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Uncertainties Around Antivirals in Severe Bell's Palsy Trial

      To the Editor:
      We read the article by Lee et al
      • Lee H.Y.
      • Byun J.Y.
      • Park M.S.
      • et al.
      Steroid-antiviral treatment improves the recovery rate in patients with severe Bell's Palsy.
      with interest. This trial follows a decade of randomized controlled trials assessing the value of pharmacotherapy in Bell's palsy.
      • de Almeida J.R.
      • Al Khabori M.
      • Guyatt G.H.
      • et al.
      Combined corticosteroid and antiviral treatment for Bell palsy: a systematic review and meta-analysis.
      Overall, existing evidence supports the use of corticosteroids, although the role for antiviral medications is still debated.
      • de Almeida J.R.
      • Al Khabori M.
      • Guyatt G.H.
      • et al.
      Combined corticosteroid and antiviral treatment for Bell palsy: a systematic review and meta-analysis.
      At first glance, the trial by Lee et al
      • Lee H.Y.
      • Byun J.Y.
      • Park M.S.
      • et al.
      Steroid-antiviral treatment improves the recovery rate in patients with severe Bell's Palsy.
      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.
      First, it appears that a single otolaryngologist was the sole outcome assessor and it is unclear if this clinician was blinded. Knowledge of the patients' assigned intervention during assessment of a relatively subjective outcome would introduce detection bias, and lack of secondary assessors compounds this potential risk. Additionally, the authors did not provide adequate information to assess allocation concealment, a potential high source of bias.
      Second, a closer look at the final House-Brackmann grades does not support the superior efficacy of combination therapy. Although more combination therapy patients achieved the primary outcome (House-Brackmann grade 1 or 2) by the end of the trial, numerically more patients in the steroid group (39.3% vs 31.3% with combination therapy) achieved House-Brackmann grade 1 (ie, complete recovery, the primary outcome of most Bell's palsy studies). This lower rate of complete recovery with the addition of antivirals also was found in severe subgroups of 2 high-quality trials.
      • Sullivan F.
      • Swan I.
      • Daly F.
      Prednisolone or acyclovir in Bell's palsy [letter].
      • Axelsson S.
      • Berg T.
      • Jonsson L.
      • Engström M.
      • Kanerva M.
      • Stjernquis-Desatnik A.
      Bell's palsy – the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial.
      The high loss to follow-up and use of per-protocol analysis further compromise the durability of results.
      Lastly, the authors undermine their impartiality with apparently biased reporting of prior literature. For example, although cited in their article, the large randomized controlled trial by Sullivan et al
      • Sullivan F.M.
      • Swan I.R.C.
      • Donnan P.T.
      • et al.
      Early treatment with prednisolone or acyclovir in Bell's palsy.
      (which showed a trend towards antiviral agents producing worse outcomes) is omitted from their summary (their Table 4) and meta-analysis (their Figure 2) of recent studies. There also appear to be multiple inconsistencies in the numbers presented in their meta-analysis. Finally, presentation of their results using odds ratios (both for prior studies and their current study) exaggerates the apparent benefit of antiviral agents.
      In summary, we feel that the trial as reported does not provide robust evidence of benefit with antiviral agents in severe Bell's palsy. Greater transparency from the authors would, however, allow for a better assessment of the potential value of this intervention.

      References

        • Lee H.Y.
        • Byun J.Y.
        • Park M.S.
        • et al.
        Steroid-antiviral treatment improves the recovery rate in patients with severe Bell's Palsy.
        Am J Med. 2013; 126: 336-341
        • de Almeida J.R.
        • Al Khabori M.
        • Guyatt G.H.
        • et al.
        Combined corticosteroid and antiviral treatment for Bell palsy: a systematic review and meta-analysis.
        JAMA. 2009; 302: 985-993
        • Sullivan F.
        • Swan I.
        • Daly F.
        Prednisolone or acyclovir in Bell's palsy [letter].
        N Engl J Med. 2008; 358 (author reply, 307): 306-307
        • Axelsson S.
        • Berg T.
        • Jonsson L.
        • Engström M.
        • Kanerva M.
        • Stjernquis-Desatnik A.
        Bell's palsy – the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial.
        Clin Otolaryngol. 2012; 37: 283-290
        • Sullivan F.M.
        • Swan I.R.C.
        • Donnan P.T.
        • et al.
        Early treatment with prednisolone or acyclovir in Bell's palsy.
        N Engl J Med. 2007; 357: 1598-1607

      Linked Article

      • Steroid-antiviral Treatment Improves the Recovery Rate in Patients with Severe Bell's Palsy
        The American Journal of MedicineVol. 126Issue 4
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          The extent of facial nerve damage is expected to be more severe in higher grades of facial palsy, and the outcome after applying different treatment methods may reveal obvious differences between severe Bell's palsy and mild to moderate palsy. This study aimed to systematically evaluate the effects of different treatment methods and related prognostic factors in severe to complete Bell's palsy.
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      • The Reply
        The American Journal of MedicineVol. 126Issue 12
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          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.1
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