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

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 300microg/day estradiol hemihidrate (n=33), percutaneous gel 1.5mg/day estradiol hemihidrate (n=32) or no treatment (control group, n=32). Serum E(2) 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 E(2) 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 E(2) 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.