Objective: To observe the effects of Shuanghe Zaoren granule on sleep electroencephalogram (EEG) and its clinical curative effects on patients with primary insomnia. Method: Totally 120 patients with primary insomnia were randomly divided into observation group and control group. The observation group (60 cases) was treated with Shuanghe Zaoren granule

1 pack/time

tid. The control group (60 cases) was treated with Estazolam tablets

1 mg

bedtime

qd. The therapeutic course was 2 weeks for both groups. The Pittsburgh Sleep Quality Index (PSQI)

traditional Chinese medicine (TCM) symptom score and clinical efficacy

and key parameters of sleep EEG

such as sleep latency (SL)

total sleep duration (TSA)

awakening frequency (AT)

awakening duration (ASA)

awakening sleep ratio (A/TSA)

S1

S2

S3

S4

paradoxical sleep (REM) and sleep efficiency (SE) were observed and evaluated for both groups. The clinical curative effects of the two groups were recorded. Result: The total effective rate in the observation group was 90%

which was much higher than 73%in the control group (P<0.05). Compared with before treatment

a shortened sleep latency

awakening frequency and awakening duration

prolonged deep sleep

increased sleep efficiency

shortened light sleep and paradoxical sleep (REM) were observed in the sleep EEG parameters in two groups (P<0.01). However

the sleep electroencephalogram parameters in the observation group were better than control group (P<0.05

P<0.01). The scores of PSQI in observation group and control group were 16 points and 17 points

respectively before treatment

after treatment

the PSQI score was significantly decreased to 5 points and 8 points in two groups (P<0.01). The PSQI score of observation group was significantly lower than the control group (P<0.01). Score of TCM clinical symptoms after treatment were significantly lower than that before treatment in each group (P<0.01). In the observation group

TCM clinical symptom score reduced by 3 times of the control group (P<0.01). Conclusion: Shuanghe Zaoren granule could shorten the time for falling asleep

decrease awakening frequency and awakening duration

prolong the deep sleep

improve the structure and quality of sleep

with an especially better clinical curative effect for patients with fire excess from yin deficiency and heart-spleen deficiency. Therefore

it is a safe and effective drug to treat primary insomnia.