Bell´s Palsy Clinical Trial
Official title:
Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir
Since steroids carry a moderate beneficial effect in Bell's palsy, and to address this question, valacyclovir was added to prednisone for the treatment of this condition.
Between December 2002 and December 2003, a total of 52 subjects with BP were evaluated, 42
fulfilled the inclusion criteria and entered the study, 1 patient was lost to follow-up
after the first visit, leaving a total of 41 patients with complete clinical follow-up.
To be included in the study, patients had to be evaluated within the first 72 hours and
could have no contraindications to steroid or valacyclovir therapy.
Patients were randomly assigned to either the prednisone-valacyclovir (group 1) or the
prednisone-placebo group (group 2) Among the 41 patients completing the study, 19
pertenecian al group 1 and 21 group 2 Both groups received prednisone, a dose of 1 mg/kg
body weight was given daily for 7 days (one single dose after breakfast). The treatment was
tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses
for 7 days. All subjects were instructed about eye protection and lubrication were followed
at regular intervals until recovery or for a minimum period of 3 months. Follow-up included
examination at 1, 2, 4, 8 and 12 weeks after the first visit. Patients with incomplete
recovery at 3 months were controlled until complete recovery or stabilization of the
paralysis. All subjects were evaluated for laboratories parameters. Routine blood count,
blood sugar, and liver function tests were performed at first visit.
There were no severe side effects attributable to the valacyclovir-prednisone treatment in
this study.
Informed consent was obtained from all patients. Facial nerve function was assessed using
the facial grading system (FGS) The scale used provides a quantitative score with three
components; resting symmetry, symmetry of voluntary movement and synkinesis and a composite
score was obtained.
Student's t-test was employed for quantitative….variables. Comparison of treatment results
between both groups was performed by….means of an analysis of variance (ANOVA) test of two
ways (therapy and time).
All statistical tests were considered received the same level of significance (P = 0.05).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment