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bibliographies of the randomised trials and contacted known experts in the field to identify additional published or unpublished trials.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.
BACKGROUND: To illustrate whether the steroid-antivirals treatment could acquire a better recovery in patients with Bell's palsy than the steroids alone treatment.
MATERIALS AND METHODS: We conducted an exhaustive search over Pub med/Medline, Ovid, Elsevier search engines and the Cochrane library thereby collecting the randomized controlled trials in the treatment of patients with Bell's palsy with steroid-antivirals and steroids. The qualities of relevant articles were assessed by GRADE, which was used to present the overall quality of evidence as recommended by the Cochrane Handbook for Systematic Reviews of Interventions.
RESULTS: Two investigators evaluated these papers independently, and resolved the disagreements by discussion. At last 8 eligible papers (1816 patients included: 896 treated with steroid-antivirals and 920 treated with steroids alone) match the criteria. Owing to the result (chi(2) = 12.57, P = 0.08, I(2) = 44%) presented by the formal test for heterogeneity, the fixed effect meta-analysis model was chosen. The facial muscle recovery between the steroids-antivirals group and the steroids alone group show significant differences (OR = 1.52, 95% CI: 1.20-1.94), while the statistical outcome of adverse effect shows no statistical significance (OR = 1.28, 95% CI: 0.71-2.31).
CONCLUSIONS: The present meta-analysis indicates that the steroid-antivirals treatment could improve the recovery rate in patients with Bell's palsy when comparing with the steroid alone treatment.
CLINICAL SIGNIFICANCE: This meta-analysis showed that the steroid-antivirals treatment achieved the better outcomes in patients with Bell's palsy. Clinicians should consider that steroid-antivirals therapy is an alternative choice for the patients with Bell's palsy.
PURPOSE: We conducted a systematic review with meta-analysis to evaluate efficacy of antiviral agents on complete recovery of Bell's palsy.
METHODS: We searched CENTRAL, EMBASE, MEDLINE, International Pharmaceutical Abstracts, and sources of unpublished literature to November 1, 2014. Primary and secondary outcomes were complete and satisfactory recovery, respectively. To evaluate statistical heterogeneity, we performed subgroup analysis of baseline severity of Bell's palsy as well as between-study sensitivity analyses based on risk of allocation and detection bias.
RESULTS: The 10 included randomized controlled trials (2419 patients; 807 with severe Bell's palsy at onset) had variable risk of bias, with nine trials having high risk of bias in at least one domain. Complete recovery was not statistically significantly greater with antivirals versus no antivirals in the random-effects meta-analysis of 6 trials (relative risk (RR) 1.06, 95% confidence interval (CI) 0.97-1.16; I2 = 65%). Conversely, random-effects meta-analysis of 9 trials showed a statistically significant difference in satisfactory recovery (RR 1.10, 95% CI 1.02-1.18; I2 = 63%). Response to antiviral agents did not differ visually or statistically between patients with severe symptoms at baseline and those with milder disease (test for interaction, p = 0.11). Sensitivity analyses did not show a clear effect of bias on outcomes.
CONCLUSIONS: Antiviral agents are not efficacious in increasing the proportion of patients with Bell's palsy who achieved complete recovery, regardless of baseline symptom severity.
In this evidence-based case report, the authors studied the following clinical question: What is the effect of adding antiviral agents to corticosteroids in the treatment of patients with severe or complete Bell palsy? The search yielded 250 original research articles. The 6 randomized trials of these that could be used all reported low-quality data for answering the clinical question; apart from apparent flaws, they did not primarily include patients with severe or complete Bell palsy. Complete functional facial nerve recovery was seen in 75% of the patients receiving prednisolone only and in 83% with additional antiviral treatment. The pooled risk difference of 7% (95% confidence interval, -1% to 15%) results in a number needed to treat of 14 (ie, slightly favors adding an antiviral agent). The authors conclude that although a strong recommendation for adding antiviral agents to corticosteroids to further improve the recovery of patients with severe Bell palsy is precluded by the lack of robust evidence, it should be discussed with the patient.
CONTEXT: New evidence has emerged regarding the use of corticosteroids and antiviral agents in Bell palsy. OBJECTIVE: To estimate the association of corticosteroids and antiviral agents with the risk of unsatisfactory facial recovery in patients with Bell palsy. DATA SOURCES: The search included MEDLINE, EMBASE, CENTRAL, PsychInfo, CINAHL, Web of Science, PAPERSFIRST, PROCEEDINGSFIRST, and PROQUEST to identify studies up to March 1, 2009. Study Selection and DATA EXTRACTION: Eligible studies were randomized controlled trials comparing treatment with either corticosteroids or antiviral agents with a control and measuring at least 1 of the following outcomes: unsatisfactory facial recovery (≥4 months), unsatisfactory short-term recovery (6 weeks to < 4 months), synkinesis and autonomic dysfunction, or adverse effects. Two reviewers extracted data on study characteristics, methods, and outcomes. Disagreement was resolved by consensus. RESULTS: Eighteen trials involving 2786 patients were eligible. Regression analysis identified a synergistic effect when corticosteroids and antiviral agents were administered in combination compared with alone (odds ratio for interaction term, 0.54 [95% confidence interval {CI}, 0.35-0.83]; <i>P</i> = .004). Meta-analysis using a random-effects model showed corticosteroids alone were associated with a reduced risk of unsatisfactory recovery (relative risk [RR], 0.69 [95% CI, 0.55-0.87]; <i>P</i> = .001) (number needed to treat to benefit 1 person, 11 [95% CI, 8-25]), a reduced risk of synkinesis and autonomic dysfunction (RR, 0.48 [95% CI, 0.36-0.65]; <i>P</i> < .001) (number needed to treat to benefit 1 person, 7 [95% CI, 6-10]), and no increase in adverse effects. Antiviral agents alone were not associated with a reduced risk of unsatisfactory recovery (RR, 1.14 [95% CI, 0.80-1.62]; <i>P</i> = .48). When combined with antiviral agents, corticosteroids were associated with greater benefit (RR, 0.48 [95% CI, 0.29-0.79]; <i>P</i> = .004) than antiviral agents alone. When combined with corticosteroids, antiviral agents were associated with greater risk reduction of borderline significance compared with corticosteroids alone (RR, 0.75 [95% CI, 0.56-1.00]; <i>P</i> = .05). CONCLUSIONS: In Bell palsy, corticosteroids are associated with a reduced risk of unsatisfactory recovery. Antiviral agents, when administered with corticosteroids, may be associated with additional benefit. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
Objective: To determine whether steroids plus antivirals provide a better degree of facial muscle recovery in patients with Bell's palsy than steroids alone. Design: Meta-analysis. Data sources: PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials were searched for studies published in all languages from 1984 to January 2009. Additional studies were identified from cited references. Selection criteria: Randomised controlled trials that compared steroids with the combination of steroids and antivirals for the treatment of Bell's palsy were included in this study. At least one month of follow-up and a primary end point of at least partial facial muscle recovery, as defined by a House-Brackmann grade of at least 2 (complete palsy is designated a grade of 6) or an equivalent score on an alternative recognised scoring system, were required. Review methods: Two authors independently reviewed studies for methodological quality, treatment regimens, duration of symptoms before treatment, length of follow-up, and outcomes. Odds ratios with 95% confidence intervals were calculated and pooled using a random effects model. Results: Six trials were included, a total of 1145 patients; 574 patients received steroids alone and 571 patients received steroids and antivirals. The pooled odds ratio for facial muscle recovery showed no benefit of steroids plus antivirals compared with steroids alone (odds ratio 1.50, 95% confidence interval 0.83 to 2.69; P=0.18). A one study removed analysis showed that the highest quality studies had the greatest effect on the lack of difference between study arms shown by the odds ratio. Subgroup analyses assessing causes of heterogeneity defined a priori (time from symptom onset to treatment, length of follow-up, and type of antiviral studied) showed no benefit of antivirals in addition to that provided by steroids. Conclusions: Antivirals did not provide an added benefit in achieving at least partial facial muscle recovery compared with steroids alone in patients with Bell's palsy. This study does not, therefore, support the routine use of antivirals in Bell's palsy. Future studies should use improved herpes virus diagnostics and newer antivirals to assess whether combination therapy benefits patients with more severe facial paralysis at study entry.
OBJECTIVE: To review the evidence evaluating the efficacy and safety of antiviral agents to reduce morbidity associated with Bell's palsy.
DATA SOURCES: MEDLINE, EMBASE, and PubMed were searched (all up to April 2006) for English-language, prospective, randomized, controlled clinical trials that evaluated the use of antiviral agents in Bell's palsy. Search terms included Bell's palsy, acyclovir, valacyclovir, famciclovir, and randomized controlled trials.
STUDY SELECTION AND DATA EXTRACTION: Prospective, randomized, controlled trials that evaluated efficacy and safety endpoints of antiviral agents in the treatment of Bell's palsy were included. Primary efficacy outcomes included facial paralysis recovery profile, facial paralysis recovery index, and the House-Brackmann facial nerve grading scale. Safety outcomes were also identified by each trial.
DATA SYNTHESIS: Two prospective, randomized clinical trials were included in this review, both involving the use of acyclovir for treatment of Bell's palsy. Acyclovir monotherapy was shown to be inferior to prednisone monotherapy; however, the combination of acyclovir and prednisone was found to be superior to prednisone alone. There are limited data describing the safety of acyclovir in Bell's palsy.
CONCLUSIONS: The use of acyclovir in the treatment of Bell's palsy remains controversial. Additional, adequately powered, randomized, placebo-controlled trials are needed to definitively support its use. For the time being, the evidence reviewed in this article would favor the combination of acyclovir and prednisone if commenced within the first 72 hours of symptom onset.
The objective of this study was to evaluate the effect of corticosteroids in the treatment of pediatric Bell's palsy. A systematic review of trials that included pediatric (< 16 years old) cases with Bell's palsy and involved the use of steroids was conducted. Eight trials were identified, five of which were randomized, and prednisone was used in six trials, whereas corticotropin was used in the other two. The methods of randomization and allocation concealment of the treatments used were rarely reported. Only one trial was done exclusively in children; none of the other seven trials analyzed the pediatric cases separately. Four trials reported some benefit from steroids. The pediatric trial did not provide evidence for benefit from corticosteroids. There was substantial heterogeneity in the population and interventions used; hence a meta-analysis was not done. Based on this systematic review, we do not recommend the routine use of steroids in children with Bell's palsy.
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.
