| Objective:To evaluate the effectiveness and safety of rhizoma coptidis adhesivegelatin capsule’s therapeutic action in the chronic insomnia (fire excessfrom yin deficiency) which be induced by anxiety disorder. Furthermore,the optimum dose of rhizoma coptidis adhesive gelatin capsule had beenexperimented simultaneously.Method:Adopt two methods to prove the purpose, random experiment anddouble-blind experiment.Randomly assign72patients with chronicinsomnia (fire excess from yin deficiency) whom come from clinic medicalrecord (October2012–September2013) to3groups. The patients in thefirst group and the second group had been cured by rhizoma coptidisadhesive gelatin capsule and simulation of rhizoma coptidis adhesivegelatin capsule used to cure the third group patients. The watch was8weeksand the basic medicine was paroxetine.Three groups’ Pittsburg sleep qualityindex (PSQI), sleep day, Insomnia Severity Index and Chinese medicinesymptom complex score before and after treatment had been compared. Inaddition, observe the symptoms and signs of patients who also haddysphoria in chestpalms-soles and the effect of the medicine.Results:72patients had been divided into3groups of24people each. Therewere differences in age, gender and course of disease etc. between groups.The treatment of six aspects index results are as follows.1.CLINICAL EFFECT:The clinical efficacy of total effective rate:The first group:91.7%Thesecond group:83.3%.The third group:62.5%.Statistical analysis hadsignificant difference (p<0.05). It means that the medicine of all groups can cure the chronic insomnia (fire excess from yin deficiency) which beinduced by anxiety disorder. Compare curative effect of all groups, the bestone was the first group then was the second and the last one was the thirdgroup.2.TCM SYNDROME:The clinical efficacy of total effective rate:The first group:91.6%;Thesecond group:79.4%;The third group:47.6%Statistical analysis hadsignificant difference (p<0.05). The therapy of all groups can improve thesyndromes. The curative effect of the first group was better than the thirdone. But compare with the second group, the effect had no significantdifference.3.PITTSBURGH SLEEP QUALITY INDEX (PSQI):After treatment, statistical analysis had significant difference (p<0.05).It means that the medicine of all groups had certain curative effect.Compare between two groups, the first group with the third group and thesecond group with the third group, the PSQI of the first and second groupwas higher than the third group. It means that rhizoma coptidis adhesivegelatin capsule can improve the PSQI. Furthermore, there was no significantdifferent between the first group and the second group.4.SLEEP DIARY CARD:All groups had effective on the decrease of wakeup’s frequency, the increase of nocturnal sleep time and the decrease ofsleep time. Compare all groups, the first group was the best one then wasthe second one and the last one was the third group.5. THE IMPROVEMENT OF INSOMNIA SEVERITY INDEX:On this part, three groups all have curative effect. The morbidity ofthird group’s patients compared with other two groups no significantdifferent before treatment. But after treatment, improvement of insomniaseverity indexes had significant difference (p<0.05). The first group and thesecond group were better than the third group, but there were no significantdifferent between the first one and the second one (p>0.5).6, DYSPHORIA IN CHESTPALMS-SOLES:Though the observation of selected patients with dysphoria inchestpalms-soles, found that heart vexed hot normally appear ed palm hot inclinical. However, Palm hot did not necessarily appeared heart vexed hot. Before treatment, there was no significant different between all groups (p-value>0.05). However, after therapy, the first group and the second group were better than the third group (p-value<0.05). Therefore, the experiment shown that rhizoma coptidis adhesive gelatin capsule is useful to improve symptom of dysphoria in chestpalms-soles.Conclusion:The experimental results shown that the rhizoma coptidis adhesive gelatin capsule can ease the chronic insomnia (fire excess from yin deficiency) which be induced by anxiety disorder. It can improve patients’ Pittsburgh sleep quality index (PSQI), decrease TCM syndromes, reduce the sleep lightly, increase sleep time. In addition, the effective of high-dose group were better than the lose-dose group. If patient who is with chronic insomnia (fire excess from yin deficiency) which be induced by anxiety disorder had mind annoying fever, normally the patient will appear palm hot. However, Palm hot did not necessarily appeared heart vexed hot. Rhizoma coptidis adhesive gelatin capsule is useful to improve symptom of dysphoria in chestpalms-soles. Furthermore, rhizoma coptidis adhesive gelatin capsule is safe for the treatment of chronic insomnia (fire excess from yin deficiency) which be induced by anxiety disorder. |
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