Giusy Rita Maria La Rosa, Cinzia Del Giovane, Eugenio Pedullà, Jan Kowalski, Iain Chapple, Silvia Minozzi, Amaliya Amaliya, Riccardo Polosa
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引用次数: 0
Abstract
Background: Tobacco use is a global issue, and non-combustible nicotine products (NCNPs) like electronic nicotine delivery systems, nicotine pouches, snus, and nicotine replacement therapies offer potential risk/harm reduction for smokers unable or unwilling to quit. Although NCNPs are less harmful than tobacco smoking, their impact on oral health remains unclear. A systematic review and network meta-analysis will be conducted to answer the research question: What are the oral signs and symptoms associated with NCNPs as both monotherapies and combination therapies compared to each other, placebo, standard care, no drug treatment, and combustible cigarette smoking?
Methods: We will search PubMed and Scopus databases, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to August 2024. This review will focus on randomized controlled trials (RCTs) with a minimum follow-up period of 1 month, comparing any NCNPs versus placebo, standard care, no drug treatment, combustible cigarette smoking or to each other in adult smokers. Our primary outcomes will be the number of participants reporting any oral side effect, aphthous ulcers, dry mouth and mouth irritation. Studies will be excluded if they involve: non-smokers, pregnant women, individuals with mental health or neurological disorders, participants consuming alcohol or other substances. Data will be analyzed using a network meta-analysis framework, estimating odds ratios with 95% confidence intervals. Risk of bias will be determined using the Cochrane risk of bias tool-version 2.0 for included RCTs and the Confidence In Network Meta-Analysis tool will be employed to assess the confidence of evidence contributing to each network estimate.
Discussion: Our findings will provide critical insights into the oral health implications of NCNPs, informing clinical and public health decisions. Results are expected by May 2025 and will be disseminated through publications and presentations to guide tobacco harm reduction strategies.
背景：烟草使用是一个全球性问题，非可燃尼古丁产品（NCNPs）如电子尼古丁输送系统、尼古丁袋、鼻烟和尼古丁替代疗法为不能或不愿戒烟的吸烟者提供了潜在的风险/危害降低。虽然NCNPs的危害比吸烟小，但其对口腔健康的影响尚不清楚。将进行系统回顾和网络荟萃分析，以回答研究问题：与单一治疗和联合治疗相比，安慰剂、标准治疗、无药物治疗和吸烟时，与NCNPs相关的口腔体征和症状是什么？方法：我们将检索PubMed和Scopus数据库，以及Cochrane Central Register of Controlled Trials （Central）从成立到2024年8月。本综述将重点关注随机对照试验（rct），随访期至少为1个月，比较任何NCNPs与安慰剂、标准治疗、无药物治疗、可燃香烟吸烟或成年吸烟者之间的差异。我们的主要结果将是报告任何口腔副作用、口腔溃疡、口干和口腔刺激的参与者数量。如果研究涉及：不吸烟者、孕妇、有精神健康或神经障碍的人、饮酒或其他物质的参与者，则将被排除在外。数据将使用网络元分析框架进行分析，估计95%置信区间的优势比。对纳入的随机对照试验，将使用Cochrane偏倚风险工具2.0版来确定偏倚风险，并使用网络置信度meta分析工具来评估有助于每个网络估计的证据的置信度。讨论：我们的研究结果将为NCNPs对口腔健康的影响提供重要见解，为临床和公共卫生决策提供信息。预计到2025年5月将获得结果，并将通过出版物和简报传播，以指导减少烟草危害战略。系统评价注册号：PROSPERO CRD42024565118。
期刊介绍：
Systematic Reviews encompasses all aspects of the design, conduct and reporting of systematic reviews. The journal publishes high quality systematic review products including systematic review protocols, systematic reviews related to a very broad definition of health, rapid reviews, updates of already completed systematic reviews, and methods research related to the science of systematic reviews, such as decision modelling. At this time Systematic Reviews does not accept reviews of in vitro studies. The journal also aims to ensure that the results of all well-conducted systematic reviews are published, regardless of their outcome.
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