| Objective:To observe the efficacy of balancing acupuncture guided by balancing acupuncture theory and traditional acupuncture guided by traditional Chinese medicine theory in the treatment of primary insomnia,and to explore and compare the advantages and disadvantages of balancing acupuncture and traditional acupuncture in improving primary insomnia.Methods:A total of 74 patients with primary insomnia who met the inclusion criteria and signed the informed consent were included in this study.According to the random number table,they were randomly divided into the treatment group and the control group in the ratio of 1:1,37 cases in the treatment group and 37 cases in the control group.The treatment group used the balanced acupuncture method,acupuncture points: insomnia The treatment group used balanced acupuncture,taking acupuncture points: insomnia points,alternating acupuncture points on both sides,acupuncture to the extent of the appearance of radioactive needle sensation,no needle retention.In the control group,the traditional acupuncture method was used,and the acupuncture points were taken: Sishencong,Shenting,Neiguan and Shenmen on both sides,and the local soreness and swelling were used,and the needles were kept for 30 min.5 times in1 week and 10 times in 2 weeks.Scale assessments were performed before(day 0),after(day14),and at follow-up(day 42),respectively,and an acupuncture adverse event record form was completed at any time during treatment as a basis for safety evaluation.The primary outcome index of the study was the Pittsburgh Sleep Quality Index(PSQI),and secondary outcome indexes included TCM symptom scores,Hamilton Anxiety Inventory(HAMA),Hamilton Depression Inventory(HAMD),and the overall efficacy was observed as the PSQI reduction rate.The total duration of observation in this study was 6 weeks,including a 2-week treatment period and a 4-week follow-up period,and the data of PSQI,TCM symptom score,HAMA,and HAMD were collected before(day 0),at the end of week 2(day 14),and at the end of week6(day 42),respectively.The determination of overall efficacy(cured,significant,effective,and ineffective)and was only based on the data of the treatment period for statistical analysis.SPSS26.0 software was applied to statistically analyze the data of the above-mentioned scale scores.Results:1.Case completion: during the treatment period,patients in the treatment group: 2 cases did not cooperate in receiving acupuncture treatment even after more than 1 week of enrollment;patients in the control group: 1 case’s total number of treatments was less than 4 times in 2weeks,which was less than 4/5 of the total number of treatments,and all were considered as shedding.Patients in the control group: 1 case requested to withdraw from the trial voluntarily due to adverse acupuncture reactions of dizziness and was considered as dislodged.There were no cases of shedding during the follow-up period.This trial was finally completed with 35 cases in the treatment group and 35 cases in the control group observed and included in the statistics.2.Needle-prick adverse events: patients in the control group: 1 case experienced needle sickness at the first needle-prick,which was relieved with appropriate treatment,but voluntarily withdrew from the trial due to fear and did not complete the treatment.Patients in the control group: one case presented with numbness when moving the middle finger and little finger of the left hand,and the symptoms resolved on their own after 2 days of rest and completed the follow-up treatment.Patients in the treatment group: 1 case had a painful sensation at the entry point of the right wrist after needling,which was relieved after half an hour,and the follow-up treatment was completed.The rest did not have adverse reactions to needling.3.Outcome indicators:Description of comparisons of outcome indicators.Within-group comparisons were performed by comparing pre-treatment,post-treatment,and follow-up scale total scores within the group to indicate whether there were statistical differences in the data at the three time points overall;if statistical differences existed,then pairwise comparisons were used to further indicate which specific two time points were statistically different for the comparison.Between-group comparisons refer to the comparison of scale total scores between the two groups at the three time points of pre-treatment,posttreatment,and follow-up,respectively.Statistical treatment was performed using the appropriate test according to whether the data conformed to a normal distribution.Main outcome indicators:Comparison of total Pittsburgh Sleep Quality Index(PSQI)scores: The results showed that there was a p-value less than 0.01(p < 0.01)for both groups in their respective intra-group comparisons overall and in pairwise comparisons,suggesting that there was a significant difference between the treatment and control groups in their respective intra-group comparisons of total PSQI scores at three time points overall and,specifically,in any two time points in their respective groups.This indicates that both interventions had a significant therapeutic effect on primary insomnia,and both were also significantly better than before at the follow-up stage.Comparison between groups showed that there was a P value greater than 0.05(P > 0.05)for comparison between the total PSQI groups before treatment,after treatment,and at follow-up,suggesting that none of the group comparisons were statistically significant,indicating that the two intervention methods were comparable in terms of short-term efficacy and long-term efficacy in improving the sleep status of patients with primary insomnia.Secondary outcome indicators:Comparison of TCM symptom scores(total scores): The results showed that both groups had P values less than 0.01(P < 0.01)for the respective within-group comparisons overall and for pairwise comparisons,suggesting that there was a significant difference in the comparison of TCM symptom scores(total scores)between the treatment and control groups at three time points within each group overall,and specifically,there was a significant difference in the comparison of TCM symptom scores(total scores)at any two time points within each group.This indicates that both interventions had a significant improvement in TCM symptoms related to primary insomnia,and both were also significantly better than before at the follow-up stage.Between-group comparisons showed that there were P values greater than 0.05(P > 0.05)for between-group comparisons of TCM symptom scores(total scores)before,after treatment,and at follow-up,suggesting that none of the group comparisons were statistically significant,indicating that the two intervention methods were comparable in terms of short-term efficacy and long-term efficacy in improving primary insomnia-related TCM symptoms.Comparison of Hamilton Anxiety Inventory(HAMA)total scores: The results showed that both groups had P values less than 0.01(P < 0.01)for the respective within-group comparisons overall and for pairwise comparisons,suggesting that there was a significant difference in the comparison of the total HAMA scores at three time points within each of the treatment and control groups overall,and specifically,there was a significant difference in the comparison of the total HAMA scores at any two time points within each group.This indicates that both interventions significantly improved anxiety in patients with primary insomnia,and both were also significantly better than before at the follow-up stage.The comparison between groups showed that there was a P value greater than 0.05(P > 0.05)for the comparison of total HAMA scores before,after,and at follow-up,suggesting that there was no statistical significance for any comparison between groups,indicating that the two intervention methods were comparable in terms of short-term efficacy and long-term efficacy in improving anxiety in primary insomnia patients.Comparison of the total scores of Hamilton depression scale(HAMD): The results showed that there was a P value less than 0.01(P < 0.01)for the within-group comparisons for each of the treatment and control groups overall and for pairwise comparisons,suggesting that there was a significant difference in the comparison of the total HAMD scores at three time points within each of the treatment and control groups overall,and specifically,there was a significant difference in the comparison of the total HAMD scores at any two time points within each group.This indicates that both interventions significantly improved depression in patients with primary insomnia,and both were also significantly better than before during the follow-up phase.Comparison between groups showed that there was a P value greater than 0.05(P > 0.05)for the comparison of total HAMD scores before,after,and at follow-up,suggesting that none of the group comparisons were statistically significant,indicating that the two intervention methods were comparable in terms of short-term efficacy and long-term efficacy in improving depressed mood in patients with primary insomnia.5.Overall efficacy index:The overall clinical efficacy of the two acupuncture intervention methods on patients with primary insomnia was judged by the PSQI reduction rate.The total effective rate of the treatment group was 91.43%,and the total effective rate of the control group was 88.57%.The rank data was tested by rank sum test,and there was no statistical significance in the comparison between groups(P > 0.05),indicating that the overall clinical efficacy of the two acupuncture intervention methods was comparable.Conclusion:1.In terms of both short-term and long-term efficacy,the balanced acupuncture method has a significant improvement on primary insomnia and the accompanying anxiety and depression,which is comparable to the efficacy of the traditional acupuncture method.2.Balanced acupuncture method has fewer acupuncture points,short acupuncture time,no needle retention,less adverse reactions,less symptoms,not easy to get dizzy,and high safety,so it can be promoted and applied as a new method for the treatment of primary insomnia. |
