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There were no serious adverse effects in any group. The study concluded that early treatment with prednisolone alone increases the likelihood of complete recovery and there was no additional benefit of treatment with aciclovir alone or combining with prednisolone. There have been several studies looking at the benefit of antiviral drugs with or without prednisolone. A Cochrane review in found that antivirals combined with corticosteroids improved rates of incomplete recovery compared with corticosteroids alone, but this was not significant and the evidence was low quality.
There was moderate-quality evidence that the combination reduced long-term sequelae such as excessive tear production and synkinesis. The outcome for patients who received corticosteroids alone was significantly better than for those who received antivirals alone.
Antiviral drugs alone had no benefit over placebo. None of the treatments had significant differences in adverse effects, but the evidence was again of low quality.
Physical therapies including tailored facial exercises, acupuncture to affected muscles, massage, thermotherapy and electrical stimulation have been used to hasten recovery.
However, there is no evidence for any significant benefit. A Cochrane review concluded from poor-quality evidence that tailored facial exercises can help improve facial function, mainly for moderate paralysis and chronic cases. Early facial exercise may reduce recovery time, long-term paralysis and number of chronic cases. Surgical treatment to free the facial nerve has been considered. However the evidence for this procedure is of very low quality. The aetiology is still unclear, but it is known that the symptoms are caused by swelling and inflammation of the facial nerve.
Eye protection remains crucial in preventing long-term eye complications. Early treatment with prednisolone can hasten recovery and reduce long-term sequelae. Although the quality of evidence is low to moderate, there may be some benefit in adding antiviral drugs to prednisolone.
Reasonable care is taken to provide accurate information at the time of creation. This information is not intended as a substitute for medical advice and should not be exclusively relied on to manage or diagnose a medical condition. NPS MedicineWise disclaims all liability including for negligence for any loss, damage or injury resulting from reliance on or use of this information.
Read our full disclaimer. This website uses cookies. Read our privacy policy. Skip to main content. The practice recommendations issued by the AAN do not address the use of antivirals as monotherapy. Combination Therapy: The use of antivirals and corticosteroids has been highly controversial in the past because of conflicting evidence. The two most common antivirals studied are acyclovir and valacyclovir.
First, countless studies have reiterated an acceptable safety profile for both antivirals and corticosteroids. For one commonly prescribed regimen, acyclovir and prednisone, both medications are available generically and may be easily obtained by patients without insurance. Nonpharmacologic treatment options include physical therapy, surgery, transcutaneous electrical nerve stimulation TENS , and acupuncture.
Eye Care: Often, patients are unable to completely close their eyelids, or the eyelids tend to droop, resulting in dryness or irritation. Pharmacists should reinforce adherence to prescribed medications at the appropriate dose and for the necessary duration.
Corticosteroids such as prednisone can have potentially serious adverse effects, such as blurred vision, cataracts, weakness, swelling of feet, and weight gain.
Thorough counseling can help patients avoid additional problems. Because of the high rate of spontaneous recovery, some experts question the use of pharmacologic agents. However, given the possibility of preventing potential permanent sequelae, pharmacologic therapy should be warranted. Historically, the use of corticosteroids and antivirals in combination has been controversial, but the most recent expert opinion is shifting toward a possible increased benefit with concurrent use.
Stroke Awareness. Fitness Classes. Integrative Therapy. Weight Management. Parking Information. Gift Shop. Patient Meals. Pay My Bill Online. Financial Assistance. Medical Records. Events Calendar. Contact Us. Hospital Leadership. Hospital Auxiliaries. Signs and symptoms atypical for Bell's palsy should prompt further evaluation. Patients with insidious onset or forehead sparing should undergo imaging of the head. Those with bilateral palsies or those who do not improve within the first two or three weeks after onset of symptoms should be referred to a neurologist.
Oral corticosteroids have traditionally been prescribed to reduce facial nerve inflammation in patients with Bell's palsy. Prednisone is typically prescribed in a day tapering course starting at 60 mg per day. Because of the possible role of HSV-1 in the etiology of Bell's palsy, the antiviral drugs acy-clovir Zovirax and valacyclovir Valtrex have been studied to determine if they have any benefit in treatment. Either acyclovir mg can be given five times per day for seven days or valacyclovir 1 g can be given three times per day for seven days.
Although a Cochrane review found insufficient evidence to support the use of these antivirals alone, 15 two recent placebo-controlled trials demonstrated full recovery in a higher percentage of patients treated with an antiviral drug in combination with prednisolone than with prednisolone alone percent versus 91 percent and 95 percent versus 90 percent.
It is difficult to establish a statistically significant benefit of treatment in placebo-controlled trials because Bell's palsy has a high rate of spontaneous recovery. The Copenhagen Facial Nerve Study evaluated 2, persons with untreated facial nerve palsy, including 1, with idiopathic Bell's palsy and with palsy from other causes; 70 percent had complete paralysis.
Function returned within three weeks in 85 percent of patients, with 71 percent of these patients recovering full function. Of the 29 percent of patients with sequelae, 12 percent rated it slight, 13 percent rated it mild, and 4 percent rated it severe. Given the safety profile of acyclovir, valacyclovir, and short-course oral corticosteroids, patients who present within three days of the onset of symptoms and who do not have specific contraindications to these medications should be offered combination therapy.
Patients who present with complete facial nerve paralysis have a lower rate of spontaneous recovery and may be more likely to benefit from treatment. In the past, surgical decompression within three weeks of onset has been recommended for patients who have persistent loss of function greater than 90 percent loss on electroneurography at two weeks.
However, the most widely cited study supporting this approach only reported results for a total of 34 treated patients at three different sites, included a nonrandomized control group, and lacked a blinded evaluation of outcome. The most common complication of surgery is postoperative hearing loss, which affects 3 to 15 percent of patients.
Based on the significant potential for harms and the paucity of data supporting benefit, the American Academy of Neurology does not currently recommend surgical decompression for Bell's palsy.
Some published studies have reported benefit with acupuncture versus steroids and placebo, but all had serious flaws in study design and reporting.
Patients with Bell's palsy may be unable to close the eye on the affected side, which can lead to irritation and corneal ulceration. The eye should be lubricated with artificial tears until the facial paralysis resolves. Permanent eyelid weakness may require tarsorrhaphy or implantation of gold weights in the upper lid. Facial asymmetry and muscular contractures may require cosmetic surgical procedures or botulinum toxin Botox injections.
In these cases, consultation with an ophthalmologist or cosmetic surgeon is needed. This content is owned by the AAFP.
Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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] 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. 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 ala 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 weekseven 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:. In addition, both groups will receive the following treatment when indicated:. 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. 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.
Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Do We Need to Taper Down Steroid Therapy for Bell's Palsy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Last Update Posted : July 28, See Contacts and Locations. Study Description. Detailed Description:. Acyclovir for 7 days in cases of severe BP HB Drug Information available for: Prednisone. FDA Resources. Arms and Interventions. Treatment of Bell's Palsy with prednisone, with or without tapering down. Outcome Measures. Occurrence of abnormal synchronization of facial movement where muscles, other than those intended, contract together during a particular movement pattern.
Duration of dryness, epiphora, itching, eye pain, etc. Incidence of dyspepsia, loss of blood sugar control, headache, fatigue, dizziness and insomnia, recurrent duodenal ulcers, mood swings, acute psychosis, etc. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Adult patients willing to get treatment, attending follow up visits and signing informed consent. Exclusion Criteria: Patients treated with antivirals i. Previous episodes of BP. 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.
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. Patients with low compliance for treatment according to the physician. Pregnancy or breast-feeding patients. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Bell Palsy. Drug: Prednisone tablet. Phase 4. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :.
Estimated Study Completion Date :. Drug: Prednisone tablet Treatment of Bell's Palsy with prednisone, with or without tapering down. Lady Davies Carmel Medical Center. Department of Otolaryngology, Head and Neck Surgery. May 28, Key Record Dates.
localhost › article › bells-palsy-to-treat-or-not-to-treat. Three studies reported that no side effects could be attributed to corticosteroid treatment. Based on moderate‐quality evidence from three studies ( Adverse events included an expected range of minor symptoms associated with use of prednisolone and acyclovir, such as dizziness and vomiting. During the study. To conclude, treatment with prednisolone significantly reduced mild and moderate sequelae in Bell's palsy at 12 months. Prednisolone did not reduce the number. Bell's palsy is a weakness of facial muscle from inflammation of the facial nerve. Common side effects to any steroid include dizziness. All rights reserved. Corticosteroids have therefore been used for their anti-inflammatory effect. Integrative Therapy. Children older than two years: 80 mg per kg daily divided every six hours for five days, with a maximal dose of 3, mg daily. Research Data Australia [Internet].Recent studies have shown with increasing confidence that certain pharmacologic agents, such as corticosteroids and antivirals, may be beneficial and can effect clinical improvements in the patient.
However, current evidence suggests a possible viral pathogenesis with herpes simplex virus type 1 HSV Most often, at symptom onset, patients believe that they have suffered a stroke or have an intracranial tumor. The most recent clinical guidelines by the American Academy of Neurology AAN , published in , offer a starting point for assessing the most prudent therapy strategies. Overall, the two main goals of treatment are reducing recovery time and preventing ocular complications.
Compounding the issue is the fact that researchers do not fully understand the etiology of the disease. However, the prognosis is highly promising for the majority of patients. Currently, there are no FDA-approved drugs for treatment, but the two most commonly recommended pharmacologic options are corticosteroids and antivirals. The current debate centers around the use of corticosteroids alone versus their use with antivirals. Corticosteroids: There is more credible evidence for the use of corticosteroids than for the use of antivirals.
Several different corticosteroids have been used in the past, including hydrocortisone, methylprednisolone, prednisolone, and dexamethasone. Currently, prednisone is the form most commonly used. In addition, the studies evaluated in this Cochrane Review found no serious side effects from corticosteroid treatment, making its use more advantageous. Antivirals: Because of the suspected causative viral etiology of HSV-1, antivirals such as acyclovir, valacyclovir, and famciclovir theoretically should be of benefit.
A plausible answer for the lack of efficacy is that an immunologic reaction occurs that produces increased local inflammation and exacerbation of symptoms due to the antiviral medication itself, even though the drug is active against the causative virus. This is known as Jarisch-Herxheimer reaction. The practice recommendations issued by the AAN do not address the use of antivirals as monotherapy. Combination Therapy: The use of antivirals and corticosteroids has been highly controversial in the past because of conflicting evidence.
The two most common antivirals studied are acyclovir and valacyclovir. First, countless studies have reiterated an acceptable safety profile for both antivirals and corticosteroids. For one commonly prescribed regimen, acyclovir and prednisone, both medications are available generically and may be easily obtained by patients without insurance.
Nonpharmacologic treatment options include physical therapy, surgery, transcutaneous electrical nerve stimulation TENS , and acupuncture. Eye Care: Often, patients are unable to completely close their eyelids, or the eyelids tend to droop, resulting in dryness or irritation. Pharmacists should reinforce adherence to prescribed medications at the appropriate dose and for the necessary duration.
Corticosteroids such as prednisone can have potentially serious adverse effects, such as blurred vision, cataracts, weakness, swelling of feet, and weight gain. Thorough counseling can help patients avoid additional problems. Because of the high rate of spontaneous recovery, some experts question the use of pharmacologic agents.
However, given the possibility of preventing potential permanent sequelae, pharmacologic therapy should be warranted. Historically, the use of corticosteroids and antivirals in combination has been controversial, but the most recent expert opinion is shifting toward a possible increased benefit with concurrent use.
Combined corticosteroid and antiviral treatment for Bell palsy: a systematic review and meta-analysis. Tiemstra JD, Khatkhate N. Am Fam Physician. Gilden DH. N Engl J Med. Eur J Neurology. Acta Otorhinolaryngol Ital. National Institute of Neurological Disorders and Stroke. Accessed October 13, Otol Neurotol. Cochrane Database Syst Rev.
Are corticosteroid and antiviral treatments effective for Bell palsy? Clinical Pharmacology [online database]. Accessed November 11, Micromedex Healthcare Series: CareNotes. Accessed December 15, J Neurol. Featured Issue Featured Supplements. To comment on this article, contact rdavidson uspharmacist. Related CE. View More CE. Related Content. All rights reserved.
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