Use of primidone in low doses (250 mg/day) versus high doses (750 mg/day) in the management of essential tremor. Double-blind comparative study with one-year follow-up.

Essential tremor is the most common involuntary movement; we studied 113 affected subjects (54 men, 59 women) with an average age of 63.9 years and average duration of 9.05 years. These patients participated in a double-blind study with a 1-year follow-up to compare treatment efficiency using primidone dosages of 250 mg/day (G 250, 56 patients) versus 750 mg/day (G 750, 57 patients). The study was designed with an 80% power and 95% confidence level. The statistical analysis used was an ANOVA (with Bonferroni multiple comparison test corrections); a value of p<0.004 was accepted as significant. To compare other values, a chi-square test was used; p<0.05 was considered significant. To evaluate the efficacy of the drug, clinical protocol employed the 'clinical evaluation scale for tremor'. All of the patients were evaluated a total of 13 times, once prior to the introduction of primidone and the other 12 evaluations following the initiation of the treatment. Eighty-seven patients completed the study: 15 patients abandoned the study due to undesirable side effects, five due to negative response, and six who were lost to follow-up. The percentage of patients who didn't complete the study was significantly higher in the group that received 750 mg/day of primidone (p<0.04) and more frequent as well in this same group, due to undesirable side effects (p<0.03). The patients of both G250 and G750 showed a significant improvement in each of the controls compared to the basal value (p<0.0001). No significant differences (p<0.06) were found when the averages of the evaluations of each group were compared. These responses were maintained during the entire treatment period. Low doses of primidone (250 mg/day) were equally or more effective than high doses (750 mg/day) in the control of essential tremor; this response was maintained for 12 months and furthermore, demonstrated fewer undesirable effects.

RCT Entities:   Population Interventions Outcomes