Background: Recently, several randomized controlled trials (RCTs) have evaluated the effect of N95 respirators compared with medical masks to protect against acute respiratory infections. However, these studies are limited by modest sample sizes and inconclusive results. Therefore, the goal of the present study was to review the relevant and available published RCTs with the aid of the increased power of meta-analytic methods in order to assess the effectiveness of medical masks and N95 respirators in reducing the risk of respiratory infections.
Methods: This meta-analysis follows the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for conducting and reporting results. We searched PubMed, Web of Science, Embase, and Cochrane databases from inception through April 1, 2020 to identify potentially relevant studies. Two authors (LS and JS) independently searched the titles and abstracts of the potentially eligible articles. They independently retrieved required data from the eligible trials; the data were initially tabulated for statistical analysis. Two authors (JRL and LS) independently assessed the methodological quality of the included RCTs using the Cochrane Collaboration's tool for assessing risk of bias.
Results: Six articles met the inclusion criteria. The pooled analysis showed that N95 respirators did not reduce the risk of infection with respiratory viruses compared with medical/surgical masks (5.7% vs. 7.9%; RR = 1.12; 95% CI: 0.88-1.41; p = 0.36); however, there was no statistically significant difference in laboratory-confirmed influenza between N95 and medical masks (RR = 0.91; 95% CI: 0.77-1.07; p = 0.26). Medical masks provided similar protection against other viruses, including coronavirus (RR = 0.74; 95% CI: 0.32-1.73; p = 0.49). Respiratory illness, as well as influenza-like illness were less frequently observed with N95 respirators.
Conclusions: Our meta-analysis suggests that there are insufficient data to definitively determine whether N95 respirators are superior to medical masks in protection against transmissible acute respiratory infections. Further randomized trials are necessary to compare the above methods of respiratory protection in the context of COVID-19 incidence.