Details of HTA project
Last updated: 1 July 2008 - Next update due: 8 July 2008
Research type: |
Primary Research (e.g. trial) |
Project title: |
BELL'S trial: bell's palsy: early acyclovir or prednisolone in Scotland |
 Outputs in journals arising from this project
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Project ref: |
02/09/04 |
Cost: |
£658,347 |
Chief Investigator : |
Professor Francis Michael Sullivan, Professor of R&D in General Practice/Primary Care, Tayside Centre of General Practice, Community Health Sciences, University of Dundee |
Project Website |
http://www.dundee.ac.uk/bells/ |
Project Email |
bells@tcgp.dundee.ac.uk |
Start Date: |
November 2003. |
Publication date: |
May 2009. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed. |
Plain English Summary |
Nearly 200 years after its characterisation in 1821 by Sir Charles Bell, there is no preferred treatment for facial paralysis (Bell's Palsy), a condition affecting one person in 60 during their lifetime. It has long been suspected that some combination of steroid and antiviral therapies may be effective, especially if treatment is commenced early. Previous studies have been undertaken, but none has reached a clear conclusion. The Scottish Bell's Palsy Study is the largest study ever mounted to explore the relative effectiveness of these common therapies. Patients throughout Scotland presenting with suspected Bell's Palsy at their GP's surgery, A & E departments, out-of-hours co-operatives or through NHS24 are offered the opportunity to be referred to one of 17 participating trial sites (Ear Nose and Throat departments in hospitals nationwide). If the diagnosis is confirmed and the patient is willing to join the study, then they are immediately allocated to one of the four treatment combinations prednisolone (steroid), aciclovir (antiviral), both, or neither. Through the use of placebo (dummy) medications, neither the patient, hospital staff nor study personnel know which treatment is which. Patients are visited during the 10-day treatment interval, after 3 months and possibly also after 9 months, for an assessment of the severity of onset of Bell's palsy and of the extent of their eventual recovery from it. At the end of patient recruitment and after the final assessment is made, the treatments will be identified. It is hoped by following this approach, that the most effective treatment or combination of treatments will become evident. |
Abstract: |
DESIGN. A multicentre factorial trial comparing prednisolone , aciclovir, both or neither. Scottish medical and dental practitioners and NHS24 nurses will be alerted by a series of letters to them as individuals, members of research networks, out of hours co-operatives and advertisements in the medical press. They will be reminded on a monthly basis to refer patients wth unilateral facial paralysis of no identifiable cause to their nearest ENT Unit. As soon as an eligible patient presents to the on-call registrar, they will obtain consent, contact the randomisation centre, issue trial medication and conduct baseline assessment of the degree of disability using the study instruments. Patients will be reassessed at three and 9 months. SETTING Primary medical and dental care in Scotland supported by colleagues in otorhinolaryngology, neurology, the Scottish Health Economics Research Unit, the Scottish Health Services Research Unit, NHS24 and the MRCGPRF. TARGET POPULATION. All adults in Scotland who develop unilateral idiopathic facial paralysis in the study period excluding those with diabetes and those who are pregnant. HEALTH TECHNOLOGIES BEING ASSESSED Therapy with aciclovir (or one of its esters), prednisolone and placebo. COST AND OUTCOME MEASUREMENT. Patients will be reassessed at three and 9 months using a digital camera to capture facial appearances which will be assessed by a panel of 3 experts and the Glasgow Benefits Inventory, the Health Utilities Instrument and the chronic pain grade. We will obtain permission from participating patients to review their primary care records and extract data on treatments in practice and elsewhere. The numbers of patients undergoing surgery such as tarsorrhapy or attending outpatient clinics for corneal ulceration will and other cost data will also be collected from the GP records. SAMPLE SIZE. If we simultaneously randomize approximately 240 per treatment (a total of 480) this would allow detection of differences of the order of 12%. Since the study design is factorial the power is the same for each pair-wise comparison of treatments (assuming no interaction). PROJECT TIMETABLE. Based on the power calculation and pilot work we will recruit 1/3 of all patients developing Bell's palsy within 48 hours in Scotland during the 18 month recruitment period at 10 per week across all 4 sites. |
MeSH* index primary terms: |
BELL-PALSY Q-drug-therapy; ACYCLOVIR Q-therapeutic-use; ANTIVIRAL-AGENTS Q-therapeutic-use; ANTI-INFLAMMATORY-AGENTS Q-therapeutic-use; PREDNISOLONE Q-therapeutic-use |
MeSH* index secondary terms: |
HUMAN; RANDOMIZED-CONTROLLED-TRIAL; CLINICAL-TRIAL; SCOTLAND; MULTICENTER-STUDY; FOLLOW-UP-STUDIES |
NRR* number, if applicable: |
N0484131805 (*National Research Register) |
ISRCTN* number: | ISRCTN 71548196 (*International Standard Randomised Controlled Trial Number) URL of this project on the Controlled Trials Website: http://www.controlled-trials.com/ISRCTN71548196 |
Project Protocol: |
Project protocol not available |
URL of this page: |
http://www.hta.ac.uk/1375 |
Outputs from this project
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