinese patent medicines in the treatment of stable chronic obstructive pulmonary disease(COPD) were evaluated by network Meta-analysis. The randomized controlled trial(RCT) of Chinese patent medicines for stable COPD were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, Web of Science, EMbase, and Cochrane Library with the time interval from inception to February 2024. The quality of the included RCT was evaluated by the Cochrane's risk of bias assessment tool. RevMan 5.4 and Stata 16.0 were used to establish the risk of bias diagram and perform the network Meta-analysis. A total of 113 RCTs were included, involving 8 265 patients and 14 Chinese patent medicines. The network Meta-analysis yielded the following results based on the surface under the cumulative ranking curve(SUCRA).(1) In terms of improving the forced expiratory volume in 1 second to forced vital capacity(FEV1/FVC) ratio, the top three treatments were Jingshuibao Capsules + conventional western medicine, Yupingfeng San + conventional western medicine, and Sanzi Zhike Capsules + conventional western medicine.(2) In terms of improving the clinical efficacy, the top three treatments were Yifei Capsules + conventional western medicine, Yupingfeng Granules + conventional western medicine, and Bufei Huoxue Capsules + conventional western medicine.(3) In terms of improving the percentage of predicted FEV1(FEV1%pred), the top three treatments were Jingshuibao Capsules + conventional western medicine, Bufei Granules + conventional western medicine, and Bailing Capsules + conventional western medicine.(4) In terms of improving the distance in 6 min walking test(6MWT), the top three treatments were Jingshuibao Capsules + conventional western medicine, Bailing Capsules + conventional western medicine, and Jianpi Yifei Oral Liquid + conventional western medicine.(5) In terms of reducing the COPD assessment test(CAT), the top three treatments were Bufei Granules + conventional western medicine, Yifei Capsules + conventional western medicine, and Yifei Huoxue Granules + conventional western medicine.(6) In terms of reducing the frequency of acute exacerbation of chronic obstructive pulmonary disease(AECOPD) within 1 year, the top three treatments were Yupingfeng Capsules + conventional western medicine, Yupingfeng San + conventional western medicine, and Jianpi Yifei Oral Liquid + conventional western medicine.(7) In terms of safety, 28 RCTs have reported adverse reactions, mainly involving the digestive system, circulatory system, and nervous system. The results showed that Chinese patent medicines combined with conventional western medicine improved FEV1/FVC, FEV1%pred, clinical efficacy, and 6MWT, while reducing CAT and the frequency of AECOPD within 1 year. However, due to the limitations of the included studies and the lack of direct comparisons between different interventions, these results need further validation.
Pulmonary Disease, Chronic Obstructive/physiopathology* ; Humans ; Drugs, Chinese Herbal/administration & dosage* ; Randomized Controlled Trials as Topic ; Nonprescription Drugs/therapeutic use*

Basket trial, as an innovative clinical trial design concept, marks the transformation of medical research from the traditional large-scale and single-disease treatment to the precise and individualized treatment. By gradually incorporating the Bayesian method during development, the trial design becomes more scientific and reasonable and increases its efficiency. The fundamental principle of the Bayesian method is the utilization of prior knowledge in conjunction with new observational data to dynamically update the posterior probability. This flexibility enhances the basket trial's capacity to effectively adapt to variations during the research process. Consequently, it enables researchers to dynamically adjust research strategies based on accumulated data and improve the predictive accuracy regarding treatment responses. In addition, the design concept of the basket trial aligns with the traditional Chinese medicine(TCM) principle of "homotherapy for heteropathy". The principle of "homotherapy for heteropathy" emphasizes that under certain conditions, different diseases may have the same treatment. Similarly, basket trials allow using a uniform trial design across multiple diseases, offering enhanced operational and significant practical value in the realm of TCM, particularly within the context of syndrome-based disease research. By introducing basket trials, the design of TCM clinical studies will be more scientific and yield higher-quality evidence. This study systematically categorized various Bayesian methods and models utilized in basket trials, evaluated their strengths and weaknesses, and identified their appropriate application contexts, so as to offer a practical guide for designing basket trials in the realm of TCM.
Bayes Theorem ; Humans ; Medicine, Chinese Traditional/methods* ; Research Design ; Clinical Trials as Topic/methods* ; Drugs, Chinese Herbal/therapeutic use*

Randomized controlled trial(RCT) is considered to represent the gold standard for evaluating the efficacy of interventions and has been widely used to evaluate the clinical efficacy of traditional Chinese medicine(TCM). However, there are unique challenges in implementing RCT in TCM. Patients seeking TCM treatment often have preferences for TCM due to the unsatisfactory therapeutic effect of western medicine, their personal intolerance, and their rejection of certain drugs, medical devices, or surgery. Patients are generally reluctant to be randomly assigned to a group, making it challenging to enroll patients in the control group of western medicine during the implementation of RCT in TCM. This has become a prominent problem restricting the implementation of RCT in TCM and needs to be solved urgently. Therefore, this paper introduced commonly used research designs used in solving the problem of enrolling patients in control group during the implementation of RCT in TCM, including Zelen design, partially randomized patient preference trial(PRPP), single-arm objective performance criteria(OPC), cohort studies, single-arm clinical trials using real world data(RWD) alone as the external control group, and the design method based on RWD-augmented control group samples in RCT. The paper outlined the definitions and principles of these methods, evaluated their advantages, disadvantages, and applicable scenarios, and explored their applications in the TCM field, so as to offer insights for solving the difficulty in enrolling patients in the control group during the implementation of RCT in TCM.
Humans ; Medicine, Chinese Traditional/methods* ; Randomized Controlled Trials as Topic/methods* ; Research Design ; Patient Selection ; Drugs, Chinese Herbal/therapeutic use* ; Control Groups

Network Meta-analysis was conducted to evaluate the efficacy and safety of different traditional Chinese medicine injections combined with conventional western medicine in treatment of cerebral small vessel disease(CSVD). Computerized searches were conducted in PubMed, Cochrane Library, Web of Science, EMbase, CNKI, Wanfang, VIP, and SinoMed for randomized controlled trial(RCT) published in Chinese or English using traditional Chinese medicine injections to treat CSVD. The search time is from the inception to July 15, 2024. Literature screening and statistical analysis were conducted with NoteExpress 3.0.3, RevMan 5.3.5, and Stata 15.1.6. A total of 45 articles were included, involving 3 717 patients, with 1 944 patients in the treatment group and 1 773 patients in the control group. A total of 15 kinds of traditional Chinese medicine injections were involved. Network Meta-analysis indicated that,(1) in terms of improving clinical total effective rate, the best intervention in SUCRA was Ciwujia Injection + conventional western medicine.(2) In terms of reducing NIHSS scores, the best intervention in SUCRA was Xueshuantong Injection + conventional western medicine.(3) In terms of improving ADL scores, the best intervention in SUCRA was Danshen Injection + conventional western medicine.(4) In terms of improving MMSE scores, the best intervention in SUCRA was Xueshauntong Injection + conventional western medicine.(5) In terms of improving MoCA scores, the best intervention in SUCRA was Salvianolate Injection + conventional western medicine.(6) In terms of reducing plasma viscosity(PV), the best intervention in SUCRA was Danhong Injection + conventional western medicine.(7) In terms of reducing the hematocrit, the best intervention in SUCRA was Xuesaitong Injection + conventional western medicine.(8) In terms of reducing fibrinogen, the best intervention in SUCRA was Xuesaitong Injection + conventional western medicine.(9) In terms of reducing erythrocyte sedimentation rate(ESR), the best intervention in SUCRA was Danshen Injection + conventional western medicine.(10) In terms of reducing total cholesterol(TC), triglycerides(TG), and low-density lipoprotein(LDL), the best intervention in SUCRA was Danshen Injection + conventional western medicine. The radar chart results indicated that the advantage of Salvianolate Injection lies in improving cognitive function, while the advantage of Xueshuantong Injection lies in improving neurological function. The advantage of Xuesaitong Injection lies in improving hemodynamic parameters, and the advantage of Danshen Injection lies in improving behavioral ability, hemodynamics, and blood lipid levels. In terms of safety, there was no significant difference in the incidence of adverse reactions between the traditional Chinese medicine injection treatment group and the conventional western medicine group, and no serious adverse reactions occurred. The results showed that the combination of traditional Chinese medicine injections and conventional western medicine can effectively improve the clinical total effective rate, the neurological and cognitive functions, hemodynamic parameters, and blood lipid levels of patients suffering from CSVD. In addition, more double-blind, multi-center, large-sample RCT is needed to verify these findings and to provide more high-quality evidence on the efficacy and safety of traditional Chinese medicine injections for CSVD.
Humans ; Cerebral Small Vessel Diseases/drug therapy* ; Drugs, Chinese Herbal/administration & dosage* ; Injections ; Randomized Controlled Trials as Topic

OBJECTIVE: To screen the optimal regimen of acupuncture and moxibustion for obstructive sleep apnea hypopnea syndrome (OSAHS), so as to provide the evidences for clinical decision-making. METHODS: From 7 databases in Chinese and English i.e. the Full-Text Database of China Journal Network (CNKI), Wanfang Data Knowledge Service Platform (Wanfang), VIP Information Chinese Journal Service Platform (VIP), Chinese Biomedical Literature Database (SinoMed), PubMed, Web of Science (WOS) and Cochrane Library, randomized controlled trial (RCT) articals of OSAHS treated with acupuncture and moxibustion were searched. The quality of evidence was evaluated with the modified Jadad scale, the evaluation index was established and the optimal regimen of acupuncture and moxibustion for OSAHS was screened by multi-index decision analysis. RESULTS: A total of 10 RCTs were included, and the filiform needling therapy was optimal in treatment of OSAHS. The acupoints included Lianquan (CV23), Danzhong (CV17), Zhongwan (CV12), and bilateral Kongzui (LU6), Pishu (BL20), Fenglong (ST40), Zusanli (ST36), Yinlingquan (SP9) and Zhaohai (KI6). Zusanli (ST36) received the reinforcing method, Pishu (BL20) and Fenglong (ST40) were stimulated with the reducing technique, and the rest acupoints with the uniform reinforcing-reducing. Each acupoint was manually manipulated once every 10 min during the needle retention for 30 min. Acupuncture was delivered once a day, 5 times a week and for consecutive 4 weeks. Among the included literature, the severity of disease was not reported in detail, the filiform needling was the dominant intervention, the local acupoints such as Lianquan (CV23) and Panglianquan (Extra) were mainly selected. The apnea-hypopnea index and the minimum oxygen saturation were taken as the evaluation indexes, and the effect was evaluated in reference to the generally accepted standards. The attention to safety evaluation was insufficient, the report on methodology was not adequate and the quality was low. CONCLUSION Filiform needling is the dominant therapy of acupuncture and moxibustion for OSAHS, and the local acupoints are considered specially. But the quality of clinical research should be improved.
Humans ; Moxibustion ; Acupuncture Therapy ; Sleep Apnea, Obstructive/therapy* ; Acupuncture Points ; Randomized Controlled Trials as Topic

OBJECTIVE: To explore the dose-effect relationship between the number of acupuncture sessions and the efficacy for cervical vertigo (CV). METHODS: Literature regarding randomized controlled trials (RCTs) of acupuncture for CV was retrieved from CNKI, Wanfang, VIP, Web of Science, and PubMed databases from inception to June 28th, 2024. Studies were included if patients were treated solely with acupuncture and the core prescription included Baihui (GV20)-Fengchi (GB20)-neck-jiaji (EX-B2). Outcomes included the evaluation scale for cervical vertigo symptoms and function (ESCV) score and the mean blood flow velocity of vertebrobasilar arteries. The Cochrane risk of bias assessment tool 2.0 was used to evaluate study quality. Dose-effect Meta-regression analysis was performed using the robust-error Meta-regression (REMR) method in Stata 17.0 software. RESULTS: Nineteen RCTs were included with a total of 747 patients in the experimental groups. After 10 sessions of acupuncture, the ESCV score increased to 20.29 (95% <i>CIi>: 16.77, 23.80), with a pre-post ESCV difference of 4.60 (95% <i>CIi>: 2.59, 6.60) and an improvement rate of 0.36 (95% <i>CIi>: 0.26, 0.46). After 20 sessions of acupuncture, the ESCV score increased to 21.55 (95% <i>CIi>: 18.87, 24.22), with a difference of 5.42 (95% <i>CIi>: 3.87, 6.97) and an improvement rate of 0.39 (95% <i>CIi>: 0.31, 0.48). After 10 sessions of acupuncture, the improvement rates for left vertebral artery (LVA), right vertebral artery (RVA), and basilar artery (BA) mean blood flow velocities were 0.08 (95% <i>CIi>: 0.05, 0.12), 0.09 (95% <i>CIi>: 0.05, 0.12), and 0.11 (95% <i>CIi>: 0.06, 0.15), respectively. After 14 sessions of acupuncture, the improvement rates reached their peaks: LVA [0.09 (95% <i>CIi>: 0.06, 0.12)], RVA [0.10 (95% <i>CIi>: 0.07, 0.13)], and BA [0.12 (95% <i>CIi>: 0.07, 0.16)]. CONCLUSION A nonlinear dose-effect relationship existed between the number of acupuncture sessions and the efficacy for CV. Fourteen sessions were recommended as the optimal number of acupuncture treatments.
Humans ; Acupuncture Therapy ; Randomized Controlled Trials as Topic ; Vertigo/physiopathology* ; Treatment Outcome ; Acupuncture Points ; Regression Analysis ; Male ; Female

The randomized controlled trials (RCTs) regarding acupuncture direction published from January 1st, 2013, to November 7th, 2023 were searched in China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, and VIP Chinese Journal Database. As a result, 21 RCTs were included. The problems identified included conceptual misunderstandings regarding acupuncture direction, incomplete selection strategies, confounding research factors, and inaccuracies in reporting. Based on the findings, four strategic approaches for enhancing therapeutic efficacy through acupuncture direction were summarized: aligning needle direction with the meridian pathway, directing the needle toward the lesion site, orienting the needle toward adjacent acupoints, and targeting special anatomical structures. Two additional strategies were proposed for optimizing the procedure: simplifying acupuncture operations and directing the needle toward safe anatomical sites. Recommendations were made to improve the rationality of research factor settings and the completeness of acupuncture operation reporting. Furthermore, three methods for reporting acupuncture direction were discussed: reporting the tip-pointed position, reporting the insertion angle and orientation, and reporting azimuth and polar angles, aiming to promote greater standardization and completeness in acupuncture practice and reporting.
Acupuncture Therapy/standards* ; Humans ; Acupuncture Points ; Randomized Controlled Trials as Topic ; Meridians

Through collecting the existing clinical evidences on acupuncture and moxibustion for urticaria, the distribution of evidence in this field was mapped. A systematic search of Chinese and English literature was conducted in CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library for treatment of urticaria with acupuncture and moxibustion, published up to December 31, 2023 since inception of each database. The research status in this field was summarized using an evidence mapping approach, and methodological quality was assessed. A total of 323 randomized controlled trials (RCTs) and 22 systematic reviews were included. The number of studies on acupuncture and moxibustion for urticaria has been increasing, with a significant rise in recent years. In most RCTs, the study scale was small, and the subjects focused on chronic spontaneous urticaria in adolescents and middle-aged adults, aged 14 to 60 years. Regarding the intervention measures, the single therapy of acupuncture and moxibustion was predominant such as acupoint injection, acupoint embedding thread, and filiform needling. In acupuncture with filiform needles, the commonly used acupoints were Quchi (LI11), Xuehai (SP10), Sanyinjiao (SP6), Zusanli (ST36) and Hegu (LI4). The main outcome measures referred to effectiveness rate, score of disease severity, recurrence rate, laboratory indexes, and score of quality of life; and the short-term effect was evaluated specifically. The overall methodological quality of the included studies was relatively low. It is suggested that the future research should focus on large-scale, multi-center, high-quality clinical trials, optimize the protocols for acupuncture and moxibustion intervention, standardize the outcomes, and draw the attention to the evaluation of long-term efficacy, so as to provide clinical evidences of high certainty for urticaria treated with acupuncture and moxibustion.
Humans ; Moxibustion ; Acupuncture Therapy ; Urticaria/therapy* ; Acupuncture Points ; Randomized Controlled Trials as Topic ; Adolescent ; Adult ; Young Adult

OBJECTIVE: To analyze the acupoint selection patterns and core prescriptions of acupuncture for polycystic ovary syndrome (PCOS) using data mining, and to explore the molecular mechanisms of core acupoints through network acupuncture medicine. METHODS: The randomized controlled trials (RCTs) on acupuncture for PCOS published from January 1, 2004 to July 21, 2024 were retrieved from CNKI, VIP, Wanfang, PubMed, and Web of Science databases. R software (version 4.4.0) was used for acupoint frequency and association rule analysis to identify core acupoint prescriptions. Potential targets were predicted via the STITCH and Swiss Target Prediction databases, and a "core prescription-active compounds-targets- PCOS" network was constructed. Cytoscape 3.7.1 was applied to build protein-protein interaction (PPI) networks of potential targets of core acupoint prescriptions. Key therapeutic targets were subjected to gene ontology (GO) and Kyoto encyclopedia of genes and genomes (KEGG) enrichment analyses using the DAVID and Microbioinformatics platforms. RESULTS: A total of 176 RCTs were included, covering 208 prescriptions and 89 acupoints. The five most frequently used acupoints were Guanyuan (CV4), Sanyinjiao (SP6), Zigong (EX-CA1), Zusanli (ST36) and Zhongji (CV3). Association rule analysis yielded 13 core acupoint combinations, with Guanyuan (CV4), Sanyinjiao (SP6), Zigong (EX-CA1) and Zusanli (ST36) as the core prescription. Twenty-seven active compounds were involved, with 852 potential therapeutic targets, among which 208 targets overlapped with PCOS-related targets. Network acupuncture medicine analysis suggested that the core prescription may act through targets such as estrogen receptor 1 (ESR1), proto-oncogene tyrosine-protein kinase Src (SRC), signal transducer and activator of transcription 3 (STAT3), peroxisome proliferator-activated receptor gamma (PPARG), and RAC-alpha serine/threonine-protein kinase (AKT1). GO and KEGG analyses indicated that the main pathways included the hypoxia-inducible factor 1 (HIF-1) signaling pathway, phosphatidylinositol 3-kinase-protein kinase B (PI3K-AKT) signaling pathway, and advanced glycation end products-receptor for advanced glycation end products (AGE-RAGE) signaling pathway, involving processes such as signal transduction, receptor complex formation, and cytokine activity. CONCLUSION The core acupoint prescription for PCOS might exert therapeutic effects through multiple targets and pathways, providing a theoretical basis for mechanistic research on acupoint prescriptions.
Humans ; Acupuncture Therapy ; Data Mining ; Acupuncture Points ; Polycystic Ovary Syndrome/metabolism* ; Female ; Protein Interaction Maps ; Randomized Controlled Trials as Topic