The steroid prednisolone can cure the face paralysing syndrome Bell's palsy reported The Times on 18 October 2007; 95% who took prednisolone recovered within 9 months, compared to around 80% not taking prednisolone. The newspaper was accurate in its reporting of the main findings of this well conducted, randomised controlled trial.
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The Times (1) reported that 95% of patients' with Bell's palsy who were treated with prednisolone completely recovered by nine months, compared with around 80% who received no treatment.
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The research, published in the New England Journal of Medicine (2), was a well designed double blind randomised controlled trial which assessed the effectiveness of the steroid prednisolone and the antiviral drug acyclovir for the treatment of Bell's palsy in 496 patients recruited from 17 hospitals throughout Scotland. The results showed that, compared to patients who did not receive prednisolone, early treatment with prednisolone significantly improves the chances of complete recovery at both 3 months (83.0% compared to 63.6%) and 9 months (94.4% compared to 81.6%).
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The Times was brief but accurate in its reporting of this well-conducted trial.
Evaluation of the evidence base for the use of prednisolone in the treatment of Bell's palsy.
Where does the evidence come from?
The research was carried out by Professor F. Sullivan and colleagues from the universities of Dundee, Glasgow, Aberdeen and Edinburgh and St John's Hospital, Livingston.
What were the authors' objectives?
The authors' objective was to assess whether taking the steroid prednisolone or the antiviral treatment acyclovir early after the onset of Bell's palsy improves the chances of recovery.
What was the nature of the evidence?
The study was a randomised double-blind controlled trial (RCT) conducted across 17 hospitals throughout Scotland. Five hundred and fifty one patients with a confirmed diagnosis of Bell's palsy within the previous 72 hours were randomised twice resulting in four arms of the trial. Patients were visited 3 to 5 days and 3 months after randomisation, and at 9 months if recovery at 3 months was incomplete. The primary outcome was the House-Brackmann grading system for facial-nerve function; patients were assigned to one of six grades using the median score from three independent experts based on their degree of facial-nerve function, with grade 1 indicating normal function. Secondary outcomes included quality of life, facial appearance, pain and adverse events.
What interventions were examined in the research?
The study included four treatment groups with each group receiving two treatments: 25mg prednisolone twice daily plus placebo; 400 mg acyclovir five times daily plus placebo; prednisolone plus acyclovir; or placebo plus placebo. Patients took the first dose of the study drugs before leaving hospital and the remaining doses over the subsequent 10 days.
What were the findings?
Analysis was based on 496 patients who completed the trial. The percentage of patients who recovered facial function (House-Brackmann grade 1) was significantly higher in patients taking prednisolone compared to patients not taking prednisolone both at three months (83.0% and 63.6% respectively, p<0.001), and at nine months (94.4% and 81.6% respectively, p<0.001). However, the quality of life at 9 months was rated significantly lower for patients who received prednisolone and who had not shown signs of recovery at 3 months, compared with those who did not receive prednisolone (p=0.04). No other significant differences were observed for other secondary outcomes. No significant differences were observed for any outcome between patients who were taking acyclovir and those who were not. Adverse events were generally minor symptoms associated with the drugs.
What were the authors' conclusions?
The authors' conclude that for patients with Bell's palsy, early treatment with prednisolone significantly improves their chances of complete recovery at 3 and 9 months.
How reliable are the conclusions?
This is a generally well conducted RCT with appropriate methods used to blind patients, recruiters, study visitors and outcome assessors to treatment, which reduces the potential for bias. Baseline characteristics seem comparable across the four groups. The use of the House-Brackmann grading system to assess facial nerve paralysis appears reasonable. Dropouts and adverse events were clearly described, however, although it was stated that analysis was based on intention to treat, it appears that only results for patients who completed the trial were analysed. When analysing secondary outcomes the authors have calculated odds ratios; it is not clear how these were calculated for what appear to be continuous variables. In addition, full compliance was indicated in only 77% of patients. Despite this, the authors' conclusions seem reliable.
Systematic reviews
Information staff at CRD searched for systematic reviews relevant to this topic. Systematic reviews are valuable sources of evidence as they locate, appraise and synthesize all available evidence on a particular topic.
There were two related systematic reviews identified on the Cochrane Database of Systematic Reviews (CDSR) (3,4) and four on the Database of Abstracts of Reviews of Effects (DARE) (5-8).
References and resources
1. Steriod cure is found for Bell's palsy. The Times, 18 October 2007, p30.
2. Sullivan FM, Swan IRC, Donnan PT, Morrison JM, Smith BH, McKinstry B, et al. Early treatment with prednisolone or acyclovir in Bell's palsy. New England Journal of Medicine 2007;357(16):1598-607.
3. Salinas RA, Alvarez G, Ferreira J. Corticosteroids for Bell's palsy (idiopathic facial paralysis). Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD001942. DOI: 10.1002/14651858.CD001942.pub2.
4. Allen D, Dunn L. Aciclovir or valaciclovir for Bell's palsy (idiopathic facial paralysis). Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD001869. DOI: 10.1002/14651858.CD001869.pub2.
5. 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(7):830-6. [DARE Abstract]
6. Ramsey MJ, DerSimonian R, Holtel MR, Burgess LP. Corticosteroid treatment for idiopathic facial nerve paralysis: a meta-analysis. Laryngoscope 2000;110(3 Part 1):335-41. [DARE Abstract]
7. Salman MS, MacGregor DL. Should children with Bell's palsy be treated with corticosteroids: a systematic review. Journal of Child Neurology 2001;16(8):565-8. [DARE Abstract]
8. Williamson IG, Whelan TR. The clinical problem of Bell's palsy: is treatment with steroids effective?. British Journal of General Practice 1996;46(413):743-7. [DARE Abstract]
Consumer information
NHS Direct - Bell's palsy
Bell's Palsy Association
Further information about Hitting the Headlines
Further information about Hitting the Headlines, together with selected relevant links, can be found at http://www.library.nhs.uk/hth/.
