Prednisone-Placebo vs Prednisone-Valacyclovir in Bell´s Palsy

Conditions

• Bell´s Palsy

Eligibility Criteria

Sex

ALL

Age

14 Years - 82 Years

Healthy Volunteers

Not accepted

Interventions

• prednisone- valacyclovir — DRUG
  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-placebo — DRUG
  prednisone, a dose of 1 mg/kg body weight was given daily for 7 days

Study Details

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.

Key Dates

Start date

Dec 31, 2002

Status verified

Nov 2007

Completion

Dec 31, 2003

Study Design

Enrollment

42 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 1
• Placebo Comparator: 2

Primary Outcome Measure

The following parameters were used to evaluate the final result: grade of recovery, and sequelae.Facial nerve function was assessed using the facial grading system (FGS) Normal recovery was defined as the return of facial function to FGS 90 or more. [ Time Frame: 6 months ]