乌灵胶囊治疗女性更年期焦虑抑郁状态的随机、阳性药平行对照临床试验

doi:10.3736/jcim20091104

Abstract

Background

The incidence of menopausal anxiety and depression is increasing. It can induce and aggravate a variety of somatic symptoms. Despite of the good effects of psychotropic drugs on the disease, patients’ compliance is poor. Therefore, it is necessary to find a drug which is practical, effective, and easy for patients to take.
Objective

To evaluate the efficacy of Wuling Capsule (WC), a Chinese herbal medicine, in treatment of female climacteric syndrome with depression and anxiety state. Design, setting, participants and interventions: A total of 96 outpatients of female climacteric syndrome from Department of Gynecology of Integrated Traditional Chinese and Western Medicine, Huashan Hospital, Fudan University, Department of Gynecology of Traditional Chinese Medicine, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, and Department of Traditional Chinese Medicine, Obstetrics and Gynecology Hospital, Fudan University were included. The study was designed as a randomized, positive drug parallel controlled trial. The patients were divided into WC group (64 cases) and control group (32 cases) and were orally administered Wuling Capsule and Gengnianan Tablet, respectively. Main outcome measures: The efficacy was evaluated with Kupperman menopausal index (KMI), Self-rating Depression Scale (SDS), and Self-rating Anxiety Scale (SAS) before treatment, and after 3-week and 6-week treatment.
Results

The total response rate was 89.66% (52/58) in the WC group, which was superior to that in the control group [76.67% (23/30)]. Ridit test showed that there was a significant difference between the two groups (P < 0.05). Kupperman score of the two groups decreased markedly after the treatment (P < 0.01), but there was no statistical difference between the two groups. The scales of SAS and SDS in both groups were improved obviously after the treatment (P < 0.01). Covariance analysis showed that the decrease of SAS score in the WC group was more significant than that in the control group after 3- and 6-week treatment (P < 0.05, P < 0.01), but the SDS score was improved more significantly in the WC group than in the control group after 6-week treatment (P < 0.05).
Conclusion

Both Wuling Capsule and Gengnian’an Tablet are effective in treating female climacteric patients with depression and anxiety state. Wuling Capsule is more effective to alleviate depression and anxiety as compared with Gengnianan Tablet.

Key words: Depression, Involutional, Anxiety, Positive parallel control, Randomized controlled trial, Wuling Capsule

Xing-juan Wang, Ji Li, Qin-di Zou, Ling Jin. Wuling Capsule for climacteric patients with depression and anxiety state: A randomized, positive parallel controlled trial. Journal of Chinese Integrative Medicine, 2009, 7(11): 1042-1046.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20091104

http://www.jcimjournal.com/EN/Y2009/V7/I11/1042

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References 13

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Gruop	n	Age (years)	Time of menopause (years)	FSH (IU/L)	Luteinizing hormone (IU/L)	E₂(μmol/L)
Control	30	51.57±4.37	2.75±3.04	71.94±28.99	35.18±16.05	71.33±23.22
Treatment	58	51.16±4.54	3.17±3.66	72.33±31.52	32.25±12.66	64.76±26.28

Group	n	Kupperman score	SDS score	SAS score
Control
Before treatment	30	25.13±7.54	36.03±9.00	38.40±7.70
After 3-week treatment	30	17.17±8.19**	31.50±8.12**	32.23±7.54**
After 6-week treatment	30	13.54±8.80**	29.61±7.60**	29.11±7.07**
Treatment
Before treatment	58	26.43±7.89	42.82±11.14^△△	42.77±8.44^△
After 3-week treatment	58	16.72±7.55**	33.54±8.81**	33.21±8.04**^△
After 6-week treatment	58	11.94±7.72**	29.33±8.32**^△	28.43±7.40**^△△

Wuling Capsule for climacteric patients with depression and anxiety state: A randomized, positive parallel controlled trial

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