International Platform of Registered Systematic Review and Meta-analysis Protocols

Local interventions

Background:Chronic Obstructive Pulmonary Disease (COPD) is the most common respiratory disease in clinic. Traditional Chinese medicine (TCM) lung rehabilitation has gradually been valued in the field of prevention and treatment of COPD. Acupuncture, as an important part of TCM lung rehabilitation, is carried out in clinical extensively and application. It has the advantage of improving the symptoms and quality of life of COPD cases, but the evidence-based proof is limited.Methods:Eight databases will be systematically retrieved from their inceptions to December 2021. This study will include randomized controlled trials of acupuncture in the treatment of COPD with stable stage. The main outcome will include clinical effective rate, TCM symptom score, quality of life, dyspnea, exercise capacity, lung function, frequency of acute exacerbation, adverse events. Literature screening, quality evaluation and information extraction will be completed by two independent researchers. Revman 5.3 software will be used to perform meta-analysis. Assessment of multiple systematic reviews-2 tool will be used for evaluating the methodological quality of systematic review (SR), grading of recommendations assessment will for rating the quality of evidence, and consolidated standards of reporting trials and Standards for Reporting Interventions in Clinical Trials of Acupuncture tool will for assessing the reporting quality of randomized controlled trials.Results:The findings of this SR will be presented at relevant conferences and submitted for peer-review publication.Conclusions:The findings of this SR will provide up-to-date summary proof for evaluating the effectiveness and safety of acupuncture for COPD.

Background:Diabetic nephropathy (DN) is 1 of the most serious complications of diabetes mellitus and the leading cause of end-stage renal disease in the world. Huangkui capsule, extracted from Abelmoschus manihot (L.) medic (AM), has been widely used to treat DN. However, there is no consensus on the efficacy of Huangkui capsule for DN. This study aims to perform meta-analysis to systematically review the efficacy and safety of Huangkui capsule.Methods:The following 9 electronic databases will be comprehensively searched: PubMed, web of science, MEDLINE, Embase, Cochrane Library, China National Knowledge Infrastructure, Chinese Scientific Journals Database, Wanfang data, and Chinese BioMedicine Literature Database. The retrieval time is from their inception to May 2021. According to the inclusion and exclusion criteria, 2 reviewers independently completed the study selection, data extraction, risk of bias assessment, and data synthesis. Review Manager Version 5.3 software will be used to conduct meta-analysis.Results:This study provides a high-quality synthesis to assess the efficacy of Huangkui capsule for treating diabetic nephropathy.Conclusion:The result of this systematic review will provide objective evidence-based basis to judge the effectiveness and safety of Huangkui capsule on diabetic nephropathy.

Background:Knee osteoarthritis (KOA) is a common chronic joint disease with serious health economic burden. More and more randomized controlled trials have indicated that traditional Chinese non-pharmacological therapy, including acupuncture, Tai Chi, Tuina, etc can significantly improve pain and physical function of patients with KOA. However, the effects of traditional Chinese non-pharmacological therapy for KOA remain controversial. Most previous systematic reviews did not focus on the effects of traditional Chinese non-pharmacological therapy for KOA as a whole. In Chinese community hospital, however, acupuncture, Tuina, and Tai Chi are usually in the management of KOA as whole-body treatment.Methods:The electronic databases (PubMed, Embase, MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, China Knowledge Resource Integrated Database, and Wanfang Data) will be searched. The search will include all documents from their inception to December 2021. Two reviewers independently extracted the data and assessed the risk of bias by the Cochrane Risk of Bias Tool for randomized controlled trials. The meta-analysis will be conducted with a random or fixed effect model to calculate the standardized mean difference and 95% confidence intervals based on different heterogeneity using the Review Manager Version 5.3 software. The heterogeneity will be examined by Higgins I2 statistic. The subgroup analysis will be conducted based on different types of traditional Chinese non-pharmacological therapy and different outcomes. Quality of evidence will be assessed using the Grades of Recommendation, Assessment, Development and Evaluation.Results:The current systematic review and meta-analysis will be conducted to investigate the effects of traditional Chinese non-pharmacological therapy in the management of KOA. The main outcomes will include pain and disability. The secondary outcomes will include quality of life and adverse events.Conclusion:To provide evidence for evidence-based medicine and clinical researchers to choose more effective traditional Chinese non-pharmacological therapy for KOA.INPLASY registration number:INPLASY202170098.

Background:The intracerebral hemorrhagic stroke (ICH) is associated with high mortality and severe disability in survivors, which causing about 42% of the disability-adjusted life years lost and 50% of all stroke patients dead within 1 year. Although early functional training is recommended to facility rehabilitation after the stroke, the benefit and safety are still controversial.Introduction:This systematic review aims to investigate whether early physical rehabilitation could have a beneficial effect for the patients with ICH compared with standard rehabilitation care.Methods and analysis:Pubmed, Embase, and Cochrane library will be searched to include randomized control trials which investigate the rehabilitation effective of the early mobilization for patients with ICH compared with routine nursing or standard care. Rev-Man version 5.3 will be used to perform all calculations related to the meta-analysis. Dichotomous data will be calculated in terms of a fixed or random effect model and expressed by the relative risk (RR) with 95% confidence interval (CI). The Cochrane collaborations tool in the following aspects was used to assess the risk of bias (ROB) in included studies. The inconsistency index (I2) and Chi-Squared will be applied for heterogeneity detection between clinical trials. A value of P < .05 will be considered statistically significant.Conclusion:This study will explore the role of early physical rehabilitation and provide insight for clinicals to improve rehabilitation results of ICH.Registration number:INPLASY2020110068.

Background:We aim to study the treatment of vitiligo with fire needle.Methods:We will search PubMed, Embase, the Cochrane Library, the China National Knowledge Infrastructure, Chinese Science and Technology Periodical Database, Wanfang Database, and Chinese Biomedical Literature Database of randomized controlled trials beginning from their inception to August 2020. The primary outcomes is that Complex area of white spot and Percentage of Clinical Effectiveness will be accepted as the primary outcomes. Additional outcome is the safety assessment will be considered a secondary outcome. Two independent authors will based on the Cochrane system evaluation manual 5.1.0 version of randomized controlled trial bias risk assessment tool to evaluate the risk of bias among the final included studies. And we will use the RevMan 5.3 software to analysis data.Conclusion:This study will provide evidence to judge whether fire needle is an effective therapy for vitiligo.Inplasy registration number:INPLASY2020120012.

Oesophageal cancer is one of the most common malignant tumors and has been identified as one of the leading causes of cancer death worldwide. Surgery is considered to be the optimal treatment for patients with resectable oesophageal cancer. Oesophagectomy for oesophageal cancer can significantly extend the survival period of patients and provide a potential opportunity for a cure. However, there is still controversy regarding application of neck anastomotic muscle flap embedded. This systematic review and meta-analysis will be performed to determine whether the application of neck anastomotic muscle flap embedded would benefit patients more. We will search PubMed, Web of Science, Embase, Cancerlit, the Cochrane Central Register of Controlled Trials, and Google Scholar databases for relevant clinical trials published in any language before October 1, 2020. Randomized controlled trials (RCTs), quasi-RCTs, propensity score-matched comparative studies, and prospective cohort studies of interest, published or unpublished, that meet the inclusion criteria will be included. Subgroup analysis of the type of operation, tumor pathological stage, and ethnicity will be performed. INPLASY registration number: INPLASY202080059. The results of this study will be published in a peer-reviewed journal. As far as we know, this study will be the first meta-analysis to compare the efficacy of the application of neck anastomotic muscle flap embedded in 3-incision radical resection of oesophageal carcinoma. Due to the nature of the disease and intervention methods, RCTs may be inadequate, and we will carefully consider inclusion in high-quality, non-RCTs, but this may result in high heterogeneity and affect the reliability of the results.

Background:By now, the incidence of chronic kidney disease (CKD) is increasing. The development of various CKD is attributed to the continuous aggravation of renal interstitial fibrosis (RIF) in the process of end-stage renal disease (ESRD). Oral treatment of traditional Chinese medicine (TCM) is one of the therapies for RIF. Randomized controlled trials (RCTs) of TCM treatment RIF have been reported, but its effectiveness and safety have yet been systematically investigated. Therefore, through the systematic analysis and meta-analysis, our study will summarize the effectiveness and safety of oral treatment RIF of TCM, in order to provides scientific reference for clinical practice.Methods:This protocol follows Preferred Reporting Items for Systematic Evaluation and Meta-Analysis. RCTs will be only selected. Such databases as the PubMed, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Excerpt Medical Database (Embase), WanFan Data, Chinese Biomedical Literature Database (CBM), WHO International Clinical Trials Registry Platform will be searched from the inception to June, 2020 to collect the RCTs about taking TCM orally in treating RIF. The literature according to the inclusion and exclusion criteria, data-extracted and the methodological quality evaluated will be performed independently by 2 reviewers. The clinical outcomes including renal function indices (Scr, BUN, 24-hour urinary protein quantity) and Indicators of RIF (TGF-β1, Notch1, Jagged-1). The risk of bias included in the RCTs will be evaluated by the bias risk assessment tool provided in the Cochrane System Evaluation Manual 5.1.0. Review Manager 5.3 provided by the Cochrane collaboration network will be used to process the data.Results and conclusion:Some more targeted and practical results about the efficacy of taking TCM orally in RIF have been provided by our study. The available evidence suggests that the therapeutic effects of combining TCM with Western medicine therapies is much better for RIF than Western medicine therapies only.

Background:Diabetic gastroparesis (DG) is a common autonomic neuropathy which impacts on nutritional state and quality of life in diabetic patients, and it also adversely affects glycemic control in diabetes. The prevalence of DG is growing with the number of patients with diabetes continues to increase. However, there is no definitive answer as to which of the current therapies is the best for the clinical treatment of the different manifestations of DG. The subject of this study is to answer the following question: what is the best intervention for diabetic patients with gastroparesis?Methods:Comprehensive searches of the Cochrane Library, PubMed, Embase, Medline, Central and Web of Science, and 4 Chinese databases, including China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Chinese Biomedical Literature Database, and WanFang will be completed using the following keywords DG and therapies and related entry terms. Studies will be included, according to the eligibility criteria (randomized controlled trials and controlled clinical trials, considering specific outcome measures for DG). The reference lists of included studies will be manual searched. Relevant data will be extracted from included studies using a specially designed data extraction sheet. Risk of bias of the included studies will be assessed, and the overall strength of the evidence will be summarized through GRADE. A random effects model will be used for all pairwise meta-analyses (with a 95% confidence interval). A Bayesian network meta-analysis will explore the relative benefits between the various therapies. The review will be reported using the Preferred Reporting Items for Systematic Reviews incorporating Network Meta-Analyses statement. Network meta-analysis will be performed using a Bayesian framework through the Winbugs software.Results:This network meta-analysis will identify the best effective therapy for DG.Conclusion:This study will compare and evaluate current therapies for DG, and find the best treatment of DG.