Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, VIC, Australia.
Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia.
Lancet Infect Dis. 2021 May;21(5):647-656. doi: 10.1016/S1473-3099(20)30704-0. Epub 2021 Mar 4.
To address the increasing incidence of gonorrhoea and antimicrobial resistance, we compared the efficacy of Listerine and Biotène mouthwashes for preventing gonorrhoea among men who have sex with men (MSM).
The OMEGA trial was a multicentre, parallel-group, double-blind randomised controlled trial among MSM, done at three urban sexual health clinics and one general practice clinic in Australia. Men were eligible if they were diagnosed with oropharyngeal gonorrhoea by nucleic acid amplification test (NAAT) in the previous 30 days or were aged 16-24 years. They were randomly assigned to receive Listerine (intervention) or Biotène (control) via a computer-generated sequence (1:1 ratio, block size of four). Participants, clinicians, data collectors, data analysts, and outcome adjudicators were masked to the interventions after assignment. Participants were instructed to rinse and gargle with 20 mL of mouthwash for 60 s at least once daily for 12 weeks. Oropharyngeal swabs were collected by research nurses every 6 weeks, and participants provided saliva samples every 3 weeks, to be tested for Neisseria gonorrhoeae with NAAT and quantitative PCR. The primary outcome was proportion of MSM diagnosed with oropharyngeal N gonorrhoeae infection at any point over the 12-week period, defined as a positive result for either oropharyngeal swabs or saliva samples by NAAT, and the cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit. A modified intention-to-treat analysis for the primary outcome was done that included men who provided at least one follow-up specimen over the 12-week study period. The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12616000247471).
Between March 30, 2016, and Oct 26, 2018, 786 MSM were screened and 256 were excluded. 264 MSM were randomly assigned to the Biotène group and 266 to the Listerine group. The analysis population included 227 (86%) men in the Biotène group and 219 (82%) in the Listerine group. Oropharyngeal gonorrhoea was detected in ten (4%) of 227 of MSM in the Biotène group and in 15 (7%) of 219 in the Listerine group (adjusted risk difference 2·5%, 95% CI -1·8 to 6·8). The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7).
Listerine did not reduce the incidence of oropharyngeal gonorrhoea compared with Biotène. However, previous research suggests that mouthwash might reduce the infectivity of oropharyngeal gonorrhoea; therefore, further studies of mouthwash examining its inhibitory effect on N gonorrhoeae are warranted to determine if it has a potential role for the prevention of transmission.
Australian National Health and Medical Research Council.
为应对淋病发病率上升和抗菌药物耐药问题，我们比较了李施德林和比基尼（Biotène）漱口水对男男性行为者（MSM）预防淋病的效果。
OMEGA 试验是一项在澳大利亚 3 家城市性健康诊所和 1 家普通诊所进行的多中心、平行组、双盲随机对照试验，纳入对象为过去 30 天内经核酸扩增试验（NAAT）诊断为咽淋病或年龄在 16-24 岁的 MSM。采用计算机生成的序列（1:1 比例，区组大小为 4）将他们随机分为李施德林（干预）或比基尼（对照）组。参与者、临床医生、数据收集者、数据分析师和结局评估者在分组后对干预措施进行盲法。参与者被指示每天至少用 20 毫升漱口水漱口 60 秒，持续 12 周。研究护士每 6 周采集咽拭子，参与者每 3 周采集唾液样本，通过 NAAT 和定量 PCR 检测淋病奈瑟菌。主要结局为 12 周期间任何时间 MSM 诊断为咽淋病的比例，定义为咽拭子或唾液样本的 NAAT 检测均为阳性，以及第 12 周就诊时咽淋病的累积发病率。对主要结局进行了改良意向治疗分析，纳入至少在 12 周研究期间提供了一次随访标本的男性。该试验在澳大利亚和新西兰临床试验注册中心（ACTRN12616000247471）注册。
2016 年 3 月 30 日至 2018 年 10 月 26 日，共筛选了 786 名 MSM，其中 256 名被排除。264 名 MSM 被随机分配至比基尼组，266 名分配至李施德林组。分析人群包括比基尼组 227 名（86%）和李施德林组 219 名（82%）男性。比基尼组 10 名（4%）和李施德林组 15 名（7%）男性（调整风险差 2·5%，95%CI-1·8 至 6·8）检测出咽淋病。两组在第 12 周就诊时的咽淋病累积发病率无差异（调整风险差 3·1%，95%CI-1·4 至 7·7）。
与比基尼组相比，李施德林并未降低咽淋病发病率。然而，先前的研究表明，漱口水可能会降低淋病奈瑟菌的传染性；因此，需要进一步研究漱口水对淋病奈瑟菌的抑制作用，以确定其在预防传播方面是否具有潜在作用。
澳大利亚国家卫生与医学研究委员会。
