Safety and efficacy of mycophenolate mofetil in treating neuromyelitis optica spectrum disorders: a protocol for systematic review and meta-analysis.

INTRODUCTION: Neuromyelitis 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 ANALYSIS: This 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 DISSEMINATION: Because 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 NUMBER: CRD42020164179.

Safety and efficacy of plasma exchange for the treatment of optic neuritis in neuromyelitis optica spectrum disorders: A protocol for systematic review and meta-analysis.

BACKGROUND: Neuromyelitis optica spectrum disorders (NMOSD) is an inflammatory and heterogeneous astrocyte disorder of the central nervous system (CNS), concerned because of its high pathogenicity, high risk of recurrence, and poor prognosis. Optic neuritis (ON) is the first manifestation in 30% to 50% of NMOSD patients, and eventually involved optic nerve in 70% of patients. The idiopathic ON associated with NMO is called NMO-associated ON(NMO-ON). There are substantial costs to the countries and individuals associated with treatment of NMO-ON. Intravenous corticosteroids (IVCSs), as the first-line therapy, leads to unsatisfactory outcomes for NMO-ON and is associated with potential adverse events (AEs). Emerging evidences have proved the important value and potential prospect of plasma exchange (PLEX) in NMO-ON. Although PLEX is increasingly used in NMO-ON, its therapeutic effect and safety are still controversial. There are no systematic reviews yet that evaluated the effects of PLEX against other therapies in patients with NMO-NO. It is therefore timely to perform a systematic review to assess the efficacy and safety of PLEX on current research for its potential use in clinical practice in treating NMO-ON. METHODS: The systematic review will include all of the randomized controlled trials (RCT) on the efficacy and safety of PLEX for NMO-ON. A relevant literature search by sensitive search strategies was conducted using the following electronic databases from their inception to November 30, 2019: PubMed, Web of Science, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal database (VIP) and CBM. We will also search registers of clinical trials, potential gray literature, and conference abstracts. There are no limits on language and publication status. The literature screening, data extraction, and quality assessment will be conducted by 2 reviewers independently. The reporting quality and risk of bias will be assessed by other 2 researchers. Best-corrected visual acuity (BCVA), annualized relapse rate (ARR), the frequency and extent of adverse events (AEs) will be evaluated as the primary outcome. The secondary outcomes will include expanded disability status scales (EDSS), relapse-free rate, peri-papillary retinal nerve fibers layer (pRNFL) or macular volume, visual electrophysiology examinations, standard automated perimetry examinations, time to the next attack. Meta-analysis will be performed using RevMan5.3 software provided by the Cochrane Collaboration and Stata 12.0. RESULTS: This study will provide a comprehensive review based on current evidence of PLEX treatment for NMO-ON in several aspects, including BCVA, ARR, the frequency and extent of adverse events (AEs), EDSS, relapse-free rate, etc. CONCLUSION:: The conclusion of this study will provide evidence to determine whether PLEX is an effective and safe intervention for patients with NMO-ON. ETHICS AND DISSEMINATION: It is not necessary to obtain ethical approval for this study, given that this protocol is for a systematic review. The systematic review will be published in a peer-reviewed journal, presented at conferences and will be shared on social media platforms. PROSPERO REGISTRATION NUMBER: PROSPERO CRD 42020162585.

The effectiveness and safety of Chinese medicines for the treatment of uveitis: A protocol for systematic review and meta-analysis.

BACKGROUND: Uveitis is an inflammatory and heterogeneous ocular disorder and has a profound impact on patients' life, work and family. There are substantial costs to the countries and individuals associated with treatment of the complications of uveitis and blindness. Conventional therapies did not lead to satisfactory outcomes for uveitis and are associated with substantial adverse events (AEs). Emerging evidences have proved the important value and potential prospect of Chinese medicines and its compound in uveitis. However, although Chinese medicines are widely used in uveitis, its therapeutic effect and safety are still controversial. It is, therefore, timely to perform an objective and normative systematic review to assess the efficacy and safety of Chinese medicines in treating uveitis on current research. METHODS: The systematic review will include all of the randomized controlled trials (RCT) on the efficacy and safety of Chinese medicines for uveitis. A relevant literature search by sensitive search strategies was conducted using the following electronic databases from their inception to September 30, 2019: PubMed, Web of Science, EMBASE, the Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal database (VIP) and Chinese Biomedical Literature database (CBM). The strategy combines treatment terms and disease: that is, "Medicine, Chinese Traditional" (e.g., "Medicine, Chinese Traditional", TCM, Traditional Chinese medicine, Zhong Yi Xue) and uveitis. We will also search registers of clinical trials, potential gray literature, and conference abstracts. There are no limits on language and publication status. The literature screening, data extraction, and quality assessment will be conducted by 2 reviewers independently. The reporting quality and risk of bias will be assessed by other two researchers. Best-corrected visual acuity (BCVA) and improvement in disease activity were assessed as the primary outcome. The secondary outcomes will include laboratory efficacy indexes, score changes in the National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ 25), uveitis-related tissue damage or complications, concurrent requirement of corticosteroids, immunosuppressive drugs or biologics, and AEs of treatment. Meta-analysis will be performed using RevMan5.3 software provided by the Cochrane Collaboration. RESULTS: This study will provide a comprehensive review based on current evidence of Chinese medicines treatment for uveitis in several aspects, including BCVA and improvement in disease activity, laboratory efficacy indexes, score changes in the NEI-VFQ 25, uveitis-related tissue damage or complications, etc. CONCLUSION:: The conclusion of this study will provide evidence to determine whether Chinese medicines are an effective and safe intervention for patients with uveitis. ETHICS AND DISSEMINATION: It is not necessary to obtain ethical approval for this study, given that this protocol is for a systematic review. The systematic review will be published in a peer-reviewed journal, presented at conferences and will be shared on social media platforms. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020153620.

Efficacy and safety of Chinese medicines for vitreous hemorrhage: A protocol for systematic review and meta-analysis.

BACKGROUND: Vitreous hemorrhage (VH) is a common ophthalmic disease with a high rate of blindness, which will seriously affect the quality of life of patients and bring great burden to patients' families and society. The treatment for VH contains medical therapy, lasers, and surgery. At present, there is no recognized western medicine with definite curative effect and little side effect for the treatment of VH. In most cases, PRP is not available to treat VH; intravitreal injection or surgical treatment is adopted as the primary therapy. However, in the long-term treatment, the effect of the above-mentioned treatment is not satisfactory, so many patients choose oral Chinese medicines, which has been widely used in China to treat VH. Numerous clinical trials have demonstrated that Chinese medicines can promote the absorption of VH and improve the visual function of patients. The purpose of this review is to evaluate the efficacy and safety of Chinese medicines in the treatment of VH and inform a decision aid for the clinical encounter between patients and clinicians. Besides, it is beneficial to establish a future research agenda. METHODS: The systematic review will include all of the randomized controlled trials on the efficacy and safety of Chinese medicines for VH. Nine electronic databases, namely PubMed, Web of Science, EMBASE, the Cochrane Library, Google Scholar, China National Knowledge Infrastructure (CNKI), Wanfang Database, China Science and Technology Journal database (VIP), and CBM, will be searched normatively on the basis of the rule of each database from the inception to August 31, 2019. We will also search registers of clinical trials, potential gray literature, and conference abstracts. There are no limits on language and publication status. The literature screening, data extraction, and quality assessment will be conducted by 2 reviewers independently. The reporting quality and risk of bias will be assessed by other 2 researchers. Standard of curative effect and total treatment efficacy rate were assessed as the primary outcome. The secondary outcomes will include the curative effect of single symptom and sign, the improvement rate of single auxiliary examination, withdrawal and reduction of western medicines in a course of treatment, maintenance of western medicines after the course of treatment, laboratory efficacy indexes. Meta-analysis will be performed using RevMan5.3 software provided by the Cochrane Collaboration. RESULTS: This study will provide a comprehensive review based on current evidence of Chinese medicines treatment for VH in several aspects, including standard of curative effect, total treatment efficacy rate, the curative effect of single symptom and sign, the improvement rate of single auxiliary examination, withdrawal and reduction of western medicines in a course of treatment, laboratory efficacy indexes, total treatment efficacy, and safety, among others. CONCLUSION: The conclusion of this study will provide evidence to determine whether Chinese medicines are an effective and safe intervention for patients with VH. ETHICS AND DISSEMINATION: It is not necessary to obtain ethical approval 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. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42020152321.

The effectiveness of olopatadine hydrochloride eye drops for allergic conjunctivitis: Protocol for a systematic review.

BACKGROUND: Allergic conjunctivitis (AC) is a multifactorial and common type of ocular surface disease that affects many people. The quality of life for AC patients can be significantly decreased caused by symptoms of ocular itching, swelling, redness, and tearing. Topical antihistaminics, mast cell stabilizers, non-steroidal anti-inflammatory drugs (NSAIDs), and steroids have been widely used to treat AC. Many clinical trials have indicated that olopatadine hydrochloride eye drops can provide quick relief of symptoms and signs. The purpose of this review is to evaluate systematically the effectiveness of olopatadine hydrochloride eye drops for treating AC. METHODS: A systematic review of all of the randomized controlled trials on the effectiveness and safety of olopatadine hydrochloride eye drops for AC will be conducted. We will search PubMed, Web of Science (WOS), EMBASE (OVID), the Cochrane Library, Google Scholar, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal database (VIP), Wanfang Database, and CBM, from the database inception date to October 31, 2019. There are no language or publication status restrictions. Registers of clinical trials, potential gray literature, reference lists of studies, and conference abstracts will also be searched. Two reviewers will independently read the articles, extract the data information, and assess the quality of the studies. Data will be synthesized by a heterogeneity test. The primary outcomes include the main symptom and sign scores before and after treatment, the eye redness index, the presence of eosinophils in the conjunctival scraping. Quality of life, the total treatment efficacy, and safety will be evaluated as the secondary outcomes. RevMan V.5.3 software will be used for the meta-analysis. RESULTS: The study will provide an objective and normative systematic review to evaluate the effectiveness and safety of olopatadine hydrochloride eye drops for the treatment of AC. CONCLUSION: Our review will provide useful information to judge whether olopatadine hydrochloride eye drops is an effective intervention for patients with AC. ETHICS AND DISSEMINATION: It is not necessary to obtain ethical approval as participants are not involved patients. The protocol and results will be published in a peer-reviewed journal. The systematic review will also be disseminated electronically and in print to help guide health care practice and policy. PROSPERO REGISTRATION NUMBER: PROSPERO CRD42019132232.