Do We Need to Taper Down Steroid Therapy for Bell's Palsy
Keywords
Abstract
Description
A prospective randomized controlled trial of adult patients diagnosed with BP in the otolaryngology emergency department within 72 hours of symptoms onset.
Patients will be randomized to receive one of the following steroids regimens:
1. Prednisone 1 mg/kg (max. 60 mg) daily for 7 days, 40 mg for 2 days, 20 mg for 2 days (Total 11 days)
2. Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days)
In addition, both groups will receive the following treatment when indicated:
- Mosturizing eye drops for 14 days or until complete recovery (HB-1)
- Mosturizing eye gel for 14 days or until complete recovery (HB-1)
- Omepradex once daily during prednisone treatment (unless the patient receives chronic treatment with any proton pump inhibitor).
- Acyclovir for 7 days in cases of severe BP (HB 5-6).
Patients' follow-up visits: 14 days, 1 month, 3 months. If recovery will be completed before 1 month, no more follow up visits will be taken.
In addition, side effects of prednisone use will be assessed as well as compliance to therapy and duration of additional symptoms.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 05/08/2020 |
| Estimated Enrollment Submitted: | 05/26/2020 |
| First Posted: | 05/27/2020 |
| Last Update Submitted: | 07/26/2020 |
| Last Update Posted: | 07/27/2020 |
| Actual Study Start Date: | 05/11/2020 |
| Estimated Primary Completion Date: | 04/30/2023 |
| Estimated Study Completion Date: | 07/31/2023 |
Condition or disease
Intervention/treatment
Drug: Prednisone tablet
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Tapering Down of Steroids Prednisone 1 mg/kg (max. 60 mg) daily for 7 days, 40 mg for 2 days, 20 mg for 2 days (Total 11 days) | |
| Active Comparator: No Tapering Down of Steroids Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days) |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: 1. Adult patients (≥18 years) diagnosed with BP within 72 hour of onset. 2. Adult patients willing to get treatment, attending follow up visits and signing informed consent. Exclusion Criteria: 1. Patients treated with antivirals (i.e acyclovir) for any reason simultaneously, such as Herpes Zoster (Ramsay- Hunt syndrome). 2. Palsy onset > 72 hours before diagnosis or unknown onset. 3. Previous episodes of BP. 4. Patients suspected for hypothalamic-pituitary-adrenal (HPA) axis suppression who have to be cautiously tapered due to high risk for adrenal insufficiency: steroid treatment in any dosage for more the 3 weeks (due to other indication) or cushingoid appearance. 5. Contraindication for steroid use: uncontrolled diabetes or hypertension, psychosis, peptic ulcer or upper GI bleeding, liver cirrhosis or portal hypertension, known allergy to prednisone, etc. Any case in which steroid treatment was stopped earlier than planned by the patient or the physician. 6. Any conditions suspicious for non-idiopathic facial palsy: chronic otitis media, acute otitis media, mastoiditis, temporal bone/middle ear trauma, other cranial nerve neuropathies (i.e cranial nerve VIII), cerebrovascular disorders, tumor affecting facial nerve (i.e, parotid malignancy, schwannoma) or systemic causes (i.e multiple sclerosis, meningitis, sarcoidosis, HIV infection, etc). 7. Patients with low compliance for treatment according to the physician. 8. Pregnancy or breast-feeding patients. |
Outcome
Primary Outcome Measures
1. House-Brackmann scale [14 days- 90 days]
Secondary Outcome Measures
1. Time to incomplete recovery [14 days- 90 days]
2. Occurrence of Motor Synkinesis [14 days- 90 days]
3. Duration of neurological symptoms [14 days- 90 days]
4. Duration of ocular symptoms [14 days- 90 days]
5. Adverse effects of prednisone use [14 days- 90 days]
