NIHR Signal Corticosteroids improve recovery rates after Bell’s palsy

Published on 29 November 2016

Taking a corticosteroid within 72 hours of Bell’s palsy first appearing reduces the number of people with incomplete facial recovery after six months.

Bell’s palsy is a sudden onset of weakness or paralysis of the muscles on one side of the face. Most people recover completely within nine months, often with no treatment, but about three in 10 people are left with some weakness or unwanted facial movements.

This Cochrane review found that ten people needed to be treated with corticosteroid, compared to placebo tablets, to avoid one incomplete recovery. It also showed that side effects were uncommon and mild.

Corticosteroids are often already prescribed to treat Bell’s palsy in practice. This review confirms that they help. Any further trials should compare different corticosteroids against each other, rather than placebo, to find the best options in terms of timing, drug and dose.

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Why was this study needed?

Bell’s palsy affects about 12,000 people in the UK each year. It is most common in people aged 15 to 60 years.

Bell’s palsy is caused by inflammation or compression of the facial nerve, which controls the facial muscles. The cause is unknown, but it has been associated with viral infections such as the herpes virus. Occasionally the nerve can regrow along incorrect channels and lead to “synkinesis”, abnormal facial movements, or other major problems such as watering of the eye when eating. These can be particularly bothersome, long term problems for which rehabilitation is needed. This review included these problems as outcomes, but excluded some trials of antiviral treatments that were in previous reviews.

Corticosteroids have been used for some time to treat Bell’s palsy. They help to reduce inflammation and swelling, which may limit any nerve damage. This is an update of a previous Cochrane review to determine whether the strength of evidence is sufficient that their effectiveness can be considered certain.

What did this study do?

This systematic review pooled the results of seven randomised controlled trials, with a total of 895 participants, which compared corticosteroids with placebo or with no treatment. People in the studies were aged from two to 84 years, with one-sided Bell’s palsy. Six of the trials used prednisone or prednisolone, with a variety of doses and one used cortisone acetate.  In five of the trials, treatment was started within three days of the onset of symptoms. The main outcome of interest was incomplete recovery of facial movement after six months or more.

The included studies were rated as moderate to high quality for the main outcomes, which means that the results are reliable.

What did it find?

  • Corticosteroids were more effective than placebo or no treatment for reducing incomplete recovery of facial movement after six months or more. Overall, 79/452 (17%) of participants taking corticosteroids had incomplete facial recovery after six months, compared with 125/447 (28%) in the control group (risk ratio (RR) 0.63, 95% confidence interval [CI] 0.50 to 0.80).
  • Ten people needed to be treated with corticosteroids to stop one person being left with facial weakness (95% CI 6 to 20).
  • There was a significant reduction in abnormal facial movements during follow-up in participants receiving corticosteroids (RR 0.64, 95% CI 0.45 to 0.91) three studies.
  • Three studies specifically noted that there were no side effects that were caused by the corticosteroids. Combined data from three studies that recorded non-serious side effects showed no difference in rates between people taking corticosteroids and those taking placebo (RR 1.04, 95% CI 0.71 to 1.51).

What does current guidance say on this issue?

There is no national clinical guideline on the management of Bell’s palsy. Clinical Knowledge Summaries (NICE summaries of evidence for primary care) recommend that healthcare professionals should consider prescribing prednisolone for people if they are seen within 72 hours of symptoms starting.

There is no agreement on the best dose and regimen, but two options are given.

What are the implications?

This review confirms that there is enough evidence from randomised controlled trials against placebo to support the use of corticosteroids to treat Bell’s palsy within 72 hours of onset. There remains uncertainty over the best drug, dose or how long it should be taken. Future trials should compare different corticosteroids or dosing regimens.

Long term complications, such as unwanted facial movements, can still be troublesome. Treatment that reduces these might also improve recovery from this common condition.

Citation and Funding

Madhok VB, Gagyor I, Daly F, et al. Corticosteroids for Bell's palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2016;7:CD001942

Cochrane UK and the Neuromuscular Cochrane Review Group are supported by NIHR infrastructure funding.

Bibliography

Clinical Knowledge Summaries. Bell’s palsy. London: National Institute for Health and Care Excellence; 2012.

NHS Choices. Bell’s palsy. London. Department of Health; 2014.

Why was this study needed?

Bell’s palsy affects about 12,000 people in the UK each year. It is most common in people aged 15 to 60 years.

Bell’s palsy is caused by inflammation or compression of the facial nerve, which controls the facial muscles. The cause is unknown, but it has been associated with viral infections such as the herpes virus. Occasionally the nerve can regrow along incorrect channels and lead to “synkinesis”, abnormal facial movements, or other major problems such as watering of the eye when eating. These can be particularly bothersome, long term problems for which rehabilitation is needed. This review included these problems as outcomes, but excluded some trials of antiviral treatments that were in previous reviews.

Corticosteroids have been used for some time to treat Bell’s palsy. They help to reduce inflammation and swelling, which may limit any nerve damage. This is an update of a previous Cochrane review to determine whether the strength of evidence is sufficient that their effectiveness can be considered certain.

What did this study do?

This systematic review pooled the results of seven randomised controlled trials, with a total of 895 participants, which compared corticosteroids with placebo or with no treatment. People in the studies were aged from two to 84 years, with one-sided Bell’s palsy. Six of the trials used prednisone or prednisolone, with a variety of doses and one used cortisone acetate.  In five of the trials, treatment was started within three days of the onset of symptoms. The main outcome of interest was incomplete recovery of facial movement after six months or more.

The included studies were rated as moderate to high quality for the main outcomes, which means that the results are reliable.

What did it find?

  • Corticosteroids were more effective than placebo or no treatment for reducing incomplete recovery of facial movement after six months or more. Overall, 79/452 (17%) of participants taking corticosteroids had incomplete facial recovery after six months, compared with 125/447 (28%) in the control group (risk ratio (RR) 0.63, 95% confidence interval [CI] 0.50 to 0.80).
  • Ten people needed to be treated with corticosteroids to stop one person being left with facial weakness (95% CI 6 to 20).
  • There was a significant reduction in abnormal facial movements during follow-up in participants receiving corticosteroids (RR 0.64, 95% CI 0.45 to 0.91) three studies.
  • Three studies specifically noted that there were no side effects that were caused by the corticosteroids. Combined data from three studies that recorded non-serious side effects showed no difference in rates between people taking corticosteroids and those taking placebo (RR 1.04, 95% CI 0.71 to 1.51).

What does current guidance say on this issue?

There is no national clinical guideline on the management of Bell’s palsy. Clinical Knowledge Summaries (NICE summaries of evidence for primary care) recommend that healthcare professionals should consider prescribing prednisolone for people if they are seen within 72 hours of symptoms starting.

There is no agreement on the best dose and regimen, but two options are given.

What are the implications?

This review confirms that there is enough evidence from randomised controlled trials against placebo to support the use of corticosteroids to treat Bell’s palsy within 72 hours of onset. There remains uncertainty over the best drug, dose or how long it should be taken. Future trials should compare different corticosteroids or dosing regimens.

Long term complications, such as unwanted facial movements, can still be troublesome. Treatment that reduces these might also improve recovery from this common condition.

Citation and Funding

Madhok VB, Gagyor I, Daly F, et al. Corticosteroids for Bell's palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2016;7:CD001942

Cochrane UK and the Neuromuscular Cochrane Review Group are supported by NIHR infrastructure funding.

Bibliography

Clinical Knowledge Summaries. Bell’s palsy. London: National Institute for Health and Care Excellence; 2012.

NHS Choices. Bell’s palsy. London. Department of Health; 2014.

Corticosteroids for Bell's palsy (idiopathic facial paralysis)

Published on 19 July 2016

Madhok, V. B.,Gagyor, I.,Daly, F.,Somasundara, D.,Sullivan, M.,Gammie, F.,Sullivan, F.

Cochrane Database Syst Rev Volume 7 , 2016

BACKGROUND: Inflammation and oedema of the facial nerve are implicated in causing Bell's palsy. Corticosteroids have a potent anti-inflammatory action that should minimise nerve damage. This is an update of a review first published in 2002 and last updated in 2010. OBJECTIVES: To determine the effectiveness and safety of corticosteroid therapy in people with Bell's palsy. SEARCH METHODS: On 4 March 2016, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. We reviewed the bibliographies of the randomised trials and contacted known experts in the field to identify additional published or unpublished trials. We also searched clinical trials registries for ongoing trials. SELECTION CRITERIA: Randomised trials and quasi-randomised trials comparing different routes of administration and dosage schemes of corticosteroid or adrenocorticotrophic hormone therapy versus a control group receiving no therapy considered effective for this condition, unless the same therapy was given in a similar way to the experimental group. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. The main outcome of interest was incomplete recovery of facial motor function (i.e. residual facial weakness). Secondary outcomes were cosmetically disabling persistent sequelae, development of motor synkinesis or autonomic dysfunction (i.e. hemifacial spasm, crocodile tears) and adverse effects of corticosteroid therapy manifested during follow-up. MAIN RESULTS: We identified seven trials, with 895 evaluable participants for this review. All provided data suitable for the primary outcome meta-analysis. One of the trials was new since the last version of this Cochrane systematic review. Risk of bias in the older, smaller studies included some unclear- or high-risk assessments, whereas we deemed the larger studies at low risk of bias. Overall, 79/452 (17%) participants allocated to corticosteroids had incomplete recovery of facial motor function six months or more after randomisation; significantly fewer than the 125/447 (28%) in the control group (risk ratio (RR) 0.63, 95% confidence interval (CI) 0.50 to 0.80, seven trials, n = 895). The number of people who need to be treated with corticosteroids to avoid one incomplete recovery was 10 (95% CI 6 to 20). The reduction in the proportion of participants with cosmetically disabling sequelae six months after randomisation was very similar in the corticosteroid and placebo groups (RR 0.96, 95% CI 0.40 to 2.29, two trials, n = 75, low-quality evidence). However, there was a significant reduction in motor synkinesis during follow-up in participants receiving corticosteroids (RR 0.64, 95% CI 0.45 to 0.91, three trials, n = 485, moderate-quality evidence). Three studies explicitly recorded the absence of adverse effects attributable to corticosteroids. One trial reported that three participants receiving prednisolone had temporary sleep disturbances and two trials gave a detailed account of adverse effects occurring in 93 participants, all non-serious; the combined analysis of data from these three trials found no significant difference in adverse effect rates between people receiving corticosteroids and people receiving placebo (RR 1.04, 95% CI 0.71 to 1.51, n = 715). AUTHORS' CONCLUSIONS: The available moderate- to high-quality evidence from randomised controlled trials showed significant benefit from treating Bell's palsy with corticosteroids.

Long term problems are particularly troublesome for two out of ten people following Bell’s palsy. NHS choices describe some of these:

  • Eye-mouth synkinesias – a result of the nerve growing back in a different way. It can cause the eye to wink when eating, laughing or smiling. Sometimes it can become so severe that the eye can close completely during meals.
  • Facial tightness (contracture) – facial muscles are permanently tense. It can lead to facial disfigurement such as the eye becoming smaller, the cheek becoming more bulky, or the line between the nose and the mouth becoming deeper.
  • Loss or reduced sense of taste – when damaged nerves do not repair properly.
  • Tears when eating, known as 'crocodile tears'.

Expert commentary

The present review offers further support for the consensus on the use of prednisolone in Bell’s Palsy for adults, (in agreement with UK NICE and US National Guideline Clearing House guidelines). There are caveats, however. Prednisolone reduced those with incomplete recovery from 28% to 19% (at six months), and 10 people would need to be treated to obtain one improvement. Some studies stressed the need for early treatment, (<72hr from onset), more than the review. Puzzlingly, cosmetically disabling sequelae were similar between those on steroids and placebo but synkinesis was reduced. Results from continuing studies may reveal more.

Professor Jonathan Cole, Consultant in Clinical Neurophysiology, Poole Hospital

Categories

  •   Medicines, Nervous system disorders