The Reply

Abstract

The efficacy of antiviral medications in patients with Bell's palsy has not been completely determined. However, because herpes simplex virus is present in 31%-79% of these patients, antiviral agents have been tested in many clinical trials.1Hato N. Murakami S. Gyo K. Steroid and antiviral treatment for Bell's palsy.Lancet. 2008; 371: 1818-1820Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar In our study, recovery in patients with Bell's palsy was assessed by an otolaryngologist blinded to patient allocation, eliminating any bias. Although not mentioned in our article, 3 other otolaryngologists participated in treating patients with steroids or steroids plus antivirals. For ethical reasons, this study did not involve a placebo group. Although previous studies have included placebo groups, both steroids alone and steroids plus antivirals yielded better treatment outcomes than placebo. Strictly speaking, only House-Brackmann Grade I is considered complete recovery. In previous studies,2Yeo S.W. Lee D.H. Jun B.C. et al.Analysis of prognostic factors in Bell's palsy and Ramsay Hunt syndrome.Auris Nasus Larynx. 2007; 34: 159-164Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar, 3Numthavaj P. Thakkinstian A. Dejthevaporn C. Attia J. Corticosteroid and antiviral therapy for Bell's palsy: a network meta-analysis.BMC Neurol. 2011; 11: 1Crossref PubMed Scopus (54) Google Scholar, 4Berg T. Marsk E. Engström M. et al.The effect of study design and analysis methods on recovery rates in Bell's palsy.Laryngoscope. 2009; 119: 2046-2050Crossref PubMed Scopus (25) Google Scholar however, recovery to House-Brackmann Grade I or II was defined as a good or satisfactory outcome, favorable effects or complete recovery. Therefore, in this study, both Grades I and II were deemed favorable or complete recovery. Loss to follow-up is inevitable in every clinical study. Rates of loss to follow-up in our steroid and steroid-plus-antivirals group were similar (13.7% vs 12.4%). Intention-to-treat analysis showed that the recovery rate was significantly higher in the combination than in the steroid group (82.8% vs 66.4%, P = .014), as did per-protocol analysis. We did not cite the Sullivan et al study5Sullivan F.M. Swan I.R. Donnan P.T. et al.Early treatment with prednisolone or acyclovir in Bell's palsy.N Engl J Med. 2007; 357: 1598-1607Crossref PubMed Scopus (477) Google Scholar because that study pooled patients with moderate to severe Bell's palsy into a single group without specifying the percentages of patients according to severity of disease. Because our study included only patients with severe Bell's palsy, the Sullivan data could not be directly compared with our findings and was inappropriate for inclusion in our meta-analysis. All clinical studies have flaws, depending on study design, patient inclusion and exclusion criteria, treatment methods, methods of measurement and analysis, interpretation of data, and suitability of follow-up period. Our study also had limitations, as cited in the article and as mentioned in the letter by Turgeon and Allan. Studies on facial palsy inevitably include subjective criteria, which depend on evaluation by observers, rather than being objectively measurable quantities. Improvements in study design and methods of measurement may provide additional information on treatment of these patients. Uncertainties Around Antivirals in Severe Bell's Palsy TrialThe American Journal of MedicineVol. 126Issue 12PreviewWe read the article by Lee et al1 with interest. This trial follows a decade of randomized controlled trials assessing the value of pharmacotherapy in Bell's palsy.2 Overall, existing evidence supports the use of corticosteroids, although the role for antiviral medications is still debated.2 At first glance, the trial by Lee et al1 seems to identify a subgroup of patients with Bell's palsy who benefit from antiviral medications. However, we believe that some limitations cast doubt on the conclusions of this trial. Full-Text PDF