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

[1]	Ma XW . Gengnianan tablet in treatment of 308 cases of menopausal syndrome[J]. Shaanxi Zhong Yi, 2006,10(27):1175
	马西文 . 更年安片治疗妇女更年期综合征308例[J]. 陕西中医, 2006,10(27):1175
[2]	Wang Y, Zhang HY . A paralleled compared study of Wuling capsule and Deanxit in the treatment of general anxiety disorder[J]. Shanghai Jing Shen Yi Xue, 2005,17(3):158-159 doi: 10.3969/j.issn.1002-0829.2005.03.010
	王瑛, 张海音 . 乌灵胶囊和黛力新治疗广泛性焦虑症对照研究[J]. 上海精神医学, 2005,17(3):158-159 doi: 10.3969/j.issn.1002-0829.2005.03.010
[3]	Zhang KN . Clinical study of levodopa and Wuling capsule in treating Parkinson’s disease and depression[J]. Xin Yi Xue., 2005,36(3):154-156
	张凯娜 . 左旋多巴与乌灵胶囊治疗帕金森病伴发抑郁的临床研究[J]. 新医学, 2005,36(3):154-156
[4]	Wang ZX . Efficacy observation of Wuling capsule in treating 78 cases of insomnia.[J]. Hebei Zhong Yi, 2003,25(12):909 doi: 10.3969/j.issn.1002-2619.2003.12.048
	王振新 . 乌灵胶囊治疗失眠78例疗效观察[J]. 河北中医, 2003,25(12):909 doi: 10.3969/j.issn.1002-2619.2003.12.048
[5]	Jin H, Wang SZ, Shen Y, Yang CY, Jin WD . Combination of Wuling capsule and anti-psychotics in post-psychosis fatigue state[J]. Lin Chuang Xin Shen Ji Bing Za Zhi, 2004,10(4):247-248 doi: 10.3969/j.issn.1672-187X.2004.04.008
	金红, 王素珍, 沈莹, 杨春玉, 金卫东 . 乌灵胶囊联合抗精神病药物治疗精神后衰弱状态[J]. 临床心身疾病杂志, 2004,10(4):247-248 doi: 10.3969/j.issn.1672-187X.2004.04.008
[6]	Li PG, Su TF . Wuling capsule in treating 86 cases of cardiac neurosis[J]. Shi Yong Zhong Yi Yao Za Zhi, 2005,21(9):555
	李品贵, 苏太峰 . 乌灵胶囊治疗心脏神经官能症86例[J]. 实用中医药杂志, 2005,21(9):555
[7]	Yue J. Obstetrics and gynecology. Beijing: People’s Medical Publishing House. 2004. Chinese.
	乐杰 . 妇产科学. 北京:人民卫生出版社. 2004.
[8]	Cao ZY. China obstetrics and gynecology[M]. Beijing: People’s Medical Publishing House, 1999: 2281
	曹泽毅 . 中华妇产科学[M]. 北京: 人民卫生出版社, 1999: 2281
[9]	Zhang MY. Manual for psychiatric rating scale[M]. Changsha: Hunan Science & Technology Press, 1998: 35, 42
	张明园 . 精神科评定量表手册[M]. 长沙: 湖南科学技术出版社, 1998: 35, 42
[10]	Zheng XY. Guidelines for clinical research on Chinese new herbal medicines(trial implementation)[M]. Beijing: Medical Science and Technology Publishing House of China, 2002
	郑筱萸 . 中药新药临床研究指导原则(试行)[M]. 北京: 中国医药科技出版社, 2002
[11]	Ma XW . Gengnianan Tablet in treatment of 308 cases of female climacteric syndrome[J]. Shaanxi Zhong Yi, 2006,27(10):1175
	马西文 . 更年安片治疗妇女更年期综合征308例.[J]. 陕西中医, 2006,27(10):1175
[12]	Han J, Gao SQ . Clinical use of Wuling capsule and its adverse effects[J]. Zhongguo Yao Fang, 2007,18(15):1184-1186 doi: 10.3969/j.issn.1001-0408.2007.15.030
	韩洁, 高素强 . 乌灵胶囊的临床应用及不良反应[J]. 中国药房, 2007,18(15):1184-1186 doi: 10.3969/j.issn.1001-0408.2007.15.030
[13]	Zuo PP, Ma ZZ, Chen WR, Tang LJ, Shen Q, Sun XH, Shen Y . Studies on the sedative and sleeping effects of Wuling mycelia and its pharmacological mechanism.[J]. Zhongguo Yao Xue Za Zhi, 1999,34(6):374-377 doi: 10.3321/j.issn:1001-2494.1999.06.007
	左萍萍, 马志章, 陈婉如, 唐利军, 沈琦, 孙晓华, 沈云 . 乌灵菌粉的镇静作用及其机理研究[J]. 中国药学杂志, 1999,34(6):374-377 doi: 10.3321/j.issn:1001-2494.1999.06.007

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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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