Am Fam Physician. 2009 Mar 15;79(6):435-436.
Each month, three presenters review an interesting journal article in a conversational manner. These articles involve “hot topics” that affect family physicians or “bust” commonly held medical myths. The presenters give their opinions about the clinical value of the individual study discussed. The opinions reflect the views of the presenters, not those of AFP or the AAFP.
This Month’s Article
Sullivan FM, Swan IR, Donnan PT, et al. Early treatment with prednisolone or acyclovir in Bell’s palsy. N Engl J Med. 2007;357(16):1598–1607.
Does pharmacologic treatment of Bell palsy with acyclovir or steroids increase the rate of full recovery in affected adults?
What does this article say?
Andrea: Bell palsy is an idiopathic, acute paralysis of the facial nerve that affects 20 to 30 persons in 100,000 annually. Although full recovery is the norm, up to 30 percent of patients can have residual facial paralysis, pain, and resulting psychological dysfunction because of their physical appearance.1
The authors of this study attempted to shed some light on the effectiveness of the now common medical practice of prescribing corticosteroids and antivirals for Bell palsy. They asked if prednisolone 25 mg twice daily for 10 days or acyclovir (Zovirax) 400 mg five times daily for 10 days, alone or in combination, could improve the rate of recovery from Bell palsy. Overall, 551 patients were randomized using block randomization to receive acyclovir plus placebo, acyclovir plus prednisolone, prednisolone plus placebo, or placebo plus placebo within 72 hours of symptom onset.
The authors found that after three and nine months, more patients who were randomized to prednisolone achieved full recovery. To determine “full” recovery, three independent and blinded specialists (a plastic surgeon, a neurologist, and an otolaryngologist) applied the House-Brackmann grading system for facial nerve function to digital photographs of each patient.2 Acyclovir did not augment the response to prednisolone if given in combination, and was not equivalent to prednisolone if given alone. The number needed to treat with prednisolone to achieve one additional full recovery of facial nerve function (as defined by photographs and the House-Brackmann system) was 6 at three months and 8 at nine months.
Should we believe this study?
Andrea: Sort of—I think they did a lot of things right with this study. First, the authors pulled patients from practices that reflect where our patients come from: 70 percent from family physicians’ offices and 7 percent from the emergency department. So, we know that this patient population is equivalent to ours.
Mark: This was a high-quality trial based on the Jadad criteria.3 It was appropriately randomized and double-blinded, and had an intention-to-treat analysis for the primary outcome, including descriptions of what happened to the patients who were excluded or had withdrawn or dropped out.
This RCT also included more patients than two 2004 Cochrane reviews on the same topic, and thus, has more power to determine a difference in outcome. The Cochrane authors concluded that there was insufficient evidence to support the use of steroids or antivirals for the treatment of Bell palsy. However, there were only 179 patients included in the review of steroids and only 246 patients in the review of antivirals.4,5
Bob: And this study wasn’t industry sponsored! We know that studies sponsored by the pharmaceutical industry tend to favor the drug of that company—probably because of inappropriate comparators or publication bias.6
Andrea: The results are a mixed bag, however. They addressed a specific outcome—complete facial nerve recovery versus incomplete recovery on a scale of 1 to 6 scored by physicians. Based on this, there was a 94 versus 82 percent full recovery of facial nerve function when given prednisolone versus placebo. But who cares what the physicians think—what do the patients think? The authors attempted to address this in a secondary analysis at three and nine months after diagnosis. Unfortunately, they did not include the 357 patients who had fully recovered at the three-month evaluation. The limited data suggest that patients who took prednisolone and did not fully recover at three months were not much better off with respect to self-rated pain, appearance, and quality of life than patients who did not take prednisolone.
What should the family physician do?
Andrea: I think this study suggests that it is reasonable to start prednisolone within 72 hours of the onset of Bell palsy symptoms in our adult patients. Acyclovir does not appear to provide any added benefit in the treatment of this condition. Even though children are less commonly affected, I’d like to see some additional studies on patients younger than 16 years before recommending the same treatment for them.
Mark: I agree. And remember to do the practical things as well. Assess your patient’s ability to chew effectively and completely close the eyelid. Simple things like lubricant eye drops or patching at night can decrease eye discomfort.
Bob: And if you live in parts of the country where Lyme disease is prevalent, think about Lyme disease as an etiology for a 7th cranial nerve palsy, and consider serology testing before initiating steroid therapy.
If a patient presents within 72 hours of symptom onset, it is reasonable to use prednisolone 25 mg twice daily for 10 days to increase the likelihood of full recovery of facial nerve function. Remember, this is different from patient perception of their facial appearance.
The number needed to treat for one additional full recovery is 6 at three months and 8 at nine months.
In this study, acyclovir was of no benefit in the treatment of Bell palsy.
Don’t forget practical considerations in the treatment of Bell palsy. Lubricant eye drops, pain management, and chewing instruction are all important for patient comfort.
A study should only change your practice if it is applicable to your patient population, such as in this case, where the study patients presented to a family physician or the emergency department, and were not part of a subspecialist’s highly selected patient population.
Randomized controlled trials should meet the following criteria: they should provide an appropriate description of randomization; they should be double blind; and they should provide a description of withdrawals and dropouts.
Look for nonindustry-sponsored studies—they are less likely to have publication bias or use inappropriate comparisons.
This study used block randomization to assign patients in small groups. This type of randomization is done to decrease the likelihood of too many patients being randomized to a single treatment. In this study, randomization was in blocks of four. So, one person in each block was randomized to one of the four treatment protocols.
REFERENCESshow all references
1. Gilden DH. Clinical practice. Bell’s palsy. N Engl J Med. 2004;351(13):1323–1331....
2. House JW, Brackmann DE. Facial nerve grading system. Otolaryngol Head Neck Surg. 1985;93(2):146–147.
3. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17(1):1–12.
4. Salinas RA, Alvarez G, Ferreira J. Corticosteroids for Bell’s palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2004;(4): CD001942.
5. Allen D, Dunn L. Aciclovir or valaciclovir for Bell’s palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2004;(3):CD001869.
6. Lexchin J, Bero LA, Diulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ. 2003;326(7400):1167–1170.
For more information on EBM terms, see the EBM Toolkit at http://www.aafp.org/afp/ebmtoolkit.
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