Valacyclovir and prednisolone treatment for Bell's palsy: a multicenter, randomized, placebo-controlled study.
OBJECTIVE
To investigate the effects of valacyclovir and prednisolone in comparison with those of placebo and prednisolone for the treatment of Bell's palsy, excluding zoster sine herpete.


METHODS
Prospective, multicenter, randomized placebo-controlled study.


METHODS
Six academic tertiary referral centers.


METHODS
Ultimately, 221 patients with Bell's palsy who were treated within 7 days of the onset. Serological and polymerase chain reaction examinations were performed to distinguish Bell's palsy from zoster sine herpete.


METHODS
The patients were treated with either valacyclovir (dosage, 1,000 mg/d for 5 days) plus prednisolone (VP [n = 114]) or placebo plus prednisolone (PP [n = 107]) administered orally.


METHODS
Recovery from the palsy was defined as a score higher than 36 using Yanagihara 40-point scoring system without facial contracture or synkinesis. The patients were followed up until complete recovery occurred or for more than 6 months in cases with a poor prognosis.


RESULTS
The overall rate of patient recovery among those treated with VP (96.5%) was significantly better (p < 0.05) than the rate among those treated with PP (89.7%). The rate of patient recovery was also analyzed by classifying the initial severity of facial palsy. In cases of complete or severe palsy, the rates of patients treated with VP and PP who recovered were 95.7% (n = 92) and 86.6% (n = 82), respectively; the recovery rate for treatment with VP was significantly better than that with PP (p < 0.05).


CONCLUSIONS
The valacyclovir and prednisolone therapy was more effective in treating Bell's palsy, excluding zoster sine herpete, than the conventional prednisolone therapy. To our knowledge, this is the first controlled study of an antiviral agent in the treatment of a sufficient number of Bell's palsy cases based on an etiologic background.
Hato
Naohito
N
Department of Otolaryngology, Ehime University School of Medicine, Toon City, Ehime, Japan. nhato@m.ehime-u.ac.jp
Yamada
Hiroyuki
H
Kohno
Hisashi
H
Matsumoto
Shuichi
S
Honda
Nobumitsu
N
Gyo
Kiyofumi
K
Fukuda
Satoshi
S
Furuta
Yasushi
Y
Ohtani
Fumio
F
Aizawa
Hiroshi
H
Aoyagi
Masaru
M
Inamura
Hiroo
H
Nakashima
Tsutomu
T
Nakata
Seiichi
S
Murakami
Shingo
S
Kiguchi
Jun
J
Yamano
Koji
K
Takeda
Taizo
T
Hamada
Masashi
M
Yamakawa
Kazuhiro
K
D000212:Acyclovir / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D020330:Bell Palsy / Q000175:diagnosis / Q000188:drug therapy*; D003937:Diagnosis, Differential; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011239:Prednisolone / Q000627:therapeutic use*; D012720:Severity of Illness Index; D000077483:Valacyclovir; D014633:Valine / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000998:Antiviral Agents; D011239:Prednisolone; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir