title: Valacyclovir and prednisolone treatment for Bell's palsy: a multicenter, randomized, placebo-controlled study.
abstract: 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.
authors.affiliation: Department of Otolaryngology, Ehime University School of Medicine, Toon City, Ehime, Japan. nhato@m.ehime-u.ac.jp
authors.forename: Naohito
authors.initials: N
authors.lastname: Hato
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yamada
authors.forename: Hisashi
authors.initials: H
authors.lastname: Kohno
authors.forename: Shuichi
authors.initials: S
authors.lastname: Matsumoto
authors.forename: Nobumitsu
authors.initials: N
authors.lastname: Honda
authors.forename: Kiyofumi
authors.initials: K
authors.lastname: Gyo
authors.forename: Satoshi
authors.initials: S
authors.lastname: Fukuda
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Furuta
authors.forename: Fumio
authors.initials: F
authors.lastname: Ohtani
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Aizawa
authors.forename: Masaru
authors.initials: M
authors.lastname: Aoyagi
authors.forename: Hiroo
authors.initials: H
authors.lastname: Inamura
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Nakashima
authors.forename: Seiichi
authors.initials: S
authors.lastname: Nakata
authors.forename: Shingo
authors.initials: S
authors.lastname: Murakami
authors.forename: Jun
authors.initials: J
authors.lastname: Kiguchi
authors.forename: Koji
authors.initials: K
authors.lastname: Yamano
authors.forename: Taizo
authors.initials: T
authors.lastname: Takeda
authors.forename: Masashi
authors.initials: M
authors.lastname: Hamada
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yamakawa
mesh_terms: 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
chemical_list: D000998:Antiviral Agents; D011239:Prednisolone; D014633:Valine; D000077483:Valacyclovir; D000212:Acyclovir