scholarly journals Efficacy and safety of different drug monotherapies for tension-type headache in adults: study protocol for a Bayesian network meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e023748
Author(s):  
Runsheng Xie ◽  
Jinhui Tian ◽  
Yangyang Wang ◽  
Yefeng Cai ◽  
Hui Li

IntroductionTension-type headache (TTH) is the most prevalent neurological disease, with an estimated 1.5 billion cases worldwide. Pharmacotherapy should be considered by patients with TTH who have a limited response to non-pharmacological treatment. However, recommendations for the vast array of therapeutic drugs for TTH partially overlap, with conflicting recommendations for strength in different guidelines; these may confuse the decision-making process of clinicians. Hence, the aims of this study are to analyse the available direct and indirect evidence on different drug monotherapies for TTH in adults, and to generate a treatment ranking according to their efficacy and safety outcomes by using a Bayesian network meta-analysis (NMA).Methods and analysisWe will systematically search the Cochrane Library, PubMed, Web of Science, Embase, China Biomedical Literature Database, International Clinical Trials Registry Platform and other resources for eligible studies. Randomised controlled trials on different drug monotherapies for TTH will be included. Two review authors (RX and YW) will independently search and select the studies, extract the data and assess the risk of bias. A Bayesian NMA will afterwards be conducted to pool the effect measures across all types of monotherapy drugs. The ranking probabilities of the efficacy and safety of different drug monotherapies will be estimated. Heterogeneity will be quantified using the Q statistic and the I² index. Inconsistency between direct and indirect evidence will be assessed by the node-splitting model. In addition, the overall quality of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationNo ethical issues are foreseen. The results will be published in a peer-reviewed journal, which will be disseminated electronically and in print.PROSPERO registration numberCRD42018090554.

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e022142
Author(s):  
Jun Wang ◽  
Yin Wang ◽  
Hui Zhang ◽  
Ming Lu ◽  
Weilu Gao ◽  
...  

IntroductionOsteoarthritis is a common degenerative joint disease that eventually leads to disability and poor quality of life. The main symptoms are joint pain and mobility disorders. If the patient has severe pain or other analgesics are contraindicated, opioids may be a viable treatment option. To evaluate and compare the efficacy and safety of opioids in the treatment of knee or hip osteoarthritis, we will integrate direct and indirect evidence using a Bayesian network meta-analysis to establish hierarchies of these drugs.Methods and analysisWe will search the Medical Literature Analysis and Retrieval System Online, Excerpta Medica database, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and PsycINFO databases as well as published and unpublished research in international registries and regulatory agency websites for osteoarthritis reports published prior to 5 January 2018. There will be no restrictions on the language. Randomised clinical trials that compare oral or transdermal opioids with other various opioids, placebo or no treatment for patients with knee or hip osteoarthritis will be included. The primary outcomes of efficacy will be pain and function. We will use pain and function scales to evaluate the main outcomes. The secondary outcomes of safety will be defined as the proportion of patients who have stopped treatment due to side effects. Pairwise meta-analyses and Bayesian network meta-analyses will be performed for all related outcome measures. We will conduct subgroup analyses and sensitivity analyses to assess the robustness of our findings. The Grading of Recommendations, Assessment, Development and Evaluations framework will be used to assess the quality of the evidence contributing to each network assessment.Ethics and disseminationThis study does not require formal ethical approval because individual patient data will not be included. The findings will be disseminated through peer-reviewed publications or conference presentations.PROSPERO registration numberCRD42018085503.


2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Xi Zhao ◽  
Ze-qing Huang

Abstract Background Postoperative cognitive dysfunction (POCD) is a common condition after general anesthesia (GA). Previous studies have reported that propofol can ameliorate the occurrence of such disorder. However, its results are still inconsistent. Therefore, this systematic review will assess the efficacy and safety of propofol on POCD after GA. Methods Literature sources will be sought from inception to the present in Cochrane Library, MEDLINE, EMBASE, PsycINFO, Web of Science, Scopus, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure for randomized controlled trials (RCTs) assessing the administration of propofol on POCD after GA. All searches will be carried out without limitations to language and publication status. Outcomes comprise of cognitive impairments changes, impairments in short-term memory, concentration, language comprehension, social integration, quality of life, and adverse events. Cochrane risk of bias tool will be utilized to assess study quality. We will evaluate the quality of evidence for each outcome using Grading of Recommendations Assessment, Development and Evaluation approach. A narrative synthesis or a meta-analysis will be undertaken as appropriate. Discussion This study will systematically and comprehensively search literature and integrate evidence on the efficacy and safety of propofol on POCD after GA. Our findings will be of interest to clinicians and health-related policy makers. Systematic review registration PROSPERO CRD42020164096


BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035346
Author(s):  
Yuchen He ◽  
Hongyi He ◽  
Dong-Xing Xie ◽  
Xiaoxiao Li ◽  
Yilun Wang

IntroductionMost of the patients who received arthroscopic knee surgery will suffer moderate to severe pain, which can delay the rehabilitation process and increase the risk of postoperative complications. Therefore, seeking a safe and effective postoperative analgesia is necessary for promoting the application of arthroscopic surgery. This protocol aims to detail a planned systematic review and meta-analysis on the comparative efficacy and safety of single-dose intra-articular injection of analgesics for pain relief after knee arthroscopy.Method and analysisPubMed, Embase, Web of Science and Cochrane Library will be searched from inception to 1 June 2020 to retrieve randomised controlled trials (RCTs) that compared the commonly used single-dose intra-articular analgesics (ie, morphine; bupivacaine (including levobupivacaine); ropivacaine and magnesium alone or in combination) with placebo or between each other for postoperative pain relief among patients who had received knee arthroscopy. The primary outcome is pain intensity at 2-hour and 24-hour postoperatively; the secondary outcomes include side effects (eg, knee effusion, nausea, vomiting and flushing), the number of patients requiring supplementary analgesia and the time to first analgesic request. The methodological quality of the included RCTs will be assessed based on the Cochrane risk of bias table. The Bayesian network meta-analysis will be conducted using WinBUGS V.1.4.3.Ethics and disseminationSince no private or confidential patient data will be contained in the reporting, approval from an ethics committee is not required. Our study raises no ethical issue, and the results will be published in a peer-reviewed journal.PROSPERO registration numberCRD42019130876.


BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038705
Author(s):  
Qiongshuai Zhang ◽  
Guangcheng Ji ◽  
Fang Cao ◽  
Yihan Sun ◽  
Guanyu Hu ◽  
...  

IntroductionSpasticity is a common complication of poststroke, tuina is a widely used rehabilitation treatment, although there is a lack of supportive evidence on efficacy and safety for patients with poststroke spasticity. The aim of this systematic review is to assess and synthesis evidence of efficacy and safety of tuina for spasticity of poststroke.Methods and analysisA comprehensive electronic search of EMBASE, MEDLINE, Cochrane Library, Web of Science, Wiley, Springer, PEDro, Chinese Science Citation Database, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, Chinese Scientific and Journal Database (VIP), Wanfang Database (Wanfang), Japanese medical database (CiNii), Korean Robotics Institute Summer Scholars and Thailand Thai-Journal Citation Index Centre will be conducted to search literatures of randomised controlled trials of tuina for spasticity of poststroke survivors range from the establishment to 1 January 2020.There is no time of publication limitations. The primary outcome will be measured with the Modified Ashworth Scale, and the second outcome will include Fugl-Meyer Assessment Scale, surface electromyogram RMS value, the Modified Barthel Index, Stroke Specific Quality of Life Scale, quality of life 36-Item Short-Form Health Survey and Visual Analogue Scale. Cochrane Handbook for Systematic Reviews of Interventions will be used to assess the risk of bias, and GRADE will be used to access the confidence in cumulative evidence. The protocol will be conducted according to approach and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015.Ethics and disseminationEthical approval will not be required, for no primary data of individual patients were collected. We will publish the findings in a peer-reviewed journal.PROSPERO registration numberCRD42020163384.


Author(s):  
L.-J. Chen ◽  
Y.-J. Zhou ◽  
Z.-H. Wen ◽  
F. Tian ◽  
J.-Y. Li

AbstractThe current systematic review and meta-analysis aims to evaluate the efficacy and safety of iguratimod (IGU) combined with methotrexate (MTX) versus MTX alone in rheumatoid arthritis (RA). Two independent investigators searched for original randomized controlled trials (RCTs) related to the combination of IGU and MTX in RA published before November 1, 2019, in PubMed, Cochrane Library, Embase, the China National Knowledge Infrastructure (CNKI), the Chinese Biomedical Literature Database (CBM), and WanFang Data. Additionally, we searched clinical trial registry websites. We assessed the methodological quality of the included trials using the Cochrane Collaboration tool and the seven-point Jadad scale. Statistical analyses were performed using Review Manager (RevMan) 5.3 (Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014). Meta-regression and publication bias analyses were performed using Stata version 14 software (StataCorp., College Station, TX, USA). A total of 7 RCTs consisting of 665 participants, with 368 participants in the active arm and 297 in the placebo arm, were included in the meta-analysis. The American College of Rheumatology (ACR) value was better in the IGU + MTX group than in the MTX alone group, with a pooled relative risk (RR) for ACR20 (American College of Rheumatology 20% improvement criteria), ACR50, and ACR70 of 1.40 (95% CI, 1.13–1.74), 2.09 (95% CI, 1.67–2.61), and 2.24 (95% CI, 1.53–3.28), respectively. The results of the meta-analysis demonstrated that there was no statistical significance in adverse events (1.06 (95% CI, 0.92–1.23)). The combined treatment is an effective, safe, and economical treatment option for patients who do not respond well to methotrexate alone or for patients who cannot afford expensive biologics that have no confirmed efficacy.


BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e029991 ◽  
Author(s):  
Shun-Li Kan ◽  
Ling-Xiao Chen ◽  
Zhi-Fang Yuan ◽  
Wei Hu ◽  
Ru-Sen Zhu

IntroductionAnkylosing spondylitis (AS) is a universal chronic inflammatory rheumatic disease which predominantly results in chronic back pain and stiffness. However, some patients suffering from AS do not react well to pharmacological interventions. Exercise intervention has been employed for the treatment of AS and works as a complementary part of the management of AS. However, the effect of different types of exercise interventions remains unclear. The purpose of this study is to determine the relative efficacy of different types of exercise interventions for individuals with AS using a Bayesian network meta-analysis.Methods and analysisWe will conduct a systematic literature review of randomised controlled trials that compare different types of exercise interventions for individuals with AS. PubMed, EMBASE and the Cochrane Library will be searched up to February 2019. The primary outcomes are functional capacity, pain and disease activity. The risk of bias for individual studies will be evaluated according to the Cochrane Handbook. A Bayesian network meta-analysis will be performed to compare the efficacy of different types of exercise interventions. The quality of evidence will be assessed by the Grading of Recommendations, Assessment, Development and Evaluation approach.Ethics and disseminationEthical approval and patient consent are not required as this study is a meta-analysis based on published studies. The results of this network meta-analysis will be submitted to a peer-reviewed journal for publication.PROSPERO registration numberCRD42019123099.


2021 ◽  
Author(s):  
Jingxin Zhou ◽  
Wenhua Zhang ◽  
Jie Yang ◽  
Qiaoqiao Liu ◽  
Yizhen Lu ◽  
...  

Abstract Background: Diabetic kidney disease (DKD), which is a serious complication of diabetes and the leading cause of end-stage renal disease, becomes a major health concern worldwide. Keluoxin capsule, a Chinese patent medicine used for DKD, has been widely used in diabetic kidney disease, but its efficacy and safety have not yet been clarified. Therefore, the aim of this systematic review and meta-analysis is to summarize the efficacy and safety of Keluoxin capsule in the treatment of DKD. Methods: A systematic literature search will be conducted in PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, WANFANG database, VIP, SinoMED, and Chinese Biomedical Literature Database (CBM) to ensure all possible randomized controlled trials (RCT) studies on K eluoxin capsule to November 1, 2021. The primary outcome to be assessed will include the change in albuminuria and estimated glomerular filtration rate (eGFR), while secondary outcomes will be serum creatinine, blood urea nitrogen, glycated hemoglobin, total cholesterol, low-density lipoprotein cholesterol, and triglycerides, etc and adverse events. The quality of the included studies and the risk of bias will be independently assessed by two reviewers using the risk of bias assessment tool from Cochrane Handbook. We will conduct random-effects model meta-analysis using Review Manager software (Revman5.3). Discussion: This systematic review and meta-analysis will objectively evaluate the effect of Keluoxin capsule for DKD, and provide evidence for Keluoxin capsule in the treatment of DKD. Ethics and dissemination : Ethics approval is not required for this study. We aim to publish the results of this systematic review in a peer-reviewed journal. INPLASY registration number: INPLASY 2021110067.


2021 ◽  
Vol 8 ◽  
Author(s):  
Qigu Yao ◽  
Wenyi Chen ◽  
Cuilin Yan ◽  
Jiong Yu ◽  
Tian'an Jiang ◽  
...  

Background and Aims: Viral hepatitis are one of the main causes of liver cirrhosis. The treatment of portal hypertension caused by liver cirrhosis is difficult and diverse, and the therapeutic effect is unknown. Bayesian network meta-analysis was performed to compare the efficacy and safety of treatments for patients with portal hypertension and cirrhosis, including a transjugular intrahepatic portosystemic shunt (TIPS), endoscopic therapy, surgical therapy and medications.Methods: Eligible articles were searched for in PubMed, Embase, Cochrane Library and Web of Science databases from their inception until June 2020. Using the “gemtc-0.8.4” package in R v.3.6.3 software and the Just Another Gibbs Sampler v.4.2.0 program, network meta-analysis was performed using a random effects model within a Bayesian framework. The odds ratios for all-cause rebleeding, bleeding-related mortality, overall survival (OS), treatment failure and hepatic encephalopathy were determined within the Bayesian framework.Results: Forty randomized controlled trials were identified, including 4,006 adult patients and nine treatment strategies. Our results showed that distal splenorenal shunt and TIPS provided the best control of hemorrhage. Endoscopic variceal ligation with medication resulted in the highest OS rate. Medication alone resulted in poor OS and treatment failure.Conclusions: We performed a systematic comparison of diverse treatments for cirrhotic patients with portal hypertension. Our meta-analysis indicated that a TIPS and distal splenorenal shunt resulted in lower rates of rebleeding than did other therapies. Furthermore, drugs are more suitable for combination therapy than monotherapy.


2020 ◽  
Vol 2020 ◽  
pp. 1-10 ◽  
Author(s):  
Yichen Xuan ◽  
Hui Huang ◽  
Yiyong Huang ◽  
Duanyong Liu ◽  
Xiuwu Hu ◽  
...  

Background. Clinical investigators have found that the use of needling in the treatment of ankylosing spondylitis (AS) has a good clinical application prospect in recent years. However, these studies were insufficient to provide evidence for the efficacy and safety of simple-needling for AS. So, we performed a systematic review and meta-analysis to evaluate the efficacy and safety of simple-needling for treating AS. Methods. We searched the PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Wangfang database (Wanfang), Chinese Science and Technology Periodical Database (VIP), and any other gray literature sources for randomized controlled trials (RCTs) that used simple-needling to treat AS before June 2019 with the language restriction of Chinese and English. Researchers evaluated the retrieved literature studies and extracted valid data according to relevant requirements and used RevMan5.3 software for meta-analysis. Results. A total of 10 studies were included, all of which were Chinese literature studies, involving 729 patients. Compared with the control groups, simple-needling groups had a better effect on the clinical effective rate (RR = 1.20, 95% CI (1.11, 1.29), P<0.00001), TCM syndrome score (MD = −5.26, 95% CI (−5.99, −4.53), P<0.00001), symptom score (MD = −8.08, 95% CI (−10.18, −5.97), P<0.00001), and Schober test outcome (MD = 0.39, 95% CI (0.15, 0.64), P=0.002). Sensibility analysis was based on the leave-one-out cross-validation procedure, and the results showed no significant changes. Most studies did not describe adverse reactions. The funnel plot suggested publication bias on clinical effectiveness. Conclusions. This systematic review and meta-analysis demonstrated that simple-needling was effective as an intervention for AS. However, due to the low quality of the methodology of included studies, the designs of clinical trials were not rigorously standardized. Therefore, it is necessary to carry out multiquality RCTs for verification.


2019 ◽  
Vol 2019 ◽  
pp. 1-9 ◽  
Author(s):  
Xueqing Yu ◽  
Xuanlin Li ◽  
Liaoyao Wang ◽  
Ran Liu ◽  
Yang Xie ◽  
...  

Objective. The aim of this study is to evaluate the efficacy and safety of pulmonary rehabilitation (PR) in patients with idiopathic pulmonary fibrosis (IPF).Methods. Embase, PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), Chongqing VIP (CQVIP), Wanfang Data, and Chinese Biomedical Literature Database (SinoMed) were comprehensively searched. Randomized controlled trials (RCTs) that investigated the effects of PR for IPF patients were included. Literature selection and data extraction were conducted by two review authors independently. The Cochrane Collaboration’s Risk of Bias tool and RevMan software (version 5.3) were used to evaluate the quality of studies and conduct statistical analysis, respectively.Results. Seven studies (190 participants) were included. PR had a significant effect on six-minute walk distance (6MWD) (MD:48.60; 95%CI: 29.03 to 68.18;Z=4.87,P<0.00001), and 6MWD was improved more in subgroup analysis including studies conducted in Asia (MD: 53.62; 95%CI: 30.48 to 76.66;Z=4.54,P<0.00001) and Europe (MD:54.10; 95% CI: 26.65 to 101.56;Z=2.23,P=0.03). Forced vital capacity (FVC%) was higher (MD: 3.69; 95%CI: 0.16 to 7.23;Z=2.05,P=0.04). St. George’s Respiratory Questionnaire (SGRQ)/IPF-specific SGRQ (SGRQ-I) total score was lower (MD: -7.87; 95% CI: -11.44 to -4.30;Z=4.32,P<0.0001). No significant effects were found for lung diffusing capacity determined by the single-breath technique (DLCO%) (MD: 3.02; 95%CI: -0.38 to 6.42;Z=1.74,P=0.08).Conclusions. This study suggests that PR may enhance exercise capacity and improve quality of life in IPF patients. Besides, PR may also delay the decline of lung function of patients with IPF. However, further research should more fully assess the efficacy and safety of PR for IPF.


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