| Objective:To observe the clinical efficacy of the treatment of chronic insomnia disorder of Yin-deficiency and fire-hyperactivity type by the method of counterpoising yin and yang according to chronomedicine of TCM and provide a better treatment for chronic insomnia disorder.Methods:A total of ninety cases of patients with chronic insomnia disorder diagnosed with Yin-deficiency and fire-hyperactivity syndrome were selected from January 2019 to December 2019 in the outpatient department of Changzhou TCM hospital.The random number remainder method was used to divide the patients into three groups:western medicine group,routine time group and special time group,every group included thirty patients.The western medicine group was given estazolam lmg orally at(21:00?22:00)every night before sleep,the routine time group was given jiaweibaihedihuang decoction 150ml orally after breakfast(07:00?08:00)and anshen prescription 150ml orally after dinner(18:00?19:00),and the special time group was given jiaweibaihedihuang decoction orally at youshi(17:00?19:00)and anshen prescription orally at haishi(21:00?23:00),the course of treatment was four weeks.Safety indicators and adverse reactions were observed during treatment.After treatment,each item score and total score of Pittsburgh Sleep Quality Index(PSQI)of every group were compared with the score before treatments and among the three groups to evaluate improvement of sleep quality.Total score and Single score of TCM syndrome of every group was compared with the score before treatments and compared among the three groups to evaluate the improvement of symptoms.The eflfective rate of every group was compared to evaluate the therapeutic effect of TCM among the three groups.Results:Before treatment,there were no significant differences anomg the three groups at each item score of PSQI,total score of PSQI,TCM syndrome score and Single TCM syndrome score(P>0.05),which means the three groups were comparable(hypnotic drugs were the intervention measures in this experiment,and each group had the same score,so the score of hypnotic was not included in single item comparison,but was included in the comparison of total score of PSQI).No obvious abnornality and no adverse reactions were found in the safety index during the treatment.After treatment,each item score of PSQI and the total score of PSQI of each group was lower than before(P<0.05).The scores of six items were separately compared in pairs between groups.There was no significant difference in sleep quality,hours of sleep,sleep efficiency and sleep disorder items among the three groups(P>0.05).There was significant difference in sleep time and daytime function items among the three groups(P<0.05).The score of sleep time of special time group and western medicine group were lower than routine time group group(P<0.05),there was no significant difference between special time group and western medicine group.The score of daytime function of special time group and routine time group were lower than western medicine group(P<0.05),and special time group was lower than routine time group(P<0.05).There was no significant difference in total score of PSQI among the three groups(P>0.05).Total score and single score of TCM syndrome of every group was lower than before(P<0.05).Total score of TCM syndrome of special time group and routine time group were lower than western medicine group(P<0.05),and special time group was lower than routine time group(P<0.05).In the Single TCM syndrome score comparison,the score of cardinal symptom of western medicine group were lower than the score before treatment(P<0.05).Only two single TCM syndrome score of secondary symptoms were lower than the score before treatment,which were feverishness in palms and soles and night sweat(P<0.05),the restless was not(P>0.05).All the Single TCM syndrome score of routine time group and special time group were lower than before treatment(P>0.05).There was no significant difference in the score of trouble falling asleep between the special time group and western medicine group(P>0.05),both of them were lower than routine time group(P<0.05)·There was no significant difference in the score of shallow sleep between the routine time group and special time group(P>0.05),both of them were lower than western medicine group(P<0.05).There was no significant difference in the score of waking all night among three groups(P>0.05).There was no significant difference in the score of feverishness in palms,night sweat,thirst and tinnitus forgetful between the routine time group and special time group(P>0.05),both of them were lower than western medicine group(P<0.05).the score of soreness of waist and spermatorrhea and palpitate of the routine time group and special time group were lower than western medicine group(P<0.05),and special time group was lower than routine time group.Pairwise comparison between groups showed that both the effective rate of 90%in the special time group and that of 76.67%in the routine time group were higher than 46.67%in the western medicine group(P<0.05),and the effective rate of 90%in the special time group was higher than that of 76.67%in the routine time group(P<0.05).Research conclusions:Jiaweibaihedihuang decoction and anshen prescription can reduce each item score of PSQI,the total score of PSQI,total score of TCM syndrome and single TCM syndrome score,and improve sleep quality,symptoms of Yin-deficiency and Fire-hyperactivity,and the effect is exact.Chosing proper time of taking medicine according to the method of counterpoising yin and yang according to chronomedicine of TCM can shorten sleep time,improve daytime function and improve TCM syndrome,which is better than routine time of taking medicine.Jiaweibaihedihuang decoction and anshen prescription was safe for clinic.All in all,the clinical efficacy of the treatment of chronic insomnia disorder of Yin-deficiency and fire-hyperactivity type by the method of counterpoising yin and yang according to chronomedicine of TCM is remarkable and safe. |
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