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Valacyclovir and Prednisolone Treatment for Bell's Palsy: A Multicenter, Randomized, Placebo-Controlled Study

Hato, Naohito*; Yamada, Hiroyuki*; Kohno, Hisashi*; Matsumoto, Shuichi*; Honda, Nobumitsu*; Gyo, Kiyofumi*; Fukuda, Satoshi; Furuta, Yasushi; Ohtani, Fumio; Aizawa, Hiroshi; Aoyagi, Masaru; Inamura, Hiroo; Nakashima, Tsutomu§; Nakata, Seiichi§; Murakami, Shingo; Kiguchi, Jun; Yamano, Koji; Takeda, Taizo; Hamada, Masashi; Yamakawa, Kazuhiro

doi: 10.1097/01.mao.0000265190.29969.12
Facial Nerve

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.

Study Design: Prospective, multicenter, randomized placebo-controlled study.

Setting: Six academic tertiary referral centers.

Patients: 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.

Intervention: 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.

Main Outcome Measure: 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).

Conclusion: 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.

*Department of Otolaryngology, Ehime University School of Medicine, Ehime; †Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Hokkaido; ‡Department of Otolaryngology, Yamagata University School of Medicine, Yamagata; §Department of Otolaryngology, Nagoya University, School of Medicine, Nagoya; ∥Department of Otolaryngology, Nagoya City University Hospital, Nagoya; and ¶Department of Otolaryngology, Kochi Medical School, Kochi, Japan

Address correspondence and reprint requests to Naohito Hato, M.D., Department of Otolaryngology, Ehime University School of Medicine, Shitsukawa, Toon City, Ehime 791-0295, Japan; E-mail:

This study was supported by a grant for highly advanced medical technology projects from the Ministry of Education, Culture, Sports, Science, and Technology of Japan.

© 2007 Otology & Neurotology, Inc.