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Scottish Bell's Palsy Study

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Thursday 18th October 2007

RESULTS PUBLISHED

The results of the Scottish Bell’s Palsy Study appeared today Thursday 18th October 2007 in the New England Journal of Medicine under the title

Early Treatment with
Prednisolone or Acyclovir
in Bell’s Palsy

Frank M Sullivan, Iain RC Swan, Peter T Donnan, Jillian M Morrison
Blair H Smith, Brian McKinstry, Richard J Davenport, Luke D Vale
Janet E Clarkson, Victoria Hammersley, Sima Hayavi, Anne McAteer
Ken Stewart and Fergus Daly

(N Engl J Med 2007;357:1598-607).

BACKGROUND
Corticosteroids and antiviral agents are widely used to treat the early stages of idiopathic facial paralysis (ie Bell’s palsy) but their effectiveness is uncertain.

METHODS
We conducted a double-blind, placebo-controlled, randomized, 2x2 factorial trial involving patients with Bell’s palsy who were recruited within 72 hours after the onset of symptoms. Patients were randomly assigned to receive 10 days of treatment with prednisolone, acyclovir, both agents, or placebo. The primary outcome was recovery of facial function, as rated on the House-Brackmann scale. Secondary outcomes included quality of life, appearance, and pain.

RESULTS
Altogether while the study was  running 752 patients suffering with Bell’s palsy were assessed for eligibility, of whom 551 were randomised into the study. Final outcomes were assessed for 496 patients who completed follow-up.
At three months, the proportions of patients who had recovered facial function were 83.0% in the prednisolone groups as compared with 63.6% among patients who did not receive prednisolone (p < 0.001) and 71.2% in the acyclovir groups as compared with 75.7% among patients who did not receive acyclovir (p = 0.50). After nine months, these proportions were 94.4% for prednisolone and 81.6% for non-prednisolone (p < 0.001) and 85.4% for acyclovir and 90.8% for non- acyclovir (p = 0.10).
The coded treatments issued to patients can now be revealed as

OP    Trt 1    (prednisolone + placebo)
AP    Trt 3    (acyclovir + prednisolone)
OO    Trt 2    (placebo + placebo)
AO    Trt 4    (acyclovir + placebo)

and the percentages recovered at three months and nine months in the four treatment groups are shown in the following figure.

There were no clinically significant differences between the treatment groups for secondary outcomes.
There were no serious adverse events in any treatment group.

CONCLUSIONS
In patients with Bell’s palsy, early treatment with prednisolone significantly improves the chances of complete recovery at three and nine months.
There is no evidence of a benefit from acyclovir given alone or of any additional benefit from acyclovir given in combination with prednisolone.

REGISTRATION
Current Controlled Trials number: ISRCTN 71548196.

ACKNOWLEDGEMENTS
The BELLS study was supported by a grant (02/09/04) from the Health Technology Assessment Programme of the National Institute for Health Research (Department of Health, England). The Scottish School of Primary Care was funded by the Scottish Executive (Chief Scientist Office and National Health Service Education for Scotland) during the study. Practices were reimbursed for their contributions through national Support for Science mechanisms.
We would like to take this opportunity to thank all the patients who have helped us by agreeing to participate in this national clinical trial; all the GPs, A & E staff, NHS24 nurses and others who helped by referring patients to the hospital sites; all the ENT consultants and SHOs in the wards and clinics who took the time to explain the study to patients, randomise them to treatment and issue the capsules; to Tayside Pharmaceuticals at Dundee for their dedicated attention to detail in manufacturing the capsules, bottling, labelling and distributing them; to the hospital pharmacists for managing the dispensing of the medications; to the randomisation unit at HSRU Aberdeen for the efficiency of their systems in allocating the test medications; and to Health Boards, R & D Departments and Ethics Committees nationally who provided facilities and the ethical foundation for the delivery of this study.