A five-day gradual reduction regimen of chlormadinone reduces premenstrual anxiety and depression: a pilot study.
BACKGROUND
Anxiety and depression commonly occur in premenstrual dysphoric disorder (PMDD). The PMDD symptomatology disappears once the menstrual cycle reinitiates, resembling a withdrawal syndrome.


METHODS
The present study is a pilot, controlled, double-blind study exploring the effectiveness of a premenstrual 5-day gradual reduction regimen of chlormadinone acetate on PMDD. Volunteers received an initial dose of 10 mg (five 2-mg tablets) on the 24(th) day of the menstrual cycle and one-fifth of the dose less (one tablet) each day until a dose of 2 mg (one 2-mg tablet) was reached on the 28(th) day of the menstrual cycle. The control group received placebo with a similar regimen.


RESULTS
The 5-day gradual reduction regimen of chlormadinone significantly improved (F(3.76) = 3.29, p <0.02) the daily symptoms report (DSR) scores by the third month of treatment. The resulting relative risk was 4.09 (confidence interval: 1.15-14.57, p <0.005, 95% CI). Compared to placebo, chlormadinone clinically and statistically reduced the severity of depression, anxiety, food cravings, mood swings and cramps. A statistical reduction of symptoms such as poor coordination, irritability, feeling out of control, hopelessness, decreased interest and headache was detected but was not clinically relevant. No changes occurred in concentration difficulties, tiredness, insomnia, swelling, breast tenderness and aches. As side effects, 30% of the volunteers showed changes in the length of the menstrual cycle, and 15% experienced dyspepsia.


CONCLUSIONS
A 5-day gradual reduction regimen of chlormadinone improves some of the discomforting ailments associated with PMDD, namely, depression and anxiety.
Contreras
Carlos M
CM
Unidad Periférica Xalapa, Laboratorio de Neurofarmacología, Instituto de Investigaciones Biomédicas, UNAM e Instituto de Neuroetología, Universidad Veracruzana, Veracruz, México. ccontreras@uv.mx
Azamar-Arizmendi
Georgina
G
Saavedra
Margarita
M
Hernández-Lozano
Minerva
M
D000293:Adolescent; D000328:Adult; D000726:Androgen Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D001007:Anxiety / Q000188:drug therapy*; D002715:Chlormadinone Acetate / Q000008:administration & dosage* / Q000009:adverse effects; D003863:Depression / Q000188:drug therapy*; D005260:Female; D006801:Humans; D010865:Pilot Projects; D010919:Placebos; D011293:Premenstrual Syndrome / Q000188:drug therapy*; D016896:Treatment Outcome
D000726:Androgen Antagonists; D010919:Placebos; D002715:Chlormadinone Acetate