Improving Outcomes for Patients with New Onset Bell’s Palsy
Improving Outcomes for Patients with New Onset Bell’s Palsy
Abstract & Commentary
By Penny Tenzer, MD, Associate Professor, Vice Chair of Academic Affairs, Department of Family Medicine & Community Health, Chief of Service, Family Medicine, University of Miami Hospital, University of Miami Miller School of Medicine. Dr. Tenzer reports no financial relationships relevant to this field of study.
Synopsis: The authors conducted a literature review of Medline and the Cochrane database to identify studies comparing outcomes in Bell’s palsy patients who received steroid/antiviral agents vs no medication. Patients with new onset Bell’s palsy treated with steroids displayed significantly better improvement in facial function compared with patients not taking this medication.
Source: Gronseth GS, Paduga R. Evidence-based guideline update: Steroids and antivirals for Bell palsy: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology 2012;79:2209-2213.
The authors researched and graded all studies published in Medline and the Cochrane database from January 2000 through January 2012 that compared facial functional outcomes in patients with Bell’s palsy who received steroid/antivirals and those who did not. The evidence was graded between Class I-IV using the American Academy of Neurology (AAN) therapeutic classification of evidence scheme. They compared facial function recovery in patients who were treated with these medications to patients who were not treated. Nine studies of patients receiving steroids and antiviral therapy were published, identified, and reviewed. Two of the studies were identified as Class I due to their high methodologic quality. Only controlled trials with prospective outcomes involving a minimum of 20 patients with new onset Bell’s palsy over at least 3 months of follow-up were included.
Facial functional recovery was defined as “good” or “complete” using the same criteria used for the 2001 AAN guidelines. The authors rated studies for their risk of bias using the AAN 4-tiered classification of evidence scheme for therapeutic studies. The strength of the recommendation was linked to the strength of the evidence. For the purpose of this review and study, the term steroid was used for any steroid regardless of the specific medication type, dose, or route of delivery. This is true as well for the evaluation of antiviral agents. The search revealed 340 citations, of which the authors reviewed 38 potentially relevant articles. In the end, nine articles met criteria for inclusion for updating the Bell’s palsy guidelines.
The authors identified three articles that compared the use of steroids vs placebo in patients with new onset Bell’s palsy.1-3 Only Class I or II grading studies were discussed and used for recommendations in these updated guidelines.
In the two Class I studies, patients were enrolled within 3 days of the onset of facial palsy to receive steroid treatment vs placebo. Both studies used prednisolone. Patients received prednisolone at 60 mg/d for 5 days followed by a 5-day taper in one study and 25 mg twice daily for 10 days in the other study.1,2 All studies used masked outcome assessment and had high rates of follow-up. The three Class II studies did not describe concealed allocation. These studies enrolled fewer than 100 patients each and described complete follow-up and masked outcome assessment.3-5 One of the Class II studies used IV prednisone.3 The other two used oral steroid preparations.
The two Class I studies demonstrated a significant increase in the probability of complete recovery in patients randomized to steroids (research data [RD] favoring steroids 12.8% and 15%), translating to a number needed to treat of six to eight. None of the Class II studies demonstrated a significant benefit from steroids. However, these studies lacked the statistical precision to exclude a clinically meaningful effect of steroids. The most common adverse effects reported were insomnia and dyspepsia.
The authors concluded that it was therefore highly likely that steroids are effective in increasing the probability of complete facial functional recovery for patients with new onset Bell’s palsy.
In addition to reviewing the effectiveness of steroids, the authors did the same review and evaluation for patients with new onset Bell’s palsy treated with antiviral agents. The authors identified eight articles published during this time, five of which were Class IV due to non-independent, non-masked, nonobjective outcome assessment and therefore not used for the guideline article.
None of the Class I studies demonstrated a significant improvement with the use of antivirals compared with placebo (random-effects Mantel-Haenszel pooled RD 4% favoring placebo, 95% confidence interval [CI], -3% to 11%). Although a benefit of antivirals was not observed in comparison to placebo, some authors have suggested antivirals might have an additional benefit when added to steroids.1,6,7
All of the studies reviewed specifically compared outcomes in patients on steroids and antivirals with those patients on steroids only. No significant benefit of antivirals added to steroids as compared with steroids alone was observed in the Class I and II studies. However, the 95% CIs of the Class I studies indicate that the studies’ statistical precision was insufficient to exclude a modest benefit or harm of antivirals added to steroids (random-effects Mantel-Haenszel pooled RD 0, 95% CI -8% favoring steroids alone to 7% favoring antivirals plus steroids). Adding the Class II studies to the meta-analysis fails to importantly increase the precision of the analysis (pooled RD 4% favoring steroids plus antivirals, 95% CI -4% to 12%).
None of the studies demonstrated a significant increase in any adverse event for patients randomized to an antiviral agent.
Based on these data, the authors concluded that it is very likely that antivirals used in patients with new onset Bell’s palsy do not moderately increase the probability of improved facial functional recovery (two Class I studies).1,7 In addition, they recommended that for patients with new-onset Bell’s palsy, oral steroids should be offered to increase the probability of recovery of facial nerve function (Level A).
For patients with new-onset Bell palsy, antivirals (in addition to steroids) might be offered to increase the probability of recovery of facial function (Level C). Patients offered antivirals should be counseled that a benefit from antivirals has not been established, and, if there is a benefit, it is likely that it is modest at best (RD < 7%).
Commentary
Bell’s palsy is an acute, peripheral facial paresis with an unknown cause.8 Often the diagnosis is established without difficulty.9 Yet, upwards of 30% of patients with Bell’s palsy fail to recover facial function completely.10 The disease has an annual incidence of 20 per 100,000. Thus, thousands of patients with Bell’s palsy are left with permanent, potentially disfiguring facial weakness each year.
In the 2001 guidelines, the Quality Standards Subcommittee of the AAN concluded that for patients with Bell’s palsy, a benefit from steroids, acyclovir, or facial nerve decompression has not been definitively established.11 However, available evidence suggests that steroids are probably effective and acyclovir (combined with prednisone) is possibly effective in improving facial functional outcomes. Well-designed studies of the effectiveness of treatments for Bell’s palsy are still needed.
Over the years, physicians have gone back and forth on whether to treat patients with Bell’s palsy with medication at all, and if so, when and what is the ideal treatment regimen. I have noted changing opinion several times on whether to use steroids and/or antivirals and up to what point they are effective. These updated guidelines reaffirm that there is strong evidence that using steroids within 72 hours of facial palsy increases the likelihood of good to full recovery. The questions remain regarding the added or individual benefit, if any, in using antiviral medications.
Does it follow that we should use steroids in all patients diagnosed with Bell’s palsy? I do not believe this is a predetermined conclusion. As with many patients we see, we need to discuss the benefits and risks, as well as cost and side effects as part of informed consent and make a collaborative decision individual to each patient. Steroids should be used cautiously at the lowest dose and shortest timeframe needed due to their side-effect profile. This is particularly true for patients with comorbid conditions such as diabetes mellitus, hypertension, peptic ulcer disease, or osteoporosis. In these cases, it is vital to consider whether to treat and then counsel our patients accordingly.
In addition, it is difficult to assess whether antiviral medications are effective independently or as an additive agent for improving outcomes in patients with facial palsy. The subgroup analysis seemed to show no difference in the 12-month recovery phase between patients treated with prednisolone alone as compared with patients treated with prednisolone and valcyclovir, slightly favoring the valcyclovir group (modest benefit at best).12 This raises the question of whether it is worthwhile to have the additional expense and possible side effects of the antiviral agents.
Currently, the studies and recommendations support the usage of medication if started within 72 hours of the facial paresis. What do we do if a patient comes in a day or two later with worsening symptoms? Our tendency is to attempt to help our patients in acute distress as well as do our best to improve long-term recovery. Besides assuring that there are no other medical concerns confusing the picture, the options, evidence, pros, and cons should be discussed for a joint decision.
Looking into the future, it would be helpful to have studies comparing the outcomes of patients with Bell’s palsy who receive steroids with and without antivirals. It would also be useful to compare outcomes in studies in which treatment is started after the first 72 hours. Even more than a decade since the release of the 2001 guidelines, the reaffirmation of the efficacy of steroids with two Class I studies and Level A evidence maintains that they are the standard for first-line recommendation to patients with new onset Bell’s palsy and no contraindications.
References
1. Engström M, et al. Prednisolone and valacyclovir in Bell’s palsy: A randomised double-blind, placebo controlled, multicentre trial. Lancet Neurol 2008;7:993-1000.
2. Sullivan FM, et al. Early treatment with prednisolone or acyclovir in Bell’s palsy. N Engl J Med 2007;357: 1598-1607.
3. Lagalla G, et al. Influence of early high-dose steroid treatment on Bell’s palsy evolution. Neurol Sci 2002;23: 107-112.
4. May M, et al. The use of steroids in Bell’s palsy: A prospective controlled study. Laryngoscope 1976;86:1111-1122.
5. Taverner D. Cortisone treatment of Bell’s palsy. Lancet 1954;2:1052-1056.
6. Minnerop M, et al. Bell’s palsy: Combined treatment of famciclovir and prednisone is superior to prednisone alone. J Neurol 2008;255:1726-1730.
7. Yeo SG, et al. Acyclovir and steroid versus steroid alone in the treatment of Bell’s palsy. Am J Otolaryngol 2008; 29:163-168.
8. Hauser WA, et al. Incidence and prognosis of Bell’s palsy in the population of Rochester, Minnesota. Mayo Clin Proc 1971;46:258-264.
9. Katusic SK, et al. Incidence, clinical features, and prognosis in Bell’s palsy. Ann Neurol 1986;20:622-627.
10. Peitersen E. The natural history of Bell’s palsy. Am J Otol 1982;4:107-111.
11. Grogan PM, Gronseth GS. Practice parameter: Steroids, acyclovir, and surgery for Bell’s palsy (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2001;56:830-836.
12. de Ru JA, et al. Is antiviral medication for severe Bell’s palsy still useful? Lancet Neurol 2009;8:509; author reply 509-510.
The authors conducted a literature review of Medline and the Cochrane database to identify studies comparing outcomes in Bells palsy patients who received steroid/antiviral agents vs no medication. Patients with new onset Bells palsy treated with steroids displayed significantly better improvement in facial function compared with patients not taking this medication.Subscribe Now for Access
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