The idiopathic peripheral facial paralysis described by the Scottish doctor BELL occurs predominantly in middle-aged adults and usually resolves spontaneously. However, residual symptoms persist in one out of every three to five patients. The significance of the herpes simplex virus in this disease has not been finally clarified. Apart from measures to protect the eye, treatment is often given early with a glucocorticoid such as prednisolone (DECORTIN H etc.) and/or an antiviral drug such as aciclovir (ZOVIRAX etc.) or its precursor valaciclovir (VALTREX). The benefit of these agents in the unlicensed indication is insufficiently confirmed (1,2).

A large Scottish multicentre study (3) financed with public money has now compared the efficacy of taking 50 mg prednisolone, 2,000 mg aciclovir or a combination of the two for ten days with placebo in a factorial design (a-t 2003; 34: 100). 551 patients with an average age of 44 years with unilateral facial weakness or paresis without an obvious cause were included in the randomised double-blind study. The symptoms had to be present no longer than 72 hours. At the start, the patients had on average moderately impaired facial nerve function, which was recorded photographically (average of 3.6 on the House-Brackmann scale*) (3).

After three months, the facial paralysis resolved completely in 83% with prednisolone compared to 64% without prednisolone (Number Needed to Treat [NNT]: 6), and after nine months, it had resolved in 94% compared to 82% (NNT: 8). In contrast, aciclovir remained without benefit: after three months, 71% were asymptomatic without aciclovir and 76% with aciclovir; after nine months 85% were asymptomatic with antiviral therapy and 91% without the virostatic drug. On placebo alone, 65% had recovered after three months and 85% after nine months (3).

The study, which included more patients than meta-analyses of the subject to date (1,2), appears at first glance to have been conducted with a solid method. However, the reliability of the results is diminished by the fact that the primary end point was altered without comment by the authors. According to the protocol (4) it was originally planned to compare the rate of incompletely recovered patients with a House-Brackmann grade of at least 3 and not, as in the publication, the rate of completely recovered patients, that is, those with House-Brackmann grade 1. Since the moderate baseline levels of the patients are not far distant from the threshold of the originally planned end point, the suspicion arises that no significant result was achieved. A statement by the authors in response to a query by the a-t in this regard is still awaited.

	The efficacy of treatment of Bell's palsy with corticosteroids or antiviral drugs was up to now insufficiently proven.
	A recent Scottish study identifies a possible benefit after three and nine months of taking prednisolone (DECORTIN H etc.) for ten days, but not aciclovir (ZOVIRAX etc.), which even appears detrimental.
	The uncommented change of the primary end point weakens the reliability. However, we regard a trial of treatment with prednisolone as justified.

(R = randomised study, M = meta-analysis)

1

ALLEN, D. et al.: Aciclovir or valaciclovir for Bell's palsy. The Cochrane Database of Systematic Reviews 2007; Issue 4; Stand März 2004

2

SALINAS, R.A. et al.: Corticosteroids for Bell's palsy. The Cochrane Database of Systematic Reviews 2007; Issue 4; position in June 2004

3

SULLIVAN, F.M. et al.: N. Engl. J. Med. 2007; 357: 1598-607

4

Supplementary Appendix to ref. 3 or http://www.dundee.ac.uk/bells/sbps_files/sbps_protocol.rtf

*

House-Brackmann scale: grade 1 = normal symmetrical function in all regions, grade 3 = non-distorting weakness, possibly elevation of the eyebrow not possible, asymmetrical mouth movement, marked synkinesias or spasms. Maximum severity: grade 6, where no functional movement is possible.