| ObjectiveTo know the basic characteristics of insomnia in Guangzhou and surrounding areas,and compare it with CBT-i with standard treatment of insomnia,from clinical features,sleep and physical fitness related assessment scales,polysomnography(PSG),etc.The dimensionality evaluation of Shuxin Anshen ointment in the treatment of chronic insomnia,the clinical efficacy,and its effect on the patient’s emotional state and quality of life,provide a basis for further clinical application of Shuxinanshen ointment.MethodThe subjects of chronic insomnia were studied using non-randomized controlled trials.The sample size was used to estimate 116 patients in each group.The experimental group was treated with Shuxin Anshen cream orally,and the control group was given standard insomnia cognitive behavioral therapy.The treatment course was 2 months and followed up for 1 month.Subjective evaluation was performed using the PSQI,PHQ-9,GAD-7,Insomnia TCM Quality of Life Scale,and clinical efficacy evaluation.Based on the objective parameters of the PSG as objective criteria,the sleep perception parameters of the Shuxin Anshen ointment treatment group and the cognitive behavioral treatment group were evaluated,including sleep latency,sleep efficiency,sleep maintenance time,sleep time,number of wakefulness,and number of wakefulness.,Oxygen concentration,heart rate,duration and proportion of sleep in each period,apnea hypopnea index,limb movement and so on.Result1.Both the ointment group and the CBT-i group had a significant effect in reducing the subjective sleep latency.From the end of the first month of treatment,the latency to sleep in the two groups was significantly shortened,and the shortened time was similar.At the end of the second month of treatment,the sleep latency of the two groups continued.Significantly less than before,and the CBT-i group was superior to the cream group.The subjective sleep latency of both groups was still lower than that of the previous month at the end of March,suggesting that both have better long-term efficacy.From the point of subjective sleep latency,both the ointment group and the CBT-i group can reduce the latency to sleep and have a stable therapeutic effect,and the CBT-i group is superior to the ointment group.2.The subjective sleep maintenance time was evaluated at the observation sites in both the ointment group and the CBT-i group.The two groups had significant improvements at the end of January and the end of February,and the subjective sleep maintenance time at the end of March was still higher than at the end of February.However,the difference was not significant,and there was no significant difference in subjective sleep maintenance between the two groups at each observation time point.It is suggested that both treatment methods have an improvement on subjective sleep maintenance and the efficacy is stable,and there is no significant difference in the efficacy of the two treatments.3.The two groups had a similar improvement in subjective sleep efficiency than subjective sleep maintenance,and also had significant improvement in efficacy at the end of January and the end of February.At the end of March,the improvement was still better than at the end of February,but the difference was not significant.There was no significant difference in the subjective sleep efficiency between the two groups at each observation time point.It is suggested that both treatment methods can significantly improve the subjective sleep efficiency,and the efficacy is stable,and there is no significant difference in the efficacy of the two.4.PSQI included sleep quality,sleep time,total sleep time,sleep efficiency,sleep disturbances,sleep aids,and daytime function scores.All factor scores decreased significantly after treatment.Among them,the improvement of the sleep quality score was most obvious.There was a significant decrease at the end of January,at the end of February,and at the follow-up period of the treatment,suggesting that the short-term and long-term effects of the two treatments on sleep quality are very impressive.There is no significant difference at this point in time.Sleep time,total sleep time,sleep efficiency,sleep disorders,sleep aids,and daytime functional factors scored significantly better at the end of January than at the end of treatment.At the end of the second month of treatment and at the follow-up period,the score was lower than before,but it was not significant..The sleep time score CBT-i group was better than the cream group at the end of the second month of treatment and the follow-up period.There was no significant difference in the other items at each observation time point.5.The total PSQI scores in the ointment group and CBT-i group improved significantly after treatment.Both groups showed significant reductions at the end of January and the end of February.Although the score at the end of March was reduced,the difference was not significant compared with before,and there was no significant difference in the total PSQI score between the two groups.It is suggested that the two treatment methods have a reduced effect on the total PSQI score and the effect is stable,and there is no significant difference in the efficacy of the two.6.The scores of the two groups on the emotion-related score scales(PHQ-9,GAD-7)were similar to those of the PSQI scores,and the scores of the PHQ-9 and GAD-7 groups were significantly different between the two groups at the end of January and the end of February.Although the scores decreased at the end of March,the difference was not significant.The PHQ-9 and GAD-7 scores of the two groups were not significantly different at each observation time point.It is suggested that these two treatment methods have an improvement effect on the scores of PHQ-9 and GAD-7,and the effect is stable.There is no significant difference between the two groups of efficacy.7.The changes in scores of TCM quality of life scales for insomnia in the ointment group and the CBT-i group were significantly improved at the end of January compared with before treatment.Although the scores at the end of February and at the follow-up period were lower than before,the changes were not significant.There was no significant difference between the groups at each time point.8.The Shuxin Anshen cream group had significant differences in the objective sleep latency,sleep efficiency,duration of awakeness,and improvement in wakefulness after sleep.There was no significant difference before and after the rest of treatment.The CBT-i group had significant improvement in objective sleep latency,sleep efficiency,and N3 latency,and there was no significant difference before and after the rest of the treatment.In the comparison between groups,after treatment,the duration of N1 stage and the proportion of N1 in total sleep in the CBT-i group were smaller than those in the Shuxin Anshen ointment group,and there was a significant difference,suggesting that the proportion of light sleep was small and there was no significant difference in the rest.ConclusionShuxin Anshen cream has obviously improved the subjective and objective sleep quality of chronic insomnia,and it is particularly prominent for daytime functional improvement compared with Western medicine treatment.There was a significant improvement in anxiety and depression,and the efficacy was comparable to that of cognitive-behavioral treatment.Shuxin Anshen cream is highly available in terms of treatment availability and cost-effectiveness,and has clinical significance. |
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