The efficacy of moxibustion and acupuncture therapy for ankylosing spondylitis: A protocol for an overview of systematic reviews and meta-analysis

Background:Ankylosing spondylitis is a complex and progressive autoimmune inflammatory disease with a worldwide prevalence ranging up to 0.9%. Several systematic reviews and meta-analyses of traditional Chinese medicine alternative therapies, such as acupuncture or moxibustion, have demonstrated the effectiveness of moxibustion and acupuncture in the treatment of ankylosing spondylitis. However, there is no relevant literature to comprehensively evaluate the evidence. The purpose of this overview is to synthesize and evaluate the reliability of evidence generated in the systematic review (SR) and meta-analysis of moxibustion and acupuncture as a primary or complementary therapy for patients with ankylosing spondylitis.Methods:PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese National Knowledge Infrastructure, Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database were searched for systematic reviews and meta-analysis that review the efficacy of acupuncture or moxibustion as the primary treatment for patients with Ankylosing Spondylitis. The literature published before August 2020 will be selected. Additionally, the relevant SRs and meta-analyses that unpublished or ongoing will be searched in PROSPERO and INPLASY. The methodological guidelines for overviews will be used to review and extract data by 2 reviewers, and their will do it independently. Methodology quality will be analyzed by the assessment of multiple systematic reviews-2and the risk of bias by POBIS. For the included studies, we will adopt the following results as primary evaluation indicators: effective rate, visual analogue scale and bath AS disease activity index. Reviewers will assess the certainty of evidence by Grading of Recommendations Assessment, Development and Evaluation.Results:The results will be published in a peer-reviewed journal.Conclusion:This overview will provide comprehensive evidence of moxibustion and acupuncture for patients with Ankylosing Spondylitis.     

Risk factors of enteral feeding intolerance in severe acute pancreatitis patients: A protocol for systematic review and meta-analysis

Background:Patients with severe acute pancreatitis (SAP) have gastrointestinal dysfunction, and enteral nutrition intolerance is easy to occur during the implementation of enteral nutrition, which leads to the suspension or termination of enteral nutrition. Enteral nutrition cannot tolerate the influence of many factors. At present, there is a lack of analysis on the influencing factors of enteral nutrition intolerance in patients with SAP. Therefore, this study analyzed the factors of enteral nutrition intolerance in patients with SAP by meta-analysis, to provide a basis for the protection of enteral nutrition in patients with SAP.Methods:Databases (PubMed, Embase, Cochrane Library, Web of Science, China Biology Medicine Database, China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang) were searched using index words to find relevant studies published before March 2021. Meta-analyses of relative risk were performed for the identification of risk factors.Results:We will disseminate the findings of this systematic review and meta-analysis via publications in peer-reviewed journals.Conclusion:This study systematically reviewed the existing evidence and determined the incidence and predictors of enteral nutrition intolerance in patients with SAP.     

Dental caries and associated factors among Chinese children and adolescents: A protocol for systematic review and meta-analysis

Background:Dental caries is a common disease under the action of many factors. Dental caries may occur in all age groups, among which children and adolescents are at high risk of dental caries. Early identification of the risk factors of dental caries is very important for clinical staff to prevent and intervene as soon as possible and reduce the incidence of dental caries. Although Chinese scholars have studied and summarized the risk factors of dental caries in children and adolescents, the conclusions are different. Therefore, in this study, meta-analysis was used to summarize the risk factors of dental caries in Chinese children and adolescents, and to explore the characteristics of high-risk groups of dental caries, so as to provide reference for early detection and prevention of dental caries.Methods:Medical specialty databases like PubMed, Embase, Cochrane Library, Web of Science, China Biology Medicine Database, China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database were consistently and exhaustively searched. According to the method of evidence-based medicine, the inclusion and exclusion criteria were established, and the meta-analysis of all eligible research results was carried out by using Review Manager 5.3 software.Results:We will disseminate the findings of this systematic review and meta-analysis via publications in peer-reviewed journals.Conclusions:Our study was carried out to estimate the pooled prevalence of dental caries and its associated factors among Chinese children and adolescents.OSF Registration Number:DOI 10.17605/OSF.IO/RA9D6.     

The research for the function evaluation of facial nerve and the mechanisms of rehabilitation training

Background:Peripheral facial paralysis (PFP) is a common peripheral neural disease. Acupuncture treatment combined with PFP rehabilitation exercises is a routine method of PFP treatment. This article is to provide a new visual and objective evaluation method for exploring the mechanism and efficacy of acupuncture treatment on PFP, and develop an interactive augmented facial nerve function rehabilitation training system with multiple training models.Methods:This prospective and observational trial will recruit 200 eligible participants for the following study. In the trial, the laser speckle contrast analysis (LASCA) technology will be applied to monitor the microcirculation of facial blood flow during acupuncture, and real-time monitoring algorithms, data sampling, and digital imaging methods will be conducted by machine learning and image segmentation. Then, a database of patient facial expressions will be built, the correlation between surface blood flow perfusion volume and facial structure symmetry will be analyzed, combined with scale assessment and electrophysiological detection. In addition, we will also explore the objectivity and effectiveness of LASCA in the evaluation of facial paralysis (FP), and the changes in blood flow microcirculation before and after acupuncture treatment will be analyzed.Results:The standard image of the facial target area with facial nerve injury will be manually segmented by the convolutional neural network method. The blood flow images of the eyelid, cheek, and mandible of the patients’ affected and healthy side will be compared and evaluated. Laser speckle blood flow symmetry Pr and its changes in FP condition evolution and prognosis outcome will be measured, and relevant characteristic signals values will be extracted. Finally, COX regression analysis method is conducted to establish a higher accuracy prediction model of FP with cross-validation based on laser speckle blood flow imaging technology.Conclusions:We use modern interdisciplinary high-tech technologies to explore the mechanism of acupuncture rehabilitation training in PFP. And we will provide evidence for the feasibility of using the LASCA technique as a typing diagnosis of FP in the acupuncture rehabilitation treatment of PFP.Registration number:ChiCTR1800019463     

Traditional Chinese medicine for gouty arthritis: A protocol for meta-analysis

Background:Gouty arthritis (GA) is a chronic disease caused by monosodium urate crystal deposition. Repeated attacks of arthritis may lead to the deposition of urate to form gout stone, resulting in joint deformity and joint damage. Although GA is not fatal, it causes low work productivity and low quality of life. Western drug, such as febuxostat, colchicine, allopurinol, often cannot get satisfying curative effect, and may even lead to serious side effects, such as exfoliative dermatitis or uremia. However, the therapeutic effect of Traditional Chinese medicine is very satisfactory. The treatment effect of simiao powder, a Chinese patent medicine, combined with acupuncture was widely used on treatment of GA. Although it has been widely used in clinical practice, its relative effectiveness and safety have not been confirmed. Therefore, this study will use meta-analysis to verify the efficacy and safety of simiao powder combined with acupuncture in the treatment of GA.Methods:All randomized controlled trial of simiao powder combined with acupuncture for the treatment of RA from their inception 29 October, 2020 will be searched form the China National Knowledge Infrastructure, Wanfang Database, Chinese Science and Technology Periodical Database, Chinese Biomedical Literature Database, Pubmed, Embase, Web of Science, and the Cochrane library. Two authors will independently select studies, extract data based on pre-designed inclusion and exclusion criteria. Methodological quality assessment and risk of bias will be assessed using Cochrane bias risk tool. All data analysis will be conducted using Revman5.3, WinBUGS 1.4.3, and Stata14.2 software.Results:We will compare the different outcome indicators of various studies to provide a synthesis of the efficacy and safety of Simiao powder combined with acupuncture for GA patients. The main outcome measures included efficacy, remission rate (no drug symptoms), recurrence rate, clinical absolute score and relative score. Secondary outcome measures included related adverse reactions and uric acid concentration.Conclusion:The findings of the study will provide helpful evidence for the efficacy and safety of simiao powder combined with acupuncture in the treatment of GA.Registration number:This study protocol have been funded through a protocol registry. The registry number is INPLASY2020110028     

The effect of whole-body vibration exercise on postmenopausal women with osteoporosis: A protocol for systematic review and meta-analysis

Background:Osteoporosis (OP) is an age-related disease characterized by reduced bone mass and increased bone fragility. It is more common in older people and postmenopausal women. As a new type of exercise training for OP, whole-body vibration (WBV) exercise has been proved to have a good effect on postmenopausal women with OP. It can increase bone density and improve strength and balance in postmenopausal population, which has certain clinical value, but lacks evidence-based medicine evidence. This study aims to systematically study the effectiveness of WBV exercise on postmenopausal women with OP.Methods:The English databases (PubMed, Embase, Web of Science, The Cochrane Library) and Chinese databases (China National Knowledge Network, Wanfang, Weipu, China Biomedical Database) were searched by computer. From the establishment of the database to February 2021, the randomized controlled clinical studies on WBV exercise on postmenopausal women with OP were conducted. The quality of the included studies was independently extracted by 2 researchers and literature quality was evaluated. Meta-analysis of the included studies was performed using RevMan5.3 software.Results:In this study, the efficacy and safety of WBV exercise on postmenopausal women with OP were evaluated by lumbar spine bone density, femoral neck bone density, pain, incidence of falls, incidence of fractures, and quality of life scale score, etc.Conclusion:This study will provide reliable evidences for the clinical application of WBV exercise on postmenopausal women with OP.Ethics and dissemination:Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval will not be required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.OSF Registration number:DOI 10.17605/OSF.IO/WPYT9     

Efficacy and safety of acupuncture combined with analgesics on lung cancer pain: A protocol for systematic review and meta-analysis

Background:Lung cancer (LC) is the malignant tumor with the highest incidence in the world, and treatment methods include surgery, radiotherapy, chemotherapy, and immunotherapy. Cancer pain is a common symptom in patients with LC, and the clinical treatment is to relieve it with analgesics. Acupuncture can relieve cancer pain. This study aims to systematically study the efficacy and safety of acupuncture combined with analgesics on cancer pain in patients with LC.Methods:From the beginning to April 2021, search Medline, Embase, Cochrane Central Controlled Trials Register (Central), China National Knowledge Infrastructure (CNKI), Wanfang Database, China Biomedical Literature Database (CBM), and Chinese Science Journal Database (VIP database). Search the international clinical trial registration platform and the Chinese clinical trial registration platform to find ongoing or unpublished trials. The main outcome indicator is the total effective rate of analgesia, and the secondary outcome indicator is pain intensity score and adverse reactions. The RevMan 5.4 software will be used for statistical analysis.Results:This study will provide the latest evidence for acupuncture combined with analgesics to relieve LC pain.Conclusion:The conclusion of this study is to evaluate the effectiveness and safety of acupuncture combined with analgesics in alleviating LC pain.INPLASY registration number:INPLASY202150051     

A randomized controlled trial protocol of the cardiovascular safety and efficacy of liraglutide in the treatment of type 2 diabetes

Background:Recently, many clinical experiments have evaluated the influences of liraglutide in the treatment of type 2 diabetes. However, the outcomes of these studies are inconsistent, and the number of high-quality prospective trials that conducted to assess the cardiovascular safety is limited. Hence, for this research, it was implemented for the assessment of the cardiovascular effectiveness and safety of liraglutide in type 2 diabetes patients.Methods:This research was a 26-week active controlled and randomized trial. Our research protocol follows the guidelines of Good Clinical Practice issued via the Helsinki Declaration and International Conference on Coordination. All the patients will receive the written informed consent in order to involve in our clinical experiment. The participants with type 2 diabetes aged from 18 years to 80 years, patients with 45.0 kg/m² body-mass index or less, and with glycosylated hemoglobin of 7.5 to 10.0 percent, and received metformin (daily 1500 mg or more) for 3 months or longer were eligible. All the patients were randomized to 1 of 2 interventions (in the ratio of 1:1): liraglutide placebo once daily (blinded) and liraglutide once daily (blinded), respectively, both combined with the glimepiride and metformin (open-labeled). For the efficacy variable, the major endpoint was the baseline glycated hemoglobin change after treating for 26 weeks. The secondary end points involved: the percentage of participants who achieved the goals of postprandial blood glucose, fasting blood glucose, and glycosylated hemoglobin; the changes of mean postprandial blood glucose, fasting blood glucose, and the body weight, pancreatic B-cell function index, and changes in blood pressure and insulin resistance assessed by homeostasis model.Conclusions:For this research, the limitations involve the short trial period and the limitation of glimepiride in some countries, thus excluding the maximum doses of glimepiride.Trial registration:This study protocol was registered in Research Registry (researchregistry6306).     

Diagnostic value of copeptin combined with hypersensitive cardiac troponin T detection in early acute myocardial infarction: A protocol of randomized double-blind diagnostic trial

Background:The sensitivity and specificity of the routine detection of acute myocardial infarction (AMI) in early diagnosis are not high, which can not meet the clinical needs. Copeptin combined with hypersensitive cardiac troponin T (hs-cTnT) is a new detection scheme, and its value in the early diagnosis of acute myocardial infarction is still unclear. Accordingly, the aim of this study is to evaluate the diagnostic value of copeptin combined with hypersensitive troponin T detection in early acute myocardial infarction.Methods:This is a prospective, randomized; double-blind diagnostic trial to investigate the diagnostic value of copeptin combined with hypersensitive troponin T detection in early acute myocardial infarction. Approved by the clinical research ethics of our hospital. Patients were randomly divided into one of 2 test protocols: (A) copeptin combined with hs-cTnT group and (B) cardiac troponin I (cTnI) group. Patients, doctors, nurses, inspectors, and data-gathering assistants were blinded to group allocation. We will focus on the sensitivity comparison of the 2 detection methods at different time periods and the sensitivity and specificity comparison of the two detection methods. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).Discussion:The purpose of this study is to evaluate the diagnostic value of copeptin combined with hypersensitive cardiac troponin T detection in early acute myocardial infarction. The results of this study will establish clinical evidence for the detection of high sensitivity cardiac troponin T in the early diagnosis of acute myocardial infarction.Ethics and dissemination:Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.OSF Registration number:DOI 10.17605/OSF.IO/6TE5Z.     

Acupuncture for chronic pelvic pain in patients with SPID: A protocol for systematic review and meta-analysis

Background:Chronic pelvic pain (CPP) is one of the common sequela of pelvic inflammatory disease, the pathological factors are adhesions, scarring and pelvic congestion which caused by inflammation, often cause abdominal pain and lumbosacral soreness, and aggravated after fatigue, sexual intercourse and during menstruation. It is difficult to treat because special pathological changes. Although acupuncture has gained increased popularity for the management of CPP, evidence regarding its efficacy is lacking. Therefore, a systematic review of acupuncture for chronic pelvic pain in patients with SPID is required to provide available evidence for further study.Methods and analysis:We will conduct a systematic review of randomized controlled trials (RCTs) that investigate the effect and safety of acupuncture for the treatment of chronic pelvic pain patients with SPID. We will electronically search the literature in the databases of PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, the Web of Science, China National Knowledge Infrastructure (CNKI), Wan-fang Digital Periodicals, Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP) and select eligible articles. Data extraction will be conducted by 2 researchers independently, and risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. The primary outcomes will be total effective rate and VAS pain score, and the secondary outcomes include the recurrence rate and adverse reaction. All data analysis will be conducted by software Review Manager V.5.3.Results:This study will provide the latest analysis of the currently available evidence for the efficacy of acupuncture for chronic pelvic pain in patients with SPID.PROSPERO registration number:CRD42020193826.