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

Do We Need to Taper Down Steroid Therapy for Bell's Palsy: A Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Bell Palsy
• Intervention / Treatment: Drug: Prednisone tablet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Itai Margulis, MD; Phone Number: 972-48250279; Email: itayma@clalit.gov.il
• Study Contact Backup: Name: Raanan Cohen-Kerem, MD; Phone Number: 972-48250005; Email: raanan@clalit.org.il

Study Locations

• Israel
  • North
    • Haifa, North, Israel, 3436212
      • Recruiting
      • Lady Davies Carmel Medical Center. Department of Otolaryngology, Head and Neck Surgery
      • Contact: Itai Margulis, MD; Phone Number: +97248250279; Email: itayma@clalit.org.il
      • Contact: Yoav Yanir, MD; Phone Number: +97248250433; Email: yoavya@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)	Drug: Prednisone tablet; Treatment of Bell's Palsy with prednisone, with or without tapering down.
Active Comparator: No Tapering Down of Steroids; Prednisone 1 mg/kg (max. 60 mg) daily for 7 days (Total 7 days)	Drug: Prednisone tablet; Treatment of Bell's Palsy with prednisone, with or without tapering down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
House-Brackmann scale	Time to complete recovery (Grade I- normal function) of facial palsy using the House-Brackmann scale for assessment. The scale is assessed by an ENT physician in four standard poses: at rest, with a forced smile, with raised eyebrows, and with eyes tightly closed and scored between I (normal function)- VI (complete palsy, worse outcome).	14 days- 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to incomplete recovery	Time to presentation of House-Brackmann Grade II or worse and the difference between House-Brackmann scores between visits (i.e improvement from House-Brackmann 4 to 2)	14 days- 90 days
Occurrence of Motor Synkinesis	Occurrence of abnormal synchronization of facial movement where muscles, other than those intended, contract together during a particular movement pattern.	14 days- 90 days
Duration of neurological symptoms	Duration of hypoesthesia (trigeminal/ glossopharyngeal), periauricular pain, dysgusia, hyperacusis	14 days- 90 days
Duration of ocular symptoms	Duration of dryness, epiphora, itching, eye pain, etc	14 days- 90 days
Adverse effects of prednisone use	Incidence of dyspepsia, loss of blood sugar control, headache, fatigue, dizziness and insomnia, recurrent duodenal ulcers, mood swings, acute psychosis, etc	14 days- 90 days

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Investigators: Study Director: Yoav Yanir, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Prednisone; Steroids; Adverse Effects; Tapering Down; House Brackmann
• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Facial Nerve Diseases; Bell Palsy; Facial Paralysis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: CMC-20-0001-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No