| Objective1.Study the characteristics of intestinal flora in patients with spleen deficiency type non-insomnia,patients with spleen deficiency type insomnia,and patients with spleen deficiency and stomach heat type insomnia;2.To observe the efficacy and safety of Bupiweixieyin Yinhuo Shengyang Decoction in treating spleen deficiency and stomach heat type insomnia,and further explore its intervention mechanism from the intestinal flora.Explore new ideas for insomnia treatment to expand the scope of application of Chinese medicine for insomnia.MethodsIn this study,spleen deficiency type non-insomnia,spleen deficiency type insomnia,and spleen deficiency stomach heat type insomnia were used as the research objects,and subjects were recruited from the Department of Psychological Sleep,Guangdong Provincial Hospital of Traditional Chinese Medicine.The sleep quality,intestinal flora,and their correlations were evaluated in the three groups.The spleen deficiency and stomach heat type insomnia group was treated with Bupi stomach diarrhea Yinhuo Shengyang decoction for 28 days to evaluate the efficacy and safety before and after treatment,including assessment of changes in sleep quality and intestinal flora.ResultsA total of 32 patients with spleen deficiency type non-insomnia group,21 cases with spleen deficiency type insomnia group,and 26 cases with spleen deficiency stomach heat type insomnia group were included.The following results are described using data that fits the normal distribution,and data that does not fit the normal distribution are described using the median(Q1,Q3).1.Results of Spleen Deficiency and Insomnia Syndrome1.1 Demographic characteristics(1)Age Spleen deficiency and non-insomnia group:28(25,29.5)years old;Spleen deficiency type insomnia group:47(29,52)years old;Spleen deficiency and stomach heat type insomnia group:33(27.5,50.5)years old.(2)Gender The spleen deficiency and insomnia ratio is 1:1;the spleen deficiency and insomnia group ratio is 1:2.5;the spleen deficiency and stomach heat insomnia group ratio is 1:2.25.1.2 Sleep quality(1)PSQISpleen deficiency type non-insomnia group:5.48±1.91 points;spleen deficiency type insomnia group:13.84±2.002 points;spleen deficiency stomach heat type insomnia group:13.58±2.18 points.(2)ISISpleen deficiency type non-insomnia group:4.57±4.00 points;spleen deficiency type insomnia group:20.57±3.404 points;spleen deficiency stomach heat type insomnia group:20.93±4.141 points.The insomnia group showed no insomnia level;the two insomnia groups generally showed mild to moderate insomnia.1.3 Intestinal flora(1)Sample diversityThere was no significant difference in the intestinal flora α-diversity of the spleen deficiency type non-insomnia group,the spleen deficiency type insomnia group,and the spleen deficiency stomach heat type insomnia group(P>0.05).(2)Species differences:1)Class2)Genus3)Similarities and differences of three groups of Flora function(3)Firmicutes/Bacteroidetes(F/B)and Bacilli/Clostridia(B/C)ratioThe spleen deficiency type insomnia group,spleen deficiency type insomnia group,and spleen deficiency stomach heat type insomnia group showed a significant decreasing trend in B/C.ratio,and the difference was statistically significant(P<0.05);There was no statistically significant difference in F/B ratio between the spleen deficiency type non-insomnia group,the spleen deficiency type insomnia group,and the spleen deficiency type insomnia group(P>0.05).The two insomnia groups showed an increasing trend compared with the spleen deficiency type non-insomnia group(P>0.05).2.Efficacy and safety evaluation of Bupiweixieyin Yinhuo Shengyang Decoction on spleen deficiency and stomach heat insomnia2.1 Sleep qualityAfter the intervention,the total PSQI and ISI scores were significantly lower than before the intervention(P<0.05),and the subjective sleep quality of the patients was improved.The sleep efficiency of the PSG showed an upward trend compared with that before the intervention(P>0.05).2.2 Safety evaluation(1)Analysis of inspection indicatorsThe abnormal indicators in the test group in this study are mainly reflected in a small number of patients with mild abnormalities such as occult blood,fecal occult blood,and liver function,a total of 3 patients.One case of fecal occult blood may be related to the patient’s history of hemorrhoids;one case of urinary occult blood did not rule out the presence of chronic urinary tract infections;two patients had a slight increase in alanine aminotransferase,in view of the high sensitivity and poor specificity of this indicator.,Susceptible to lifestyle influences such as exercise,eating,drinking,staying up late,etc.The patient did not report other symptoms of discomfort and could not be determined to be directly related to Chinese medicine.(2)Analysis of adverse reactionsThere were no serious adverse events in this study.There were 2 mild adverse events in the study.One patient was emotionally upset and one had gastrointestinal symptoms.None of the above adverse events were related to medication,and all of them improved or healed before the end of the intervention.This shows that the spleen and stomach diarrhea Yin Huo Sheng Yang Decoction has certain safety.3.Therapeutic effect of Bupiweixieyin Yinhuo Shengyang Decoction on spleen deficiency and insomnia3.1 Alpha diversity of intestinal floraAfter the intervention,the Simpson index of alpha diversity in the experimental group showed a downward trend and then a slight upward trend,and the difference was not statistically significant(P>0.05).3.2 Differential flora(1)Level of phylum:(2)Level of class:(3)Level of genus:1)Probiotics:2)Conditional pathogenic bacteria:3)Other bacteria:3.3 Ratio of Firmicutes/Bacteroidete(F/B)and ratio of Bacilli/Clost ridia(B/C)After the intervention,the F/B ratio decreased significantly compared with that before the intervention(P<0.05);the B/C ratio showed a downward trend compared with before the intervention,and the difference was not statistically signif icant(P>0.05).Conclusion(1)Spleen deficiency non-insomnia,spleen deficiency type insomnia,spleen deficiency stomach heat type insomnia showed a trend of insomnia severity,and with the progress of insomnia syndrome,patients showed different characteristics in the intestinal flora.Compared with the spleen deficiency non-insomniac group,the spleen deficiency insomniac group has fewer probiotics and increased conditional pathogenic bacteria;the spleen deficiency stomach heat insomnia is that probiotic bacteria are significantly reduced and the conditional pathogenic bacteria are increased.Combined with the immunological characteristics of significantly different flora,it is suggested that insomnia with different syndromes may cause changes in specific flora,leading to intestinal dysfunction and activating a series of intestinal immune responses.(2)Spleen and stomach diarrhea Yinhuo Shengyang decoction can effectively improve the subjective and objective sleep quality of patients with spleen deficiency and stomach heat insomnia,especially improve the time to fall asleep,sleep duration,sleep rhythm,daytime spirit,sleep efficiency and so on.Its curative mechanism may involve regulating the intestinal flora-immunoinflammatory pathway and intestinal flora-substance metabolism pathway.Spleen and stomach diarrhea Yinhuo Shengyang decoction can increase or adjust the abundance of probiotics;reduce the abundance of conditionally pathogenic bacteria,and regulate the special flora of thick-walled bacteria The ratio of Bacillus phylum and the ratio of Bacillus/Clostridium to regulate intestinal immunity and material metabolism,and promote the intestinal flora to stabilize.Therefore,the effect of Bupiweixieyinhuoshengyang decoction on insomnia of spleen deficiency and stomach heat may be related to the regulation of intestinal flora. |
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