| ObjectiveTo evaluate the clinical therapeutic effect of "strong or weak stimulation" acupuncture treatment for liver fire type primary insomnia from the aspects of the Pittsburgh sleep quality index,TCM syndrome,anxiety and depression,average amount of insomnia drugs and life quality,so as to’ further verify the importance and necessity of stimulation amount in acupuncture treatment.Methods1.Grouping and blinding method:A total of 66 cases of patients with primary insomnia of fire derived from stagnation of liver-Qi type who meet the inclusion criteria were included.Random digits table was applied to allocate them into 4"strong stimulation"group(33 cases)and "weak stimulation" group(33 cases).The subjects,efficacy evaluators and statistical analyzers were blind to treatment allocation.2.Acupoint selection:Both groups were applied with the following acupoints:Sishencong(EX-HN1),Shenmen(HT7),Sanyinjiao(SP6),Shenmai(BL62),Zhaohai(K16),Xingjian(LR2)and Xia Xi(GB43).3.Manipulation method:Subjects were led to supine position and then sterilized the skin around the acupoints.1)The strong stimulation group:Sishencong were penetrated toward Baihui,needling through aponeurosis with 0.5 inch in depth,making a 150 degree between the body of the needle and the scalp.Sanyinjiao was needled 1.2 inch in depth,Shenmen,Shenmai,Zhaohai,Xingjian,Xia Xi were all needled with 0.5 inch in depth.After obtaining Deqi response in each acupoint,twisting and reducing method in 360° angle was applied for about 10 seconds,with frequency of 120-160 times per minute.Manipulation was applied every 10 minutes and the needles were retained for 30 minutes.2)The weak stimulation group:Sishencong were penetrated toward Baihui,needling through aponeurosis with 0.2 inch in depth,making a 15° degree between the body of the needle and the scalp.Sanyinjiao,Shenmen,Shenmai,Zhaohai,Xingjian and Xia Xi was all needled with 0.2 inch in depth.After obtaining Deqi response in each acupoint,no manipulation was applied and the needles were retained for 30 minutes.4.Course of treatment and follow-up:Both groups of patients were treated in the afternoon,treatment was proceeded once a day in the first week,continuous treating for 5 days,and then rest for 2 days.In the second to the fourth week,we treated the patients every other day for 3 times in one week.The treatment included four weeks(a total of 14 times)with a follow-up of 2 months.5.Curative effect index:1)The main outcome measure was the Pittsburgh Sleep Quality Index Scale(PSQI).2)The secondary outcome measures were the Self-rating Anxiety Scale(SAS),Self-rating Depression Scale(SDS),TCM syndrome scale,average amount of insomnia drugs and The MOS 36-item Short Form Health Survey(SF-36).6.Observation point:Recorded the score of PSQI,SAS,SDS,TCM syndrome scale and the average amount of insomnia drugs on the last day of the 0th,1th,2th,3th,4th,8th and the 12th week.Also,recorded the score of SF-36 on the last day of the 0th and the 4th week.Results1.PSQIIn the first week of treatment,compared with baseline period,all scores of both groups were reduced.There were significant statistical differences of SQ,SL,ST,SE,SD,HD,DF and TS(P≤0.01)in the strong stimulation group.However,there were statistical differences of SQ,SL,ST,SE and TS(P<0.05)and no significant statistical differences of SD,HD and DF(P>0.05)in the weak stimulation group.When comparing to each other,all the scores of the strong stimulation group were lower than the weak stimulation group with statistical differences in SQ,SL,ST,SE,SD,DF and TS(P<0.05)and no statistical differences in HD(P>0.05).In the fourth week of treatment,compared with baseline period,all scores of both groups were reduced,there were significant statistical differences of SQ,SL,ST,SE,SD,HD,DF and TS(P<0.01)in the strong stimulation group.However,there were statistical differences of SQ,SL,ST,SE,SD,DF and TS(P<0.05)and no satistical differences of HD(P>0.05)in the weak stimulation group.When comparing to each other,all the scores of the strong stimulation group were lower than the weak stimulation group with statistical differences in SQ,SL,ST,SE,SD and TS(P≤0.05)and no statistical differences in HD and DF(P>0.05).In the first follow-up,compared with baseline period,all scores of both groups were reduced,there were statistical differences of SQ,SL,ST,SE,SD,DF and TS(P≤0.05)and no statistical differences of HD(P>0.05)in the strong stimulation group;there were significant statistical differences of SQ,SL,ST,SE,SD and TS(P<0.01),however,there were no statistical differences of HD and DF(P>0.05)in the weak stimulation group.In the first follow-up,compared with the fourth week,the SD score in the strong stimulation group were the same as each other and the other scores of the both groups were increased.There were statistical differences of SQ,SL,ST,SE,HD and TS(P<0.05)and no statistical differences of SD,DF(P>0.05)in the strong stimulation group.There were statistical differences of SQ,ST,SE,DF and TS(P<0.05)and no statistical differences of SL,SD and HD(P>0.05)in the weak stimulation group.When comparing to each other in the first follow-up,all the scores of the strong stimulation group were lower than the weak stimulation group with statistical differences in SQ,SL,ST,SE,SD,DF and TS(P<0.05)and no statistical differences in HD(P>0.05).In the second follow-up,compared with the baseline period,all scores of the both groups were reduced,the results of the the strong stimulation group was the same as the-first follow-up;there were significant statistical differences in SQ,ST,SE,SD and TS(P<0.01)and no statistical differences of SL,HD and DF(P>0.05)in the weak stimulation group.In the second follow-up,compared with the fourth week,all scores of the both groups were increased,there were statistical differences of SQ,SL,ST,SE,HD,DF and TS(P<0.05)and no statistical differences of SD(P>0.05)in the strong stimulation group.There were statistical differences of SQ,SL,ST,SE,DF and TS(P<0.05)and no statistical differences of SD and HD(P>0.05)in the weak stimulation group.When comparing to each other in the second follow-up,the results were the same as the first follow-up.In the second follow-up,compared with the first follow-up,the SD and HD score in the weak stimulation group were the same as each other and the other scores of the both groups were increased.There were statistical differences of SQ,ST,SE,DF and TS(P<0.05)and no statistical differences of SL,SD,HD(P>0.05)in the strong stimulation group.There were statistical differences of SL,ST,SE,DF and TS(P<0.05)and no statistical differences of SQ,SD,HD(P>0.05)in the weak stimulation group.2.TCM SyndromeIn the first week,compared with the baseline period,all scores of the both groups were reduced with significant statistical differences(P<0.01).When comparing to each group in the first week,all scores of the strong stimulation group were lower than the weak stimulation group with statistical differences(P<0.05).The results of the second week,the third week and the fourth week were the same as the first week.In the first follow-up,compared with the baseline period,all scores of the both groups were reduced with significant statistical differences(P<0.01).In the first follow-up,compared with the fourth week,all scores of the both groups were increased and there were significant statistical differences in the weak stimulation group(P<0.01)and no statistical differences(P<0.05)in the strong stimulation group.In the second follow-up,compared with the baseline period,all scores of the both groups were reduced with significant statistical differences(P<0.01).In the second follow-up,compared with the fourth week,all scores of the both groups were increased with statistical differences(P<0.05).In the second follow-up,compared with the first follow-up,all scores of the both groups were increased with significant statistical differences(P<0.01).When respectively comparing to each group in the first follow-up and the second follow-up,all the scores of the strong stimulation group were lower than the weak stimulation group with significant statistical differences(P<0.01).3.SDS and SASIn the first week,compared with the baseline period,both SDS and SAS scores of the two groups were reduced with significant statistical differences(P<0.01).When comparing to each group in the first week,all scores of the strong stimulation group were lower than the weak stimulation group with statistical differences(P<0.05).When comparing to each group in the fourth week,all scores of the strong stimulation group were lower than the weak stimulation group with statistical differences(P<0.05)in SDS scores and no statistical differences(P>0.05)in SAS scores.In the first follow-up,compared with the baseline period,both SDS and SAS scores of the two groups were reduced with significant statistical differences(P<0.01).In the first follow-up,compared with the fourth week,both SDS and SAS scores of the strong stimulation group were reduced with no statistical differences(P>0.05)and both SDS and SAS scores of the weak stimulation group were increased with significant statistical differences(P<0.01).In the second follow-up,compared with the baseline period,both SDS and SAS scores of the two groups were reduced with significant statistical differences(P<0.01).In the second follow-up,compared with the fourth week,both SDS and SAS scores of the strong stimulation group were reduced with no statistical differences(P>0.05)and both SDS and SAS scores of the weak stimulation group were increased with significant statistical differences(P<0.01).In the second follow-up,compared with the first follow-up,both SDS and SAS scores of the strong stimulation group were reduced with no statistical differences(P>0.05)and both SDS and SAS scores of the weak stimulation group were increased with statistical differences(P<0.05).When respectively comparing to each group in the first follow-up and the second follow-up,all the SDS and SAS scores of the strong stimulation group were lower than the weak stimulation group with significant statistical differences(P<0.01)in SDS scores and no statistical differences(P>0.05)in SAS scores.4.Average Amount of Insomnia DrugsIn the first week,compared with the baseline period,average amount of insomnia drugs of the both groups were reduced with significant statistical difference(P<0.01)in the strong stimulation group and no statistical differences(P>0.05)in the weak stimulation group.This effect was strengthened with the increasing of acupuncture treatments,and it lasted for 4 weeks.When respectively comparing to each group in the first week and the fourth week,both scores of the strong stimulation group were lower than the weak stimulation group with no statistical differences(P>0.05).In the first follow-up,compared with the baseline period,average amount of insomnia drugs of the both groups were reduced with significant statistical difference(P<0.01).In the first follow-up,compared with the fourth week,average amount of insomnia drugs of the both groups were increased with statistical difference(P<0.05).In the second follow-up,compared with the baseline period,average amount of insomnia drugs of the both groups were reduced with significant statistical difference(P<0.01).In the second follow-up,compared with the fourth week,average amount of insomnia drugs of the both groups were increased with statistical difference(P<0.05).In the second follow-up,compared with the first follow-up,the score of the strong stimulation group had no change and the score of the weak stimulation group increased,while,both had no statistical differences(P>0.05).When respectively comparing to each group in the first follow-up and the second follow-up,both of the strong stimulation group scores were lower than the weak stimulation group with no statistical differences(P>0.05).5.SF-36In the fourth week of treatment,compared with baseline period,all scores of both groups were increased.There were significant statistical differences of PF,RP,BP,GH,VT,SF,RE,MH,HT and total score(P<0.01)in the strong stimulation group,however,there were significant statistical differences of PF,RP,GH,VT,SF,RE,MH,HT and total score(P<0.01)and no statistical differences of BP(P>0.05)in the weak stimulation group.When comparing to each other in the fourth week,all scores of the strong stimulation group were higher than the weak stimulation group with statistical differences in BP(P<0.05)and no statistical differences in PF,RP,GH,VT,SF,RE,MH,HT and total score(P>0.05).Conclusion1.The method of "strong stimulation" and "weak stimulation" are both effective for liver fire type primary insomnia,which mainly reflect in ameliorating the sleeping status,improving depression and anxiety status and TCM syndrome,reducing insomnia medication and improving the life quality of the patients.With the increasing of the times of acupuncture treatment,the curative effect of the two groups are gradually strengthened.In each treatment stage,the effect of the "strong stimulation" group in every aspect above is better than that of the "weak stimulation" group.2.Both of the "strong stimulation" group and the "weak stimulation" group have certain long-term curative effect in the above-mentioned aspects.The curative effect of both groups are reduced to a certain extent over time,while the long-term curative effect of "strong stimulation" group is better than that of the "weak stimulation" group,and the differences can last for 12 weeks.3."Strong stimulation" acupuncture treatment shows rapid onset and long-time sustained efficacy,as well as good safety without serious adverse reaction in treating primary insomnia.4.Mastering the appropriate amount of stimulation for the treatment of liver fire type primary insomnia has important significance. |
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