Traditional Chinese medicine for irritable bowel syndrome: A protocol for meta-analysis

Background:Irritable bowel syndrom (IBS) is a common functional gastrointestinal disorder which is characterized as recurrent abdominal pain, abdominal discomfort, and abnormal bowel habits such as diarrhea, constipation, both or alternate appear. Although IBS is not fatal, it seriously affects the patients’ daily life and work. Western drug, such as antidiarrheals, gastrointestinal antispasmodic, often cannot get satisfying curative effects. However, the therapeutic effect of Traditional Chinese medicine (TCM) on IBS is very satisfactory which was shown in a large number of randomized controlled trials. Although TCM 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 different types of TCM in the treatment of IBS.Methods:We search 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 for all randomized controlled trial of TCM for the treatment of IBS from their inception to Oct 15, 2020. Two authors will independently select studies, extract data based on predesigned 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:This study will compare the different outcome indicators of various studies directly and indirectly, and provide a high-quality synthesis of effectiveness and safety of different TCM methods for patients with IBS. The main outcome indicators include effectiveness, remission rate (no drug symptoms), relapse rate, clinical absolute score, and relative score. Secondary outcome indicators included related adverse reactions and serum serotonin concentration.Conclusion:The conclusion of this systematic review will provide a high-quality evidence based on the efficacy and safety of different TCM treatment methods for IBS.Registration number:This study protocol has been funded through a protocol registry. The registry number is INPLASY2020100052     

Different Chinese patent medicine therapies for migraine: A protocol for systematic review and network meta-analysis

Background:Migraine is a clinically high incidence rate of neurovascular disease. It is a recurrent headache. It is characterized by nausea, vomiting, fear of voice, and photophobia. Nowadays, a large number of randomized controlled clinical studies have shown that Chinese patent medicine has the advantages of good curative effect and high safety in the treatment of migraine. However, due to the variety of proprietary Chinese medicines, their relative effectiveness and safety have not yet been verified. Therefore, this study will use the network meta-analysis method to verify the effectiveness and safety of different kinds of Chinese patent medicines in the treatment of migraine.Methods:All randomized controlled trials of Toutongning capsule, Yangxue Qingnao granule, naoxintong capsules, Tianmagouteng granules in the treatment of migraine were searched from PubMed, Cochrane Library, web of science, EMBASE, sinomed, CNKI, Wanfang database, VIP. The retrieval time is from the establishment of the database to November 18, 2020. In order to avoid omission, we will manually retrieve relevant references and conference papers. According to the inclusion and exclusion criteria, we evaluated the quality and risk of all the retrieved literatures. Methodological quality assessment and bias risk will be assessed using the Cochrane bias risk tool. Revman 5.3, WinBUGS 1.4.3, and stata14.2 software will be used for all data analysis.Results:This study will directly or indirectly compare the effectiveness of different interventions on migraine outcome indicators, and rank the effectiveness. The main outcome measures included total effective rate (total effective rate = rocovery + obvious effective + effective/total number of cases × 100%), visual analogue scale (VAS) score, and secondary outcome indicators included analgesic effect evaluation index and quality of life scale.Conclusion:To provide evidence for evidence-based medicine and clinical researchers to choose more effective Chinese patent medicines to treat migraine.     

Effectiveness comparisons of Chinese patent medicine on sciatica: A protocol for systematic review and Bayesian network meta-analysis

Background:Sciatica is one of the common clinical diseases. Studies have proved the efficacy of Chinese patent medicine (CPM) in the treatment of sciatica, so far, there has not been a complete systematic review of its effectiveness and safety, and the comparative efficacy and safety of CPM have not been ranked. Therefore, it is necessary to evaluate the efficacy and safety of these CPM by means of systematic review and network meta-analysis (NMA), and to compare them in order.Methods:We will search PubMed, Cochrane Library, EMbase, Web of Science, CNKI, Wanfang, VIP, CBM and other databases for RCTs of CPM in the treatment of sciatica, (database established until December 30, 2020). In addition, we will manually search the “Pharmaceutical Information”, “National Essential Drug List”, “Chinese Pharmacopoeia”, etc. to inquire about drug instructions, and screen the market circulation and clinically commonly used CPM. We will use RevMan software, gemtc package, GeMTC software for statistical analysis, and draw the surface under cumulative ranking area (SUCRA) to predict the order of curative effect of treatment measures.Results:Our study will compare and evaluate the effectiveness of CPM in the treatment of sciatica, and rank different CPM. The outcome indicators will include clinical efficacy, pain degree, lumbar spine function and adverse events.Conclusion:Our research will provide support for clinical practice.INPLASY registration number:INPLASY2020110073.     

Acupuncture for gouty arthritis: A PRISMA-compliant protocol for a systematic review and meta-analysis of randomized controlled trials

Backgroud:Patients with gouty arthritis suffer from intermittent attacks of pain, chronic inflammation, and joint damage. Acupuncture has been used in East Asian countries for centuries to treat various diseases, and several clinical studies have reported that acupuncture has beneficial effects on gouty arthritis. This study aims to evaluate the effect of acupuncture in patients with gouty arthritis by conducting a systematic review and meta-analysis.Methods:A comprehensive search of 8 electronic databases will be performed, including MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, 4 Korean databases (KoreaMed, Korean Studies Information Service System, Research Information Service System, and Oriental Medicine Advanced Searching Integrated System), and 1 Chinese database (China National Knowledge Infrastructure). Only randomized controlled trials comparing acupuncture to conventional treatment and acupuncture with conventional treatment to conventional treatment alone for gouty arthritis will be included. Pain intensity will be considered the primary outcome. The secondary outcomes will include the pain relief duration, total effective rate, blood uric acid level, inflammatory markers, and incidence of adverse events. Two independent researchers will perform the study selection, data extraction, and quality assessment. The methodological quality of the individual included studies will be assessed using the Cochrane risk of bias tool. In the meta-analysis, for dichotomous and continuous data, risk ratios and standardized mean differences, respectively, will be estimated in addition to 95% confidence intervals.Results: This systematic review will evaluate the effect of acupuncture treatment for patients with gouty arthritis with respect to clinical symptoms, laboratory indicators, and safety.Conclusion: Our findings will help to establish the evidence of acupuncture to treat gouty arthritis.Registration number:PROSPERO CRD42020169668.     

Efficacy and safety of pricking-blood therapy for acute gouty arthritis: A protocol for systematic review and meta-analysis

Background:Acute gouty arthritis is a joint inflammatory reaction that affects the daily quality of patients. Previous reviews of pricking-blood therapy for acute gouty arthritis have been growing, but a systematic review is not available. This study aimed to systematically investigate the efficacy and safety of pricking-blood therapy in treating acute gout arthritis.Methods:We will search for relevant literature through Chinese and English databases, with the retrieval deadline being December 2020. Databases include PubMed, Embase, Web of Science, the Cochrane Library, China National Knowledge Infrastructure, the Chongqing VIP Chinese Science and Technology Periodical Database, Wanfang Database, and China Biomedical Literature Database. We will also manually search Chinese Acupuncture & Moxibustion, Acupuncture Research, Chinese Clinical Trial Register, and unpublished studies or references. According to the inclusion and exclusion criteria, the literature will be screened, and the data are extracted independently by the 2 researchers. The primary outcomes were the total effective rate and Visual Analogue Scale (VAS) score. RevMan 5.3.5. software will be used for statistical analysis. According to the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE), each evidence of outcome quality will be appraised.Results:This study will provide a comprehensive review of current evidence for a pricking-blood therapy treatment for acute gouty arthritis.Conclusion:The efficacy and safety of picking-blood therapy in treating acute gout arthritis will be evaluated.Unique INPLASY number:INPLASY2020100094.     

Chinese patent medicine for functional dyspepsia effects: A protocol for systematic review and Bayesian network meta-analysis

Background:In recent years, many clinical studies have suggested that various Chinese patent medicines have the potential to treat functional dyspepsia (FD). This study aims to conduct a systematic review and Bayesian network meta-analysis to evaluate the effectiveness of different Chinese patent medicines for FD.Methods:A comprehensive retrieval method will be executed in the following databases: PubMed, Web of Science, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBM), VIP Database, and Wanfang Database. Clinical randomized controlled trials (RCTs) of 9 Chinese patent medicines for FD are searched, and the retrieval time is from inception to October 2021. Three reviewers will screen the RCTs that meet the inclusion criteria and extract the data independently. The outcomes include total clinical efficiency, cure rate, recurrence rate, symptom score, and adverse events. Cochrane risk-of-bias tool will be carried to assess RCTs quality. The “gemtc” package and “rjags” package in R software will be used to manage data within the Bayesian framework.Results:The results can provide relatively objective evidence to evaluate the effectiveness of these 9 Chinese patent medicines in treating FD, which may help clinicians to develop a more effective and safer treatment plan.Conclusion:This study aims to provide new options for Chinese patent medicine treatment of FD in terms of its efficacy and safety.     

Traditional Chinese medicine intervention for autism spectrum disorders: A protocol for systematic review and network meta-analysis

Background:Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by impairments in social communication, social interaction, and restrictive or repetitive behaviors. Traditional Chinese medicine (TCM) has been used in the clinical management of ASD, especially in mainland China, where studies have shown promising efficacy. However, this remains to be further explored and clarified. Therefore, the purpose of this study was to evaluate the effectiveness and safety of conventional treatment-based TCM interventions for ASD.Method:The study will be conducted from January 2022, and the following electronic databases will be searched: China Biological Medicine Database, Chinese Scientific Journals Database, Wan Fang database, and China National Knowledge Infrastructure, the Cochrane Library, Web of Science, PubMed, and EMBASE Database. Only randomized controlled trials of TCM interventions for ASD will be included. The Autism Diagnostic Observation Scale, Autism Diagnostic Interview-Revised, and Childhood Autism Rating Scale will be the primary outcome indicators. The methodological quality of this Bayesian-based network meta-analysis will be performed using the “Risk of Bias” tool. Stata 14.0 and WinBUGS 1.4.3 will be used to analyze the data. In addition, assessment of heterogeneity, inconsistency, subgroups, sensitivity, and publication bias will be conducted using the Cochrane Collaboration''s tools.Results:The results of this study will be submitted to a peer-reviewed journal for publication.Conclusion:This study will help patients recover better, provide clinical evidence for practitioners, and promote the use of TCM in ASD interventions.     

Efficacy of acupuncture combined with traditional Chinese medicine on chronic prostatitis: A protocol for systematic review and meta-analysis

Background:Chronic prostatitis is a common andrological disease, which brings many troubles to the lives of middle-aged and elderly male patients. With the increase of modern life pressure, the incidence of chronic prostatitis tends to younger, but its etiology and pathogenesis are not fully elucidated. Which seriously affects men''s health? Relevant studies have shown that acupuncture combined with traditional Chinese medicine (TCM) has a good effect on the treatment of chronic prostatitis compared with conventional western medicine; however, there is no consistent conclusion at present. The main purpose of this study is to explore whether acupuncture combined with TCM is effective in treating chronic prostatitis.Methods:The collection of randomized controlled trials related to acupuncture and TCM for chronic prostatitis will search the following electronic databases, including: PubMed, Web of Science, the Cochrane Database, EMBASE, Chinese National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform, Weipu. There are 8 electronic databases including the VIP Chinese Science and Technology Periodical Database and the China Biomedical Literature Database. The cure rate and total effective rate are the main indicators, and the recurrence rate and adverse events are the secondary indicators. Meta-analysis using RevMan5.4 provided by Cochrane Collaboration.Results:This study will provide the latest evidence of efficacy for the acupuncture combined with TCM in the treatment of chronic prostatitis.Conclusion:The effectiveness of acupuncture combined with TCM for chronic prostatitis will be evaluated.Unique INPLASY number:INPLASY202130083.     

Traditional Chinese medicine Jianpi therapy in exercise-induced fatigue: A protocol for systematic review and meta-analysis

Background:Exercise-induced fatigue (EIF) is a common occurrence in sports competition and training. It may cause trouble to athletes’ motor skill execution and cognition. Although traditional Chinese medicine Jianpi therapy has been commonly used for EIF management, relevant evidence on the effectiveness and safety of Jianpi therapy is still unclear.Methods:Databases including PubMed, Embase, Web of Science, the Cochrane Library, SinoMed, China Science and Technology Journal Database (VIP), China National Knowledge Infrastructure (CNKI), and Wanfang will be searched for relevant randomized controlled trials from databases from 2000 to 2021. Randomized controlled trials related to traditional Chinese medicine Jianpi therapy in the treatment and management of EIF will be included. Systematic review and meta-analysis of the data will be performed in RevMan 5.3 according to the Preferred Reporting Items of Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Two authors independently performed the literature searching, data extraction, and quality evaluation. Risk of bias was assessed using the Cochrane Risk of Bias Tool for randomized clinical trials.Results:This systematic review and meta-analysis will summarize the latest evidence for traditional Chinese medicine Jianpi therapy in EIF. The results will be submitted to a peer-reviewed journal once completed.Conclusion:The conclusion of our research will provide evidence to support traditional Chinese medicine Jianpi therapy as an effective intervention for patients with EIF.OSF Registration DOI: 10.17605/OSF.IO/NRKX4.     

Comparative efficacy and safety of traditional Chinese patent medicine for cognitive dysfunction in diabetic cognitive dysfunction: A protocol for systematic review and Bayesian network meta-analysis

Background:More and more studies have shown that cognitive dysfunction is one of the main complications of diabetes. The disorder of glucose and lipid metabolism seriously damages brain function and accelerates the conversion to dementia. At present, there are no drugs that can directly treat diabetic cognitive dysfunction. All drugs for the treatment of this disease achieve the purpose of treatment through strict control of blood sugar levels. This method has great limitations. Traditional Chinese patent medicines (TCPMs) work through multiple targets and multiple pathways, which can not only effectively correct the state of glucose and lipid metabolism disorders, but also significantly improve cognitive ability, but there is a lack of systematic evaluation of their effectiveness and safety. We use the method of network meta-analysis to systematically and comprehensively compare the effectiveness and safety of different Chinese patent medicines.Methods:We will comprehensively search the following databases, including Web of Science, PubMed, The Cochrane Library, EMBASE, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Wanfang database and China BioMedical Literature. We will include all randomized controlled trials that meet the inclusion criteria, starting from the establishment of the database until September 2021. Two researchers will independently screen the literature based on inclusion criteria. While extracting data, we also assess the risk of bias in the included studies. All the data and evidence obtained will be evaluated by the method of Bayesian network meta-analysis.Results:This study will evaluate the effectiveness and safety of various TCPMs for diabetic cognitive dysfunction.Conclusion:The results of this study will provide valuable references for the clinical application of TCPMs, and assist clinicians in formulating more reasonable diagnosis and treatment strategies.Ethics and dissemination:This study does not require ethical approval.International Platform of Registered Systematic Review and Meta-analysis Protocols registration number:INPLASY202190008.     

Acupuncture combined with Chinese herbal medicine on non-alcoholic fatty liver disease: A protocol for systematic review and meta-analysis

Background:Non-alcoholic fatty liver disease (NAFLD) is a global health burden. However, there are no approved drugs for NAFLD. A number of studies have shown that acupuncture combined with Chinese herbal medicine (CHM) can be beneficial for NAFLD. However, high-quality trials are still lacking. Therefore, we aimed to conduct a systematic review and meta-analysis to assess the effectiveness and safety of acupuncture combined with CHM for NAFLD.Methods:Eight electronic databases including PubMed, the Cochrane Library, Web of Science, EMBASE, China National Knowledge Infrastructure, Chinese Scientific and Technical Journals Database, and Wan-fang Database from inception to November 2021 will be searched. We will also search for Clinical Trials Registry Platforms as a supplement. Randomized controlled trials on acupuncture combined with CHM for NAFLD will be included. Literature screening, data extraction, and risk of bias assessment were independently conducted by 2 reviewers. All differences between the 2 reviewers will be discussed and resolved by a third reviewer. Revman5.3 software will be used for meta-analysis.Result:This study aimed to evaluate the effectiveness and safety of acupuncture combined with CHM for NAFLD.Conclusion:The findings of this study will provide more evidence to determine whether acupuncture combined with CHM for NAFLD is an effective and safe intervention for NAFLD.     

Chinese herbal medicine for previous cesarean scar defect: A protocol for systematic review and meta-analysis

Background: Previous cesarean scar defect (PCSD) is a gynecological disease that can cause bleeding after intercourse, prolonging menstrual period, intermenstrual bleeding, dysmenorrhea, and even lead to infertility. Chinese herbal medicine plays an important role in the treatment of gynecological diseases in China and East Asia. This study aims to assess the efficacy and safety of Chinese herbal medicine for PCSD.Methods: We search the following databases: PubMed, the Cochrane Library, Chinese Biomedical Literature Database (CB), Chinese Science and Technique Journals Database (VIP), EMBASE, Chinese National Knowledge Infrastructure Database (CNKI), and the Wanfang Database. Other sources will also be searched like Google Scholar and gray literature. All databases mentioned above are searched from the start date to the latest version. Randomized controlled trials will be included which recruiting PCSD participants to assess the efficacy and safety of Chinese herbal medicines against controls (placebo or other therapeutic agents). Primary outcomes will include the size of PCSD, menstrual cycle, menstrual phase, menstrual volume, duration of disease, security index. Two authors will independently scan the searched articles, extract the data from attached articles, and import them into Endnote X8 and use Microsoft Excel 2013 to manage data and information. We will assess the risk of bias by Cochrane tool of risk of bias. Disagreements will be resolved by consensus or the participation of a third party. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. The meta-analysis in this review will use RevMan 5.3 software.Results: The study aims to evaluate the efficacy and safety of the treatment that Chinese herbal medicine for PCSD.Conclusion: This study of the meta-analysis could provide evidence for clinicians and help patients to make a better choice.INPLASY registration number:INPLASY202090080     

Acupuncture combined with traditional Chinese medicine preparation for the treatment of marrow suppression after chemotherapy: A protocol for systematic review and meta-analysis

Background:From the perspective of evidence-based medicine, the efficacy and safety of combined therapy for marrow suppression after chemotherapy is still unclear. Given that there is no high-quality meta-analysis to incorporate existing evidence, the purpose of this protocol is to design a systematically review and meta-analysis of the level I evidence to ascertain the efficacy and safety of acupuncture combined with traditional Chinese medicine preparation for marrow suppression after chemotherapy.Methods:The following databases will be searched electronically by keyword combination mode: 4 British literature databases including PubMed, EMBASE, Scopus, and Cochrane Library, and 4 Chinese literature databases, including Chinese national knowledge infrastructure, VIP, and Wan fang database. The randomized controlled trials on acupuncture plus traditional Chinese medicine preparation for marrow suppression after chemotherapy will be included. The primary outcome is the elevation of hemoglobin, platelets, leukocytes, and neutrophils. The other outcomes include clinical symptoms, quality of life, and absolute value of reticulocyte. Risk bias analysis of the studies will be performed independently by 2 reviewers using the Cochrane Risk of Bias Assessment Tool.Results:The review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings.Conclusion:This protocol will provide a reliable theoretical basis for the following research.     

External therapy of Chinese medicine for postherpetic neuralgia: A protocol for systematic review and meta-analysis

Background:Postherpetic neuralgia (PHN), the most common complication of herpes zoster, brings about a health-care burden at both the individual and societal levels. External therapy of Chinese medicine (ETCM) is an effective treatment of PHN generally available in China, yet there is incomplete evidence to evaluate the efficacy and safety of it.Methods:This protocol is based on the previous reporting items. We will search 3 English databases (PubMed, EMBASE, and the Cochrane Library) and 3 Chinese databases (CNKI, CBM, and Wan Fang Database) until January 2020. RCTs to evaluate the efficacy and safety of external therapy of Chinese medicine for postherpetic neuralgia will be included. The primary outcome will be assessed by VAS or NRS. We will use the criteria provided by Cochrane Handbook 5.3.0 for quality evaluation and risk assessment, and use the Revman 5.3 software for meta-analysis.Ethics and dissemination:Ethical approval is not required for systematic review and meta- analysis. The results of this review will be disseminated in a peer-review journal.PROSPERO registration number:CRD42020163511.     

Comparative efficacy and safety of traditional Chinese patent medicine in the treatment of Mycoplasma pneumoniae pneumonia in children: A protocol for systematic review and meta-analysis

Background:Mycoplasma pneumoniae pneumonia (MPP) is a common respiratory disease in children. Its incidence rate is increasing year by year. The drug resistance rate of macrolide antibiotics and other conventional treatment methods is higher, and there are limitations in clinical application. Traditional Chinese patent medicine (TCPM) is a powerful weapon to treat this disease. At present, there is no comparison of the safety and effectiveness of multiple TCPMs in the treatment of MPP in children. Therefore, we take the method of network meta-analysis to systematically compare the efficacy of various TCPMs in the treatment of this disease.Methods:We will conduct comprehensive searches of Cochrane Library, PubMed, Web of Science, Clinical Trials, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Chinese BioMedical Literature, Wanfang Database, and other electronic databases. The time frame is set from the establishment of the database to October 2020. All randomized controlled trials that meet the inclusion criteria will be included in this study. The 2 researchers will independently screen the literature according to the inclusion criteria, extract the data, and assess the bias risk of the included study. We will evaluate all the obtained data and evidence through Bayesian network meta-analysis, and use Stata 15.0 to process and analyze the data.Results:Through this study, we will evaluate the efficacy and safety of a variety of TCPMs for the treatment of MPP in children.Conclusion:The purpose of this study is to provide a strong reference for clinical application of TCPMs in the treatment of MPP in children, and to provide an important basis for clinicians to make correct judgments and put forward accurate treatment plans.Ethics and dissemination:This review does not involve any human or animal experiments and therefore does not require ethical approval.INPLASY registration number:INPLASY 2020100108