| ObjectiveTo evaluate clinical effectiveness of different acupuncture manipulation in treating liver fire type of perimenopausal sleep disorders from multiple aspects and time,so as to further verify the importance of reinforcing and reducing method in different levels and acupuncture manipulation in acupuncture therapy.MethodsSubjects were perimenopausal sleep disorders patients recruited from Guangdong Provincial Hospital of TCM.According to proportion of 1:1:1,99 subjects who met the inclusion criteria were randomly divided into three groups:group 1(strong manipulate stimulation),group 2(weak manipulate stimulation)and group 3(no acupuncture manipulation),with 33 subjects in each group.Group 1:Used disposable sterile needle for the therapy(0.20×25mm).Selected acupoints as follows:Sishencong(EX-HN1),Anmian,Shenmen(HT7),Guanyuan(CV4),Sanyinjiao(SP6),Zulinqi(GB41)and Taichong(LR3).After obtaining Deqi response in each acupoint,used mild reinforcing-reducing method at CV4 and SP6,and used reducing method with twisting needle in 360° angle for about 10s,and frequency 120 times per minute at others.Manipulation was applied every 10min until needle retaining time reached 30min,same as other two groups.Group 2:Selected same acupoints as Group 1.After obtaining Deqi response in each acupoint,used mild reinforcing-reducing method at CV4 and SP6,and used reducing method with twisting needle in 180°angle for about 10s,and frequency of 90 times per minute at others.Group 3:Selected same acupoints as other two groups,but used no manipulation after acupuncture.All groups of subjects were treated every other day for 3 times a week,continuous treating for 4 weeks,with a follow-up for 1 month.Recorded PSQI scores,Kupperman scores,TCM symptoms scores,Spitzer scores etc.in the beginning,2nd,4th and 8th week.Results1.Baseline characteristics and all curative effect index of three groups had no significant difference(P>0.05)before treatment,which could be considered as comparable.2.PSQI scores:Compared with the baseline period,scores of three groups at all time-points were reduced significantly(P<0.05).When comparing to each other,scores of group 1 had significant differences with other two groups at all time-points(P<0.05),while scores of group 2 had significant differences(P<0.05)with group 3 in the 4th,8th week but none(P>0.05)in the 2nd week.It suggested that in term of PSQI scores,both group 1 and group 2 were better than group 3,but group 1 had faster effectiveness and was more stable in long-term effect.3.Kupperman scores:Compared with the baseline period,scores of three groups at all time-points were reduced significantly(P<0.05).When comparing to each other,in the 2nd week,there were significant differences between group 1 and group 3(P<0.05),but no significant difference between group 1 and group 2,group 2 and group 3(P>0.05).In the 4th and the 8th week,scores of group 1 had significant differences with other two groups(P<0.05),while scores of group 2 had significant differences(P<0.05)with group 3 in the 4th week but none(P>0.05)in the 8th week.It suggested that in term of Kupperman scores,both group 1 and group 2 were better than group 3,but group 1 was more stable in long-term effect.4.TCM symptoms scores:Compared with the baseline period,scores of three groups at all time-points were reduced significantly(P<0.05).When comparing to each other,in the 2nd week and the 4th week,there were significant differences between group 1 and group 3,group 2 and group 3(P<0.05),but no significant difference between group 1 and group 2(P>0.05).In the 8th week,the pairwise comparison of three groups all showed significant differences(P<0.05).It suggested that in term of TCM symptoms scores,both group 1 and group 2 were better than group 3,but group 1 was similar to group 2.5.Spitzer scores:Compared with the baseline period,scores of three groups in the 4th week were increased significantly(P<0.05).When comparing to each other,there was no significant difference among 3 groups in the 4th week(P>0.05).It suggested that in term of Spitzer scores,3 groups were similar to each other.6.Overall effectiveness:After treatment,the total effective rates of three groups were 93.33%,80.00%and 76.67%respectively.It suggested that in term of overall effectiveness,group 1 was better than other two groups,while group 2 was similar to group 3.7.Adverse event:There were a few cases of local pain or bleeding at the acupoints after acupuncture,but no other adverse events or serious adverse events occurred.ConclusionIn this study,the strong manipulate stimulation had significant advantage in the treatment for liver-fire type of perimenopausal sleep disorders,in terms of sleep quality,perimenopausal symptoms,life quality and TCM symptoms,with high safety with few adverse events.Besides,the strong manipulate stimulation group also showed better effectiveness than the weak and no manipulation group,which is worth to further promotion in clinical use. |