Do different delivery systems of hormone therapy have different effects on psychological symptoms in surgically menopausal women? A randomized controlled trial

Abstract 

Objective

To compare the influence of different delivery forms of estrogen therapy on menopausal and psychological symptoms in surgically menopausal women.

Study design

Surgically menopausal women were assigned to a 1-year-therapy with oral conjugated estrogen 0.625mg/day (n=35), intranasal 300μg/day estradiol hemihidrate (n=33), percutaneous gel 1.5mg/day estradiol hemihidrate (n=32) or no treatment (control group, n=32). Serum E₂ and FSH levels, Kupperman's Scale used to assess climacteric symptoms, Hamilton Depression Scale (HDRS) and Hamilton Anxiety Rating Scale (HARS) scores were assessed before and after 1-year-therapy.

Results

After 1 year, the greatest increase in E₂ was in the oral group, followed by the transdermal gel, and then the intranasal group (oral vs transdermal gel: p=0.022: oral vs intranasal: p=0.0001; transdermal gel vs intranasal: p=0.0001). All treatment groups improved significantly in total Kupperman index score and HARS (p<0.05) with no difference between the groups. With regard to HDRS, all treatment groups improved significantly (p<0.05) with the greatest improvement in the oral group, and no difference between transdermal gel and intranasal groups (oral vs transdermal gel: p=0.015; oral vs intranasal: p=0.001; transdermal gel vs intranasal: p=0.735). Control group scored worse in all tests after study (p<0.05). All scores correlated significantly with post-treatment serum E₂ and FSH levels (p<0.001).

Conclusion

Oral, intranasal and percutaneous gel estradiol therapies significantly improve menopausal and psychological symptoms in surgically menopausal women with oral route better than transdermal gel and intranasal modalities against depressive mood.

Keywords: Menopause, Hormonal therapy, Climacteric symptoms, Depression, Anxiety