Randomized double-blinded, placebo-controlled clinical trial of famciclovir for reduction of Ménière's disease symptoms.

OBJECTIVE

To conduct a clinical trial of famciclovir for symptom control in Meniere's disease.

STUDY DESIGN AND

SETTING

Randomized, double-blinded placebo-controlled clinical trial in a tertiary referral center, with 12 subjects in the active treatment arm and 11 subjects in the placebo arm.

RESULTS

There were no serious adverse events. Twenty-five percent of the famciclovir group and 18% of the placebo group showed a reduction in number of vertigo spells, the primary efficacy endpoint. This difference was not statistically significant. All subjects improved in dizziness and health-related quality of life. There was a trend for the famciclovir arm to have less fluctuation in hearing relative to the placebo arm.

CONCLUSION

No dramatic effects of famciclovir were found on vertigo or dizziness. Some promising effects on reduction of the fluctuation in hearing were observed.

SIGNIFICANCE: Famciclovir may suppress the fluctuation of hearing in Meniere's disease, but had a minimal effect on vertigo or dizziness symptoms in this study. The probable multifactorial etiology in Meniere's disease requires that further studies be conducted to determine the effects of antiviral medications.

EBM RATING: A.