Condition category
Nervous System Diseases
Date applied
10/08/2004
Date assigned
16/08/2004
Last edited
27/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dundee.ac.uk/bells/

Contact information

Type

Scientific

Primary contact

Prof Frank Sullivan

ORCID ID

Contact details

Tayside Centre for General Practice
University of Dundee
Kirsty Semple Way
Dundee
DD2 4BF
United Kingdom
+44 (0)1382 420022
f.m.sullivan@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 02/09/04, 2002PS27

Study information

Scientific title

Acronym

BELLS

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

Ethics approval

Not provided at time of registration.

Study design

2 x 2 randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.dundee.ac.uk/bells/sbps_files/sbps_pis_a4_nul.rtf

Condition

Bell's Palsy

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

prednisolone, aciclovir

Primary outcome measures

1. House-Brackmann grading system for facial nerve function
2. Health Utilities Index
3. Chronic pain grade
4. Costs

Secondary outcome measures

1. Brief Pain Inventory
2. Derriford Appearance Questionnaire (DAS59)

Overall trial start date

01/11/2003

Overall trial end date

30/06/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

720

Participant 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

Recruitment start date

01/11/2003

Recruitment end date

30/06/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tayside Centre for General Practice
Dundee
DD2 4BF
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Nethergate
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 344000
university@dundee.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17942873
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19833052

Publication citations

  1. Results

    Sullivan FM, Swan IR, Donnan PT, Morrison JM, Smith BH, McKinstry B, Davenport RJ, Vale LD, Clarkson JE, Hammersley V, Hayavi S, McAteer A, Stewart K, Daly F, Early treatment with prednisolone or acyclovir in Bell's palsy., N. Engl. J. Med., 2007, 357, 16, 1598-1607, doi: 10.1056/NEJMoa072006.

  2. Results

    Sullivan FM, Swan IR, Donnan PT, Morrison JM, Smith BH, McKinstry B, Davenport RJ, Vale LD, Clarkson JE, Hern√°ndez R, Stewart K, Hammersley V, Hayavi S, McAteer A, Gray D, Daly F, A randomised controlled trial of the use of aciclovir and/or prednisolone for the early treatment of Bell's palsy: the BELLS study., Health Technol Assess, 2009, 13, 47, iii-iv, ix-xi 1-130, doi: 10.3310/hta13470.

Additional files

Editorial Notes