Do We Need to Taper Down Steroid Therapy for Bell's Palsy
Status:
Recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
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.