Treatment Bell´s Palsy: Prednisone vs Prednisone Valacyclovir
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 82 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Bell´s palsy evaluated within the first 72 hours.
排除标准
- •Peptic ulcer
- •Tuberculosis
- •Moderate or severe diabetes
- •Moderate or severe hypertension
- •Manifest cardiac disease
- •Psychosis
- •Renal or hepatic dysfunction, and
- •Pregnancy.
研究组 & 干预措施
1
干预措施: prednisone- valacyclovir (Drug)
2
干预措施: prednisone-placebo (Drug)
结局指标
主要结局
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.
时间窗: 6 months
次要结局
未报告次要终点
