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Clinical efficacy of herbal medicine for soothing liver and strengthening spleen combined with probiotics in the treatment of insomnia and its influence on serum levels of 5-hydroxytryptamine,melatonin and vasoactive intestinal peptide
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DOI   10.11656/j.issn.1672-1519.2024.03.04
Key Words   soothing liver and invigorating spleen method;probiotics;insomnia;5-hydroxytryptamine(5-HT);melatonin(MT);vasoactive intestinal peptide(VIP);polysomnography(PSG)
Author NameAffiliationE-mail
YAN Saiqiang Graduate School, Hebei University of Chinese Medicine, Shijiazhuang 050091, China  
WANG Chao Graduate School, Hebei University of Chinese Medicine, Shijiazhuang 050091, China  
ZHANG Xun Graduate School, Hebei University of Chinese Medicine, Shijiazhuang 050091, China  
LIU Ao Graduate School, Hebei University of Chinese Medicine, Shijiazhuang 050091, China  
CHENG Li Sleep Center, First Affiliated Hospital of Hebei University of Chinese Medicine, Shijiazhuang 050010, China chengli36524@qq.com 
Abstract
    [Objective] To observe the clinical efficacy of Shugan Jianpi method combined with probiotics in the treatment of insomnia (liver depression and spleen deficiency type) and the influence of serum 5-hydroxytryptamine (5-HT),melatonin (MT) and vasoactive intestinal peptide(VIP) levels. [Methods] A total of 130 insomnia patients with traditional Chinese medicine syndrome differentiation of liver depression and spleen deficiency treated in the outpatient department of sleep center of the First Affiliated Hospital of Hebei University of Traditional Chinese Medicine from October 2021 to October 2022 were selected as research objects. According to the random number table method,they were divided into the observation group(65 cases) and the control group(65 cases). The control group was given dexzopiclone tablets,2 mg/day,oral before sleep. Observation group was given based on the liver spleen method for traditional Chinese medicine from fried particles and bifidobacterium lactobacillus sanlian living bacterium,are 2 times/day,after meals. The treatment course of both groups was 4 weeks. The changes of pittsburgh sleep quality index (PSQI) score,hamilton depression scale (HAMD-17) score,gastrointestinal symptoms(GSRS) score,serum 5-HT,MT,VIP level and polysomnogram(PSG) related parameters before and after treatment were observed in the 2 groups. PSQI,HAMD-17 and GSRS scores were repeatedly observed at follow-up 2 weeks after drug withdrawal. And the clinical efficacy and safety evaluation of 2 groups of patients. [Results] 1) PSQI,HAMD-17 and GSRS scores:after 4 weeks of treatment and 2 weeks of follow-up after drug withdrawal,PSQI factor scores,PSQI total score,HAMD-17 score and GSRS score of 2 groups were lower than before treatment(P<0.05);the sleep time,sleep quality,sleep disorder,daytime dysfunction and other factors scores of PSQI,PSQI total score,HAMD-17 score and GSRS score of observation group were significantly lower than those of control group(P<0.05).2) Laboratory indicators:after 4 weeks of treatment,serum 5-HT,MT and VIP levels in 2 groups were higher than before treatment(P<0.05);the levels of 5-HT,MT and VIP in the observation group were significantly higher than those in the control group(P<0.05).3) PSG monitoring:after 4 weeks of treatment,the total sleep time(TST),sleep latency(SL) and awakening time(AWT) of PSG in the two groups were better than those before treatment(P<0.05). The improvement degree of TST and AWT parameters of PSG in the observation group was obviously better than that in the control group(P<0.05),while the improvement degree of SL parameters was lower than that in the control group,but there was no statistically significant difference(P>0.05).4) Clinical efficacy:after 4 weeks of treatment,the recovery rate of observation group was 70.97%,which was higher than that of control group 45.16%(P<0.05).5) Incidence of adverse reactions:during treatment,the incidence of adverse reactions in the observation group was 4.84%,lower than that in the control group 22.58%(P<0.05). [Conclusion] Soothing the liver and strengthening the spleen combined with probiotics can effectively improve patients' sleep quality,improve depression and gastrointestinal function,and enhance the levels of related neurotransmitters and hormones. The clinical efficacy is accurate,the long-term efficacy is significant,and fewer adverse reactions,and the safety is high.

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