Efficacy of hormone replacement plus antidepressant for anxiety and depression in patients with menopause syndrome

Rui YUAN; Qin PENG; Qiong LIAO; Hongxia LI

ABSTRACT

BACKGROUND:

There are many drawbacks with hormone replacement therapy for menopausal syndrome. The blood levels of 5-HT and norepinephrine are lower. Fluoxetine hydrochlorde(ProzacR) is a selective serotonin reuptake inhibitor which is widely used in treating anxiety and depression,

OBJECTIVE:

To evaluate the effect of combined antidepressant and estrogen therapy compared to estrogen alone in the treatment of perimenopausal syndrome in this prospective open study.

DESIGN:

Randomized comparative study.

SETTING:

Department of Obstetrics and Gynecology of the First Affiliated Hospital of Chongqing Medical University

PARTICIPANTS:

From November 2003 to December 2004, 60 female patients with diagnosed menopausal syndrome of 3-12 month duration, aged (46±3) years, from Department of Obstetrics and Gynecology of the First Affiliated Hospital of Chongqing Medical University were enrolled into the study after giving their informed consents. The patients were randomly divided into two equal groups with Group 1 (n=30) receiving a combination of antidepressant + estrogen and Group 2 (n=30) receiving estrogen only.

METHODS:

Patients in Grgup 1 received fluoxetine hydrochloride (ProzacR) 20 mg orally every morning plus oral estradiol 1 mg once every two weeks for 2 months. Patients in Group 2 received only oral estradiol 1 mg once every two weeks for two months. Patients were not taking any other drug during the treatment period. At the end of two month treatment all patients were evaluated with the following 3 assessment tools ①female menopausal symptom evaluation with the following 4 categories Complete symptom relief, markedly improved, improved and no effect. Overall efficacy was defined as 50% symptom improvement. ② Hamilton Depression Scale which reflects energy level and psychosomatic factor of sleep and anxiety. ③Menopause index Which are description of clinical evaluation and adverse effects; this would help to assess the safety of using both drugs in treating the menopausal syndrome.MAIN OUTCOME

MEASURES:

female menopausal symptom assessment, hamilton depression scale, and menopause index.

RESULTS:

① In female menopausal symptom assessment group 1 showed better results in the complete relief and markedly improved scores. ②Hamilton Depression Scale group 1 also showed better scores than Group2(In Groupl, the scores at week 1 to 8 were 25,18,15,10,8,5,5,4 respectively ,in Group 2, the scores at week 1 to 8 were 25,17,15,14,13,12,13,13 respectively). ③ Group 3 showed a significant better score in the menopausal index with improvement in sleep disorder, anxiety and depression than Group 2 (In Group 1 the scores at week 1-8 were 32,22.5,15,15,14,15,15,14 respectively,In group 2, the scores at week 1 to 8were 33,21,16,14,13,12,13,13 respectively) ,there was no significant difference of incidence of adverse events as compared with Group 3 .

CONCLUSION:

Combined therapy of fluoxetire hydrochlarde(PROZAC)plus estrogen showed better efficacy in the treatment of menopausal syndrome than estrogen alone.