| Objective: The clinical trial was conducted to assess the clinical efficacy of modified Gegenqinlian Decoction in the treating gastrointestinal damp-heat type of sleeplessness for improved sleep status and TCM symptoms,and to offer ideas and referrals for the treating insomnia in TCM.Methods: We screened and selected 60 non-sleeping patients who met the enrollment criteria,and randomly split them into a test group of 30 patients(given modified Gegenqinlian Decoction and Zopiclone Tablets)and a reference group of 30 patients(given Zopiclone Tablets)with a 4-week treatment phase.Patients were graded on the Pittsburgh Sleep Quality Index(PSQI)and the Chinese medicine symptoms scale before and after treatment,and the data were handled with SPSS.26.0 software.Results: A total of 2 cases were shed due to loss of contact(test group)and self-administration of other sleep aids(control group),29 cases in the test and control groups,separately,for a final total of 58 cases.1.No comparative statistical value of baseline data between the two groups before therapy(P>0.05),which could be compared.2.Comparison of PSQI scores:Both interventions lowered total and individual PSQI scores(P<0.05),and the pilot group could make better reduction in the total PSQI marks,sleep disorders and daytime functions disorders single scores(P<0.05).3.Comparison of TCM syndrome score:Both ways of intervention decreased the total score of TCM indications(P<0.05),and it was more remarkable in the test group(P<0.05);with regard to individual elements(11 items in total),the scores of 7 items,namely,excessive dreaming,abdominal distension,abdominal pain,loose and unpleasant stools,vomiting and nausea,thirst and little drinking,tongue and pulse,were lower in the test group after treatment(P<0.05),and all 11 points decreased in the test group when contrasted within the group(P<0.05),2 scores of sleeping difficulty,nocturnal awakening or early arising dropped in the control group(P<0.05),and the remaining 9 items were not statistically significant(P>0.05).4.Comparative efficacy:In regard to the effective rate of overall sleep improvement(89.7% in the test group and 75.9% in the control group)and the eficiency rate of TCM evidence(86.2% in the test group and 31.0% in the control group),the test group was superior to the control group and the difference was obvious(P<0.05).5.Safety analysis:during this study,58 patients were able to tolerate the drug,no obvious adverse reactions occurred,All normal basic vital signs.Only one case in the control group showed slight giddiness,which was treated under monitoring and later remitted on its own.No abnormalities in test group.Conclusion:1.Overall sleep status can be improved by modified Gegenqinlian Decoction,and it’s superior in addressing sleep difficulties and daytime impairments.2.The modified Gegenqinlian Decoction can effectively improve the TCM syndromes of patients with insomnia of gastrointestinal damp-heat type,and it is better in improving multiple dreams,abdominal distension,abdominal pain,loose stool,vomiting,anorexia,thirst and less drink,tongue and pulse,and its clinical application is relatively safe. |