Does adding estrogen to the hormone-free days of an oral contraceptive cycle reduce menopausal symptoms in perimenopausal OC users? - OC

Journal of Family Practice, Oct, 2001 by Thomas E. Bielanski

Blumel JE, Castelo-Branco C, Binfa L, Aparicio R, Mamani L. A scheme of combined oral contraceptives for women more than 40 years old. Menopause 2001; 8:286-89.

* BACKGROUND Women older than 40 years using OCs for birth control often experience perimenopausal symptoms, such as hot flashes, vaginal dryness, or emotional disturbances, especially during the hormone-free days of an OC cycle. The authors of this study conducted a randomized controlled trial to assess whether the addition of estrogen to the hormone-free days during OC use can reduce perimenopausal symptomatology.

* POPULATION STUDIED The study population included 60 healthy Chilean women aged 40 to 49 years presenting to various outpatient clinics with mood disorders or hot flashes who were already taking OCs. Women taking concurrent psychiatric medications were excluded.

* STUDY DESIGN AND VALIDITY This was a randomized controlled double-blind study during 3 cycles of OC use. A total of 26 women received an OC containing 20 [micro]g of ethinyl estradiol and 150 [micro]g desogestrel for 21 days followed by 7 placebo tablets; the other group of 34 women received the same OC combination, followed by 2 placebo tablets and then 5 identical-appearing ethinyl estradiol tablets (10 [micro]g). Three women from the placebo group and 1 woman from the estrogen group did not complete the study. The patients were evaluated at baseline and the end of 3 cycles using the Greene scale. This scale, a questionnaire tool used to analyze 21 perimenopausal symptoms in the categories of vasomotor, somatic, psychologic, and sexual function, is intended to standardize climacteric complaints for comparative purposes.

The strengths of this study are the randomized double-blind design that appropriately concealed treatment group assignment and the use of a standardized assessment scale. The limitations of this study are the small number of patients studied (60) and the relatively short duration of the study (3 cycles). The authors also did not discuss side effect data between the study groups.

* OUTCOMES MEASURED The outcomes measured were changes in vasomotor symptoms, symptoms of depression, somatic symptoms (headaches, musculoskeletal pain, and dizziness) and sexual dysfunction between the 2 study groups.

* RESULTS There were no significant differences at baseline between the treatment groups regarding age, height, weight, or parity. Symptom scores at the end of the study (3 months later) were improved in both the estrogen and placebo groups; however, there was statistically significant greater improvement in the estrogen group. Depression scores fell 61% in the estrogen group versus 24% in the placebo group (P [is less than] .004). Likewise, somatic scores fell 59% versus 32% (P [is less than] .04); vasomotor scores fell 76% versus 48% (P [is less than] .03); and sexual dysfunction scores fell 75% versus 33% (P [is less than] .002) in the estrogen and placebo groups. Anxiety scores did not differ between the groups. Interestingly, headache scores were reduced with estrogen but not with placebo.

RECOMMENDATIONS FOR CLINICAL PRACTICE

Perimenopausal women taking OCs who complain of depressive symptoms, hot flashes, or other somatic symptoms during the rest week of the 4-week cycle will likely experience a reduction in these symptoms by taking ethinyl estradiol (10 [micro]g) for 5 of the 7 rest days. Keep in mind that side effects and long-term safety have not been formally assessed.

Thomas E. Bielanski, MD
West Suburban Hospital Medical Center
Family Practice Residency
River Forest, Illinois
E-mail: doc.biet@wshmc.org