Bell's Palsy: Meta-analysis Supports Adding Anti-viral Medication to Steroid Therapy
Bell's Palsy: Meta-analysis Supports Adding Anti-viral Medication to Steroid Therapy
Abstract & Commentary
By Alan Z. Segal, Associate Professor of Clinical Neurology, Weill Cornell Medical College. Dr. Segal reports no financial relationships relevant to this field of study.
Synopsis: Review of available literature suggests that combination therapy of Bell's palsy with both steroids and anti-virals results in the best outcome.
Source: de Almeida JR, et al. Combined corticosteroid and antiviral treatment for Bell palsy: A systematic review and meta-analysis. JAMA 2009;302:985-993.
Corticosteroid treatment has been utilized for many years in the treatment of Bell's palsy even without solid evidence to support this practice. The finding of herpes virus DNA in endoneurial fluid, combined with flimsy clinical data, similarly drove the concomitant use of anti-viral therapy, as well. In 2004, a systematic Cochrane review of existing trials suggested that there was no benefit of either treatment over placebo, yet both continued to be a clinical mainstay, perhaps more out of habit than out of objective evidence. Practitioners could then feel somewhat vindicated in 2007 and 2008 when two large, randomized, controlled trials involving a total of 1,390 patients showed a clear benefit for corticosteroids over placebo. Importantly, these studies not only showed a more rapid recovery with steroids, but more crucially, showed a reduction in permanent facial weakness, contractures, and synkinesis. In contrast, these large trials showed no benefit for anti-viral agents (acyclovir or valcyclovir) given as monotherapy or in combination with steroids. Despite these results, anti-viral agents continued to be commonly prescribed. Perhaps clinicians have become accustomed to this swinging pendulum, since new data suggest that this practice may be quite appropriate.
de Almeida and colleagues reviewed 18 trials involving 2,786 patients, with approximately half of the patients derived from the two randomized studies mentioned above. While there was considerable variability in study design, the two large series used a 2´2 factorial design, treating patients with 1) steroids and anti-virals in combination; 2) steroids plus placebo; 3) anti-virals plus placebo; or 4) double placebo. Steroid treatment was associated with a relative risk of unfavorable recovery of 0.69 (p=0.004), which translates to a number needed to treat of 11. Anti-virals in isolation were not beneficial, but there did appear to be a possible synergistic effect of combination therapy. Steroids with anti-virals added produced an additional 5% of absolute benefit over steroids alone, with a number needed to treat of 20. However, these effects were of only borderline statistical significance (p=0.05). Interestingly, the comparison between steroids and anti-virals in combination against anti-virals alone produced the lowest relative risk of an unfavorable outcome (0.48), with a number needed to treat of only six.
Secondary endpoints representing a poor outcome such as synkinesis or autonomic dysfunction mirrored the primary outcome (facial nerve recovery at > 4 months). Perhaps not surprisingly, analyses of short term benefit (6 weeks to < 4 months), showed only a benefit for steroids with no effect of anti-virals in combination. In addition, timing and dosage of steroids did not prove to effect outcomes. Although there was a trend to increased benefit among patients treated within the first three days of onset and among those treated with higher steroid doses, neither of these variables reached significance. Neither steroid therapy nor anti-virals produced a significant rate of adverse events.
Commentary
Bell's palsy is generally regarded to be a benign condition. However, for the approximately 15% of patients who have residual facial paralysis or other chronic symptoms, the impact on their quality of life is hardly trivial. For this reason, neurologists and other practitioners are proactive about treatment with both steroids and anti-virals. Should a poor outcome occur, few relish the perceived consequences of failing to treat, even if this regret is not justified by the literature. As de Almeida notes, the "higher value that patients place on the uncertain incremental benefits" of combination therapy will drive the behavior of practitioners. If we present the risks and benefits to our patients-virtually no risk and a possible benefit-it is likely that both steroids and anti-virals will remain central to our armamentarium until additional studies are done.
Review of available literature suggests that combination therapy of Bell's palsy with both steroids and anti-virals results in the best outcome.Subscribe Now for Access
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