L-arginine plus drospirenone-ethinyl estradiol in the treatment of patients with PCOS: a prospective, placebo controlled, randomised, pilot study.
OBJECTIVE
To verify the effects of a pill containing drospirenone on the surrogate markers of arterial function and to evaluate the possible improvements induced by the addition of L-arginine.


METHODS
A prospective, placebo controlled, randomised, pilot study.


METHODS
University of Bologna.


METHODS
Twenty-eight young women with PCOS.


METHODS
Random submission to: drospirenone + ethinylestradiol+ a placebo (Group I; n = 15) or drospirenone + ethinylestradiol + oral L-arginine (4 g × 2/daily) (Group II, n = 13).


METHODS
Medical examination; blood measurement of nitrites/nitrates, biochemical and hormonal parameters; ultrasonographic analysis and colour Doppler evaluation of uterine, stromal ovarian and ophthalmic arteries; analysis of brachial artery flow-mediated vasodilatation; and 24-h ambulatory blood pressure monitoring. The above parameters were evaluated before and after 6 months.


RESULTS
The low dose oral contraceptive containing drospirenone favoured a pre-hypertensive state. The L-arginine supplementation increased the circulating levels of nitrites/nitrates and improved the endothelium-dependent vasodilatation counteracting the negative effect of the contraceptive pill.


CONCLUSIONS
Although, the present pilot study was conducted in a limited number of patients, it seems that the L-arginine co-treatment may improve the long-term side effects of the pill reducing the risk of cardiovascular diseases.
Battaglia
Cesare
C
Department of Gynecology and Pathophysiology of Human Reproduction, Alma Mater Studiorum-University of Bologna, Bologna, Italy. cesare.battaglia@unibo.it
Mancini
Fulvia
F
Battaglia
Bruno
B
Facchinetti
Fabio
F
Artini
Paolo G
PG
Venturoli
Stefano
S
D000328:Adult; D000735:Androstenedione / Q000097:blood; D000736:Androstenes / Q000008:administration & dosage*; D001120:Arginine / Q000008:administration & dosage*; D001783:Blood Flow Velocity / Q000502:physiology; D001916:Brachial Artery / Q000000981:diagnostic imaging / Q000502:physiology; D004958:Estradiol / Q000097:blood; D004997:Ethinyl Estradiol / Q000008:administration & dosage*; D005260:Female; D005640:Follicle Stimulating Hormone / Q000097:blood; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D010053:Ovary / Q000098:blood supply / Q000000981:diagnostic imaging; D010865:Pilot Projects; D011085:Polycystic Ovary Syndrome / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D013739:Testosterone / Q000097:blood; D018615:Ultrasonography, Doppler, Color; D014599:Uterus / Q000098:blood supply / Q000000981:diagnostic imaging; D055815:Young Adult
D000736:Androstenes; D012738:Sex Hormone-Binding Globulin; C534342:drospirenone and ethinyl estradiol combination; D013739:Testosterone; D000735:Androstenedione; D004997:Ethinyl Estradiol; D004958:Estradiol; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone; D001120:Arginine