Global trends of acupuncture clinical research on analgesia from 2010 to 2023: a bibliometric and visualization analysis.

Objective: Acupuncture, acknowledged as a potent non-pharmacological therapy, is frequently employed to alleviate pain. Despite its widespread use, there has been a lack of overarching bibliometric analysis of clinical research on acupuncture analgesia. We aimed to summarize current patterns, hotspots, and development trends in this field through bibliometric analysis. Methods: This study evaluates academic publications retrieved from the Web of Science database (2010.01-2023.09) concerning acupuncture analgesia in clinical settings. All primary and secondary studies on humans were included. To track global developmental trends, we employed several software for analyzing annual publication volumes, countries/regions, institutions, authors, cited authors, journals, cited journals, references, and keywords and to draw collaborative networks and reference co-citation network maps. Results: The final search encompassed 7,190 relevant studies, including 1,263 randomized controlled trials (RCTs) and 1,293 systematic reviews and meta-analyses. The results indicated a gradual increase in the number of annual publications on acupuncture analgesia in clinical practice. Among countries and institutions, China (2,139) and Chengdu University of Traditional Chinese Medicine (258) ranked first. Liang FR (89 articles) was the most prolific author, while MacPherson H (604) was the most cited author. MEDICINE (455) was the most productive journal, and Pain (2,473/0.20) ranked first in both the frequency and centrality of cited journals. Notably, the most frequently cited reference was a systematic review of individual patient data on acupuncture carried out for chronic pain that was published by Vickers Andrew J in 2012 (156). Burst analysis identified frontier research areas for 2010-2020, encompassing network meta-analysis, case reports, dry needling, lumbar disc herniation, cancer, post-herpetic neuralgia, insomnia, and bibliometric analysis. Conclusion: This study outlines current trends and potential future research hotspots in clinical acupuncture analgesia over the past decade. Findings emphasize the necessity for enhanced international collaboration to improve research output and translation.

Comprehensive consideration of multiple determinants from evidence to recommendations in guidelines for most traditional Chinese medicine was suboptimal: a systematic review.

BACKGROUND: The overall comprehensive consideration of the factors influencing the recommendations in the traditional Chinese medicine (TCM) guidelines remains poorly studied. This study systematically evaluate the factors influencing recommendations formation in the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) clinical practice guidelines (CPGs) and TCM CPGs. METHODS: This was a methodological review in which we searched six databases and multiple related websites. The GRADE CPGs were identified as the guidelines developed by the GRADE Working Group or the two Co-Chairs. For the TCM CPGs, we randomly selected guidelines that were published by the TCM or integrative medicine academic societies from China mainland (published by the TCM or integrative medicine academic societies of China mainland). Two reviewers independently screened and extracted data. We included CPGs published in 2018-2022. We extracted information on the influencing factors of evidence to recommendation and conducted the analyses using descriptive statistics and calculated the proportion of relevant items by IBM SPSS Statistics and Microsoft Excel to compare the differences between the GRADE CPGs and the TCM CPGs. RESULTS: Forty-five GRADE CPGs (including 912 recommendations) and 88 TCM CPGs (including 2452 recommendations) were included. TCM recommendations mainly considered the four key determinants of desirable anticipated effects, undesirable anticipated effects, balance between desirable and undesirable effects, certainty of evidence, with less than 20% of other dimensions. And TCM CPGs presented more strong recommendations (for or against) and inappropriate discordant recommendations than GRADE CPGs. GRADE CPGs were more comprehensive considered about the factors affecting the recommendations, and considered more than 70% of all factors in the evidence to recommendation. CONCLUSIONS: The TCM CPGs lack a comprehensive consideration of multiple influencing determinants from evidence to recommendations. In the future, the correct application of the GRADE approaches should be emphasized.

How well did the consensus methods apply in the guideline development of traditional Chinese medicine: a web-based survey in China.

BACKGROUND AND OBJECTIVE: Consensus methods are crucial in developing clinical guidelines. Different methods, such as the Delphi and nominal group techniques, are commonly used, but there is a lack of detailed instructions on how to implement them effectively. The survey aims to explore the opinions and attitudes of the chair, panel and working group on the critical elements of the consensus methods during guideline development. METHODS: We used a cross-sectional design to conduct this study and sent a structured questionnaire to stakeholders, including the chair, panel members, and working group participants, through the popular mobile phone application WeChat.We selected participants using a combination of purposive and snowball sampling. The questionnaire gathered information on demographics, experiences, opinions, and concerns regarding consensus methods and guideline development. RESULTS: The sample comprised 290 participants representing 31 provinces or municipalities. Among them, the most significant number of respondents (n = 107, 36.9%) were from Beijing. Most participants, specifically 211 (72.76%), held senior professional titles, while 186 (64.14%) adhered to ongoing guidelines. The Delphi method was the most commonly used consensus method (n = 132, 42.31%), but the respondents had only a preliminary understanding of it (n = 147, 47.12%). The consensus process also revealed the insufficiency of involving pharmacoeconomists, patients, and nurses. CONCLUSIONS: Consensus methods have to be standardised and used consistently in the guideline development process. The findings of this study offer insights into diverse roles and more effective ways to apply the consensus process during guideline development.

Shufeng Jiedu capsule for acute exacerbation of chronic obstructive pulmonary disease: a protocol of multicentre, randomised, double-blind, placebo-controlled trial.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) represents one of the leading causes of death worldwide. Published clinical trials suggest that the Chinese patent herbal medicine Shufeng Jiedu capsule (SFJD) is safe and may be effective for treating acute exacerbations of COPD (AECOPD). However, these effects have been reported with low or very low certainty evidence. This trial aims to evaluate the effectiveness and safety of SFJD for AECOPD. METHODS AND ANALYSIS: This study is designed as a multicentre, randomised, double-blind, placebo-controlled trial. Three hundred patients with moderate or severe hospitalised AECOPD will be recruited in Beijing, Shanghai and Hefei. Participants will be randomly assigned to SFJD and usual care or placebo and usual care at a ratio of 1:1. SFJD and placebo will be administered orally four capsules three times daily for 7 consecutive days followed by an 8-week follow-up period. The primary outcome will be COPD symptom severity as measured by the EXAcerbation of Chronic Pulmonary Disease Tool score. Secondary outcomes include clinical symptoms, quality of life, length of hospital stay, a total dose of antibiotics, the frequency of recurrence of AECOPD, haematological biomarkers, death and adverse events. This study will answer the question of whether SFJD was safe to use and will improve symptoms in people with AECOPD, and will therefore reduce the necessity for antibiotics, the risk and duration of admission to hospital, and the risk of recurrence. ETHICS AND DISSEMINATION: The ethics committee of the first affiliated hospital of Anhui Medical University, Beijing University of Chinese Medicine affiliated Dongzhimen hospital and fifth people's hospital of Shanghai Fudan University approved the study protocol. Informed written consent will be obtained from all the participants. The results of this trial will be disseminated at academic conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: ISRCTN99049821.

Evidence synthesis of Chinese medicine for monkeypox: Suggestions from other contagious pox-like viral diseases.

Background: Monkeypox, a zoonotic disease caused by an Orthopoxvirus, presents an etiology similar to smallpox in humans. Currently, there are no licensed treatments for human monkeypox, so clear and urgent research on its prophylaxis and treatment is needed. Objective: The purpose of this study was to explore the evidence of Chinese medicine for contagious pox-like viral diseases and provide suggestions for the multi-country outbreak management of monkeypox. Methods: The review was registered on INPLASY (INPLASY202270013). Ancient classics in China and clinical trials involving randomized controlled trials , non-RCTs, and comparative observational studies of CM on the prevention and treatment of monkeypox, smallpox, measles, varicella, and rubella were retrieved from the Chinese Medical Code (fifth edition), Database of China Ancient Medicine, PubMed, the Cochrane Library, China National Knowledge Infrastructure, Chongqing VIP, Wanfang, Google Scholar, International Clinical Trial Registry Platform, and Chinese Clinical Trial Registry until 6 July 2022. Both quantitative and qualitative methods were applied to present the data collected. Results: The use of CM to control contagious pox-like viral diseases was traced back to ancient Chinese practice cited in Huangdi's Internal Classic, where the pathogen was recorded nearly two thousand years back. There were 85 articles (36 RCTs, eight non-RCTs, one cohort study, and 40 case series) that met the inclusion criteria, of which 39 studies were for measles, 38 for varicella, and eight for rubella. Compared with Western medicine for contagious pox-like viral diseases, CM combined with Western medicine showed significant improvements in fever clearance time (mean difference, -1.42 days; 95% CI, -1.89 to -0.95; 10 RCTs), rash/pox extinction time (MD, -1.71 days; 95% CI, -2.65 to -0.76; six RCTs), and rash/pox scab time (MD, -1.57 days; 95% CI, -1.94 to -1.19; five RCTs). When compared with Western medicine, CM alone could reduce the time of rash/pox extinction and fever clearance. Chinese herbal formulas, including modified Yinqiao powder, modified Xijiao Dihaung decoction, modified Qingjie Toubiao decoction, and modified Shengma Gegen decoction, were frequently applied to treat pox-like viral diseases and also showed significant effects in shortening the time of fever clearance, rash/pox extinction, and rash/pox scabs. Compared with Western medicine (placental globulin) or no intervention, eight non-randomized trials and observational studies on the prevention of contagious pox-like viral diseases showed a significant preventive effect of Leiji powder among high-risk populations. Conclusion: Based on historical records and clinical studies of CM in managing contagious pox-like viral diseases, some botanical drugs could be an alternative approach for treating and preventing human monkeypox. Prospective, rigorous clinical trials are urgently needed to confirm the potential preventive and treatment effect of Chinese herbal formulas. Systematic Review Registration: [https://inplasy.com/], identifier [INPLASY202270013].

Use of antibiotics and other treatments in Chinese adults with acute cough: An online survey.

Background: This study aimed to identify use of various treatments and their association with the use of antibiotics and patient reported clinical recovery in Chinese adults with acute cough. Methods: An online survey recruiting people who had recently experienced cough was conducted. Their sociodemographic, clinical characteristics, treatments received and their perceived changes in symptoms were collected. Factors influencing avoidance of antibiotics and improvement in symptoms were explored. Results: A total of 22,787 adults with recent acute cough completed the questionnaire, covering all 34 province-level administrative units in China. Most respondents were male (68.0%), young (89.4%, aged 18-45), educated to university/degree or postgraduate level (44.6%), with a median cough severity of 6/10 on a numerical rating scale. Nearly half of the participants (46.4%) reported using antibiotics, among which 93.1% were for presumed upper respiratory tract infections (URTIs). Pharmacies (48.8%) were the most common source of antibiotics. Fewer patients took antibiotics after taking CHM (14.9%), compared to those who started with home remedies (18.0%), or allopathic non-antibiotic medication (25.0%). Antibiotics, allopathic non-antibiotic medications, CHM and home remedies were all perceived beneficial in relieving cough. Conclusions: Chinese adult responders report use of a considerable variety of treatments alone or in combination for acute cough. Patient-reported clinical recovery was similar regardless of treatment. There is likely a high proportion of inappropriate use of antibiotics for treatment of simple acute cough. As the majority of respondents did not use antibiotics as a first-line, and use of CHM was associated with relief of cough symptoms and reduction in the use of antibiotics, this presents an important opportunity for prudent antibiotic stewardship in China.

[Improving acupuncture research: progress, guidance, and future directions].

This paper makes an interpretation of the collection Acupuncture: how to improve the evidence base published by BMJ & BMJ Open. Studies show that the quality of randomized controlled trial (RCT) of acupuncture is low, and multivariable Meta-regression analysis fails to confirm most factors commonly believed to influence the effect of acupuncture. The methodological challenges in design and conduct of RCT in acupuncture were analyzed, and a consensus on how to design high-quality acupuncture RCT was developed. The number of acupuncture systematic reviews was huge but the evidence was underused in clinical practice and health policy, and a large number of western clinical practice guidelines recommended acupuncture therapy, but the usefulness of recommendations needed to be improved. In view of the problems in clinical research on acupuncture mentioned in this collection, combined with the analysis of the purpose of clinical research on acupuncture, perspectives, study types, as well as the relationship between evidence and clinical decision-making, a five-stage study paradigm of clinical research on acupuncture is proposed.

Filiform needle acupuncture for allergic rhinitis: A systematic review and meta-analysis.

BACKGROUND: Filiform needle acupuncture (FNA), the most classical and widely applied acupuncture method based on traditional Chinese medicine theory, has shown a promising effect in the treatment of allergic rhinitis (AR). OBJECTIVE: To evaluate the efficacy, safety, cost-effectiveness, and patient preference of FNA in the treatment of AR by comparing FNA with sham acupuncture, no treatment, and conventional medication. SEARCH STRATEGY: Eight electronic databases were systematically searched from inception to October 14, 2021. Additional studies were acquired from clinical trial registration platforms and reference lists. INCLUSION CRITERIA: Randomized controlled trials were included if they compared FNA with either sham acupuncture, no treatment or conventional medication for AR. DATA EXTRACTION AND ANALYSIS: Two researchers extracted data independently of each other using a predesigned data acquisition form, and results were cross-checked after completion. The primary outcome was symptom score (Total Nasal Symptom Score or Visual Analogue Scale), and the secondary outcomes were the AR control questionnaire, quality of life (QoL) score (Different versions of Rhinoconjunctivitis Quality of Life Questionnaire), medication score (use of rescue medication), mental health score, total IgE, adverse event rate, clinical economic indicators, and patient satisfaction score. Standardized mean difference (SMD) or mean difference (MD) with 95% confidence interval was used to calculate the effect size for continuous data, while risk ratio with 95% CI was used for dichotomous data. RESULTS: Thirty studies were included in this review. Compared with sham acupuncture, FNA significantly reduced the symptom score (SMD: -0.29 [-0.43, -0.15]), AR's impact on QoL (SMD: -0.23 [-0.37, -0.08]) and medication score (SMD: -0.3 [-0.49, -0.11]). Compared with no treatment, FNA dramatically reduced the symptom score (SMD: -0.8 [-1.2, -0.39]) and AR's impact on QoL (SMD: -0.82 [-1.13, -0.52]). There were no increased rates of adverse events with FNA compared to sham acupuncture and no treatment. FNA increased patient satisfaction and may be cost-effective. Most pieces of evidence from the above two comparisons were of high confidence. Moreover, FNA significantly outperformed conventional medication in reducing the symptom score (SMD: -0.48 [-0.85, -0.1]) and displayed a lower rate of adverse events, but the quality of evidence was very low. CONCLUSION: FNA is an effective and safe intervention for AR and can help with symptom relief, QoL improvement, reducing medication usage, and increasing patient satisfaction. Further studies are needed to verify its cost-effectiveness and superiority over conventional medication and the best therapeutic strategies.

Systematic review and meta-analysis of Chinese herbal formula Tongxie Yaofang for diarrhea-predominant irritable bowel syndrome: Evidence for clinical practice and future trials.

Introduction: Diarrhea-predominant irritable bowel syndrome (IBS-D) significantly decreases the quality of life of patients and their families, and affects patients' mental health. No specific western medications are available. Ancient classical Chinese medical texts have recognized Tongxie Yaofang (TXYF) as a therapy for diarrhea which is widely used in clinical practice. Standard TXYF prescription (S-TXYF) is composed of four herbal medicines: Atractylodes macrocephala Koidz. [Asteraceae; Rhizoma Atractylodis Macrocephalae.], Paeonia lactiflora Pall. [Ranunculaceae; Paeoniae Radix Alba], Citrus × aurantium L. [Rutaceae; Citri Reticulatae Pericarpium] and Saposhnikovia divaricata (Turcz. ex Ledeb.) Schischk. [Umbelliferae; Saposhnikoviae Radix]. This review aimed to evaluate the therapeutic effects and safety of S-TXYF for IBS-D. Methods: Eight English and Chinese electronic databases were searched from their inception to 25 December 2021 for randomized controlled trials (RCTs) comparing S-TXYF with placebo, western medications or no treatment for IBS-D. The primary outcome was the global improvement of IBS-D symptoms. Data were analyzed using Cochrane's Revman 5.4 software. Evidence certainty was assessed using the online GRADEpro tool for the primary outcome. Results: Eleven RCTs involving 985 adults with IBS-D were included. For global improvement of symptoms, S-TXYF was superior to western medication and placebo (moderate evidence by GRADE). Regarding the improvement of stool consistency, stool frequency and abdominal pain, S-TXYF was significantly effective than placebo. In addition, S-TXYF was superior to western medication on improving the quality of life and relieving anxiety. Six trials reported adverse events: five of them reported (non-serious) adverse events occurred in both groups, and one trial reported that 3 cases with adverse events (constipation, elevation in liver-enzyme, nausea) occurred in S-TXYF group and 3 cases with adverse events (abdominal distension, nausea) occurred in placebo group. Conclusion: Although current results showed that S-TXYF may have potential to treat IBS-D and its use appears to be safe, no a clear and confirmed conclusion can be drawn from our review as the overall inadequate design of the included trials reviewed. So more rigorous trials are warranted to establish confirmed evidence on its benefits and safety.

[Using modified Delphi method to determine the clinical questions in the Practice Guideline of Acupuncture and Moxibustion for Urinary Incontinence in Women].

With the expert consensus during the clinical questions determination in the World Federation of Acupuncture and Moxibustion Societies (WFAS) standard Practice Guideline of Acupuncture and Moxibustion for Urinary Incontinence in Women as an example, this paper focused on the specific process and results of three rounds of Delphi survey on clinical issues by experts of the guideline development group, and systematically analyzed the consistency of the modified Delphi method with the consensus of acupuncture and moxibustion experts, as well as the reflection and limitation of this consensus process, hoping to provide reference for the development of acupuncture guidelines in the same field.

Quality Evaluation and Reporting Specification for Real-World Studies of Traditional Chinese Medicine.

In recent years, the real-world studies (RWS) have attracted extensive attention, and the real-world evidence (RWE) has been accepted to support the drug development in China and abroad. However, there is still a lack of standards for the evaluation of the quality of RWE. It is necessary to formulate a quality evaluation and reporting specification for RWE especially in traditional Chinese medicine (TCM). To this end, under the guidance of China Association of Chinese Medicine, the Quality Evaluation and Reporting Specification for Real-World Evidence of Traditional Chinese Medicine (QUERST) Group, including 24 experts (clinical epidemiologists, clinicians, pharmacologists, ethical reviewer and statisticians), was established to develop the specification. This specification contains the listing of classification of RWS design and RWE, the general principles and methods of RWE quality evaluation (26 tools or scales), 25 types of bias in RWS, the special considerations in evaluating the quality of RWE of TCM, and the 19 reporting standards of RWE. This specification aims to propose the quality evaluation principles and key points of RWE, and provide guidance for the proper use of RWE in the development of TCM new drugs.

Integrating Chinese and western medicine for COVID-19: A living evidence-based guideline (version 1).

BACKGROUND: The coronavirus disease 2019 (COVID-19) has turned into a pandemic and resulted in huge death tolls and burdens. Integrating Chinese and western medicine has played an important role in the fight against the COVID-19 pandemic. PURPOSE: We aimed to develop a living evidence-based guideline of integrating Chinese and western medicine for COVID-19. STUDY DESIGN: Living evidence-based guideline. METHODS: This living guideline was developed using internationally recognized and accepted guideline standards, dynamically monitoring the release of new clinical evidence, and quickly updating the linked living systematic review, evidence summary tables, and recommendations. Modified Delphi method was used to reach consensus for all recommendations. The certainty of the evidence, resources, and other factors were fully considered, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to rate the certainty of evidence and the strength of recommendations. RESULTS: The first version of this living guidance focuses on patients who are mild or moderate COVID-19. A multidisciplinary guideline development panel was established. Ten clinical questions were identified based on the status of evidence and a face-to-face experts' consensus. Finally, nine recommendations were reached consensus, and were formulated from systematic reviews of the benefits and harms, certainty of evidence, public accessibility, policy supports, feedback on proposed recommendations from multidisciplinary experts, and consensus meetings. CONCLUSION: This guideline panel made nine recommendations, which covered five traditional Chinese medicine (TCM) prescription granules/decoction (MXXFJD, QFPD, XFBD, TJQW, and JWDY), three Chinese patent medicines (LHQW granules/capsule, JHQG granules, and LHQK granules), and one Chinese herbal injection (XBJ injection). Of them, two were strongly recommended (LHQW granules/capsule and QFPD decoction), and five were weakly recommended (MXXFJD decoction, XFBD decoction, JHQG granules, TJQW granules, and JWDY decoction) for the treatment of mild and moderate COVID-19; two were weakly recommended against (XBJ injection and LHQK granules) the treatment of mild and moderate COVID-19. The users of this living guideline are most likely to be clinicians, patients, governments, ministries, and health administrators.

Effect of Jianpi Bushen Sequential Formula on Adjuvant Chemotherapy of Colon Cancer: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: The side effects of chemotherapy-induced nausea and vomiting (CINV) and myelosuppression reduce the cancer patients' adherence to chemotherapy. Many Chinese patients choose Chinese medicine (CM) during chemotherapy to reduce side effects; however, the evidence is lacking. The efficacy of a CM herbal treatment protocol, Jianpi Bushen Sequential Formula (, JBSF) will be evaluated on chemotherapy completion rate among patients with colon cancer. METHODS: A multi-center double-blind randomized controlled trial (RCT) will be conducted on 400 patients with colon cancer who will receive 8 cycles of adjuvant chemotherapy with oxaliplatin and capecitabine (CAPEOX). Patients will be randomized 1:1 to receive the JBSF or placebo formula. The primary outcome is the overall chemotherapy completion rate. The secondary outcomes include individual chemotherapy completion rate, 4-cycle completion rate of chemotherapy, time to treatment failure, relative dose intensity and treatment toxicity. Follow-up visits will be scheduled before every and after last chemotherapy. DISCUSSION: This study will provide evidence on whether JBSF can improve the chemotherapy completion rate and reduce side effects among patients with colon cancer. (Trial registration: ClinicalTrials.gov, No. NCT03716518).

Chinese patent herbal medicine (Shufeng Jiedu capsule) for acute upper respiratory tract infections: A systematic review and meta-analysis.

BACKGROUND: Shufeng Jiedu capsule has been widely used in China for acute upper respiratory tract infections (AURTIs). The aim of this study was to evaluate its effectiveness and safety for AURTIs. METHODS: Randomized controlled trials comparing SFJD with conventional drug for patients with AURTIs were included. Eight databases were searched from their inceptions to February 2021. Data was synthesized using risk ration (RR) or mean difference (MD) with their 95% confidence interval (CI). The primary outcome was resolution time of typical symptoms. RESULTS: Twenty-five RCTs involving 3410 patients were included. SFJD in combination with conventional drug was associated with; in common cold shortening the duration of fever (MD -1.54 days, 95% CI [-2.15,-0.92], I 2 = 80%, n = 385, 3 trials) and cough (MD -1.22 days, 95% CI [-1.52, -0.93]); in herpangina, shortening the duration of fever (MD -0.68 days, 95% CI [-1.15, -0.21], I2  = 68%, n = 140, 2 trials) and blistering (MD -0.99 days, 95% CI [-1.23, -0.76], n = 386, 3 trials); in acute tonsillitis and acute pharyngitis shortening the duration of fever (MD -1.13 days, 95% CI [-1.36, -0.90], I 2 = 33%, n = 688, 7 trials) and sore throat (MD -1.13 days, 95% CI [-1.40, -0.86], I 2 = 84.1%, n = 1194, 10 trials). SFJD also improving their cure rate with a range (1-5 days). No serious adverse events were reported. CONCLUSION: Low certainty evidence suggests that SFJD appears to shorten the duration of symptoms in AURTIs, improve cure rate and seems safe for application. However, high quality placebo controlled trials are warranted to confirm its benefit.

[Application of objective performance criteria in post-marketing evaluation schemes of traditional Chinese medicine].

Traditional Chinese medicines(TCMs) have certain limitations in the clinical research design in their post-marketing evaluation, so that randomized controlled programs cannot be strictly implemented in some studies, while the objective performance criteria is a reasonable external controlled research method that has been gradually recognized at home and abroad in recent years in addition to randomized controlled trial(RCT) method. It is more mature in medical devices, surgery and other research fields, but there is no relevant report in the field of post-marketing evaluation of Chinese patent medicines. In this paper, the application prospect of the objective performance criteria and the problems were discussed in the field of post-marketing evaluation of TCM. The characteristics of as TCM are more consistent with the scope of the objective performance criteria, the application of the objective performance criteria in post-marketing evaluation of Chinese patent medicines, especially in single arm research, can break through the limitations of existing conventional clinical research methods, and improve the level of evidence, with good feasibility and advantages. However, in the application process, we should pay attention to the key issues such as the selection of index, research population, follow-up period and the reference selection, to ensure the quality of research. This research group has carried out some exploration and practice in the field of post-marketing evaluation of TCM injections by using single arm combined with the objective performance criteria, hoping to establish the key technology in this field, and provide certain research and design reference for the secondary development of Chinese patent medicines.

Optimal intervention time and risk of the activating blood and removing stasis method in acute cerebral hemorrhage patients: A randomized placebo-controlled trial.

INTRODUCTION: Stroke is the leading cause of disability-adjusted life years in neurological diseases and has become one of the top 3 fatal diseases in the world. Cerebral hemorrhage accounts for approximately 18% to 24% of all strokes in Asian countries. Cerebral hemorrhage is one of the most destructive subtypes of stroke and has high morbidity and mortality. Based on the current research, it has been confirmed that neither surgical treatment nor current drug treatment is the most preferred treatment. Traditional Chinese medicine (TCM) is increasingly being used to treat cerebral hemorrhage, and the activating blood and removing stasis (ABRS) method has received more attention. At present, there is still a lack of high-quality clinical research on the treatment of acute cerebral hemorrhage. METHOD: We designed a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial. We aim to recruit 312 cerebral hemorrhage patients aged 18 to 80 years within 24 to 72 hours after onset. In addition to routine treatment, participants will randomly receive ABRS granules or placebo for 14 days. Those enrolled within 24 to 48 hours after onset will enter strata A, and those enrolled within 49 to 72 hours (including 48-49 hours) after onset will enter strata B. The strata sample size ratio will be 1:1. The primary outcome is the disability degree (modified Rankin Scale score, mRS) at 6 months after onset. The secondary outcomes include the percentage of hematoma enlargement after treatment, Barthel index (BI), National Institutes of Health stroke scale (NIHSS) score, mortality rate, all-cause mortality rate, TCM stroke syndrome evaluation scale score, and adverse events. DISCUSSION: The study is expected to confirm the safety and effect of acute cerebral hemorrhage within 24 to 72 hours treated with the ABRS method and to determine the optimal time for intervention in this period. TRIAL REGISTRATION NUMBER: ChiCTR1900022627.

A randomized, double-blind, placebo-controlled, multicenter clinical trial for efficacy and safety of traditional Chinese medicine combined with antibiotics in the treatment of bacterial pneumonia in children.

BACKGROUND: Pneumonia is the second leading cause of death in children worldwide after preterm birth and certification. Bacteria, viruses, mycoplasma, and other microorganisms are known to be the main causes of pneumonia, of which bacterial pathogenic factors account for 12.5% of cases. The invention and application of antibiotics have improved the prognosis of children with community-acquired bacterial pneumonia (CABP) to a certain extent, but with the emergence of antibiotic resistance worldwide, the mortality of children with CABP is still high. "Maxing Shigan Decoction" and "Qingfei Decoction" have significant efficacy in the treatment of CABP in children, but there is no standardized randomized controlled trial to systematically evaluate the outcomes. METHODS: This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial that will randomize 240 patients with CABP to group of Oral Maxing Shigan Decoction, group of Qingfei Decoction or group of placebos administered 3 times a day for 7 days. This study will observe a wide range of clinically relevant endpoints that have been used in clinical trials of pneumonia, including but not limited to clinical cure rate, antibiotic application days, complete antipyretic rate, complete antipyretic days, disease efficacy, traditional Chinese medicine syndrome effect, and antibiotic upgrade treatment rates. Safety will be assessed by monitoring for the incidence of adverse events during the study. DISCUSSION: This clinical trial is the first to evaluate the efficacy and safety of "Maxing Shigan Decoction" and "Qingfei Decoction" in the treatment of children with CABP. The research results will provide a reference for future research design. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900025354. Registered on 14th October 2019-Retrospectively registered, http://www.chictr.org.cn/.

Completeness of reporting acupuncture interventions for chronic obstructive pulmonary disease: Review of adherence to the STRICTA statement.

Background: The quality of reporting of acupuncture interventions is critical to ensure the applicability and reproducibility of acupuncture clinical trials. In the past, different publications have evaluated the quality of reporting of acupuncture interventions for different clinical situations, such as knee osteoarthritis, neurological diseases or cancer. However, this has not been done for acupuncture trials for chronic obstructive pulmonary disease (COPD). Objective: To assess the quality of reporting of acupuncture interventions in trials for COPD. Methods: A total of 11 English and Chinese databases were screened up until May 2019 for randomised or quasi-randomised control trials of acupuncture for COPD. The STRICTA checklist was used to determine the quality of the reporting of acupuncture interventions. Results: A total of 28 trials were included in our review. Out of the 16 STRICTA checklist subitems analysed, only 3 were considered appropriately reported in more than 70% of the trials, while 7 were correctly reported in less than 40%. Conclusion: The adherence to STRICTA guidelines of acupuncture trials for COPD is suboptimal, and future efforts need to be addressed to improve the quality of reporting.

Berberine for diarrhea in children and adults: a systematic review and meta-analysis.

BACKGROUND: Diarrhea is a ubiquitous digestive system disease, leading to loss of fluid and electrolytes, and may be life-threatening, especially in children and adults who are immunosuppressed or malnourished. Berberine has a broad-spectrum antibiotic activity and is very widely used to treat diarrhea in China. No systematic review has been carried out to evaluate the evidence presented in clinical trials. The aim of this study was to assess the effectiveness and safety of berberine in diarrhea treatment among children and adults. METHODS: Seven databases and two clinical trial registries were searched on 1 September 2019. Randomized controlled trials were included, where participants were diagnosed (first diagnosed) as having diarrhea according to clear diagnostic criteria. Berberine alone or in combination with Western medication as intervention were included. Subgroup analyses were conducted based on children or adults, acute or persistent diarrhea, infectious or noninfectious and treatment courses. Primary outcomes were clinical cure rate and duration of diarrhea. The GRADE tool was used to assess the quality of evidence. RESULTS: A total of 38 randomized controlled trials were included involving 3948 participants (including 27 trials on 2702 children) were included. Compared with antibiotics, berberine plus antibiotics showed better results in both adults and in children in general, especially when given for 7 days or 3 days in acute infectious diarrhea of children. Compared with the control groups, using berberine alone or in combination with montmorillonite, probiotics, and vitamin B increased the clinical cure rate of diarrhea. The use of berberine alone or berberine combined with montmorillonite reduced the duration of hospitalization. Using berberine had significantly better laboratory indicators (isoenzyme, inflammatory factors, myocardial enzyme, and fecal trait) and fewer systemic symptoms than the no berberine groups. Overall, 22 of 27 trials on children used berberine as an enema. No deaths and serious adverse events were reported. The quality of evidence of included trials was moderate to low or very low. The impact of different dosages, frequencies and treatment durations on the outcomes was not evaluated due to insufficient number of trials. CONCLUSION: This review demonstrated that berberine was generally effective in improving clinical cure rates and shortening the duration of diarrhea compared with control groups. No severe adverse event was reported. However, there is still a lack of high-quality evidence for evaluating the efficacy and safety of berberine. TRIAL REGISTRATION: PROSPERO CRD42020151001 (available from http://www.crd.york.ac.uk/PROSPERO/).