For Bell’s palsy, start steroids early; no need for an antiviral

CAVEATS: Valacyclovir

Hato et al,⁹ in a Japanese study, showed that valacyclovir reaches a level of bioavailability that is 3 to 5 times more than acyclovir and may add some benefit to recovery when used in conjunction with prednisolone, particularly in more severe cases of Bell’s palsy.

The Hato study was a prospective, multicenter, randomized, placebo-controlled study that investigated the effects of valacyclovir (1000 mg/d for 5 days) and prednisolone in comparison with the effects of placebo and prednisolone for the treatment of Bell’s palsy.

The study outcomes included complete recovery from palsy; patients were followed until recovery occurred or more than 6 months in cases with severe prognosis. The patients in the Hato study had an average Yanagihara score of 15 when rating their facial palsy (which falls between House–Brackmann grades 4 and 5).

The overall rate of recovery of those treated with valacyclovir and prednisolone (96.5%) was significantly better (P<.05) than the rate among those treated with placebo and prednisolone (89.7%). In cases of complete or severe palsy, the rates of patients treated with both agents vs prednisolone alone who recovered were 95.7% (n=92) and 86.6% (n=82) (P<.05; NNT=11).

One big difference between the Sullivan and Hato studies is that the patients recruited for the Hato study had much more severe facial palsy (rated between 4 and 5) than in the Sullivan study (average=3.6), which suggests that there may be a use for valacyclovir in treating patients with complete facial palsy.⁶ Patients were all recruited from tertiary care centers as opposed to mainly from primary care settings as in the Sullivan study, consistent with the greater severity of cases in the Hato study.

Outcome assessors were not blinded to treatment assignments or stage of assessment in the Hato study, raising major concerns about the validity of the findings given the nature of facial paralysis as an outcome measure. We find the Sullivan study a more rigorous and convincing study. Nonetheless, future research may verify their findings and support the use of valacyclovir in the most severe cases of Bell’s palsy. For now, we are not convinced.

CHALLENGES TO IMPLEMENTATION: Easy to put into practice

Thankfully, some changes in practice are easy to implement. This is one of them. For those who prefer to prescribe prednisone, the dose of prednisolone used in the study, 25 mg bid, is equivalent to 60 mg of prednisone.

PURL surveillance system methodology
This study was selected and evaluated using FPIN’s Priority Updates from the Research Literature (PURL) surveillance system methodology.