Guide

Critical Review Form
Meta-analysis
Corticosteroids for Bell’s palsy (idiopathic facial paralysis) Cochrane Database of Systematic Reviews 2010, Issue 3. Art. No.: CD001942
Objective: “To determine the effectiveness and safety of corticosteroid
therapy in people with Bell’s palsy.” (p. 2)

Methods: Three authors searched the Cochrane Neuromuscular
Disease Group Trials Specialized Register, MEDLINE, EMBASE, and
LILACS using Bell’s palsy and its synonyms as search terms. They also
reviewed bibliographies and contacted study authors for additional
references. Irrespective of time since symptoms began, the Cochrane
authors included all randomized or quasi-randomized studies using
corticosteroid or ACTH hormone therapy. They extracted trial data to
conduct an intention-to-treat analysis generating risk-ratios by a fixed
effects model for the primary outcome of incomplete facial motor
function at six-months or more after randomization.

Two Cochrane authors extracted data and assessed
methodological quality of each trial on several domains: randomization
method, blinding, potential to conduct an ITT analysis, and number of
losses to follow-up. Two a priori subgroup analyses were planned:
1) Patients with treatment less than 48-hours after symptom
2) Patients with complete facial paralysis.
Question
Comments
Are the results valid?
Yes. Does the use of corticosteroid therapy improve outcomes in Was the search for relevant Yes, the Cochrane investigators searched the Cochrane studies details and Neuromuscular Disease Group in addition to three electronic databases and a hand-search of relevant bibliographies. In addition, they also contacted original study investigators. Yes. “None of the trials was considered a poor quality trial”. (p. Uncertain. “Disagreement was resolved by discussion.” (p. 3). The Cochrane authors do not report how often disagreements What are the results?
Eight trials totaling 1569 participants were identified, only The corticosteroid used in each trial was different: cortisone acetate 200 mg in divided doses x3 d then 100 mg QD x 3-days then 50 mg QD x 2-days Prednisone 410 mg in descending doses over 10 day Prednisone 1 gm IV daily x3 days, then 0.5 mg IV daily x3 days Methyl-prednisone 1 mg/kg/daily for 10 days with subsequent 3- to 5-day taper Prednisolone 25 mg twice daily for 10 day - Prednisolone 60 mg QD x5 d, then ↓ 10mg/day for 10 days The primary outcome was incomplete facial paralysis recovery at 6-months Seven trials with 1507 participants demonstrated a significant improvement in facial paralysis recovery in the steroid group with moderate heterogeneity (Fig 2, p. 7): RR 0.71 (95% CI 0.61- 0.83) NNT 10 (95% CI 7 – 18) I2 = 55%. Heterogeneity is likely due to variable inclusion of patients Cosmetic disfigurement at six months (secondary outcome)
Five trials of 668 participants demonstrating no effect (see Fig 3, p.8) RR 0.97 (95% CI 0.44 – 2.15) with I2 = 0%. Motor synkinesis or autonomic dysfunction
Two trials with 901 participants demonstrated significant reduction with steroids: RR 0.60 (95% CI 0.44 – 0.81) NNT 12 (95% CI 6 – 25) with I2 = 0%. Most studies did not report adverse effects and those that did failed to detect significant effects in steroid group. Subjects with complete facial paralysis had no benefit (RR Patients receiving steroids less than 48-hours after symptom onset had less incomplete recovering at 6-months: RR 0.51 (95% CI 0.32 – 0.80) NNT 11 (95%, CI 7 – 32), I2 = 70%. No, there was significant heterogeneity (I2 > 25%) noted for several of the meta-analyses so a random-effects model ought to have been utilized. III.
Will the results help me in
caring for my patients?
Corticosteroids within 72-hours of symptom onset reduce the results to apply them to rates of incomplete facial paralysis resolution and motor the care of my patients? synkinesis without apparent adverse effects. No. How was facial paralysis severity graded? Was it consistent from trial-to-trial? Are the scales useelatethat matters? What about corneal ulcerations or dry eye symptoms? What is the optimal dose, duration, and type of steroid for Bell’s palsy? Probably. Steroids are cheap, readily available, safely used for a wide variety of inflammatory pathology (asthma, migraines, sore throat, etc). Future cost benefit analyses will need to assess the morbidity of incomplete facial recovery against the inconvenience of an ED evaluation for Bell’s palsy with the expense/side effect profile of a short-course of steroids.
Limitations
1) Failure to conduct random-effects analysis when significant
heterogeneity noted.

2) Overly optimistic interpretation of findings for some outcomes.
3) Failure to elaborate on the “holes” left by the existing literature
or to contemplate cost-benefit for steroids in Bell’s palsy.

Bottom Line

In adults with Bell’s palsy less than 72-hours after symptom onset,
steroids improve the likelihood of complete facial recovery (NNT 10 but
I2 = 55%) and reduce rates of motor synkinesis/autonomic dysfunction
at six months (NNT 12, I2 0%) with significant adverse effects. Future
trials will need to assess the optimal timing, steroid, dosing, and
duration to achieve benefit. In the meantime there is no apparent
reason not to use a single corticosteroid for 10 – 14 days in adult Bell’s
palsy patients presenting within three days in onset.

Source: http://emed.wustl.edu/Portals/2/Answer%20Key%20PDF/2010/September2010/Sept2010AK1.pdf