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Low Dose Danazol
in the Treatment of

M Deeny, R Hawthorn, DM Hart (Stobhill Gen Hospital, Glasgow) Postgraduate Medicine 1991;67:450-454

Premenstrual Syndrome: Appeareing in KEY Obstetrics and Gynecology 1991;4(4):31

Premenstrual syndrome (PMS) remains incompletely understood, but it appears to be related to the menstrual cycle. This study evaluated danazol, used in a dose of 100mg twice daily, in comparison with placebo in 19 patients having severe PMS. Danazol was given for 3 months in a double-blind crossover trial.

Thirty patients completed treatment with danazol and 29 with placebo. Significantly greater improvement occurred with danazol. Breast discomfort, irritability, depression, anxiety, mood swings, crying, depressed libido, and abdominal swelling all were less evident with danazol than with placebo (Table 4). Menstrual change and nausea were more frequent with danazol, but there were no clinically serious side effects. Body weights were similar at the end of treatment.

Danazol lessens most of the common symptoms of PMS as well as the overall severity of the disorder. Significant androgenic changes did not occur in the present patients. The salutary effects of danazol in women with PMS do not depend on the occurrence of amenorrhea.

This well-designed placebo controlled trial indicates that a low dose of danzol, 100mg twice a day, was effective in relieving many of these patients' premenstrual symptoms. Menses continued in two-thirds of the patients, and clinical side effects were minimal with this low doage of danazol. It may be worthwhile to try this treatment for 6 months or so in some women with severe premenstrual symptoms who fail to respond to other treatments. D. R. Mishell, Hr., M.D.

Breast discomfort 2.920.9 P < 0.01P < 0.01
Irritability6.922.1 P < 0.01P < 0.01
Depression2.912.9 P < 0.01P < 0.01
Anxiety3.812.9 P < 0.05P < 0.05
Mood swings1.812.6 P < 0.05P < 0.01
Crying1.85.0 not significantnot significant
Depressed libido 33.657 P < 0.01P < 0.01
Headaches4.39.7 not significantnot significant
Fluid Retention4.34.4 not significantP <0.01
Abdominal swelling4.7515.7 P < 0.01P < 0.01
Increased appetite 3.33.4 not significantnot significant

ns: P>= 0.05
[Courtsey of Deeny M, Hawthorn R, Hart DM: Postgrad Med J 1991;67:450-54

Dr. Lichten's Breakthrough Lectures on Pelvic Pain, Endometriosis and PMS and 9 others are available on CD-ROM in Audio-Visual Format.


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Installed: July 1, 1996
Updated: January 17, 2000