Reactivation of herpes simplex virus type 1 and varicella-zoster virus and therapeutic effects of combination therapy with prednisolone and valacyclovir in patients with Bell's palsy.
To determine whether reactivation of herpes simplex virus (HSV) type 1 or varicella-zoster virus (VZV) is the main cause of Bell's palsy and whether antiviral drugs bring about recovery from Bell's palsy.
                Randomized, multicenter, controlled study.
                One hundred fifty patients with Bell's palsy were enrolled in this study. The patients were randomly assigned to a prednisolone group or a prednisolone-valacyclovir group, in whom virologic examinations for HSV-1 and VZV were performed by simple randomization scheme in sealed envelopes. The recovery rates among various groups were analyzed using the Kaplan-Meier method and the Cox proportional hazards model.
                Reactivation of HSV-1, VZV, and both viruses was detected in 15.3%, 14.7%, and 4.0% of patients, respectively. There was no significant difference in recovery rates between the prednisolone group and the prednisolone-valacyclovir group, although recovery in the patients with HSV-1 reactivation tended to be higher in the prednisolone-valacyclovir group than in the prednisolone group. There was a significant difference in recovery among age groups and between individuals with complete and incomplete paralysis.
                Reactivation of HSV-1 or VZV was observed in 34% of the patients with Bell's palsy. The effect of combination therapy with prednisolone and valacyclovir on recovery was not significantly higher than that with prednisolone alone.
We found no evidence that anti-viral agents have a beneficial effect on outcomes in Ramsay Hunt syndrome, despite their widespread use in this condition. The use of these drugs in patients with herpes zoster infections in other parts of the body might suggest that they have a role in herpes zoster oticus. As usual, the absence of positive evidence of benefit (or, in this case, the 'negative' result of one small, statistically under-powered study) does not necessarily indicate that antivirals are ineffective. However, these drugs are associated with a number of adverse effects and this must be taken into consideration when undertaking the requisite risk-benefit analysis before instigating treatment.