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Non-randomised trial, 2002

Is it safe to use hormone therapy alongside GnRH-agonist treatment for severe PMS?

In this small study, yes. Hormone therapy appeared safe and effective, protecting bone health and controlling PMS symptoms.

Early or limited evidence 5 women with severe PMS from an academic medical center

What they did

Pilot non-randomized trial at an academic medical center. 5 women with severe PMS received GnRH-agonist injections (leuprolide acetate 3.75 mg monthly). After 1 month, hormone replacement therapy was added: 1 mg estradiol daily plus 0.35 mg norethindrone on alternating days. Women were followed for an average of 37.7 months.

What they found

Bone density in the spine and hip remained stable throughout treatment. No woman experienced return of pelvic pain or mood swings after starting hormone therapy. All women stopped having periods within the first 3 months of hormone therapy and remained without periods.

What it means for you

This combination may be safe for long-term use in severe PMS and may protect bone health. This was a small pilot study with no control group, so we cannot be sure the results apply more broadly or that the hormone therapy caused the good outcomes. Larger studies are needed.

5

Number of women with severe PMS

37.7 months

Average length of follow-up for PMS patients

3 months

Time until all women stopped having periods

About the study

Original title
Prevention of bone loss and hypoestrogenic symptoms by estrogen and interrupted progestogen add-back in long-term GnRH-agonist down-regulated patients with endometriosis and premenstrual syndrome
Authors
Mitwally MF, Gotlieb L, Casper RF
Journal
Menopause (New York, N.Y.)
Year
2002
Study design
Non-randomised trial
Participants
15
What was tested
GnRH-agonist (leuprolide) plus hormone therapy with estradiol and norethindrone

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