Do We Need to Taper Down Steroid Therapy for Bell's Palsy
Do We Need to Taper Down Steroid Therapy for Bell's Palsy
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.
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.
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.