[Effects of Kuntai Capsule and hormone replacement therapy on cognitive function and mental symptoms of early postmenopausal women: a randomized controlled trial].
BACKGROUND
Conjugated equine estrogen (CEE) treatment, a hormone replacement therapy, is restricted for use in perimenopausal and postmenopausal women because of security issues. Consequently, traditional Chinese herbal medicine has become an alternative choice for the patients with contraindications to hormone replacement therapy.


OBJECTIVE
To evaluate the efficacy and safety of Kuntai Capsule and CEE in treating cognitive function disorder and mental symptoms of early postmenopausal women.


METHODS
A total of 57 cases of early postmenopausal women from Outpatient Department of West China Women and Children's Hospital were included. The subjects were randomly divided into two groups: Kuntai group with 28 cases and CEE group with 29 cases. The patients in Kuntai group received 6 g Kuntai capsules three times a day. The patients in CEE group received CEE 0.3 mg and 0.6 mg alternately once a day (average dose of 0.45 mg/d). The patients with intact uterus in CEE group were treated with 2 mg medroxyprogesterone acetate daily.


METHODS
In one-year treatment course, the recognition function and mental symptoms of each patient were investigated by questionnaires of Mini-Mental State Examination (MMSE), Kupperman, and quality of life (QOL) every three months. Both intention-to-treat (ITT) and per-protocol set (PPS) analyses were done.


RESULTS
The MMSE, Kupperman index and QOL scores at each time point were improved as compared with those before treatment (P<0.05), however there were no statistical differences between the two groups (P>0.05). The MMSE scores showed a tendency to escalate while mental symptoms investigated by Kupperman index and QOL scale showed a downtrend. No severe adverse effects occurred in the study phase and no statistical difference in incidence of side effects between the two groups was found except for vaginal bleeding. The incidence rates of vaginal bleeding in CEE and Kuntai groups were 39.3% and 11.1% respectively (P=0.029).


CONCLUSIONS
Both Kuntai Capsule and CEE may contribute to maintain the cognitive function and ameliorate mental symptoms of early postmenopausal women.
Li
Wen-juan
WJ
Department of Obstetrics and Gynecology, West China Second Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China.
Xu
Liang-zhi
LZ
Liu
Hong-wei
HW
Zhang
Jing
J
Tang
Liu-lin
LL
Zhou
Ling-ling
LL
Zhuang
Jing
J
Liu
Ying
Y
Liu
Xiao-fang
XF
D000328:Adult; D003071:Cognition / Q000187:drug effects*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008593:Menopause; D008606:Mental Processes / Q000187:drug effects*; D008875:Middle Aged; D008517:Phytotherapy; D017698:Postmenopause
D004365:Drugs, Chinese Herbal; D004966:Estrogens, Conjugated (USP)