Steroids and antivirals for Bell's palsy.

The Problem

A 45-year-old man presents with a 2-day history of right eye dryness and facial weakness. His symptoms started with right eyelid twitching, progressed to dryness in the right eye, and eventually developed into an asymmetric smile with deviation of his lips to the left when speaking. He reports slurring of speech, lip biting, and altered taste sensation. He is otherwise healthy and denies recent tick bites, rashes, fevers, or head or facial trauma. On exam, ocular fluorescein is negative for corneal abrasions. He has loss of his right nasolabial fold and is unable to crease his forehead. The rest of his ear, nose, and throat exam is unremarkable. He has normal facial sensation, and his neurologic exam is otherwise normal. You diagnose facial nerve paralysis and wonder about the evidence supporting the use of steroids and antivirals for improving outcomes in facial nerve palsy.

The Question

In patients with suspected facial nerve palsy, does the combination of steroids plus antivirals decrease the time to recovery, compared with steroids or antivirals alone?

The Search

You go to PubMed (www.pubmed.gov) and enter "steroids AND antivirals AND Bell's palsy" and limit the search to randomized, controlled trials. Your search yields a relevant study (see box at right).

Our Critique

The study was a well-conducted trial addressing a recognized knowledge gap. The study showed that prednisolone was effective both alone and in combination with acyclovir; however, acyclovir was ineffective alone and gave no additional benefit in combination with prednisolone. Interestingly, vestibular neuritis also has a putative viral etiology and is not effectively treated with antivirals, while steroids appear to improve vestibular function. In our clinical practice, patients with severe deficits at onset who fail to have meaningful improvement over the first few weeks are referred to a subspecialist for consideration of other possible etiologies (for example, mass lesions compressing the facial nerve).

Clinical Decision

You prescribe prednisolone 60 mg/day for 10 days along with artificial tears every hour and Lacrilube at night. You give him a handout on facial expression exercises that he is to conduct in the mirror several times per day. By 5 days, he has complete recovery from his facial paralysis.

F.M. Sullivan et al.

Early treatment with prednisolone or acyclovir in Bell's palsy. N. Engl. J. Med. 2007; 357:1598-607.

* Design and Setting: Study with 2-by-2 factorial design with steroids and antivirals, done at 17 hospitals in Scotland.

* Subjects: Eligible subjects were at least 16 years old with unilateral facial nerve weakness with no identifiable cause. Patients had to be referred to an otorhino-laryngologist within 72 hours of symptom onset. Patients were excluded if they were pregnant or breast-feeding or had uncontrolled diabetes, herpes zoster, multiple sclerosis, systemic infection, sarcoidosis, and "other rare conditions." Eligible subjects were randomized through an automatic randomization service.

* Intervention: Patients were randomized twice into four study groups: oral prednisolone 25 mg twice daily and oral placebo (lactose) five times daily, oral placebo twice daily and oral acyclovir 400 mg five times daily, oral prednisolone 25 mg twice daily and oral acyclovir 400 mg five times daily, and two placebo capsules twice and five times daily. Patients were to take the first dose before leaving the hospital and the remaining doses over the next 10 days.

* Outcomes: The primary outcome measure was scores on the House-Brackmann grading system for facial nerve function, which assigns patients to one of six categories on the basis of the degree of facial nerve function. Outcomes were assessed by documenting the facial appearance of patients in digital photographic images in four standard poses: at rest, with forced smile, with raised eyebrows, and with eyes tightly closed. Outcomes were assessed at 3 months and again at 9 months if the patient had not completely recovered at 3 months. Photographs were assessed and graded independently by a panel of three experts blinded to study arm assignment. Secondary outcomes were quality of life, facial appearance, and pain.

* Results: No significant interactions between prednisolone and acyclovir were observed (that is, the medications together were not shown to have a multiplicative therapeutic effect). At 3 months, complete recovery was observed in 83% of patients who received prednisolone, compared with 64% who did not (adjusted odds ratio 2.44). No difference was observed in the complete recovery rates in the acyclovir comparison groups (71.2% with acyclovir vs. 75.7% without acyclovir) at 3 months. At 9 months, the rates of complete recovery were 94.4% for patients who received prednisolone and 81.6% for those who did not (adjusted odds ratio 3.32). No significant difference in complete recovery was observed between patients receiving acyclovir (85.4%) or not (90.8%). Notably, 85.2% of subjects receiving double placebo had full recovery at 9 months. No significant differences were observed in secondary measures between the groups.

BY JON O. EBBERT, M.D., AND ERIC G. TANGALOS, M.D.

DR. EBBERT and DR. TANGALOS are with the Mayo Clinic in Rochester, Minn. They have no conflict of interest to report. To respond to this column or suggest topics for consideration, write to Dr. Ebbert and Dr. Tangalos at our editorial offices or e-mail them at imnews@elsevier.com.