| Objective:To evaluate the effect of TIP sleep regulating technique on different periods of sleep quality and sleep belief of primary insomnia. Study the difference of TIP sleep regulating technique and zopiclone on sleep quality and sleep belief of primary insomnia. Assess the clinical efficacy of TIP sleep regulating technique in the treatment of primary insomnia.Method:According to the included criteria of the Natural Science Foundation project "the Mechanism Study of Insomnia Treated by Chinese Traditional Chinese Medicine Relaxation Induction Therapy", insomnia patients are enrolled from psychology department and sleep medicine clinic at Guang’An Men Hospital, China academy of Chinese Medical Sciences.45subjects meeting the included criteria in patients with primary insomnia randomly assigned at a2:1ratio to TIP group (n=30) and Zopiclone group (n=15). TIP Group first listen to Wang’s hypnotic music for15minutes, and receive sleep regulation technique of TIP twice per week for30minutes. In addition, they are asked to listen to Wang’s hypnotic music1time before bedtime per night. The whole process lasts for4weeks. Zopiclone group, patients are asked to take zopiclone3.75mg per night30minutes before bedtime. And the maximum dose can be7.5mg according to their condition. The whole process lasts for4weeks. Before and after treatment, Insomnia patients are monitored by polysomnography (PSG) monitor to get the parameters about sleep process and sleep structure from objective way, while using the Pittsburgh Sleep Quality index (PSQI) to assess subjective sleep quality. In addition, Sleep Beliefs questionnaire is used to evaluate the improvement of sleep beliefs in patients with insomnia. After end of treatment,8-week follow-up will be completed with the tools of Pittsburgh Sleep Quality Index (PSQI) and the Sleep Beliefs questionnaire. All the data was analyzed by statistical software SPSS13.0.Result:1. The Pittsburgh Sleep Quality Index (PSQI) evaluationInter group comparison:after treatment, compared to Zopiclone group, TIP group was superior in the sleep latency, sleep time, sleep efficiency, sleep medication and daytime function, total score of PSQI(P<0.05); The follow-up data, compared to zopiclone group, TIP group was significantly superior in the PSQI sleep quality, sleep disturbance, daytime function, the total score (P<0.05); There is significantly difference in hypnotic drugs between groups (P<0.05). No other significant differences were seen (P>0.05). By the chi-square test, there was a significant difference (P<0.05) in effective rate and TIP group is superior to zopiclone group.Inner group comparison:after treatment for one month, TIP group are significantly improved in PSQI sleep quality, sleep latency, sleep time, sleep efficiency, sleep disorders, sleep medication, daytime function, total score (P<0.05); Zopiclone group was significantly improved in the PSQI sleep quality, sleep latency (P<0.05); No other significant changes were seen (P>0.05). Both groups have no differences between the end of treatment and8-week follow-up(P<0.05).2. The Polysomnogram (PSG) evaluationInter group comparison:after treatment, there is no significant difference in PSG sleep process and sleep structure of the indicators between two groups(P>0.05).Inner group comparison:after treatment, TIP group sleep efficiency have significantly improved(P<0.05), S2%is significantly decreased (P<0.05), there is a significant increase in SWS sleep time (P<0.05), no other significant differences were seen(P>0.05); zopiclone group has no significant differences in the PSG (P>0.05).3. Sleep Beliefs questionnaireInter group comparison:after treatment, compared to zopiclone group, TIP group were improved significantly in items of difficulty falling asleep, early awakening, environmental interference, daytime function and total score(P<0.05). The data of follow-up, compared to zopiclone group, TIP group improved significantly in items of difficulty falling asleep (P<0.05). No other significant difference was seen (P>0.05).Inner group comparison:after treatment, TIP group improved significantly in items of difficulty falling asleep, half-way easy to wake up, wake up early, environmental interference, daytime function, more than a dream or a nightmare and total score (P<0.05); zopiclone group improved significantly in items of difficulty falling asleep, sleep confidence questionnaire, half-way easy to wake up have a significant improvement (P<0.05). Both the groups has no significant differences between the end data and follow-up data (P>0.05).Conclusion:1. Sleep regulation technique of TIP can reduce sleep latency, increase sleep time.; improve sleep quality, improve sleep efficiency, improve daytime function and reduce the dependence of the hypnotic drug. Zopiclone group can reduce sleep latency, improve sleep quality. Compared to zopiclone group, TIP Sleep Regulation Technique is superior in shortening sleep latency, increasing sleep time, improving daytime function, decreasing hypnotic drug. Compared to zopiclone group, TIP has a more stable long-term efficacy in sleep quality, sleep disorders and day function. The result suggests that TIP sleep regulating technique is effective, long-lasting and stable.2. Before and after treatment, sleep regulation technique of TIP can improve the PSG sleep efficiency and increase SWS sleep time, reduce S2sleep time. And Zopiclone group has no significant changes in PSG. The results suggest Sleep regulation technique of TIP can not only improve subjective sleep quality, also can be useful for altering objective sleep indicators.3. Sleep regulation technique of TIP can strengthen sleep belief by reducing difficulty falling asleep, half-way easy to wake up, wake up early, environmental interference, daytime state, dream or nightmare. And zopiclone group improves sleep belief by reducing difficulty in falling asleep, half-way easy to wake up. The result suggests sleep regulation technique of TIP is advanced in reducing difficulty falling asleep, early awakening, and environmental interference, daytime state than zopiclone group. 4. Research confirms TIP Sleep Regulation Technique and Zopiclone in the treatment of primary insomnia are effective.Compared to Zopiclone group, TIP Sleep Regulation Technique is superior in the clinical efficacy of the treatment of primary insomnia.5. Our study provides evidence for the efficacy of sleep regulation technique of TIP for primary insomnia. Because of some limitations of the current study, further studies are necessary to verify the result. |
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