The International Journal Of Risk & Safety In Medicine[JOURNAL]
Sun
200 papers
Treatment of microcirculation dysfunction in type 2 diabetic mellitus with Shenqi compound prescription: A protocol of systematic review and meta-analysis of randomized clinical trials.
Zhong M, Song X, Zhang X … +6 more , Chen J, Wang L, Xia J, Tang X, Chen QI, Yang B
Medicine (Baltimore) · 2020 Oct · PMID 33031271 · Full text
INTRODUCTION: Type 2 diabetic mellitus (T2DM) is a chronic disease. In 2013, the International Diabetes Federation showed that the total number of diabetic patients aged 20 to 79 years in China was 89 million, and it is...
INTRODUCTION: Type 2 diabetic mellitus (T2DM) is a chronic disease. In 2013, the International Diabetes Federation showed that the total number of diabetic patients aged 20 to 79 years in China was 89 million, and it is expected to increase to 143 million by 2035. The incidence of T2DM and its complications in patients with blood glucose is gradually increasing, and there are low awareness rate, low diagnosis rate and high disability rate, which has become a global public health problem. Microcirculation Dysfunction in Type 2 diabetic mellitus (MDT2DM) plays an important role in the development of diabetic nephropathy, diabetic retinopathy, diabetic neuropathy and diabetic foot disease. It is 1 of the common etiological mechanisms of diabetic chronic complications. Patients with MDT2DM, serious complications, increase the quality of life of patients with social impact. Diabetic lower extremity microcirculation disease (dlemd) is the main cause of the occurrence, development and difficult healing of diabetic foot. Microvascular disease is microcirculation dysfunction. It has been proved that Shenqi compound prescription can treat T2DM macrovascular disease and microvascular dysfunction. However, due to the lack of evidence and no specific methods or suggestions, it is necessary to conduct a systematic evaluation of Shenqi compound prescription to provide effective evidence for further research. METHODS AND ANALYSIS: The following databases will be searched from their inception to August 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and China National Knowledge Infrastructure. PRIMARY OUTCOMES:: superoxide dismutase, malondialdehyde, C-reactiveprotein, HOMA-IR, advanced glycation end products , FPG, 2hBG, glycosylated hemoglobinA1c, fasting insulin ; ADDITIONAL OUTCOMES:: low density lipoprotein, high density lipoprotein, triglycerides, total serum cholesterol. 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. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the efficacy and safety of Shenqi compound prescription in treating patients with MDT2DM CONCLUSION:: The systematic review of this study will summarize the current published evidence of Shenqi compound prescription in the treatment of MDT2DM, and further guide its popularization and application. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. OPEN SCIENCE FRA MEWORK (OSF) REGISTRATION NUMBER: August 24, 2020.osf.io/es6z7. (https://osf.io/es6z7).
The efficacy and safety of auricular point combined with moxibustion for insomnia: A protocol for systematic review and meta-analysis.
Jin R, Wang X, Lv Y … +4 more , Xu G, Yang C, Guo Y, Li X
Medicine (Baltimore) · 2020 Oct · PMID 33031258 · Full text
BACKGROUND: Insomnia is a common sleep disorder, which seriously affects people's quality of life and work ability. In China, auricular therapy and moxibustion therapy have a long history in treating insomnia. Clinical s...
BACKGROUND: Insomnia is a common sleep disorder, which seriously affects people's quality of life and work ability. In China, auricular therapy and moxibustion therapy have a long history in treating insomnia. Clinical studies have shown that auricular point and moxibustion can effectively improve insomnia symptoms. At present, auricular point combined with moxibustion in the treatment of insomnia has been widely used in China, but its overall effectiveness and safety are still unclear. There is a lack of systematic evaluation of auricular point combined with moxibustion in the treatment of insomnia. This paper aims to evaluate the efficacy and safety of auricular point combined with moxibustion in the treatment of insomnia. METHODS: Retrieve randomized controlled trials of auricular point combined with moxibustion from PubMed, EMbase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, WanFang, the Chongqing VIP Chinese Science and Technology Periodical Database, and China biomedical literature database from their establishment to August 2020. Search Baidu Scholar, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry for unpublished gray literature. Two researchers independently applied RevMan 5.3 software for data extraction and risk assessment of bias. RESULTS: This study evaluated the efficacy and safety of auricular point combined with moxibustion in the treatment of insomnia from Pittsburgh sleep quality index, Rhone planck sleepiness scale, Traditional Chinese medicine syndrome scores, Hamilton anxiety scale (HAMA), Hamilton Depression, 5-hydroxytryptamine, incidence of adverse reactions, and other aspects. CONCLUSION: This study will provide theoretical support for the clinical application of auricular point combined with moxibustion in the treatment of insomnia. ETHICS AND DISSEMINATION: The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/8VZRJ.
Effectiveness and safety of traditional Chinese medicine Shaoyao Gancao Tang for the treatment of restless leg syndrome: A protocol for systematic review and meta-analysis.
Chen Y, Huang W, Liu L … +5 more , Tumilty S, Liu D, You Y, Zheng C, Baxter GD
Medicine (Baltimore) · 2020 Oct · PMID 33019415 · Full text
BACKGROUND: A growing body of clinical trials has demonstrated that traditional Chinese medicine Shaoyao Gancao Tang may improve restlessness leg syndrome (RLS). This review aims to systematically assess its effectivenes...
BACKGROUND: A growing body of clinical trials has demonstrated that traditional Chinese medicine Shaoyao Gancao Tang may improve restlessness leg syndrome (RLS). This review aims to systematically assess its effectiveness and safety in the treatment of patients with RLS. METHODS: Eight databases will be searched from the inception to 31 August 2020, including the Chinese Biological Medicine Database, China National Knowledge Infrastructure, Wanfang Database, VIP Information Database, the Cochrane Library, PubMed, EMBASE, and the Web of Science. All published randomized controlled trials that meet the prespecified eligibility criteria will be included. The primary outcomes include the changes in the International Restless Legs Syndrome Rating Scale and the restless sensation assessed by visual analog scales, and the secondary outcomes include effective rate, adverse event rate, quality of life measures, and improvement in the sleep quality index. Study selection, data extraction, and assessment of bias risk will be conducted independently by 2 reviewers. Data synthesis will be carried out with RevMan software (V.5.3.5). Subgroup and sensitivity analysis will be performed when necessary. The strength of the evidence will be assessed by the Grading of Recommendations Assessment, Development and Evaluation System. RESULTS: A high-quality synthesis of current evidence of Shaoyao Gancao Tang's effectiveness and safety for patients with RLS will be provided. CONCLUSION: This systematic review will provide evidence of whether Shaoyao Gancao Tang is an effective and safe intervention for RLS.
Acupuncture for pain relief of women undergoing transvaginal oocyte retrieval: A meta analysis and systematic review protocol.
Guo XL, Li X, Wei W … +4 more , Wang RR, Xiao F, Liu LY, Xu J
Medicine (Baltimore) · 2020 Sep · PMID 32991459 · Full text
BACKGROUND: Pain during oocyte retrieval, which can make the in-vitro fertilization process an unpleasant experience, is becoming a common problem. Although there are many analgesic methods available in the clinical sett...
BACKGROUND: Pain during oocyte retrieval, which can make the in-vitro fertilization process an unpleasant experience, is becoming a common problem. Although there are many analgesic methods available in the clinical setting, they are not therapeutically equivalent, and some are associated with varying adverse reactions. In recent years, acupuncture analgesia has been used in the perioperative period of oocyte retrieval because of its perceived efficacy and safety. The purpose of this systematic review and meta-analysis is to provide evidence that acupuncture is effective in the treatment of vaginal oocyte retrieval pain. METHODS: Electronic searches of the following six databases will be conducted by two qualified reviewers: MEDLINE, EMBASE, China National Knowledge Infrastructure, Chinese Biomedical Medicine database, VIP database and Wanfang database. Three clinical trial registries will also be searched: World Health Organization International Clinical Trial Registry Platform, Chinese Clinical Trial Registry, Cochrane Central Register of Controlled Trials and ClinicalTrials.Gov. All searches will cover the period from inception of the database/registry to March 2020 and will be limited to publications in English and Chinese. Data identification, data selection, data extraction, and bias risk assessment will be conducted independently by3ν two or more qualified reviewers, including those who selected the studies. Visual analogue scale scores will be calculated as the primary outcome. Secondary outcomes will include results of other subjective pain rating scales, including Likert scales or other defined numerical or non-numerical scales, self-assessed by patients before, during, and after oocyte retrieval. We will use STATA software (Version 16) to perform meta-analyses, and the Grading of Recommendations, Assessment, Development and Evaluations framework to grade the quality of evidence. If quantitative analysis is not available, a systematic narrative synthesis will be provided. PROSPERO REGISTRATION NUMBER: CRD42020170095.
Acupuncture and related techniques for restless legs syndrome: A protocol for systematic review and meta-analysis.
Xiang J, Li H, Xiong J … +6 more , Hua F, Huang S, Jiang Y, Qiang H, Xie F, Wang M
Medicine (Baltimore) · 2020 Sep · PMID 32991412 · Full text
BACKGROUND: Restless legs syndrome (RLS) is a common sensory disorder of the nervous system, which often affects the sleep quality of patients. Acupuncture and related techniques are increasingly used to treat neurologic...
BACKGROUND: Restless legs syndrome (RLS) is a common sensory disorder of the nervous system, which often affects the sleep quality of patients. Acupuncture and related techniques are increasingly used to treat neurological diseases, but their efficacy and safety for RLS are yet to be established. The purpose of this study is to summarize the effectiveness and safety of acupuncture and related techniques for RLS. METHODS: We will conduct a comprehensive data retrieval, and the electronic databases will include PubMed, Embase, Cochrane Library, WangFang Database, China National Knowledge Infrastructure, Chinese Scientific Journal Database, Chinese Biomedical Literature Database, from establishment to October 2020. We will also manually search unpublished studies and references, and contact lead authors. Randomized clinical trials (RCTs) of acupuncture and related techniques for RLS will be included. The outcomes of interest include: The total effective rate and International Restless Leg Syndrome rating scale (IRLS), Pittsburgh Sleep Quality Index (PSQI), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), adverse events, quality of life. To assess the methodological quality, we will use the Cochrane risk assessment tool. RevMan 5.3.5 software will be used to conduct data synthesis. The evidence quality of each outcome will be appraised according to Grades of Recommendation, Assessment, Development, and Evaluation (GRADE). RESULTS: The results will be published in a peer-reviewed journal. CONCLUSION: This study will provide a high-quality evidence to evaluate the efficacy and adverse reactions of acupuncture and related techniques for RLS. PROSPERO REGISTRATION NUMBER: CRD42020157957.
The effectiveness and safety of Tanreqing Injection combined with ganciclovir on the treatment of respiratory syncytial virus pneumonia in children: A protocol for systematic review and meta-analysis of randomized controlled trials.
Zhu WJ, Zhou X, Cao J … +1 more , Shi Y
Medicine (Baltimore) · 2020 Sep · PMID 32957408 · Full text
BACKGROUND: Based on the Theory of Traditional Chinese Medicine, this study systematically evaluated the effectiveness and safety of Chinese medicine preparation Tanreqing injection combined with ganciclovir on the treat...
BACKGROUND: Based on the Theory of Traditional Chinese Medicine, this study systematically evaluated the effectiveness and safety of Chinese medicine preparation Tanreqing injection combined with ganciclovir on the treatment of respiratory syncytial virus pneumonia in children, and provided new ideas and methods for the treatment of respiratory syncytial virus pneumonia (RSVP) in children. At the same time, it also studies the effectiveness and safety of the combination of Chinese and Western medicine on the treatment of related diseases from the direction of evidence-based medicine. METHODS: The relevant literature was searched by the computer in the electronic network databases, the retrieved databases include Chinese database and English database, English database includes PubMed, Cochrane Library, Embase and Web of Science. Chinese database includes: CNKI, SinoMed, WangFang Date, VIP and other networks electronic full-text database, conducting a randomized controlled trial of Tanreqing Injection combined with ganciclovir (study group) and ganciclovir alone (control group) on the treatment of RSVP in children and the retrieval time limit is set from the establishment of each database to July 1, 2020. According to the inclusion and exclusion criteria, the literature is independently searched and screened by 2 researchers, and conducting the full-text retrieval and evaluation of the research to be included, and extracting the information and checking it after reading the full-text; In case of disagreement, a third researcher will be invited to participate, and the decision is made after discussion by the 3 researchers. They were using the bias risk assessment tool provided by the Cochrane Handbook for Systematic Reviews of Interventions 3.0.2 to evaluate the selected literature. They were using RevMan 5.3 statistical software to conduct statistical analysis. RESULTS: This study will be carried out in full accordance with the steps of systematic review as required in the Cochrane Handbook for Systematic Reviews of Interventions. All research results will be published publicly in international academic journals with peer review. CONCLUSION: After the meta-analysis of Tanreqing injection combined with ganciclovir on the treatment of RSVP in children, this paper will give a scientific and objective judgment on the effectiveness and safety of the combined use of Chinese and Western medicine on the treatment of RSVP in children, to provide evidence-based medical evidence for the clinical application, effectiveness and safety of Chinese and Western medicine combined on the treatment of RSVP in children. PROSPERO REGISTRATION NUMBER: OSF platform, registration number: j2bz5.
The efficacy of taking traditional Chinese medicine orally in renal interstitial fibrosis: A protocol for a systematic review and meta-analysis.
Yu G, Guo M, Zou J … +2 more , Zhou X, Ma Y
Medicine (Baltimore) · 2020 Sep · PMID 32957343 · Full text
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...
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.
Treatment of intestinal graft-versus-host disease with unrelated donor fecal microbiota transplantation capsules: A case report.
Mao D, Jiang Q, Sun Y … +6 more , Mao Y, Guo L, Zhang Y, Man M, Ouyang G, Sheng L
Medicine (Baltimore) · 2020 Sep · PMID 32957333 · Full text
INTRODUCTION: Fecal microbiota transplantation (FMT), administering fecal suspensions via a nasoduodenal tube, has achieved a promising effect in the treatment of intestinal graft-versus-host disease (GvHD) in some pilot...
INTRODUCTION: Fecal microbiota transplantation (FMT), administering fecal suspensions via a nasoduodenal tube, has achieved a promising effect in the treatment of intestinal graft-versus-host disease (GvHD) in some pilot studies. In this study, oral FMT capsules from unrelated donor were used for the first time in the treatment of intestinal GvHD. Patient concerns: A 31-year-old male who was diagnosed as "myelodysplastic syndromes with excess blasts II" (intermediate risk 2 of international prognostic scoring system) received human leukocyte antigen -matched sibling donor allogeneic hematopoietic stem cell transplantation. The patient developed diarrhea, vomiting, and bloody stool on 28 days after transplantation. DIAGNOSIS: Intestinal acute GvHD was diagnosed clinically with histological confirmation by colonoscopy and pathological biopsy. INTERVENTIONS: This patient was treated with first cycle of oral FMT capsules after failure to initial treatment of methylprednisolone (2 mg/kg/d) combined with recombinant human tumor necrosis factor-α receptorII: IgG Fc fusion protein (25 mg, biw). The symptoms of intestinal GvHD were relieved but recurred 11 days later. Second cycle of oral FMT capsules was carried out. OUTCOMES: After 2 cycles of fecal bacteria transplantation, intestinal GvHD was gradually controlled and did not recur again during the 2-month follow-up. The diversity and structure of the intestinal flora after FMT was closer to that of healthy donors than that before. CONCLUSION: Our case showed oral FMT capsules could be used as a treatment option for corticosteroid refractory intestinal GvHD. Further studies are warranted to assess the clinical efficacy and safety of oral FMT capsules in the treatment of intestinal GvHD. RATIONALE: Fecal microbiota transplantation (FMT), administering fecal suspensions via a nasoduodenal tube, has achieved a promising effect in the treatment of intestinal graft-versus-host disease (GvHD) in some pilot studies. In this study, oral FMT capsules from unrelated donor were used for the first time in the treatment of intestinal GvHD. PATIENT CONCERNS: A 31-year-old male who was diagnosed as "myelodysplastic syndromes with excess blasts II" (intermediate risk 2 of international prognostic scoring system) received human leukocyte antigen -matched sibling donor allogeneic hematopoietic stem cell transplantation. The patient developed diarrhea, vomiting, and bloody stool on 28 days after transplantation. DIAGNOSES: Intestinal acute GvHD was diagnosed clinically with histological confirmation by colonoscopy and pathological biopsy. INTERVENTIONS: This patient was treated with first cycle of oral FMT capsules after failure to initial treatment of methylprednisolone (2 mg/kg/d) combined with recombinant human tumor necrosis factor-a receptorII: IgG Fc fusion protein (25 mg, biw). The symptoms of intestinal GvHD were relieved but recurred 11 days later. Second cycle of oral FMT capsules was carried out. OUTCOMES: After 2 cycles of fecal bacteria transplantation, intestinal GvHD was gradually controlled and did not recur again during the 2-month follow-up. The diversity and structure of the intestinal flora after FMT was closer to that of healthy donors than that before. CONCLUSION: Our case showed oral FMT capsules could be used as a treatment option for corticosteroid refractory intestinal GvHD. Further studies are warranted to assess the clinical efficacy and safety of oral FMT capsules in the treatment of intestinal GvHD. LESSONS: There is still a possibility of recurrence after the treatment of GvHD with capsule fecal microbiota transplantation. How to optimize the dosage and treatment course of fecal microbiota capsule administration needs further exploration.
Large dosage Huanglian (Rhizoma Coptidis) for T2DM: A protocol of systematic review and meta-analysis of randomized clinical trials.
Wang L, Huang X, Yue R … +5 more , Yang H, Zhang X, Tian Y, Ding N, Zhou L
Medicine (Baltimore) · 2020 Sep · PMID 32957328 · Full text
INTRODUCTION: Type 2 diabetes mellitus(T2DM) is a widespread attention of the world's major health problems. The international diabetes federation (IDF) has released the "global overview of diabetes (ninth edition)". By...
INTRODUCTION: Type 2 diabetes mellitus(T2DM) is a widespread attention of the world's major health problems. The international diabetes federation (IDF) has released the "global overview of diabetes (ninth edition)". By 2019. It can lead to complications and even death. Among them, the use of Rhizoma Coptidis (Huanglian) at large dose has also been proved to be effective in clinical practice. However, due to the lack of evidence, there is no specific method or suggestion, so it is necessary to carry out systematic evaluation on coptis coptis and provide effective evidence for further research. METHODS AND ANALYSIS: We will search the following electronic databases from their inception to May 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure. Primary outcomes:fasting blood glucose and glycosylated haemoglobin (A1c). SECONDARY OUTCOMES: plasma insulin,blood lipid profile,adverse events,and cost associated with the intervention and hospital visit. 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. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. RESULTS: The results of this study will systematically evaluate the effectiveness and safety of large dose of Huanglian intervention for people with T2DM. CONCLUSION: The systematic review of this study will summarize the current published evidence of large dose of Huanglian for the treatment of T2DM, which can further guide the promotion and application of it. ETHICS AND DISSEMINATION: This study is a systematic review, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations.Open Science Framework(OSF)registration number: July 21, 2020. https://osf.io/w7bj6.
Efficacy and safety of ginkgo preparation in patients with vascular dementia: A protocol for systematic review and meta-analysis.
Wang M, Peng H, Peng Z … +5 more , Huang K, Li T, Li L, Wu X, Shi H
Medicine (Baltimore) · 2020 Sep · PMID 32925798 · Full text
BACKGROUND: Vascular dementia has become the second most common type of dementia after Alzheimer disease. At present, there is no uniform standard for VaD treatment guidelines among countries. The efficacy of ginkgo bilo...
BACKGROUND: Vascular dementia has become the second most common type of dementia after Alzheimer disease. At present, there is no uniform standard for VaD treatment guidelines among countries. The efficacy of ginkgo biloba in the treatment of vascular dementia is still controversial. The purpose of this study is to evaluate the effectiveness and safety of ginkgo biloba in the treatment of vascular dementia through meta-analysis. METHODS: Six English databases (PubMed, Web of science, Medline, EBASE, Springer Cochrane Library, and WHO International Clinical Trials Registry Platform) and 4 Chinese databases (Wan fang Database, Chinese Scientific Journal Database, China National Knowledge Infrastructure Database(CNKI) and Chinese Biomedical Literature Database) will be searched normatively according to the rule of each database from the inception to August 1, 2020. Two reviewers will independently conduct article selection, data collection, and risk of bias evaluation. Any disagreement will be resolved by discussion with the third reviewer. Either the fixed-effects or random-effects model will be used for data synthesis based on the heterogeneity test. The change in the scores on mini-mental state examination, activity of daily living scale and Montreal cognitive assement will be used as the main outcome measure, Hamilton depression scale, Hastgawa dementia scale, blessed dementia scale, clinical dmentia rating scale as the secondary outcome. Treatment emergent symptom scale, general physical examination (temperature, pulse, respiration, blood pressure), Routine examination of blood, urine and stool, electrocardiogram, liver and kidney function examination as the security indexs. RevMan5.3.5 will be used for meta-analysis. RESULTS: This study will provide high-quality evidence to assess the effectiveness and safety of ginkgo preparation for vascular dementia. CONCLUSION: This systematic review will explore whether ginkgo preparation is an effective and safe intervention for vascular dementia. ETHICS AND DISSEMINATION: Ethical approval are not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and will be shared on social media platforms. This review will be disseminated in a peer-reviewed journal or conference presentation. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020167851.
Assessment of the efficacy of α-lipoic acid in treatment of diabetes mellitus patients with erectile dysfunction: A protocol for systematic review and meta-analysis.
Cai J, Chen J, Zeng Q … +5 more , Liu J, Zhang Y, Cheng H, Yao S, Chen Q
Medicine (Baltimore) · 2020 Sep · PMID 32899103 · Full text
BACKGROUND: Diabetes mellitus with erectile dysfunction (DMED) is one of the most common causes of disability in diabetic population, and its pathogenesis is related to a variety of factors. Because its pathogenesis is c...
BACKGROUND: Diabetes mellitus with erectile dysfunction (DMED) is one of the most common causes of disability in diabetic population, and its pathogenesis is related to a variety of factors. Because its pathogenesis is complex and the existing treatment methods have limitations, DMED is difficult to treat in clinical. Recently, some studies have shown that α-lipoic acid (ALA) is associated with DMED, but there is no systematic review and meta-analysis on the relationship between ALA and DMED. METHODS: We will search each database from the built-in until July 2020. The English literature mainly searches Cochrane Library, PubMed, EMBASE, and Web of Science, while the Chinese literature comes from CNKI, CBM, VIP, and Wangfang database. Simultaneously we will retrieve clinical registration tests and grey literatures. This study only screen the clinical randomized controlled trials (RCTs) about ALA for DMED to assess its efficacy. The 2 researchers worked independently on literature selection, data extraction, and quality assessment. The dichotomous data is represented by relative risk (RR), and the continuous is expressed by mean difference (MD) or standard mean difference (SMD), eventually the data is synthesized using a fixed effect model (FEM) or a random effect model (REM) depending on whether or not heterogeneity exists. Erectile dysfunction (ED) will be diagnosed by the International Index of Erectile Function 5 (IIEF-5) score. Finally, meta-analysis was conducted by RevMan software version 5.3. RESULTS: This study will synthesize and provide high quality to evaluate the effectiveness of ALA supplementation for the treatment of DMED. CONCLUSION: This systematic review aims to provide new options for ALA supplementation treatment of DMED in terms of its efficacy and safety. PROSPERO REGISTRATION NUMBER: INPLASY202070130.
The efficacy and safety of Chinese herbal compound or combined with western medicine for pediatric adenoidal hypertrophy: A protocol for systematic review and meta-analysis.
Wang P, Kong W, Shan Y
Medicine (Baltimore) · 2020 Sep · PMID 32899056 · Full text
BACKGROUND: Traditional Chinese medicine (TCM) or combined with western medicine in the treatment of pediatric adenoidal hypertrophy has been widely used in clinical practice, but the overall efficacy and safety is still...
BACKGROUND: Traditional Chinese medicine (TCM) or combined with western medicine in the treatment of pediatric adenoidal hypertrophy has been widely used in clinical practice, but the overall efficacy and safety is still unclear. This paper aims to evaluate the efficacy and safety analysis of TCM or combined with western medicine for pediatric adenoidal hypertrophy. METHODS: PubMed, EMbase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), WanFang, the Chongqing VIP Chinese Science and Technology Periodical Database, and China biomedical literature database (CBM) were searched for randomized controlled trials of TCM or combined with western medicine for pediatric adenoidal hypertrophy from the date of establishment to July 2020, and Baidu Scholar, Google Scholar, International Clinical Trials Registry Platform (ICTRP), and Chinese Clinical Trials Registry (ChiCTR) were searched for unpublished grey literature. Two researchers independently applied RevMan 5.3 software for data extraction and risk assessment of bias. RESULTS: The effectiveness and safety of TCM or combined with western medicine for pediatric adenoidal hypertrophy is evaluated by means of the Adenoid (A) /(Nasopharyngeal (N) ratio, clinical efficacy, integral score of TCM syndromes, clinical single symptom score, disease specific quality of life for children with obstructive sleep apnea 18 items survey (OSA-18), Interleukin 4 (IL-4) and adverse reaction incidence. CONCLUSION: This study will provide theoretical support for the clinical application of TCM or combined with western medicine for pediatric adenoidal hypertrophy. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/J76AG.
The effectiveness and safety of moxibustion for treating benign prostatic hyperplasia: A protocol for systematic review and meta-analysis.
Chen H, Li Q, Fang T … +7 more , Liao A, Xiang S, Guo Z, Chen M, Guo Y, Liu F, Yang F
Medicine (Baltimore) · 2020 Sep · PMID 32899049 · Full text
BACKGROUND: Benign prostatic hyperplasia (BPH) is a disease of the urinary system. It is common in middle-aged and elderly men. Moxibustion is widely used to manage BPH and the associated lower urinary tract symptoms, bu...
BACKGROUND: Benign prostatic hyperplasia (BPH) is a disease of the urinary system. It is common in middle-aged and elderly men. Moxibustion is widely used to manage BPH and the associated lower urinary tract symptoms, but there is still lack of systematic review of moxibusiton for BPH. So the aim of this review is to comprehensively evaluate the effectiveness and safety of moxibustion in the treatment of BPH. METHODS: The following 8 electronic databases including PubMed (1966-2020), EMbase (1980-2020), the Cochrane Library, Web of Science (1900-2020), China National Knowledge Infrastructure Database (1979-2020), WanFang Database (1998-2020), Chinese Scientific Journal Database (1989-2020), and Chinese Biomedical Literature Database (1979-2020) will be searched. No language restrictions will be used. Researchers will retrieve databases, identify trials, extract data, and evaluate the quality of eligible randomized controlled trials, independently. The outcomes will include: total effective rate, the American Urologic Association Symptom Score, International Prostate Symptom Score, urinary flow rate (measured in mL/s), changes in prostate size (measured in cc), quality of life, side effects and adverse events. The quality of methodology and evidence will be rated by using the Cochrane risk-of-bias assessment tool and grading of recommendations, assessment, development, and evaluation tool, respectively. Data synthesis will be presented by the manager of the Cochrane Collaboration's RevMan 5.3.0. RESULTS: We will show the results of this study in a peer-reviewed journal. CONCLUSIONS: The findings will provide credible clinical evidence of moxibustion treatment for BPH. PROSPERO REGISTRATION NUMBER: CRD42020190630.
Pediatric massage therapy for restoring pediatric lung function from COVID-19: A protocol for systematic review and meta-analysis.
Zhou KL, Dong S, Wang K … +4 more , Fu GB, Niu Y, Xue XN, Guo S
Medicine (Baltimore) · 2020 Aug · PMID 32872009 · Full text
BACKGROUND: The novel coronavirus disease 2019 (COVID-19) has caused an international outbreak of a respiratory illness and grown to be a global public health emergency since patients were first detected in Wuhan, China....
BACKGROUND: The novel coronavirus disease 2019 (COVID-19) has caused an international outbreak of a respiratory illness and grown to be a global public health emergency since patients were first detected in Wuhan, China. Given the rapidly growing pandemic and the overwhelmed medical system, there is an urgent need of alternative medicine to help children relieve symptoms during self-quarantine, and possibly to help increase their chances of survival and recovery from COVID-19. By using various manual techniques at specified locations on the surface of the body, pediatric massage manipulation can unblock meridians, promote the circulation of qi and blood and strengthen resistance to pathogens. METHODS: We will search the following electronic databases: Wanfang and Pubmed Database, CNKI, CENTRAL, CINAHL, EMBASE and MEDLINE. Each database will be searched from inception to June 2020. The entire process will include study selection, data extraction, risk of bias assessment and meta-analyses. RESULTS: This systematic review will evaluate the existing evidence of pediatric massage therapy for restoring pediatric lung function from COVID-19. The outcomes will include the improvement of pulmonary function and adverse effect. CONCLUSION: This proposed systematic review will evaluate the existing evidence and explore the potential role of pediatric massage therapy on the effectiveness and safety in pulmonary function of COVID-19 convalescent children. PROSPERO REGISTRATION NUMBER: CRD42020193396.
The efficacy and safety of acupuncture and moxibustion combined with western medicine for obsessive-compulsive disorder: A protocol for systematic review and meta-analysis.
Tian C, Fan Y, Xu J … +5 more , Huang Y, Wang W, Wang S, Song R, Li X
Medicine (Baltimore) · 2020 Aug · PMID 32871865 · Full text
BACKGROUND: Obsessive-compulsive disorder is common, chronic mental disorder, which is characterized by recurrent, unwanted, or intrusive thoughts and repetitive behaviors or mental action. Acupuncture and moxibustion, a...
BACKGROUND: Obsessive-compulsive disorder is common, chronic mental disorder, which is characterized by recurrent, unwanted, or intrusive thoughts and repetitive behaviors or mental action. Acupuncture and moxibustion, as a popular form of complementary and alternative therapy, have the advantages of low side effects, high safety, and low cost. The research showed that acupuncture and moxibustion have a good clinical efficacy on obsessive-compulsive disorder. However, there is no literature to systematically evaluate the efficacy and safety of acupuncture and moxibustion in treating obsessive-compulsive disorder. Thus, this study is aimed to evaluate the efficacy and safety of acupuncture and moxibustion for obsessive-compulsive disorder patients, providing reliable evidence for clinical application. METHODS: Randomized controlled trials of acupuncture and moxibustion combined with western medicine for the treatment of obsessive-compulsive disorder will be searched in the databases including PubMed, EMBASE, the Cochrane library, Web of science, China National Knowledge Infrastructure(CNKI), WanFang, the Chongqing VIP Chinese Science and Technology Periodical Database, and China biomedical literature database (CBM) from inception to June, 2020. In addition, Baidu, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry will be searched to obtain the gray literature and relevant data that have not yet been published. Two qualified researchers will extract data and assess the risk of bias from included studies dependently. Statistical analysis is performed in RevMan 5.3 software. RESULTS: The efficacy and safety of acupuncture and moxibustion combined with western medicine for obsessive-compulsive disorder will be assessed based on the total effective rate, Hamilton Anxiety Scale score, Hamilton Rating Scale for Depression score, Clinical Global Impression score, side effects, and so on. CONCLUSIONS: The proposed systematic review and meta-analysis of acupuncture and moxibustion combined with western medicine for treating obsessive-compulsive disorder is expected to provide reliable evidence for clinical application. ETHICS AND DISSEMINATION: The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/CDGTW.
Comparing stroke prevention therapy of direct oral anticoagulants and vitamin K antagonists in patients with atrial fibrillation: a nationwide retrospective observational study.
Paschke LM, Klimke K, Altiner A … +2 more , von Stillfried D, Schulz M
BMC Med · 2020 Aug · PMID 32847578 · Full text
BACKGROUND: Direct oral anticoagulants (DOACs) are not only increasingly being used for the initial stroke prevention therapy but progressively also substitute vitamin K antagonist (VKA) treatment in patients with non-va...
BACKGROUND: Direct oral anticoagulants (DOACs) are not only increasingly being used for the initial stroke prevention therapy but progressively also substitute vitamin K antagonist (VKA) treatment in patients with non-valvular atrial fibrillation (AF). DOACs have been compared regarding therapeutic efficacy and adverse outcomes to warfarin in several pivotal studies and showed non-inferiority in terms of stroke prevention and superiority in terms of bleeding complications. However, comprehensive comparative studies are lacking for phenprocoumon, a VKA prescribed frequently outside the USA and the UK and accounting for 99% of all VKA prescriptions in Germany. Patients treated with phenprocoumon seem to meet more often international normalized ratio values in the therapeutic range, which may have implications concerning their efficacy and safety. This study aims at comparing the risk of stroke and bleeding in phenprocoumon- and DOAC-treated patients with AF in an adequately powered observational study population. METHODS: Retrospective analysis of stroke and bleeding incidence of 837,430 patients (1.27 million patient years) treated with DOAC or phenprocoumon for stroke prevention in German ambulatory care between 2010 and 2017. Relative risks of stroke and bleeding were estimated by calculating cox regression-derived hazard ratios (HR) and 95% confidence intervals (CI) of propensity score-matched cohorts. RESULTS: Patients treated with DOAC had an overall higher risk for stroke (HR 1.32; CI 1.29-1.35) and a lower risk for bleeding (0.89; 0.88-0.90) compared to phenprocoumon. When analyzed separately, the risk for stroke was higher for dabigatran (1.93; 1.82-2.03), apixaban (1.52; 1.46-1.58), and rivaroxaban (1.13; 1.10-1.17) but not for edoxaban (0.88; 0.74-1.05). The risk for bleeding was lower for dabigatran (0.85; 0.83-0.88), apixaban (0.71; 0.70-0.73), and edoxaban (0.29; 0.17-0.51) but not for rivaroxaban (1.03; 1.01-1.04). CONCLUSIONS: This study provides a comprehensive view of the stroke and bleeding risks associated with phenprocoumon and DOAC use in Germany. Phenprocoumon may be preferable to DOAC treatment for the prevention of strokes in AF in a real-world population cared for in ambulatory care.
The efficacy and safety of warming acupuncture and moxibustion on rheumatoid arthritis: A protocol for a systematic review and meta-analysis.
Shang J, Fan W, Dou Z … +3 more , Wu L, Lu B, Qian J
Medicine (Baltimore) · 2020 Aug · PMID 32846836 · Full text
BACKGROUND: Rheumatoid arthritis (RA), as an autoimmune disease, can eventually lead to joint deformity and loss of function, seriously reduce the quality of life of patients and increase economic burden. As a traditiona...
BACKGROUND: Rheumatoid arthritis (RA), as an autoimmune disease, can eventually lead to joint deformity and loss of function, seriously reduce the quality of life of patients and increase economic burden. As a traditional Chinese therapy, warming acupuncture and moxibustion is safe, economical, and has few side effects. At present, some studies have shown that warming acupuncture and moxibustion has a certain effect on RA, but there is no evidence of evidence-based medicine. The purpose of this study was to evaluate the efficacy and safety of warming acupuncture and moxibustion in the treatment of rheumatoid arthritis. METHOD: Randomized controlled trials of warming acupuncture and moxibustion treating RA will be searched in the databases including PubMed, EMBASE, the Cochrane library, Web of science, China National Knowledge Infrastructure (CNKI), WanFang, the Chongqing VIP Chinese Science and Technology Periodical Database (VIP), and China biomedical literature database (CBM) from inception to July, 2020. In addition, Baidu, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry will be searched to obtain the gray literature and relevant data that have not yet been published. Two qualified researchers will extract data and assess the risk of bias from included studies independently. Statistical analysis is performed in RevMan 5.3 software. RESULTS: The primary outcome is symptom evaluation including morning stiffness, pain, and joint swelling. The number of joints affected by RA, Rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), C reactive protein (CRP), anti-cyclic peptide containing citrulline (A-CCP), and adverse effects, will be evaluated as secondary outcomes. CONCLUSIONS: This study will compare the efficacy and safety of warming acupuncture and moxibustion with common acupuncture in the treatment of RA, providing reliable evidence for clinical application. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/C8RY9.
The efficacy of Qigong exercises for post-stroke mental disorders and sleep disorders: Protocol for a systematic review and meta-analysis.
Dong X, Zhang R, Guo Y … +2 more , Chen L, Liu Y
Medicine (Baltimore) · 2020 Aug · PMID 32846809 · Full text
BACKGROUND: Post-stroke mental disorders (PSMDs) and post-stroke sleep disorders (PSSDs) are quite common condition in stroke's patients. Qigong has been widely applied as a replaced and useful treatment for PSMDs and PS...
BACKGROUND: Post-stroke mental disorders (PSMDs) and post-stroke sleep disorders (PSSDs) are quite common condition in stroke's patients. Qigong has been widely applied as a replaced and useful treatment for PSMDs and PSSDs. However, the exact effects and safety of Qigong have yet be systematically investigated. Our study focused on summary of efficacy and safety of Qigong for the treatment of advanced PSMDs and PSSDs through the systematic analysis and meta-analysis, in order to provide scientific reference for the clinical. METHODS: The protocol followed Preferred Reporting Items for Systematic Review and Meta-Analyses Protocols. Relevant randomized controlled trials were only considered. Search strategy will be performed in 4 English database including Cochrane Library, PubMed, Web of Science, Excerpt Medical Database, 4 Chinese Database including Chinese Biomedical Literature Database, China National Knowledge Infrastructure, China Scientific Journal Database, Wanfang Database, and WHO International Clinical Trials Registry Platform. Papers in English or Chinese published from their inception to 30 June 2020. Study selection and data extraction will be performed independently by 2 investigators. The clinical outcomes including overall Hamilton depression scale, Hamilton anxiety scale, the mental health part of the MOS item short from health survey, Generic Quality of Life Inventory-74, Center for Epidemiologic Studies Depression Scale, Pittsburgh sleep quality index. Based on the Cochrane Assessment tool and Physiotherapy Evidence Database scale, a modified assessment form should be used to evaluate the methodological quality. Review Manager 5.3 was used for data analysis and risk of bias. RESULTS AND CONCLUSION: We provide some more practical and targeted results examine the effect of Qigong exercises for PSMDs and PSSDs in the relative meta-analysis. We find out defects or inadequacies of Qigong in previous studies. The findings of this research will provide more evidence-based guidance in clinical practice and more rigorous study.International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) registration number: INPLASY202070051.
The efficacy and safety of acupoint application combined with western medicine for allergic rhinitis: A protocol for systematic review and meta-analysis.
Huang Y, Fan Y, Tian C … +4 more , Zhang M, Yang S, Ji Y, Zhang Q
Medicine (Baltimore) · 2020 Aug · PMID 32769925 · Full text
BACKGROUND: Acupoint application combined with western medicine has been used for treating allergic rhinitis widely. However, the efficacy and safety of acupoint application combined with western medicine for allergic rh...
BACKGROUND: Acupoint application combined with western medicine has been used for treating allergic rhinitis widely. However, the efficacy and safety of acupoint application combined with western medicine for allergic rhinitis are unclear. This study aims to evaluate the efficacy and safety of acupoint application combined with western medicine for allergic rhinitis. METHODS: Randomized controlled trials of acupoint application combined with western medicine for allergic rhinitis will be searched in PubMed, EMbase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, WanFang, the Chongqing VIP Chinese Science and Technology Periodical Database, and China biomedical literature database from inception to July, 2020. And Baidu Scholar, Google Scholar, International Clinical Trials Registry Platform, and Chinese Clinical Trials Registry will be searched to obtain more relevant studies comprehensively. Two researchers will perform data extraction and risk of bias assessment independently. Statistical analysis will be conducted in RevMan 5.3. RESULTS: This study will summarize the present evidence by exploring the efficacy and safety of acupoint application combined with western medicine for the treatment of allergic rhinitis. CONCLUSIONS: The findings of the study will provide helpful evidence for the efficacy and safety of acupoint application combined with western medicine in the treatment of allergic rhinitis, facilitating clinical practice and further scientific studies. ETHICS AND DISSEMINATION: The private information from individuals will not publish. This systematic review also will not involve endangering participant rights. Ethical approval is not required. The results may be published in a peer-reviewed journal or disseminated in relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/NSGJH.
Acupuncture for the treatment of dry eye: Protocol for systematic review and meta-analysis.
Zhu Y, Zhao Q, Jia H … +2 more , Zhang H, Zhang Y
Medicine (Baltimore) · 2020 Aug · PMID 32769924 · Full text
BACKGROUND: As a common ophthalmic disease, dry eye (DE) may bring several adverse effects on the quality of life for patients. In recent years, Acupuncture (AC) is becoming increasingly popular for treating DE. Thus, we...
BACKGROUND: As a common ophthalmic disease, dry eye (DE) may bring several adverse effects on the quality of life for patients. In recent years, Acupuncture (AC) is becoming increasingly popular for treating DE. Thus, we conceived this systematic review aims to evaluate the effectiveness and safety of AC for DE objectively. METHODS: The search results are restricted to randomized controlled trials and human studies. We will establish the inclusion criteria through discussion and design a detailed literature search strategy for each database. Articles are searched from 4 English databases (the Cochrane Library, PubMed, Web of Science, and EMBASE) and 4 Chinese databases (Wangfang, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Chinese scientific and technical journals database). The relevant studies published from the date of database inception until January 2020 will be collected. We will also search (International Clinical Trials Registry Platform), PROSPERO, and potential gray literature. Two reviewers independently perform literature screening, information extraction, and assessment of study quality. The outcome measures include primary outcome measures (Schirmer I test and break-up time), secondary outcome measures (Ocular Surface Disease Index, corneal fluorescein staining, and tear osmolarity), and safety outcome measures. Assessment of bias risk and data processing are performed using RevMan 5.3 software ( the Nordic Cochrane Centre, Copenhagen, Denmark). RESULTS: We will evaluate the curative effect of AC for DE comprehensively based on multiple outcome measures. CONCLUSION: This systematic review will provide evidence for the effectiveness and safety of AC in the treatment of DE. PROSPERO NUMBER: CRD42019144790.
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