| ObjectiveThis study evaluates the clinical efficacy of Ling Gui Ba Fa combined with Wen Tong method in the treatment of primary insomnia of deficiency of both Heart and Spleen through Pittsburgh sleep quality index,degree of excessive awakening,TCM syndromes,anxiety emotion and quality of life,and explores the clinical application of Ling Gui Ba Fa combined with fire needle in acupuncture and moxibustion.Methods1.Grouping and blinding method:The randomized,single-blind,controlling clinical study design was adopted in this study.Patients with primary insomnia of deficiency of both heart and spleen were selected and randomly numbered into treatment group and controlled group according to the ratio of 1:1.Blindness was administered to statisticians and efficacy assessors.2.Treatment group:acupoint selection:(1)Ling Gui Ba Fa:according to the clinic visiting time,finding out the main acupoints opened at that time,and their upper and lower matching acupoints Zulinqi matching with Waiguan,Shengmai matching with Houxi,Gongsun matching with Neiguan,Zhaohai matching with Lieque;(2)Wei Tong method:Baihui,Si Shen Cong,Shenting,Sanyinjiao(both side),Shenmen(both side),Neiguan(both side);(3)Wen Tong method:Pishu(both side),Xinshu(both side).Operational methods:0.25*25mm disposable acupuncture needles were selected to open points according to the Ling Gui Ba Fa.According to the principle that men first left and women first right,main acupoints were firstly opened and then the matching acupoints on the opposite side were pricked.All the acupoints were pricked straightly except Lieque(15 degree towards the patient’s thumb).Twisting and reinforcing method was used after getting Qi,then administrating the Wen Tong method.The depth of needling was about 1.2 inches in Sanyinjiao;0.5inches in Shenmen and Neiguan,Baihui and Shenting should be needled obliquely,while the body and scalp of the needle should be penetrated o.5inch into cap-like aponeurosis at 15 degrees toward Baihui when pricking Sishencong.The needle twisted once every 10 minutes and retained for a total time of 30 minutes.After pulling out the needles,at patients’ prone position,used 0.5mm OD fire needles to punctuated Pishu and Xinshu points on the bladder meridian into 0.3cm with red burned fire needle tip.After needling,pressing sterile dry cotton ball on the pricking points for 1 minute.Asking the patients to keep the needle part clean and avoiding pinhole infection.3.Control group:Baihui,Sishencong,Shenting,Shenmen(both sides),Neiguan(both sides),Sanyinjiao(both sides),Pishu(both sides),Xinshu(both sides).Operational methods:The insertion depth of the the needle is about 1.2 inches for Sanyinjiao,0.5 inches for Neiguan and Shenmen,0.5inches for Baihui and Shenting,15 degrees for Sishencong,0.5 inches for Xinshu and Pishu toward the spine.After getting Qi,the needle was twisted once every 10 minutes and retained for a total time of 30 minutes.4.Course of treatment and follow-up:The two groups were treated with acupuncture once every other day,and three times a week lasting for 4 weeks,which were totally 12 times in all.Wen Tong method has been used twice a week for 4 weeks,which was totally 8 times in all.The follow-up period was 2 months.5.Evaluation index and observation time:Pittsburgh Sleep Quality Index(PSQI)was used as the main therapeutic outcome,while Over-Awareness Scale(HAS),Hamilton Anxiety Scale(HAMA),Quality of Life Scale(SF-36)and TCM Syndrome Scales were used as the secondary therapeutic outcomes.The changes of PSQI,HAS,HAMA and TCM syndrome scores were observed before treatment,1 week after treatment,2 weeks after treatment,3 weeks after treatment,4 weeks after treatment,8 weeks after treatment and 12 weeks after treatment.The changes of SF-36 indexes were observed before treatment and 4 weeks after treatment.And the response rate of the two groups were compared and analyzed.Results1.PSQI The total scores of PSQI and its separated components within the two groups at 1 week,2weeks,3 weeks and 4 weeks after treatment were significantly improved when compared with baseline(P<0.05).The total PSQI scores of the treatment group were lower than those of the control group at 1,2,3 and 4 weeks after treatment(P<0.01).The scores of PSQI components in the treatment group were better than those in the control group in terms of sleep quality and time at 1 week after treatment(P<0.05).In addition to sleeping time and hypnotic drugs,the scores in the treatment group at 2 weeks were lower than those in the control group(P<0.05).Except for hypnotic drugs,the scores in the treatment group at 3 and 4 weeks after treatment were lower than those in the control group(P<0.05),with statistical difference(P<0.05).The total PSQI score and each component score of the treatment group at 8 and 12 weeks follow-up were significantly improved comparing with those OD baselines(P<0.01).The total PSQI scores of the treatment group at 8 weeks and 12 weeks follow-up were significantly different from those at 4 weeks(P<0.01).At 8 weeks follow-up and 4 weeks after treatment,all the values of the treatment group increased significantly,except for sleep quality and hypnotic drugs(P<0.05).At 12 weeks follow-up and 4 weeks after treatment,the values of the treatment group increase,except for hypnotic drugs(P<0.05).The total score of PSQI and its components in the control group were significantly improved after 8 and 12 weeks of follow-up(P<0.05).The total PSQI scores of the control group at 8 weeks and 12 weeks follow-up were significantly different from those at 4 weeks of treatment(P<0.05).When being compared with 4 weeks after treatment,the values of control group increased significantly at 8 weeks and 12 weeks follow-up.As for the score of PSQI components.There was no significant difference in hypnotic drugs(P>0.05),but other aspects did have obvious difference(P<0.05).2.TCM Syndrome Scale scoreThere were significant differences in TCM Syndrome Scale scores between the two groups at 1,2,3and 4 weeks of treatment(P<0.01),and there were significant differences in TCM syndrome total scores between the two groups at each time point of treatment(P<0.01).The total scores of the two groups at 8 weeks and 12 weeks were significantly lower than those before treatment(P<0.01).The total scores of the two groups increased in 8 weeks of treatment comparing with 4 weeks of treatment,in 12 weeks of treatment comparing with 4 weeks of treatment,and in 8 weeks of treatment comparing with 12 weeks of treatment(P<0.05).The total scores of TCM syndromes in the treatment group were lower than those in the control group at 8 weeks and 12 weeks of treatment respectively,and there was significant difference between the two groups(P<0.01).3.HAS and HAMA scalesComparing with the total scores of HAS and HAMA before treatment,the total scores of the two groups at 1 week,2 weeks,3 weeks and 4 weeks after treatment decreased significantly(P<0.01).There was no significant difference in HAS and HAMA total scores between the two groups at 1 week after treatment(P>0.05),but there was significant differences at 2,3 and 4 weeks after treatment(P<0.01).The total scores of HAS and HAMA in the two groups decreased at 8 weeks comparing with those before treatment and at 12 weeks comparing with those before treatment(P<0.01).The total scores of HAS and HAMA in the two groups increased significantly at 8 weeks vs 4 weeks,12 weeks vs 4 weeks,and 12 weeks vs 8 weeks,respectively(P<0.01).The total scores of HAS and HAMA in the treatment group were significantly lower than those in the control group at 8 and 12 weeks(P<0.01).4.SF-36 scaleAfter 4 weeks of treatment,comparing with before treatment,the total score of SF-36 and the scores of each dimension significantly increased within and between the two groups(P<0.01).Comparing with the control group,the SF-36 scores in the treatment group were higher.There were significant differences in health change,social function,overall health and energy between the two groups(P<0.05).Conclusion1.Both the treatment group and the control group can effectively treat the primary insomnia of deficiency of both heart and spleen.They can improve the sleep quality,the accompanying systemic symptoms of insomnia,anxiety,excessive awakening and the quality of life of the patients.The overall effect of the treatment group and the improvement of the above related with indicators are better than that of the control group,and with the increase of the time of acupuncture treatment,the efficacy of Ling Gui Ba Fa combining with Wen Tong method was more obvious.2.The treatment group and the control group have a certain long-term effect on improving sleep quality,and insomnia accompanied by systemic symptoms,anxiety and excessive awakening.However,the effect has a certain degree of decline after the cessation of treatment.The long-term effect of the treatment group is better than that of the control group in the above related with indicators.The difference of the effect can last for at least 12 weeks.3.In the treatment group,Ling Gui Ba Fa was used to open acupoints on time and Wen Tong method was used to treat primary insomnia with deficiency of both heart and spleen.The effect lasted for a long time and was safe without serious adverse reactions. |
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