Efficacy and safety of Zuogui Pill in treating osteoporosis: Study protocol of a systematic review.
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ABSTRACT:
SUBMITTER: Chen G
PROVIDER: S-EPMC6407973 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:IntroductionOsteoporosis (OP) is a prevalent skeletal disease with high mortality and morbidity, followed by acute and chronic back pain, severe spinal deformity and dysfunction. First-line drugs for OP work through antiresorptive or anabolic mechanisms. Although with good efficacy, these drugs still have certain limitations in clinical application due to delivery routes, medication cycles and cost issues. Nowadays, statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) appear to be potentially promising drugs for OP. Despite the controversy, previous studies have shown the efficacy of statins in treating OP. Other studies have further indicated that the therapeutic effect of OP in statin-treated patients is dose dependent. However, scientists have not yet reached a consensus on the use of statins for the treatment or which statin to choose first. This study aims to review the literature, ascertaining the relative efficacy and safety of statins for patients with OP using a Bayesian network meta-analysis.Methods and analysisWe will systematically search the following databases: MEDLINE, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Wanfang Database, China Science and Technology Journal Database, Chinese BioMedical Literature Database and preprint servers to include randomised controlled trials that compare different statins for treating OP. Primary outcomes are the incidence of overall fractures and bone mineral density changes. Secondary outcomes contain adverse effects and bone turnover markers. All items of this review will comply with the Cochrane Handbook, and the quality of evidence will be evaluated by Grading of Recommendations Assessment, Development and Evaluation. A traditional pairwise meta-analysis and the Bayesian network meta-analysis will be performed to compare the efficacy of different statins.Ethics and disseminationEthical approval is not required since this is a protocol study for meta-analyses. Results will be submitted to a peer-reviewed journal.Prospero registration numberCRD42021242619.Search datesFrom database inception to February 2022.
| S-EPMC9115030 | biostudies-literature
Project description:IntroductionLeg ulcers (LUs) not only seriously affect life and work of patients, but also bring huge economic burden to the society. As a potential underused biological debridement, larval therapy provides help for the treatment of LUs. The purpose of our research is to assess whether patients with LUs can benefit from larval therapy.Methods and analysisThe following electronic databases will be searched: PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure Database, Wanfang Database and Chinese Biological Medicine. Randomised controlled trials are eligible for inclusion. There will be no restrictions with respect to language and search date is up to June 2020. Primary outcomes investigated are complete healing rate after treatment, time to ulcer healing, reduction of wound surface area and adverse events. Risk ratios will be used for categorical data; weighted mean difference will be used for measurement data. Subgroup analysis and sensitivity analysis will be considered if heterogeneity exists. The results of data synthesis will be performed by narrative summary and quantitative analysis.Ethics and disseminationThis systematic review does not require the approval of the ethics committee because individual data on patients are not collected. The results of the study will be disseminated in peer-reviewed journals.Prospero registration numberCRD42020176953.
| S-EPMC7545619 | biostudies-literature
Project description:BackgroundHead lice infestation is a major public health problem around the globe. Its treatment is challenging due to product failures resulting from rapidly emerging resistance to existing treatments, incorrect treatment applications and misdiagnosis. Various head lice treatments with different mechanism of action have been developed and explored over the years, with limited report on systematic assessments of their efficacy and safety. This work aims to present a robust evidence summarising the interventions used in head lice.MethodThis is a systematic review and network meta-analysis which will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement for network meta-analyses. Selected databases, including PubMed, Embase, MEDLINE, Web of Science, CINAHL and Cochrane Central Register of Controlled Trials will be systematically searched for randomised controlled trials exploring head lice treatments. Searches will be limited to trials published in English from database inception till 2021. Grey literature will be identified through Open Grey, AHRQ, Grey Literature Report, Grey Matters, ClinicalTrials.gov, WHO International Clinical Trials Registry and International Standard Randomised Controlled Trials Number registry. Additional studies will be sought from reference lists of included studies. Study screening, selection, data extraction and assessment of methodological quality will be undertaken by two independent reviewers, with disagreements resolved via a third reviewer. The primary outcome measure is the relative risk of cure at 7 and 14 days postinitial treatment. Secondary outcome measures may include adverse drug events, ovicidal activity, treatment compliance and acceptability, and reinfestation. Information from direct and indirect evidence will be used to generate the effect sizes (relative risk) to compare the efficacy and safety of individual head lice treatments against a common comparator (placebo and/or permethrin). Risk of bias assessment will be undertaken by two independent reviewers using the Cochrane Risk of Bias tool and the certainty of evidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations guideline for network meta-analysis. All quantitative analyses will be conducted using STATA V.16.DiscussionThe evidence generated from this systematic review and meta-analysis is intended for use in evidence-driven treatment of head lice infestations and will be instrumental in informing health professionals, public health practitioners and policy-makers.Prospero registration numberCRD42017073375.
| S-EPMC8112437 | biostudies-literature
Project description:BackgroundInsomnia has become a universal subhealth disease, affecting more and more modern people's health and quality of life. At present, western medicine is only symptomatic treatment for insomnia. Bailemian Capsule (BLMC) is a proprietary Chinese medicine for treating insomnia. It has been widely used in China, but lacks evidence for evidence-based medicine. At the same time, the clinical efficacy and safety of BLMC are controversial. Therefore, the effectiveness and safety of BLMC in the treatment of insomnia are studied and systematically evaluated in this study. It provides reliable theoretical support for the treatment of insomnia with Traditional Chinese Medicine and the combination of traditional Chinese and Western medicine.MethodsThe information was retrieved from electronic databases, Cochrane, PubMed, EMBASE, SinoMed, China National Knowledge Infrastructure, VIP Data, and WangFang Data. Randomized controlled trials on the BLMC in the treatment of insomnia were conducted. There was no limitation on the literature language. RevMan 5.3 software and STATA 12.0 software were used to perform the meta-analysis.ResultsThis review will be to assess the efficacy and safety of BLMC for insomnia.ConclusionOur systematic evaluation will provide evidence for the clinical efficacy and safety of BLMC in the treatment of insomnia, and will be published in the form of academic papers in the future to provide new ideas for clinicians in the treatment of insomnia.
| S-EPMC6358357 | biostudies-literature
Project description:Background: Biological agents (also termed biologics or biologicals) play a growingly central role in the treatment of immunological diseases. However, the numerous studies published on biologics complicate the decision on the most appropriate biologic for a given disease. We aim to address this problem by publishing a series of systematic reviews evaluating the safety and efficacy of B cell-targeting biologics for the treatment of immune-mediated diseases. This article assesses the safety and efficacy of atacicept, a recombinant fusion protein consisting of the binding portion of transmembrane activator and CAML interactor (TACI; also known as tumor necrosis factor receptor superfamily member 13B), which is able to bind the cytokines B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). Objective: To evaluate atacicept's safety and efficacy for the treatment of immune-mediated disorders compared to placebo, conventional treatment or other biologics. Methods: The PRISMA checklist guided the reporting of the data. We searched the PubMed database between 4 October 2016 and 26 July 2018 concentrating on immune-mediated disorders. Results: The literature search identified 118 articles. After screening titles and abstracts against the inclusion and exclusion criteria and assessing full texts, ten articles were finally included in a narrative synthesis. Conclusions: Atacicept failed to show an effect in multiple sclerosis, optic neuritis, rheumatoid arthritis, and systemic lupus erythematosus. In patients with systemic lupus erythematosus, atacicept led to increased infection rates, but this adverse effect was not seen in the other treated diseases.
| S-EPMC7105675 | biostudies-literature
Project description:Background: During the past years biologic agents (also termed biologicals or biologics) have become a crucial treatment option in immunological diseases. Numerous articles have been published on biologicals, which complicates the decision making process on the use of the most appropriate biologic for a given immune-mediated disease. This systematic review is the first of a series of articles assessing the safety and efficacy of B cell-targeting biologics for the treatment of immune-mediated diseases. Objective: To evaluate rituximab's safety and efficacy for the treatment of immune-mediated disorders compared to placebo, conventional treatment, or other biologics. Methods: The PRISMA checklist guided the reporting of the data. We searched the PubMed database between 4 October 2016 and 26 July 2018 concentrating on immune-mediated disorders. Results: The literature search identified 19,665 articles. After screening titles and abstracts against the inclusion and exclusion criteria and assessing full texts, 105 articles were finally included in a narrative synthesis. Conclusions: Rituximab is both safe and effective for the treatment of acquired angioedema with C1-inhibitor deficiency, ANCA-associated vasculitis, autoimmune hemolytic anemia, Behçet's disease, bullous pemphigoid, Castleman's disease, cryoglobulinemia, Goodpasture's disease, IgG4-related disease, immune thrombocytopenia, juvenile idiopathic arthritis, relapsing-remitting multiple sclerosis, myasthenia gravis, nephrotic syndrome, neuromyelitis optica, pemphigus, rheumatoid arthritis, spondyloarthropathy, and systemic sclerosis. Conversely, rituximab failed to show an effect for antiphospholipid syndrome, autoimmune hepatitis, IgA nephropathy, inflammatory myositis, primary-progressive multiple sclerosis, systemic lupus erythematosus, and ulcerative colitis. Finally, mixed results were reported for membranous nephropathy, primary Sjögren's syndrome and Graves' disease, therefore warranting better quality trials with larger patient numbers.
| S-EPMC6743223 | biostudies-literature
Project description:IntroductionNeuromyelitis optica spectrum disorders (NMOSD) is an inflammatory and heterogeneous astrocyte disorder of the central nervous system with the characteristic of higher incidence in women and Asian people. Most patients with NMOSD have a course of recurrence and remission that is prone to cause paralysis and blindness. Several studies have confirmed the efficacy and promising prospect of mycophenolate mofetil (MMF) in the treatment of NMOSD. Yet its therapeutic effect and safety are controversial. Although there has been two published literature that is relevant to the topic of this study, both of them have certain defects, and they can only provide answers about the efficacy or safety of MMF in the treatment of NMOSD from partial perspectives or conclusions. This research aims to perform a direct and comprehensive systematic review and meta-analysis to evaluate MMF's effectiveness and safety in treating NMOSD.Methods and analysisThis systematic review will cover all comparative researches, from randomised controlled trials to cohort studies, and case-control study. A relevant literature search will be conducted in PubMed, Web of Science, EMBASE, the Cochrane Library, China National Knowledge Infrastructure, Wanfang Database, China Science and Technology Journal Database and Chinese Biomedical Literature Database from their inception to 31 June 2020. We will also search registers of clinical trials, potential grey literature and abstracts from conferences. There are no limits on language and publication status. The reporting quality and risk of bias will be assessed by two researchers independently. Expanded Disability Status Scales and annualised relapse rate will be evaluated as the primary outcome. The secondary outcomes will consist of the frequency and severity of adverse events, best-corrected visual acuity, relapse-free rate and time to the next attack. A meta-analysis will be performed using RevMan V.5.3 software provided by the Cochrane Collaboration and Stata V.12.0.Ethics and disseminationBecause the data used for this systematic review will be exclusively extracted from published studies, ethical approval and informed consent of patients will not be required. The systematic review will be published in a peer-reviewed journal, presented at conferences and will be shared on social media platforms.Prospero registration numberCRD42020164179.
| S-EPMC7705552 | biostudies-literature
Project description:Many cancer patients experience leucopoenia during chemotherapy. Granulocyte- colony-stimulating factor (G-CSF) is used to treat chemotherapy-induced leucopoenia (CIL) but has various limitations. Clinical trials have indicated that acupuncture may prevent bone marrow suppression and increase leucocyte counts after chemotherapy. The objective of this review is to assess the efficacy and safety of acupuncture for treating CIL.This systematic review will electronically search the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Library, Medline, EMBASE, the China National Knowledge Infrastructure Database (CNKI), the Chinese Biomedical Literature Database (CBM), the Chinese Scientific Journal Database (VIP Database) and the Wanfang database from their inception to 1 January 2016. Other sources will also be searched including potential grey literature, conference proceedings and the reference lists of identified publications and existing systematic reviews. Two reviewers will independently search the databases, perform data extraction and assess the quality of studies. Data will be synthesised by either the fixed-effects or the random-effects model according to a heterogeneity test. White blood cell counts will be assessed as the primary outcome. Adverse effects, incidence of leucopoenia, quality of life and physical condition will be evaluated as secondary outcomes. RevMan V.5.3 will be employed for data analysis. The results will be expressed as risk ratios for dichotomous data and mean differences for continuous data.The protocol does not need ethics approval because individuals cannot be identified. The review will be reported in a peer-reviewed publication or at a relevant conference.CRD42015027594.
| S-EPMC4885439 | biostudies-other
Project description:IntroductionIntravenous immunoglobulin (IVIG) was reported to be the third most used monotherapy in livedoid vasculopathy (LV). There is currently a lack of randomized controlled clinical trials and no standardized therapeutic regimen for IVIG therapy in LV.MethodsWe performed a systematic review of the efficacy and safety of IVIG in treating patients with LV using PubMed, Cochrane, and Embase databases.ResultsEighty LV patients from 17 articles were included, receiving IVIG therapy at a dose of 1-2.1 g/kg body weight every 4 weeks. The effective rate of IVIG therapy in LV patients was 95% (76/80) in published studies, showing a good clinical response for resolution of pain, skin ulcerations, and neurological symptoms, and reducing the dependence on glucocorticoids and immunosuppressive agents. IVIG therapy was well tolerated, and no severe adverse events were observed.ConclusionOverall, to a certain degree, IVIG is probably a safe and effective treatment alternative for refractory LV patients, which still need to be confirmed by large-scale randomized controlled clinical trials.
| S-EPMC9134453 | biostudies-literature
Project description:Objective: This study aimed to clarify the efficacy and safety of Xinbao pill (XBP) as an adjunctive treatment for chronic heart failure (CHF). Methods: Randomized controlled trials (RCTs) on the efficacy and safety of XBP in the treatment of CHF were searched from the six databases. The risk of bias assessment tool recommended by Cochrane Handbook 5.1 were used to assess the methodological quality of the included studies. RevMan 5.3 software was used for meta-analysis. The subgroup and sensitivity analyses were also performed. The grading recommendations assessment, development, and evaluation (GRADE) technique were used to assess the evidence's certainty. Results: Nine RCTs with a total of 882 patients were identified in this study. The meta-analysis demonstrated that XBP as adjunctive therapy was superior to conventional medicine alone for the treatment of CHF in improving the left ventricular ejection fraction (LVEF; MD = 5.34; 95% CI 4.68 to 5.99; p < 0.001), the total effective rate (RR = 1.21; 95% CI, 1.14 to 1.29; p < 0.001), the cardiac output (MD = 0.56; 95% CI 0.42 to 0.70; p < 0.001), the stroke volume (MD = 3.42; 95% CI 2.03 to 4.81; p < 0.001) and the 6-min walking distance (6-MWD; MD = 31.95; 95% CI 21.83 to 42.06; p < 0.001), meanwhile reducing the left ventricular end-diastolic diameter (LVEDD; MD = -3.22; 95% CI -4.03 to -2.42; p < 0.001) and left ventricular end-systolic dimension (LVESD; MD = -2.93; 95% CI -3.80 to -2.06; p < 0.001). Regarding safety, a total of 2.4% (11/456) adverse reactions occurred in the XBP groups while 3.9% (18/456) in the control group. The outcomes' evidentiary quality ranged from "very low" to "moderate". Conclusion: This study indicated that XBP as adjunctive therapy combined with conventional medicine seemed to be safe and more effective than conventional medicine alone in treating CHF. However, due to the poor methodological quality of the included RCTs, further well-designed RCTs are required to confirm the efficacy and safety of XBP.
| S-EPMC8924547 | biostudies-literature