Clinical trial NCT04406376: Do We Need to Taper Down Steroid Therapy for Bell's Palsy
Official title: Do We Need to Taper Down Steroid Therapy for Bell's Palsy: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bell Palsy
Keywords: Tapering Down
Adverse Effects
House Brackmann
Steroids
Prednisone
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to recieve 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)
Primary purpose: TREATMENT

Brief summary: Bell's palsy \[BP\] is defined as acute idiopathic peripheral facial palsy or paralysis.

Additional symptoms frequently include pain around or behind the ear, impaired tolerance to ordinary levels of noise and disturbed sense of taste on the same side. It affects men and women more or less equally.

There is a consensus in the literature regarding the importance of steroid treatment for improving recovery rates and sequela of BP. Moreover, there is increasing level of high quality of evidence in recent years for a combined antiviral and steroids treatment for severe BP (House Brackmann \[HB\] 5-6).

Adverse effects (AEs) were reported in 1-12% of patients treated with steroids, antivirals or placebo. The AEs reported were dyspepsia, loss of blood sugar control, headache, fatigue, dizziness and insomnia, recurrent duodenal ulcers, mood swings, and acute psychosis. All effects resolved when treatment was stopped.

Although steroid and antivirals are widely used for BP, there is a high variability of steroids treatment, both in the dosage given and in the way of tapering down.

Among the different steroid regimens used were: prednisone 1 mg/kg for 5 days tapered to 10 mg/day for remaining 5 days; prednisone (1 mg/kg for 10 days then tapered to zero over the next 6 days); prednisolone 60 mg for 5 days, 30 mg for 3 days, and 10 mg for 2 days.

House-Brackmann (HB) system is widely used for facial function assessment. It is based on a six-grade score, where grade I is normal function, grade VI is complete absence of facial motor function, and grades II to V are intermediate.

Steroid-induced side effects generally require tapering of the drug as soon as the disease being treated is under control. Tapering must be done carefully to avoid both recurrent activity of the underlying disease and possible cortisol deficiency resulting from hypothalamic-pituitary-adrenal axis (HPA) suppression. However, according to a review by Furst et al (2019), a patient who has received any dose of glucocorticoid for less than 3 weeks or patients treated with alternate-day prednisone at a dose of less than 10 mg (or its equivalent) are unlikely for HPA suppression. They concluded that short-term glucocorticoid therapy (up to three weeks), even if at a fairly high dose, can simply be stopped and need not to be tapered..

According to the above, the investigators assume that a rapid withdrawal of steroids after short course of treatment for BP should neither influence the efficacy or safety of treatment.

Finally, steroid regimen may be hard to follow for some patients and can results in confusion and frustration. Simplifying steroid regimen, such as skipping withdrawal if not necessary, may solve this problem.

The objective of our study is to determine the effectiveness and safety of prednisone treatment with no tapering down for Bell's Palsy.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: House-Brackmann scale
timeFrame: 14 days- 90 days
Secondary outcomes:
measure: Time to incomplete recovery
timeFrame: 14 days- 90 days
measure: Occurrence of Motor Synkinesis
timeFrame: 14 days- 90 days
measure: Duration of neurological symptoms
timeFrame: 14 days- 90 days
measure: Duration of ocular symptoms
timeFrame: 14 days- 90 days
measure: Adverse effects of prednisone use
timeFrame: 14 days- 90 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Lady Davies Carmel Medical Center. Department of Otolaryngology, Head and Neck Surgery
state: North
Study officials:
affiliation: Carmel Medical Center
name: Yoav Yanir, MD
role: STUDY_DIRECTOR
References: