Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy
Condition: Bell´s Palsy
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): prednisone- valacyclovir; prednisone-placebo
Intervention type(s): Drug; Drug
Intervention description(s): prednisone, a dose of 1 mg/kg body weight was given daily for 7 days. The treatment was tapered over the next 14 days. Those taking valacyclovir received 1000 mg in two daily doses for 7 days.; prednisone, a dose of 1 mg/kg body weight was given daily for 7 days
Intervention MeSH terms: Valacyclovir; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bell´s palsy; prednisone; valacyclovir