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Bell's palsy: Early aciclovir and/or prednisolone in Scotland
ISRCTN ISRCTN71548196
DOI 10.1186/ISRCTN71548196
ClinicalTrials.gov identifier
EudraCT number
Public title Bell's palsy: Early aciclovir and/or prednisolone in Scotland
Scientific title
Acronym BELLS
Serial number at source HTA 02/09/04, 2002PS27
Study hypothesis 1. To describe the resolution of neurological deficit and cosmetic, psychological and functional recovery in each of four groups of patients: those treated with prednisolone, aciclovir, both, or neither.
2. To determine which group of patients have the greatest reduction in neurological disability scores on the House and Brackmann grading system at 3 and 9 months after randomisation.
3. To compare self-reported health status (including assessments of pain) at 3 and 9 months after randomisation.
4. To compare the incremental cost per neurological deficit resolved and incremental cost per QALY in the study groups
Lay summary
Ethics approval Not provided at time of registration.
Study design 2 x 2 randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Bell's Palsy
Participants - inclusion criteria Adults (16 or older) diagnosed with Bell's Palsy and with no excluding conditions and who can be consented at participating centres in Scotland within 72 hours of onset.
Participants - exclusion criteria 1. Pregnancy
2. Uncontrolled diabetes (HbA1c >8%)
3. Peptic ulcer disease
4. Suppurative otitis media
5. Herpes zoster
6. Multiple sclerosis
7. Sarcoidosis and other rarer conditions
8. Inability to give informed consent
9. Breast-feeding
10. Patients with systemic infection
Anticipated start date 01/11/2003
Anticipated end date 30/06/2007
Status of trial Completed
Patient information material Patient information can be found at: http://www.dundee.ac.uk/bells/sbps_files/sbps_pis_a4_nul.rtf
Target number of participants 720
Interventions Design is 2x2 Randomised Controlled Trial (RCT), the 4 arms being:
1. Prednisolone and placebo
2. Aciclovir and placebo
3. Prednisolone and aciclovir
4. Placebo and placebo
Dosage as follows: prednisolone 50 mg/day x 10 days, aciclovir 2000 mg/day x 10 days, lactose placebo indistinguishable.
Primary outcome measure(s) 1. House-Brackmann grading system for facial nerve function
2. Health Utilities Index
3. Chronic pain grade
4. Costs
Secondary outcome measure(s) 1. Brief Pain Inventory
2. Derriford Appearance Questionnaire (DAS59)
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.dundee.ac.uk/bells/
Publications 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17942873
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19833052
Contact name Prof  Frank  Sullivan
  Address Tayside Centre for General Practice
University of Dundee
Kirsty Semple Way
  City/town Dundee
  Zip/Postcode DD2 4BF
  Country United Kingdom
  Tel +44 (0)1382 420022
  Fax +44 (0)1382 420010
  Email f.m.sullivan@dundee.ac.uk
Sponsor University of Dundee (UK)
  Address Nethergate
  City/town Dundee
  Zip/Postcode DD1 4HN
  Country United Kingdom
  Tel +44 (0)1382 344000
  Fax +44 (0)1382 201604
  Email university@dundee.ac.uk
Date applied 10/08/2004
Last edited 27/10/2009
Date ISRCTN assigned 16/08/2004
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