Bells palsy: treatment with famciclovir and prednisone compared with prednisone alone: a randomized, controlled trial

Aim of the study: Bell's palsy (BP) is a common idiopathic lesion of the peripheral facial nerve. Most patients recover, but up to 16% of patients have relevant sequelae. HSV reactivation has been proposed as pathogenic mechanism. The benefit of antiviral drugs in patients with BP is still controversial. We performed a randomized, controlled prospective trial to compare prednisone (P) therapy with the combination of prednisone and famciclovir (P+F) in BP. Clinical outcome, virus antibody (ab)-titres and electroneurgraphic changes (ENG) were compared.

Methods: Patients with untreated BP since <1 week underwent clinical examination, cranial computer-tomography, electroneurography and laboratory testing including cerebrospinal fluid and serum examination for possible bacterial/viral causative agens. Severity of BP was evaluated with the House-Brackmann Scale (HBS). Using ENG the relative differences of latency and amplitude of the motor action potential of the facial nerve between affected and unaffected side were calculated. Patients admitted on even dates were treated with P alone (1mg/kg body weight for 4 days) whereas patients admitted on odd dates were treated with P+F (250mg 3x/day for 7 days). At follow-up visit after 3 months patients were re-examined including HBS, ENG, serum virus ab-titres.

Results: 167 patients were included, 118 patients completed clinical follow-up. 67 patients received P, 51 received P+F. An improvement of 4–5 grades at the HBS was significantly more common in the P+F group (29.4%) than in the P group (11.9%), whereas no or only slight improvements were more common in the P group (29.9%) than in the P+F group (17.6%); (Chi-square-test, p=0.02). Patients with an initial HBS grade of 5 or 6 had a significantly better chance to reach normal function, if they were treated with P+F instead of P only (73.7% vs. 47.1%; Cochran-Armitage Trend Test, p=0.03). ENG and serum ab-titre did not provide significant information regarding the patient selection for virostatic therapy nor were they useful to evaluate the therapeutic effect.

Conclusion: Patients treated with P+F were more likely to reach a better degree of recovery and had a greater chance to achieve normal function in case of severe BP than patients receiving P alone. Although we could not determine whether a HSV infection or reactivation was present in these particular cases, it is thus reasonable to use a combination of a virostatic drug and prednisone in patients with severe BP.