The effectiveness and safety of botulinum toxin injections for the treatment of sialorrhea with Parkinson's disease: a systematic review and meta-analysis.
{"title":"The effectiveness and safety of botulinum toxin injections for the treatment of sialorrhea with Parkinson's disease: a systematic review and meta-analysis.","authors":"Chun-Lan Yang, Jia-Peng Huang, Ying-Chao Tan, Ting-Ting Wang, Han Zhang, Yun Qu","doi":"10.1186/s40360-023-00694-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Botulinum toxin (BoNT) injection is an important adjunctive method to treat sialorrhea. The purpose of this systematic review was to analyze the effect and safety of BoNT injections in the intervention of sialorrhea with Parkinson's disease (PD).</p><p><strong>Methods: </strong>We searched PubMed, Web Of Science (WOS), Scopus, Cochrane CENTRAL, and Embase from inception until April 2022. Randomized controlled trials or randomized crossover trials comparing BoNT with placebo in sialorrhea with PD were eligible. PRISMA guidelines were used to carry out the meta-analysis. The Drooling Severity Frequency Scale (DSFS) score and the number of adverse events (AEs) were the primary and secondary outcomes, respectively. Standardized mean differences (SMDs) and risk differences (RDs) are used to express continuous and categorical outcomes, respectively. Heterogeneity among these studies was evaluated using I<sup>2</sup> tests. We used the GRADE tool to assess the certainty of evidence (COE).</p><p><strong>Results: </strong>Eight articles involving 259 patients compared BoNT injections with a placebo for PD with sialorrhea. This meta-analysis showed a significant reduction in DSFS scores between BoNT injections and placebo (SMD=-0.98; 95% CI, -1.27 to 0.70, p<0.001; COE: high). This meta-analysis showed a significant difference in AEs between BoNT injections and placebo (RD=0.15; 95% CI, 0.05 to 0.24, p=0.002; COE: low).</p><p><strong>Conclusions: </strong>The pooled results suggest that BoNT injections have some effect on DSFS scores with sialorrhea caused by PD. There are also mild adverse events, which generally recover within a week or so. The results indicate that BoNT injection is one of the treatments for sialorrhea caused by PD, but we need to pay attention to adverse events. In addition, the follow-up time was extended to observe oral hygiene, ulceration or dental caries, and digestive function.</p><p><strong>Trial registration: </strong>Our review protocol was registered on PROSPERO (42021288334).</p>","PeriodicalId":9023,"journal":{"name":"BMC Pharmacology & Toxicology","volume":"24 1","pages":"52"},"PeriodicalIF":2.8000,"publicationDate":"2023-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10571401/pdf/","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Pharmacology & Toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s40360-023-00694-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 1
Abstract
Background: Botulinum toxin (BoNT) injection is an important adjunctive method to treat sialorrhea. The purpose of this systematic review was to analyze the effect and safety of BoNT injections in the intervention of sialorrhea with Parkinson's disease (PD).
Methods: We searched PubMed, Web Of Science (WOS), Scopus, Cochrane CENTRAL, and Embase from inception until April 2022. Randomized controlled trials or randomized crossover trials comparing BoNT with placebo in sialorrhea with PD were eligible. PRISMA guidelines were used to carry out the meta-analysis. The Drooling Severity Frequency Scale (DSFS) score and the number of adverse events (AEs) were the primary and secondary outcomes, respectively. Standardized mean differences (SMDs) and risk differences (RDs) are used to express continuous and categorical outcomes, respectively. Heterogeneity among these studies was evaluated using I2 tests. We used the GRADE tool to assess the certainty of evidence (COE).
Results: Eight articles involving 259 patients compared BoNT injections with a placebo for PD with sialorrhea. This meta-analysis showed a significant reduction in DSFS scores between BoNT injections and placebo (SMD=-0.98; 95% CI, -1.27 to 0.70, p<0.001; COE: high). This meta-analysis showed a significant difference in AEs between BoNT injections and placebo (RD=0.15; 95% CI, 0.05 to 0.24, p=0.002; COE: low).
Conclusions: The pooled results suggest that BoNT injections have some effect on DSFS scores with sialorrhea caused by PD. There are also mild adverse events, which generally recover within a week or so. The results indicate that BoNT injection is one of the treatments for sialorrhea caused by PD, but we need to pay attention to adverse events. In addition, the follow-up time was extended to observe oral hygiene, ulceration or dental caries, and digestive function.
Trial registration: Our review protocol was registered on PROSPERO (42021288334).
背景:肉毒杆菌毒素(BoNT)注射液是治疗唾液溢液的重要辅助方法。本系统综述的目的是分析BoNT注射液在帕金森病(PD)唾液溢出干预中的效果和安全性。方法:从开始到2022年4月,我们搜索了PubMed、Web of Science(WOS)、Scopus、Cochrane CENTRAL和Embase。随机对照试验或随机交叉试验比较BoNT与安慰剂治疗唾液溢性帕金森病是合格的。PRISMA指南用于进行荟萃分析。脱水严重程度-频率量表(DSFS)评分和不良事件数(AE)分别是主要和次要结果。标准化平均差(SMD)和风险差(RD)分别用于表示连续和分类结果。使用I2检验来评估这些研究之间的异质性。我们使用GRADE工具来评估证据的确定性(COE)。结果:8篇涉及259名患者的文章将BoNT注射与安慰剂治疗患有唾液溢的PD进行了比较。这项荟萃分析显示,BoNT注射与安慰剂相比,DSFS评分显著降低(SMD=-0.98;95%CI,-1.27-0.70,P结论:合并结果表明,BoNT注射液对PD引起的唾液溢的DSFS评分有一定影响。还有轻度不良事件,通常在一周左右内恢复。结果表明,BoNT注射液是治疗PD引起的唾液溢的方法之一,但需要注意不良事件。此外,延长随访时间,观察口腔卫生、溃疡或龋齿以及消化功能。试验注册:我们的审查方案已在PROSPERO上注册(42021288334)。
期刊介绍:
BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.