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Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (4): 321-327.doi: 10.3736/jcim20100404

• Original Clinical Research • Previous Articles     Next Articles

Effects of Kuntai Capsule and hormone replacement therapy on cognitive function and mental symptoms of early postmenopausal women: a randomized controlled trial

Wen-juan Li , Liang-zhi Xu),Hong-wei Liu, Jing Zhang, Liu-lin Tang, Ling-ling Zhou, Jing Zhuang, Ying Liu, Xiao-fang Liu   

  1. Department of Obstetrics and Gynecology, West China Second Hospital, Sichuan University, Chengdu 610041, Sichuan Province, China
  • Received:2009-11-12 Accepted:2010-03-01 Online:2010-04-20 Published:2010-04-15
  • Contact: Liang-zhi Xu E-mail:liangzxu@126.com

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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.Design, setting, participants and interventions: 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.Main outcome measures: 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).
Conclusion

Both Kuntai Capsule and CEE may contribute to maintain the cognitive function and ameliorate mental symptoms of early postmenopausal women.

Key words: Perimenopause, Chinese herbal drug, Estrogen replacement therapy, Cognition, Randomized controlled trial

Figure 1

Flow diagram of this randomized trial"

Table 1

Patients completed follow-up at each time point in two groups"

Group n Number of patients
3 months 6 months 9 months 12 months
CEE 29 28 24 23 25
Kuntai 28 25 21 20 22

Table 2

Characteristics of baseline data in two groups"

Items CEE group Kuntai group P value
Age ($\bar{x}$±s, years) 49.21±4.08 48.89±4.21 0.78
Age at menopause ($\bar{x}$±s, years) 47.48±3.85 47.25±4.21 0.83
Menopausal time（Median, months） 18.0 11.5 0.38
Body mass index (kg/m2) 21.86±2.39 21.07±1.70 0.16
Waist-hip ratio ($\bar{x}$±s) 0.89±0.05 0.86±0.06 0.02
E2 ($\bar{x}$±s, ng/L) 14.66±8.22 13.36±8.02 0.55
FSH ($\bar{x}$±s, IU/L) 77.54±20.72 78.74±18.17 0.82
Systolic blood pressure ($\bar{x}$±s, mmHg) 112.64±10.36 114.64±12.63 0.66
Diastolic blood pressure ($\bar{x}$±s, mmHg) 74.64±8.42 73.14±8.48 0.55

Table 3

ITT and PPS analyses of cognitive and mental changes in MMSE, Kupperman index and quality of life at each time point in two groups ($\bar{x}$±s)"

Data set Group n MMSE Kupperman index Quality of life
ITT CEE
Before treatment 29 27.97±2.78 4.90±3.02 12.66±8.14
Three-month treatment 29 28.76±2.18* 3.37±2.74** 7.83±8.99**
Six-month treatment 29 29.17±2.09* 3.03±2.50** 7.31±6.42**
Nine-month treatment 29 29.17±2.11* 2.72±2.99** 5.97±6.26**
Twelve-month treatment 29 29.28±2.07* 2.34±2.44** 4.83±7.33**
Kuntai
Before treatment 28 28.21±3.84 5.68±3.49 12.96±11.01
Three-month treatment 28 27.96±4.02* 3.46±2.78** 10.46±10.02**
Six-month treatment 28 28.61±3.10* 3.61±3.86** 8.25±10.56**
Nine-month treatment 28 28.96±2.20* 2.54±2.56** 5.04±6.22**
Twelve-month treatment 28 28.89±2.20* 2.14±2.49** 5.46±6.54**
PPS CEE
Before treatment 24 27.25±6.11 4.67±3.12 13.38±8.74
Three-month treatment 24 29.29±1.20* 3.17±2.71** 8.25±9.83**
Six-month treatment 24 29.79±0.59* 2.63±2.18** 7.29±6.80**
Nine-month treatment 24 29.79±0.66* 2.25±2.74** 5.46±6.45**
Twelve-month treatment 24 29.92±0.28* 2.00±2.23** 4.38±7.72**
Kuntai
Before treatment 19 28.95±1.47 5.32±3.68 13.21±12.47
Three-month treatment 19 29.00±1.92* 2.95±2.91** 8.32±7.90**
Six-month treatment 19 29.79±0.54* 3.42±4.48** 7.47±11.87**
Nine-month treatment 19 29.95±0.23* 1.79±2.64** 2.79±4.33**
Twelve-month treatment 19 29.79±0.54* 1.47±2.46** 3.26±4.82**

Figure 2

ITT and PPS analyses of MMSE scores at each time point in two groups"

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