For Bell’s palsy, start steroids early; no need for an antiviral
The scale was applied to photographs of patients taken while smiling, raising eyebrows, at rest, and closing eyes. The photographs were assessed and graded independently by 3 experts: an otolaryngologist, a neurologist, and a plastic surgeon. They were unaware of the study group assignment or stage of assessment.
Of 496 patients who completed the study, 357 recovered fully at 3 months, with no further treatment needed. Of the remaining patients, 80 had fully recovered at 9 months and 59 still had some facial-nerve deficit. At 3 months, there was a significant difference in recovery rates in prednisolone comparison groups: 83% with prednisolone vs 63.6% without prednisolone, a difference of 19.4 percentage points (95% confidence interval [CI], 11.7 to 27.1; P<.001, number needed to treat [NNT]=5). There was no significant difference in recovery rates in acyclovir comparison groups: 71.2% with acyclovir vs 75% not treated with acyclovir, a difference of 4.5 % percentage points (95% CI, –12.4 to 3.3; unadjusted P=.30; adjusted P=.50). At 9 months, the rates of complete recovery were 94.4% in prednisolone treated groups vs 81.6% in no prednisolone treatment groups (NNT=8) (TABLE).
TABLE
Complete recovery was significantly higher in the group that received prednisolone without an antiviral
| ACYCLOVIR ARM | PLACEBO ARM | |||
|---|---|---|---|---|
| ACYCLOVIR + PREDNISOLONE | ACYCLOVIR + PLACEBO | PLACEBO + PREDNISOLONE | PLACEBO + PLACEBO | |
| Number of patients who completed therapy | 124 | 123 | 127 | 122 |
| % complete recovery* at 9 months | 92.7% | 78.0% | 96.1% | 85.2% |
| * Grade 1 on House-Brackmann scale, indicating normal function. | ||||
| Source: Adapted from Sullivan et al.1 | ||||
Adverse events
Adverse events included an expected range of minor symptoms associated with use of prednisolone and acyclovir, such as dizziness and vomiting. During the study, 3 patients died under circumstances unrelated to treatment: 2 were receiving double placebo and 1 received only acyclovir.1
WHAT’S NEW: A treatment based on patient-oriented evidence
Neither corticosteroids nor antivirals are new treatments for Bell’s palsy. What is new is that we know what works (corticosteroids) and what does not work (antivirals). This randomized controlled trial finally gives us the evidence on patient-oriented outcomes that we need to make confident recommendations, primarily because it enrolled twice as many patients as all trials compiled for the Cochrane systematic reviews on this topic.7,8
As an interesting side note, this is a good case study of how pathophysiologic reasoning sometimes leads us to good medical practice (corticosteroids in this case) and sometimes does not (antivirals in this case).
Isn’t it good to know that we can actually help patients with Bell’s palsy with corticosteroids and that antivirals are not necessary?
