Vitamin E treatment for tardive dyskinesia. Veterans Affairs Cooperative Study #394 Study Group.
BACKGROUND
Several short-term, controlled trials have documented the efficacy of vitamin E in treating tardive dyskinesia. However, the persistent nature of the disease prompted us to perform a multicenter, longer-term trial of vitamin E.


METHODS
The study was a prospective, randomized, 9-site trial of up to 2 years of treatment with d-vitamin E (1600 IU/d) vs matching placebo. One hundred fifty-eight subjects with tardive dyskinesia who were receiving neuroleptic medications were enrolled. The blinded assessments performed were clinical (Abnormal Involuntary Movements Scale, Barnes Akathisia Scale, and Modified Simpson-Angus [for Extrapyramidal Symptoms] Scale) and electromechanical assessments of movement disorders, psychiatric status (Brief Psychiatric Rating Scale), and functioning (Global Assessment of Functioning). There were no significant differences in baseline demographic characteristics or in study assessments between the group that received vitamin E and the group that received placebo.


RESULTS
Vitamin E was well tolerated and subject compliance with medication was good and similar between treatment groups. One hundred seven subjects (70% of those receiving vitamin E and 66% of subjects receiving placebo) completed at least 1 year of treatment. There were no significant effects of vitamin E on total scores or subscale scores for the AIMS, electromechanical measures of dyskinesia, or scores from the other 4 scales.


CONCLUSIONS
This long-term, randomized trial of vitamin E vs placebo found no evidence for efficacy of vitamin E in the treatment of tardive dyskinesia.
Adler
L A
LA
Psychiatry Service, New York Department of Veterans Affairs Medical Center, NY 10010, USA.
Rotrosen
J
J
Edson
R
R
Lavori
P
P
Lohr
J
J
Hitzemann
R
R
Raisch
D
D
Caligiuri
M
M
Tracy
K
K
D014150:Antipsychotic Agents / Q000009:adverse effects; D004409:Dyskinesia, Drug-Induced / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010808:Physical Examination; D010919:Placebos; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D014481:United States; D014493:United States Department of Veterans Affairs; D014810:Vitamin E / Q000627:therapeutic use*
D014150:Antipsychotic Agents; D010919:Placebos; D014810:Vitamin E