Comparative effectiveness of multiple acupuncture therapies for primary insomnia: a systematic review and network meta-analysis of randomized trial.

Background: The coronavirus disease 2019 (COVID-19) continues to spread globally. Due to the higher risk of mortality, the treatment of severe or critical patients is a top priority. Traditional Chinese medicine (TCM) treatment has played an extremely important role in the fight against COVID-19 in China; a timely evidence summary on TCM in managing COVID-19 is crucial to update the knowledge of healthcare for better clinical management of COVID-19. This study aimed to assess the effects and safety of TCM treatments for severe/critical COVID-19 patients by systematically collecting and synthesizing evidence from randomized controlled trials (RCTs) and observational studies (e.g., cohort). Methods: We searched nine databases up to 19th March 2022 and the reference lists of relevant publications. Pairs of reviewers independently screened studies, extracted data of interest, and assessed risk of bias. We performed qualitative systematic analysis with visual presentation of results and compared the direction and distribution of effect estimates for each patient’s important outcome. We performed sensitivity analyses to observe the robustness of results by restricting analysis to studies with low risk of bias. Results: The search yielded 217,761 records, and 21 studies (6 RCTs and 15 observational studies) proved eligible. A total of 21 studies enrolled 12,981 severe/critical COVID-19 patients with a mean age of 57.21 years and a mean proportion of men of 47.91%. Compared with usual supportive treatments, the effect estimates of TCM treatments were consistent in direction, illustrating that TCM treatments could reduce the risk of mortality, rate of conversion to critical cases, and mechanical ventilation, and showed significant advantages in shortening the length of hospital stay, time to viral clearance, and symptom resolution. The results were similar when we restricted analyses to low-risk-bias studies. No serious adverse events were reported with TCM treatments, and no significant differences were observed between groups. Conclusion: Encouraging evidence suggests that TCM presents substantial advantages in treating severe/critical COVID-19 patients. TCM has a safety profile that is comparable to that of conventional treatment alone. TCMs have played an important role in China’s prevention and treatment of COVID-19, which sets an example of using traditional medicine in preventing and treating COVID-19 worldwide.

/pdf/role-of-traditional-chinese-medicine-in-treating-severe-or-2ho95ux4.pdf

Role of Traditional Chinese Medicine in Treating Severe or Critical COVID-19: A Systematic Review of Randomized Controlled Trials and Observational Studies

Abstract Background Recently, the quality of clinical trials conducted in China has made considerable progress. However, clinical trials conducted in China still fall below the global average standard. The aim of this systematic review was to assess studies that investigated the quality of clinical trials conducted in China, summarize the issues, and provide suggestions for conducting high-quality clinical trials in China. Methods We comprehensively searched studies that investigated the quality of clinical trials conducted in China in the following databases from inception to December 1, 2021: National Knowledge Infrastructure, the Chinese Science and Technology Periodical Database, WanFang Data, China Biology Medicine, PubMed, and Embase. We then analyzed the issues in clinical trial registration, ethics review, implementation, and reporting. SPSS 25.0 software was used for data analysis. The data synthesis was conducted using summary statistics and a narrative format. Results A total of 90 studies were analyzed, there were 50 studies with 0–5 citation counts (55.56%), 18 studies with 5–10 citation counts (20%), 9 studies with 10–15 citation counts (10%), and 13 studies with more than 15 citation counts (14.44%). Eight (8.89%) studies were conducted by a supervision department, 38 (42.22%) by organizations with GCP qualification, and 44 (48.89%) by third parties. Additionally, there were some problems in the ethical review process of clinical trials, clinical trial registration process, clinical trial implementation process, and clinical trial reporting process. Conclusions The current study shows that the quality problems of clinical trials in China still exist. The reported problems are related to the process of clinical trials, including ethical review, registration, implementation, reporting. Due to the limited quantity and quality of included studies, the conclusions of this study need to be verified by high-quality studies. Review registration Not registerated in PROSPERO. 

/pdf/quality-problems-of-clinical-trials-in-china-evidence-from-3e5s5t0p.pdf

Quality problems of clinical trials in China: evidence from quality related studies

Abstract Severe acute pancreatitis (SAP) onset and development are closely associated with intestinal barrier injury. Evidence from clinical practice and research has shown that electroacupuncture (EA) at the Zusanli (ST36) acupoint can improve intestinal barrier function and abdominal symptoms in patients with SAP; however, the specific mechanisms of action remain unclear. This study aimed to observe the changes in the intestinal microbiota and metabolites in SAP rats and to explore the effect of EA at ST36 on intestinal barrier injury in SAP rats. 16S rRNA gene sequencing combined with microbial diversity analysis, short‐chain fatty acids (SCFAs)‐targeted metabolomics, immunohistochemistry, immunofluorescence, western blotting, and other techniques were used to explore the mechanism of EA at bilateral ST36 acupoints on SAP‐related intestinal barrier injury. Our results showed that EA at ST36 could repair intestinal barrier injury by modulating intestinal microecology, thereby reducing intestinal inflammation, restoring intestinal function, and ultimately alleviating the prognosis of SAP. Our study provides new insights into the mechanisms and treatment of intestinal barrier injury in patients with SAP from the perspectives of microbiota and SCFAs regulation.

Electroacupuncture at ST36 modulates the intestinal microecology and may help repair the intestinal barrier in the rat model of severe acute pancreatitis

Key Points Question What is the content of the comments posted on the bioRxiv and medRxiv preprint platforms? Findings In this cross-sectional study, 7.3% of preprints from 2020 had received at least 1 comment (mean follow-up of 7.5 months), with a median length of 43 words. Criticisms, corrections, or suggestions (most commonly regarding interpretation, methodological design, and data collection) were the most prevalent types of content in these comments, followed by compliments and questions. Meaning This study found that, although rare, when comments were present on the preprint platforms, they addressed relevant topics that would be expected to emerge from peer review.

Characterization of Comments About bioRxiv and medRxiv Preprints

Introduction Acupuncture has been accepted in many Western countries and clinical trials have been increasing recently. However, the problems of insufficient and low-quality evidence remain, and substantially hinder the development of acupuncture clinical trials. We therefore aim to develop a guideline to strengthen the quality of acupuncture clinical trials, in accordance with WHO handbook for guideline development and the Reporting Items for practice Guidelines in HealThcare. The guideline will help to improve the quality of acupuncture clinical trials. Methods and analysis We will search for studies on the quality of acupuncture clinical trials using PubMed, EMBASE, Web of Science, China National Knowledge Infrastructure, Wanfang Data, China Science and Technology Journal Database, The Cochrane Library, the WHO and Health Technology Assessment websites, and other sources. We will also check reference lists and contact experts in the field. We will systematically evaluate the quality of acupuncture clinical trials, and extract and summarise the quality problems and countermeasures of such trials. We will also systematically review clinical trial quality control manuals and systems and formulate research questions on quality control in acupuncture clinical trials. Finally, we will develop the guideline and establish a comprehensive quality control system to ensure high quality acupuncture clinical trials. We will also evaluate the guideline and will update the guideline to reflect new scientific evidence. Ethics and dissemination Ethics committee approval and informed consent are not required for developing guideline because only published data will be used, however, we will interview the patients, the ethics committee approval has been got from West China Hospital of Sichuan Unversity (Number: 2021-1188). We will publish all manuscripts arising from this research and present the findings at conferences. Guideline registration number IPGRP-2021CN093.

/pdf/strengthening-the-quality-of-clinical-trials-of-acupuncture-2cvpzfrb.pdf

Strengthening the quality of clinical trials of acupuncture: a guideline protocol

This is a protocol for developing a guideline to establish the evidence ecosystem of acupuncture. It describes all steps that will be followed in line with the World Health Organization Handbook for Guideline Development and the Reporting Items for practice Guidelines in Healthcare (RIGHT). The key steps included guideline protocol development, guideline registration, systematic review of acupuncture evidence issues, systematic review of methods for establishing evidence ecosystem, survey of acupuncture stakeholders regarding potential acupuncture evidence issues, development of potential items for guidelines, Delphi method for guideline item development, consensus meeting, drafting guideline, peer review, approval, and publishing. This future guideline will help to establish evidence ecosystem of acupuncture, which will facilitate the application of acupuncture in clinical practice.

A Protocol of a Guideline to Establish the Evidence Ecosystem of Acupuncture

Background Pregnancy-related low back pain (PLBP) affects the daily living activities of pregnant women, even leading to fetal agitation and threatened abortion. Kinesio taping (KT) can improve the circulation of blood and provide elastic supports, which is a reliable method to treat low back pain. At present, although many studies have been published on the effects of KT on PLBP, the results are inconsistent, and some studies even report that KT does not affect PLBP. there is still a lack of high-level clinical evidence for the treatment of PLBP with KT. Therefore, this study proposes a protocol for a systematic review and meta-analysis of published Randomized Controlled Trials (RCTs) to evaluate the efficacy and safety of KT for PLBP. Methods This protocol is guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. We will search the following database sources of the RCTs: PubMed, the Cochrane Library, EMBASE, Web of Science, Chinese Biomedical Literature Database (CBM), Chinese National Knowledge Infrastructure Database (CNKI), Chinese Science, and the Wanfang Database. From the establishment of the database to April 2021. The retrieval word adopts the combination of theme words and free words. Take “Kinesiotape, Tape Athletic, Orthotic Tape, Athletic Tape, Pregnancy, Pregnancies, Gestation, low back pain” as a term for retrieval. Two independent investigators will conduct an electronic literature search, study selection, data extraction, and quality assessment to summarize and evaluate the efficacy of KT in the treatment of PLBP. Retrospective trials are not included, and the risk of bias will be assessed using the Cochrane bias risk tool. All data analysis will be conducted using Revman5.3 software. Results Quality outcomes in systematic review studies depend on inclusion and search criteria to obtain high-quality data, as well as how the data are processed and interpreted. Among the results, this study will objectively and comprehensively evaluate the efficacy and safety of the randomized controlled trial of KT in the treatment of PLBP, and make a detailed analysis of the effect of KT in the treatment of PLBP. The results will be analyzed by the Visual Analogue Scale of Pain and the Roland Morris Dysfunction Questionnaire. If applicable, a subgroup analysis will also be performed, which will be grouped according to the duration of pregnancy, grade of pain, etc. Finally, the results are submitted to a peer-reviewed journal for publication. Conclusion Based on the results, this study will analyze and summarize the effect of KT on improving PLBP. It includes whether KT can improve the pain and lumbar function of PLBP, or it has adverse effects and reactions on pregnant women, then analysis and interpretation of other related issues. It is expected that the results of this study will provide a reference to the method and time of taping for clinical staff, as well as high-quality evidence to resolve the effect of KT on low back pain and provide corresponding guidance for pregnant women with low back pain. It aims to improve the status of low back pain in pregnant women and improve their physical health. Protocol registration number PROSPERO CRD42021250373; https://clinicaltrials.gov/.

/pdf/effect-of-kinesio-taping-on-pregnancy-related-low-back-pain-iehceo6b.pdf

Effect of Kinesio taping on Pregnancy-related low back pain: A protocol for systematic review and meta-analysis

Background. Nursing educational research is very important for the development of the nursing discipline. There have been many randomised controlled trials (RCTs) of nursing education, and the outcomes are highly heterogeneous and waste resources. The study aims to report the methodological framework to establish a core outcome set (COS) for RCTs of nursing education. Methods. The study will be conducted in the following five steps: (a) establish nursing education COS working groups; (b) develop an initial list of outcomes of nursing education by systematic review and semistructured interview; (c) Delphi survey with different stakeholders to reach a preliminary consensus on the core outcome of nursing education; (d) expert consultation to form the outcome pool; (e) expert consensus meeting to form the nursing education COS. Results. The goal is to develop a COS that includes stakeholders’ interest in nursing education to determine which outcomes should be reported and how they should be measured. Conclusions. By performing the study, the nursing education COS will be established, which will help to reduce reporting bias and resource waste, and provide enough results for nursing education systematic reviews.

Development of a Core Outcome Set for Randomised Controlled Trials of Nursing Education: A Methodological Framework

In this study, we reported a methodological framework for the development of a guideline for establishing a regulatory science system for supervising the application of artificial intelligence for traditional Chinese medicine (TCM). It introduced all of the key steps for developing the guideline as follows: the composition of the guideline expert groups, summary steps, agency, purpose, targeted population, writing, publishing, updating, dissemination, dynamic monitoring, and evaluation. The guideline will provide the basis for national authorities to effectively regulate artificial intelligence technology and enrich the supervisory system for TCM, and it will be of great significance to TCM.

https://downloads.hindawi.com/journals/ecam/2022/9680203.pdf

Establishing a Regulatory Science System for Supervising the Application of Artificial Intelligence for Traditional Chinese Medicine: A Methodological Framework

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