| Objective: To evaluate the effectiveness and safety of Shuyu Ningxin prescription in the treatment of perimenopausal insomnia of liver stagnation and fire type,and provide reference for clinical diagnosis and treatment in the future.Methods: We selected 70 patients with insomnia in perimenopause in Shijiazhuang Hospital of Traditional Chinese Medicine.The sufferers were splited into two groups: treatment group 35 cases: Shuyu Ningxin prescription provided by the decocting room of Shijiazhuang Hospital of Traditional Chinese Medicine 2 times a day,200 ml each time,warm after breakfast and dinner,for a course of 4 weeks;In the control group(n= 35):Estezolam was taken orally,1 tablet/time,once a day,half an hour before going to bed.The course of treatment is four weeks.Four weeks later,the scores of Pittsburgh Sleep Quality Score(PSQI),TCM Syndrome Scale(TCM),modified Kupperman,serum sex hormone level and safety index were observed and compared,To analyze the clinical efficacy and safety of Shuyu Ningxin prescription in the treatment of perimenopausal insomnia.Results: 34 patients were accomplished this research of the treatment group,while 33 patients of another group also were achieved this research.After 4 weeks of observation and study,the following results were obtained:(1)Evaluation of sleep efficacy: according to the PSQI score reduction rate,the total effective treatment group and the control group were not significantly different(82.35% vs 75.76%),not statistically significant(P>0.05).(2)PSQI score: After treatment,the total score of PSQI and the scores of each factor showed a decrease in both groups compared with before treatment,with statistical significance(P<0.05);with no significant difference between groups(P>0.05).(3)Evaluation of the efficacy of TCM syndromes: the total effective rate of the treatment group was better than that of the control group(91.18% VS 66.67%),with significant difference(P<0.05).(4)Score of TCM Syndrome Scale: According to the total score of TCM Syndrome,after treatment,compared within the group,both groups have decreased(P<0.05),and both groups have a certain effect in improving TCM syndromes;between groups In comparison,the total score of TCM symptoms in the treatment group was lower than that in the control group(P<0.05).The scores of symptoms in the treatment group decreased significantly after treatment(P<0.01);the control group did not improve significantly in terms of tinnitus and constipation(P>0.05),and the remaining symptoms improved significantly(P<0.05);after treatment,the two groups had the same effect in terms of sleep restlessness(P>0.05),and the remaining symptoms in the treatment group were lower than those in the control group(P<0.01).(5)Results of modified Kupperman: The total score of modified Kupperman decreased in different degrees after treatment in the two groups(P<0.05),and the decrease was more obvious in the treatment group after treatment than in the control group(P<0.05).The treatment group was better than the control group in improving symptoms related to perimenopausal period.Look from various symptoms improved Kupperman integral,within two way after treatment,the treatment group in sweat hot flashes,insomnia,anxiety,depression,dizziness,fatigue weakness,headache,heart palpitations,skin formication,degree of sexual life,the respect such as urinary tract infections fall big(P<0.05),there was no statistically significant difference yu symptom scores(P>0.05);The control group decreased significantly(P<0.05)in insomnia,restlessness,fatigue,headache;and there was no significant difference in residual symptom score(P<0.05).The scores of the treatment group were lower than those of the control group after treatment,with significantly in flashes,sweating,anxiety,depression,vertigo(P<0.05).But the others were not statistically significant(P>0.05).(6)Hormone levels: There was no significant difference in serum E2,LH and FSH of the two groups after treatment(P>0.05).(7)Safety evaluation: During the treatment,the treatment group did not see obvious symptoms of discomfort,the control group of 4 patients appeared mild dry mouth,drowsiness,fatigue and other phenomena.Conclusion:(1)Shuyu Ningxin Decoction can obviously improve the sleep condition,TCM syndromes and peri-menopausal symptoms of the patients with perimenopausal insomnia of liver depression and fire type,and the curative effect is remarkable.(2)In the treatment process,no negative consequences appeard in the Shuyu Ningxin Formula group,which is safe and effective,and has clinical promotion value.(3)The regulation of Shuyu Ningxin prescription on hormone level in perimenopausal period still needs further study,and more evidence-based evidence is needed in clinical practice. |
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