Objective: To systematically evaluate the efficacy and safety of the adjuvant therapy with traditional Chinese medicines (TCM) in treating perimenopausal insomnia. Method: The PubMed

Cochrane Library

OVID

EMbase

CNKI

WanFang Data and VIP databases between 2010 and December 2014 were searched through computer to collect all RCTs on the comparison of the combined therapy of TCM and western medicines and the simple therapy of western medicines in treating perimenopausal insomnia. The data extraction form was designed. Two researchers independently screened the littérateurs

extracted data and evaluated the literature bias risk according to the inclusion standards. The Meta-analysis was operated by using RevMan 5.2.6 software. Result: A total of 21 RCTs involving 1 608 patients were included. The result of Meta-analysis indicated t hat the TCM adjuvant therapy group was superior to the control group in terms of clinical effectiveness[OR=3.26

95%CI(2.50

4.26)

P<0.000 01]

recurrence rate[OR=4.21

95%CI(2.46

7.22)

P<0.000 01]and total scale of PSQI[MD=-2.28

95%CI(-2.78

-1.78)]. With respect to the sleep improvement

the TCM adjuvant therapy group was also better than the control group in quality of sleep[MD=-0.40

95%CI(-0.73

-0.06)]

time of sleeping[MD=-0.54

95%CI(-0.91

-0.16)]

hour of sleep[MD=-0.41

95%CI(-0.60

-0.22)]

efficiency of sleep[MD=-0.38

95%CI(-0.56

-0.20)]

disorders of sleep[MD=-0.37

95%CI(-0.55

-0.19)]

application of hypnotic drugs[MD=-0.32

95%CI(-0.47

-0.18)]

daytime dysfunction[MD=-0.29

95%CI(-0.47

-0.10)]and scale of Kupperman[MD=-5.48

95%CI(-9.87

-1.09)

P=0.01]. With respect to the syndrome evaluation

the TCM adjuvant therapy group showed a better effect than the conventional treatment group in relieving patients' hot flash and sweating[MD=-1.65

95%CI(-1.84

-1.45)]

irritability[MD=-0.99

95%CI(-1.13

-0.85)]

dizziness and palpitation[MD=-2.18

95%CI(-2.92

-1.43)]and mental burnout[MD=-1.89

95%CI(-2.07

-1.72)]. At the level of endocrine hormone

the TCM adjuvant therapy group can better improve the estradiol (E2) level[MD=17.70

95%CI(1.89

33.52)]and reduce the level of follicle-stimulating hormone (FSH)[MD=-11.51

95%CI(-20.49

-2.53)]

but with no statistical significance in difference in luteinizing hormone (LH)[MD=-5.85

95%CI(-13.01

1.30)]. No serious or frequent adverse effect was reported for the two groups. Conclusion: The Meta-analysis suggests that the adjuvant intervention with TCM can improve patients' sleep disorders

enhance the quality of sleep

with less adverse effect. However

there are only a few research methodologies and reports in a low quality. The above results shall be further proved by well-designed large-sample-size studies.