Alprazolam in the treatment of premenstrual syndrome. A double-blind, placebo-controlled trial
P. J. Schmidt, G. N. Grover and D. R. Rubinow
Biological Psychiatry Branch, National Institute of Mental Health, Bethesda, Md.
OBJECTIVE: To evaluate the efficacy of alprazolam in the treatment of
premenstrual syndrome. DESIGN: A randomized, double-blind,
placebo-controlled, crossover trial of alprazolam during eight menstrual
cycles. SETTING: Outpatient clinic at the National Institute of Mental
Health, Bethesda, Md. PARTICIPANTS: Twenty-two women with prospectively
confirmed premenstrual syndrome entered this study. All subjects were
either self-referred or were referred by their physicians. All reported
having regular menstrual cycle lengths, were taking no medication, and were
free of current or recent medical or psychiatric illness. Two subjects did
not complete the trial. INTERVENTION: Participants were assigned to receive
alprazolam or placebo as follows: cycle 1, 0.25 mg of alprazolam or placebo
three times daily beginning on menstrual cycle day 16; cycle 2, 0.50 mg of
alprazolam or placebo three times daily according to the regimen during the
first cycle; cycles 3 and 4, 0.75 mg of alprazolam or placebo three times
daily from menstrual cycle day 16 and continued throughout the fourth
menstrual cycle to evaluate the efficacy of relatively long-term
(approximately 6 weeks) treatment with alprazolam. MAIN OUTCOME MEASURES:
Daily self-report symptoms ratings were completed during the entire study
period. RESULTS: We observed no significant differences in the severity of
premenstrual symptom ratings during alprazolam administration compared with
placebo on any scale except the Beck Depression Inventory Scale. The Beck
Depression Inventory ratings demonstrated a statistically (F1,19 = 7.1, P
< .05), but not clinically, significant improvement in depressive
symptoms during alprazolam administration compared with placebo.
CONCLUSION: Our findings do not support alprazolam as a uniformly effective
treatment for the symptoms of premenstrual syndrome.
