Main objective: to compare the effects of electro-acupuncture and escitalopram oxalate tablets on mild-to-moderate perimenopausal depression, and to evaluate the safety of electroacupuncture stimulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
252
8 acupoint: Guanyuan, Zigong (bilateral), Tianshu(bilateral), Sanyinjiao(bilateral), Hegu(bilateral), Taichong(bilateral), Baihui, Yintang. Every patient is supposed to have 36 times acupuncture treatment. 30 minutes per time. Baihui, Yintang, Zigong (bilateral), Tianshu (bilateral) are applied with electro-acupuncture device with dilatational wave, current frequency: 10/50Hz, intensity: 0.5\~1.0 mA
escitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
RECRUITINGChange from Baseline in scores of the 17-item Hamilton depression rating scale (HAMD-17)
Time frame: 0 week, 4th week, 8th week, 12th week, 16th week and 24th week
Change from Baseline in scores of the Menopause-Specific Quality of Life questionnaire (MENQOL)
Time frame: 0 week, 4th week, 8th week, 12th week, 16th week, 20th week and 24th week
Change from Baseline in level of estradiol (E2),
Time frame: 0 week, 12th week
Change from Baseline in level of follicle-stimulating hormone (FSH)
Time frame: 0 week, 12th week
Change from baseline in level of Luteinizing hormone (LH)
Time frame: 0 week, 12th week
Change from baseline in level of FSH/LH
Time frame: 0 week, 12th week
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