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     

Clinical safety and outcome of recombinant tissue plasminogen activator in patients with stroke attributable to small artery occlusion: A protocol for systematic review and meta-analysis

Background:Recent observations raised concern that the intravenous recombinant tissue plasminogen activator (rt-PA) may result in damage to stroke patients caused by small artery occlusion (SAO). Thus, we perform a protocol for meta-analysis to investigate the efficacy and safety of intravenous thrombolysis with rt-PA in SAO-patients.Methods:The search-style electronic libraries, including Pubmed, Embase, the Cochrane Library, Web of Science, Wanfang Data, VIP Chinese Journals, and China Biomedical Literature Service System are used for document retrieval in June 2021 with no restrictions on language. The risk of bias in include articles will be assessed using the Cochrane Risk of Bias Tool. We perform the meta-analysis by Stata version 10.0 software and calculated the statistics using the inverse variance statistical method. Binary outcomes are presented as Mantel-Haenszel-style risk ratios with 95% confidence interval. Continuous outcomes are reported as mean differences.Results:The results of the article will be shown in a peer-reviewed journal.Conclusion:Intravenous rt-PA may be effective and safe in SAO-patients.     

The efficacy and safety of Tuina for diabetic gastroparesis: A protocol for systematic review and meta-analysis

Background:Diabetic gastroparesis (DGP) is one of the most common complication of diabetes. At present, despite the increasing number of clinical researches of treatment with Tuina have been reported, there are no systematic reviews of Tuina therapy for DGP. Therefore, it is of great significance to evaluate its safety and efficacy as a complementary and alternative therapy.Methods and analysis:Randomized controlled trials (RCTs) of Tuina therapy in the treatment of DGP will be retrieved from PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wan Fang Database (Wan Fang), Chinese Biomedical Literature Database (CBM), VIP Database for Chinese Technical Periodicals (VIP), Medline, and Clinical Trial Register (CTR). We will consider articles published in English or Chinese between database initiation and October 2021. Research selection, data extraction, risk of bias assessment, and meta-analyses will be independently completed by 2 researchers. Our researchers will use Revman 5.3 software, provided by the Cochrane Collaborative Network for conducting systematic reviews and meta-analysis.Results:This systematic review provides a high-quality synthesis to assess the effectiveness and safety of Tuina therapy for treating DGP.Conclusion:The conclusions of our study will provide evidence to determine whether Tuina therapy is an effective and safe intervention for patients with DGP.Systematic review registration: INPLASY2021110019     

Efficacy and safety of Shufeng Jiedu capsule in the treatment of COVID-19: A protocol for systematic review and meta analysis

Background:Coronavirus disease 2019 (COVID-19) epidemic is spreading worldwide. Shufeng Jiedu capsule (SFJDC) is a commonly used drug in the treatment of COVID-19. However, there is insufficient evidence for clinical efficacy and safety.Methods:Two authors will independently search the Chinese National Knowledge Infrastructure (CNKI), VIP database, Wanfang database, the Cochrane Library, EMBASE, PubMed and Web of Science, in English and Chinese. All analysis will be performed based on the Cochrane Handbook for Systematic Reviews of Interventions. Review Manager 5.3 and Stata 16.0 software will be used to analyze the eligible data.Results:This protocol will conduct a systematic review and meta-analysis of literature listed above, and reliable outcomes about the clinical efficacy and safety of SFJDC in the treatment of COVID-19 will be obtained.Conclusions:These findings will provide guidance for clinicians and patients using SFJDC for COVID-19 treatment.PROSPERO Registration Number:CRD42020185764.     

Effects of eye-acupuncture combined with rehabilitation training for poststroke dyskinesia: A protocol for systematic review and meta-analysis

Introduction:Poststroke dyskinesia is the most common clinical symptom after stroke, which greatly affects the patients’ daily life. Eye-acupuncture is an effective method for stroke. And the rehabilitation training has been widely used for patients suffer from stroke. However, whether eye-acupuncture combined with rehabilitation training has greater clinical efficacy for poststroke dyskinesia is still unknown. Our aim in this systematic review was to evaluate the clinical efficacy of eye-acupuncture combined with rehabilitation training (EACRT) as a treatment for dyskinesia after stroke.Methods and analysis:We will search the following 4 databases of registered trials and 7 electronic databases from inception to March 2021:Cochrane Stroke Group, Cochrane Central Register of Controlled, the World Health Organization International Clinical Trials Registry Platform, the Chinese Clinical Trial Registry; PubMed, MEDLINE, Embase, CNKI, VIP, WanFang, and CBM. All relevant randomized controlled trials focus on EACRT will be included. The primary outcome will be the Fugl-Meyer Assessment. The Secondary outcomes will include Activity of Daily Living, clinical effective rate and the Visual Analogue Score. Two reviewers will independently conduct the Study selection and data extraction. The data synthesis and assessment of risk of bias will be performed by RevMan5.2.Ethics and dissemination:The ethical approval is unnecessary that systematic review is based on published articles other than patients. The results of this meta-analysis will be published in an open access (OA) journal according to the Preferred Reporting Item for Systematic Review and Meta-analysis (PRISMA).PROSPERO registration number:CRD42020168278.     

Efficacy and safety of pasireotide for Cushing's disease: A protocol for systematic review and meta-analysis

Background:Cushing''s disease (CD) is associated with increased risk of mortality, myocardial infarction, stroke, peptic ulcers, fractures and infections. The prevalence of CD is nearly 40 per million and higher in women than in men. When surgery has failed, is not feasible, or has been refused, pharmacotherapy can be considered a valuable option. Pasireotide is the first medical therapy officially approved for adult patients with CD. We will conduct a comprehensive systematic review and meta-analysis to systematically evaluate the efficacy and safety of pasireotide for CD.Methods:Five English databases (PubMed, Web of Science, Embase, Cochrane Library, and OVID) and 3 Chinese databases (China National Knowledge Infrastructure, China Science and Technology Journal Database, and Chinese Biomedical Literature Database) will be searched from their respective inception of databases to December 2020. Two reviewers will select articles, extract data and assess the risk of bias independently. Any disagreement will be resolved by discussion with the third reviewer. Review Manager 5.3 software will be used for data synthesis. The Cochrane risk of bias assessment tool will be used to evaluate the bias risk.Results:This systematic review and meta-analysis will conduct a comprehensive literature search and provide a systematic synthesis of current published data to explore the efficacy and safety of pasireotide for CD.Conclusions:This systematic review and meta-analysis will provide clinical evidence for the efficacy and safety of pasireotide for CD, and inform our understanding of the value of pasireotide in improving CD clinical signs and symptoms. The conclusions drawn from this study may be beneficial to patients, clinicians, and health-related policy makers.Study registration number:INPLASY2020110070.     

Effect of thrombolysis in a mobile stroke unit versus in hospital for patients with ischemic stroke: A protocol for systematic review and meta-analysis of randomized controlled trials

Introduction:Ischemic stroke caused by arterial occlusion is the cause of most strokes. The focus of treatment is rapid reperfusion through intravenous thrombolysis and intravascular thrombectomy. Two acute stroke management including prehospital thrombolysis and in hospital have been widely used clinically to treat ischemic stroke with satisfied efficacy. However, there is no systematic review comparing the effectiveness of these 2 therapies. The aim of this study is to compare the effect of prehospital thrombolysis versus in hospital for patients with ischemic stroke.Methods and analysis:The following electronic databases will be searched: Web of Science, PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), China Biology Medicine disc (CBM), Wanfang Database, and Chinese Scientific Journal Database.The randomized controlled trials of prehospital thrombolysis versus in hospital for ischemic stroke will be searched in the databases from their inception to December 2020 by 2 researchers independently. Onset to therapy (OTT) duration and National Institute Health Stroke Scale (NIHSS) scores will be assessed as the primary outcomes; safety assessment including intracerebral hemorrhage (ICH) and mortality will be assessed as the secondary outcomes. The Review Manager 5.3 will be used for meta-analysis and the evidence level will be assessed by using the method for Grading of Recommendations Assessment, Development and evaluation Continuous outcomes will be presented as the weighted mean difference or standardized mean difference with 95% confidence interval (CI), whereas dichotomous data will be expressed as relative risk with 95% CI. If heterogeneity existed (P < .05), the random effect model was used. Otherwise, we will use the fixed effect model for calculation.Ethics and dissemination:Ethical approval is not required because no primary data are collected. This review will be published in a peer-reviewed journal.PROSPERO registration number:CRD42020200708     

Efficacy and safety evaluation of bright light therapy in patients with post-stroke insomnia: A protocol for systematic review and meta-analysis

Background:Post-stroke insomnia (PSI) is a common and severe illness among the complications of stroke. Although there are plenty of drugs currently used for PSI treatment, they generate several side effects and other problems. Bright light therapy (BLT) is thought to be relatively safe and effective in treating PSI patients. Despite this, there is still a lack of systematic review on BLT in the treatment of PSI. Allowing for this, the aim of this study is to assess the efficacy and safety of BLT for PSI.Methods:The meta-analysis and systematic review will perform a comprehensive electronic search for items fulfilling the required criteria in Web of Science, Google Scholar, Wan Fang database, MEDLINE, Baidu Scholar, PubMed, SinoMed, Embase, Chinese Biomedical Literature Database (CBM), China national knowledge infrastructure database (CNKI), Cochrane Library Central Register of Controlled Trials (CENTRAL), and Wei Pu database from establishment to January 1, 2022. We will select articles, collect data, and assess the methodology quality. And we will set the primary outcome and secondary outcomes in this research. RevMan 5.3 software will be used to analyze the data for this investigation.Results:The work of this research will be published in peer-reviewed scientific journals.Conclusion:The aim of this study is to assess the efficacy and safety of BLT for PSI and present robust scientific evidence concerning BLT for PSI.Registration:INPLASY2021100065.     

Acupuncture and massage combined with rehabilitation therapy for hemiplegia after stroke: A protocol for systematic review and meta-analysis

Background:The purpose of this study was to evaluate the effectiveness and safety of acupuncture and massage combined with rehabilitation in the treatment of hemiplegia after stroke.Methods:To collect relevant literature, we will research following databases: Medicine, PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure, Wan-Fang Database, Chongqing VIP Chinese Science and Technology Periodicaols Database, and China Biomedical Database; the time is from its creation to May 2021, and the language is limited to Chinese and English. In addition, we will retrieve other literature resources, including the Chinese Clinical Trial Register and conference articles. Two reviewers will independently complete the literature screen and data extraction and quality assessment of the included studies will be independently completed by two other researchers. The primary outcomes included the Modified Ashworth scale and the simplified Fugl-Meyer Assessment scale. The Modified Barthel Index, the China Stroke Scale, and adverse reactions as secondary outcomes were assessed. RevMan V.5.4.1 software will be used for meta-analysis, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) will be used to assess the quality of evidence.Results:This systematic review will provide a high-quality synthesis to evaluate the efficacy and safety of acupuncture and massage combined with rehabilitation in the treatment of hemiplegia after stroke, providing a reference for the safe and effective treatment of hemiplegia after stroke.Conclusion:This study provides evidence that acupuncture and massage combined with rehabilitation therapy is effective.Ethics and dissemination:The protocol of the systematic review does not require ethical approval because it does not involve humans. This article will be published in peer-reviewed journals and presented at relevant conferences.Systematic review registration:INPLASY202210026.     

The effect of trifluridine/tipiracil for patients with heavily pretreated metastatic gastric cancer: A protocol for systematic review and meta-analysis

Background:Gastric cancer is a global health problem with high incidence rate and mortality rate. Due to the limitations of traditional chemotherapy drugs, such as patient intolerance, low efficacies and serious adverse effects, trifluridine/tipiracil has been considered to be a promising treatment for patients with heavily pretreated metastatic gastric cancer. However, the relevant systematic review has not been occurring. The presentation of this protocol is to scientifically evaluate the efficacy and safety of trifluridine/tipiracil in patients with highly pretreated metastatic gastric cancer.Methods:The protocol followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. We will systematically search MEDLINE, PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure Database (CNKI), VIP Chinese Science and Technology Periodical Database (VIP), Wan Fang Database up to November 1, 2020 to identify published articles. Using the Cochrane risk assessment tool to assess the methodological quality of the RCTs, and all included studies will be analyzed according to the criteria in the Cochrane Handbook. Review Manager 5.3 software will be used for literature quality evaluation and data analysis.Results:Objective to evaluate the efficacy and safety of trifluridine/tipiracil in patients with heavily pretreated metastatic gastric cancer by analyzing the eligible data extracted under limited conditions.Conclusion:This study provides clear evidence to evaluate the effectiveness and safety of trifluridine/tipiracil for patients with highly pretreated metastatic gastric cancer, and the findings will also be published in a peer-reviewed journal.Ethics and dissemination:No ethical statement will be required for this study because there is no direct involvement of human. This review will be published in a peer-reviewed journal as a conference report or an article.Registration:OSF registration number: DOI 10.17605/OSF.IO/6MF5U.     

Tuina combined with physical therapy for spasticity of poststroke: A protocol for systematic review and meta-analysis

Background:Limb spasms are a common complication of stroke. It not only affects the quality of life of stroke survivors, but also brings an economic burden. Tuina combined with physical therapy is widely used in the rehabilitation of poststroke spasticity. However, there is no supporting evidence for its efficacy and safety. This study aimed to evaluate the effectiveness and safety of Tuinas combined with physical therapy in the treatment of spasticity after stroke.Methods:Literature will be collected from the following databases: China Biology Medicine (CBM), Wanfang Database, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), PubMed, Embase, Cochrane Library, and Web of Science; We will include randomized controlled trials of Tuina combined with physical therapy for poststroke spasticity range from the establishment to May 1, 2021. There were no limitations to the publication time, and the language was limited to Chinese and English. The primary outcome was evaluated using the Modified Ashworth scale, and the secondary outcomes were the simplified Fugl-Meyer Assessment scale, Modified Barthel Index, Functional Independence Measurement (FIM), and Visual Analog Scale. RevMan V.5.4.1 software was used for the meta-analysis. The Cochrane Intervention System Evaluation Manual analyzes the risk of bias, and the recommended grading assessment, development and evaluation are used to assess the quality of evidence.Ethics and dissemination:This study will be based on published systematic review studies, no ethical approval is required and the results of the study will be published in a peer-reviewed scientific journal.Systematic review registration:INPLASY2021110064.     

Influence of aromatic essential oil nursing on mental state of patients undergoing laparoscopic cholecystectomy: A protocol for systematic review and meta-analysis

Background:There are no evidence-based data to confirm the efficacy of aromatic essential oil nursing in patients after laparoscopic cholecystectomy (LC). Therefore, in order to provide new evidence-based medical evidence for clinical treatment, we undertook this protocol for systematic review and meta-analysis to assess the effectiveness and safety of aromatic essential oil nursing on mental state of patients undergoing LC.Methods:The retrieval strategy will be developed by the evidence-based medicine librarians for the US Library of Medicine database, the Cochrane Database of Systematic Reviews, and the Excerpta Medica database. The databases will be searched between June 2022 and July 2022. Studies will be included according to the following criteria: study population undergoing LC; group with aromatic essential oil nursing compared to a control group; outcome measures including anxiety, salivary cortisol, alpha amylase, and patient satisfaction; randomized controlled trials. All data will be analyzed using R version 3.4.3 to calculate pooled standardized mean differences for outcomes. The Cochrane Collaboration''s tool will be used to assess the risk of bias for each included article.Results:The results of this paper will fill a gap in the literature regarding this project.Conclusion:We assume that the aromatic essential oil nursing has a positive effect.Registration number:10.17605/OSF.IO/E5WC9.     

Comparative efficacy and safety of Chinese herbal medicine for knee osteoarthritis: A protocol for systematic review and network meta-analysis

Background:Knee osteoarthritis (OA) is a major public health concern causing chronic disability as well as a substantial burden on health care and the economy. However, effective treatments for knee OA were still not available. Numerous clinical studies have suggested that Chinese herbal medicine (CHM) seems to be clinically effective in treating knee OA. Thus, this study aims to evaluate the efficacy and safety of CHM in the treatment of knee OA through a systematic review and network meta-analysis.Methods:A comprehensive search will be performed in PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database, Chinese Biomedical Database, and 3 clinical trials registration websites, from the database inception to May 2021. Randomized controlled trials meeting the eligible criteria based on the PICOS framework will be included. All studies fulfilling the eligible criteria will be assessed for risk of bias using the Cochrane Collaboration''s tool. The primary outcome will be the visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index, and total effective rate. The secondary outcome is the incidence of adverse events. Data analysis will be performed using Stata, Addis, and WinBUGS.Discussion:This study will provide a reliable evidence to assess effectiveness and safety of CHM for knee OA, which may provide guidance for clinical practice.Systematic review registration:This study protocol has been registered on INPLASY202160060.     

Banxia Xiexin Decoction in the treatment of Hp-associated peptic ulcer: A protocol for systematic review and meta-analysis

Background:Studies suggested Banxia Xiexin Decoction is effective in the treatment of helicobacter pylori (HP) positive peptic ulcer. The present meta-analysis aimed at evaluating the efficacy and safety of Banxia Xiexin decoction in the treatment HP positive peptic ulcer.Methods:We will search PubMed, Web of Science, Cochrane Library, and Chinese biomedical databases from their inceptions to the November 30th, 2020. Two authors will independently carry out searching literature records, scanning titles and abstracts, full texts, collecting data, and assessing risk of bias. Review Manager 5.2 and Stata14.0 software will be used for data analysis.Results:This systematic review will determine the efficacy and safety of Banxia Xiexin decoction in the treatment HP positive peptic ulcer.Conclusion:Its findings will provide helpful evidence for the efficacy and safety of Banxia Xiexin decoction in the treatment HP positive peptic ulcer.Systematic review registration:INPLASY2020120002.     

Efficacy and feasibility of deep brain stimulation for patients with depression: A protocol for systematic review and meta-analysis

Background:Previous meta-analyses have examined the clinical efficacy and acceptability of deep brain stimulation (DBS) compared with sham therapy or paired active therapy. However, the absence of head-to-head clinical trials with some treatment comparisons creates uncertainty for decision makers. Thus, to provide new evidence-based medical evidence for clinical treatment, we undertook a meta-analysis to assess the efficacy and safety of DBS in patients with depression based on high-quality randomized controlled studies.Methods:The protocol was written following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement guidelines. PubMed/Medline and EMBASE will be searched before May 2021 for all studies, using various combinations of the following free text and key terms: deep brain stimulation; depression; random. No language restrictions will be applied. The method of data extraction will follow the approach outlined by the Cochrane Handbook for Systematic Reviews of Interventions. Review Manager software 5.3 is used for the meta-analysis. The quality of randomized trials will be assessed by Cochrane risk of bias tool for randomized controlled trials.Results:The results of our review will be reported strictly following the PRISMA criteria and the review will add to the existing literature by showing compelling evidence and improved guidance in clinic settings.OSF registration number:10.17605/OSF.IO/Q5B3S.     

Efficacy and safety of fire acupuncture for psoriasis vulgaris: A protocol of systematic review and meta-analysis of randomized clinical trials

Introduction:Fire acupuncture is commonly used for the treatment of psoriasis vulgaris, but the efficacy and safety of fire acupuncture for psoriasis vulgaris remain unclear.Methods:This systematic review and meta-analysis will be conducted and reported strictly according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Five databases including China National Knowledge Infrastructure (CNKI), Wanfang, VIP, Chinese biomedical literature, and Pubmed will be retrieved for potentially eligible studies from their inception to Jan. 2021. All randomized clinical trials comparing fire acupuncture versus no fire acupuncture in the treatment of psoriasis vulgaris will be retrieved and assessed for inclusion. RevMan5.3 software provided by Cochrane collaboration will be used for the analysis. Randomized Clinical Trials Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews of Interventions. The primary endpoint is the total effective rate, the secondary outcomes are the Psoriasis Area Severity Index (PASI) score, the recurrence rate and the adverse reactions.Results:This study will systematically evaluate the efficacy and safety of fire acupuncture for psoriasis vulgaris. The results will be published in a peer-reviewed journal.Conclusion:This systematic review will evaluate the effects of fire acupuncture in patients with psoriasis vulgaris, thus providing evidence to the clinical application of this therapy.     

Different materials of cranioplasty for patients undergoing decompressive craniectomy: A protocol for systematic review and network meta-analysis

Background:Cranioplasty is widely applied on patients who has undergone decompress craniectomy (DC) due to intractable increased intracranial pressure and the cranioplasty materials have been on the bleeding edge of biomolecular and material science. This systematic review and network meta-analysis (NMA) will be conducted to comprehensively evaluate the safety and efficacy of different cranial implants for patients with cranial defects due to various reasons.Methods and analysis:This protocol has been reported following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. The following electronic databases will be searched from the date of database establishment to September 1, 2020: PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, VIP, and Wanfang. Randomized controlled trials and non-randomized prospective studies focus on cranial implants will be included. Quality assessment will be conducted using Cochrane Collaboration''s tool or risk of bias in nonrandomized studies of interventions based on their study designs. The primary outcome will be postoperative early mortality and implant failure while various complications for secondary outcomes. Pairwise and network meta-analysis will be conducted using STATA V.14 (StataCorp, College Station, Texas, USA). Subgroup analyses and sensitivity analyses will be conducted to assess the robustness of the results.Ethics and dissemination:This systematic review does not require an ethics approval or the need to obtain informed consent. The results will be published in a peer-reviewed scientific journal.Protocol registration number:INPLASY 202110001.