| Study AObjectiveBased on a systematic review of modern acupuncture studies on primary insomnia,the clinical efficacy of acupuncture versus active drugs was assessed,so as to provide evidence for the use of balance acupuncture "triple fast needling" in insomnia treatment in real-world clinical practice.MethodsElectronic databases including CNKI,VIP,Wanfang data,Pubmed,Web of Science,Medline,CBM and The Cochrane Library were searched from inception to August,2019.Randomized controlled trials(RCTs)of acupuncture versus western medicine for the treatment of primary insomnia were identified,and then the retrieved literatures were screened according to the inclusion and exclusion criteria.The quality evaluation,data extraction and analysis of the included RCTs were conducted according to the Cochrane standard.Subgroup analyses were also performed,which were stratified by different acupuncture techniques and duration of treatment.The statistical analysis was conducted using Review Manager 5.3.ResultsA total of 5128 patients were enrolled in 61 studies,including 2613 in the trial group and 2515 in the control group.All of the studies reported methods of generating random sequences,including use of a random number table,envelopes,random blocks,or simple coin tossing.29 RCTs performed allocation concealment.Only one study mentioned blinding of participants,6 studies mentioned blinding of investigators,and none of the remaining studies mentioned the blinding method.Only two studies evaluated safety.As for intervention techniques,40 studies used acupuncture,9 used moxibustion,4 involved auricular therapy,4 used acupoint application,and 4 adopted acupoint embedding;western medicine was generally used in the control group.Meta-analysis findingsThe effect of acupuncture versus western medicine on the PSQI scoreIn the 61 studies,PSQI was used as a measure to assess sleep quality.Due to the substantial heterogeneity of the included studies,random effect model was chosen.The analysis showed that acupuncture lowered the PSQI score compared with the control group,indicating that acupuncture was associated with a greater improvement in the sleep quality of insomnia patients.We also performed subgroup analysis to determine the potential source of heterogeneity.When stratified by different acupuncture techniques,the subgroup analysis showed that compared with the control group,acupuncture,moxibustion,and acupoint application significantly reduced the PSQI score,but such an effect was not observed for auricular therapy and acupoint embedding.When stratified by duration of treatment(2 weeks vs 3 weeks vs 4 weeks),no statistical differences were identified among these subgroups.Regardless of treatment duration,acupuncture intervention consistently lowered the PSQI score as compared with the control group.Publication biasTest for publication bias was conducted according to different outcome measures,and the results showed that publication bias might exist in the studies reporting the PSQI outcome.ConclusionAcupuncture is effective in the treatment of primary insomnia,but the methodological quality of the included clinical trials is generally poor.Study BObjectiveTo evaluate the time-effect relationship of balance acupuncture“triple fast needling”in treating primary insomnia,and to determine whether the choice of coarse or fine needle would affect the clinical efficacy.MethodsA randomized,controlled,parallel and open-label clinical trial was performed.74 patients with primary insomnia were randomly divided into 4 groups,i.e.coarse needle treatment group,fine needle treatment group,coarse needle control group,and fine needle control group.The two treatment groups were treated with balance needle,while the two control groups were treated with non-acupoint acupuncture.A 0.35×25 mm filiform needle was used as coarse needle,while a 0.20X25 mm filiform needle was used as fine needle.The treatment was administered once daily,five days a week,for a total of four weeks.The Insomnia Severity Index(ISI)and Pittsburgh Sleep Quality Index(PSQI)were assessed before treatment as well as at 1 week,2 weeks and 4 weeks.Safety outcomes were also evaluated and recorded.ResultsAt the end of treatment,2 patients were lost to follow-up,1 in treatment group and 1 in control group.Finally,72 patients(36 from treatment group and 36 from control group)were included in the intention-to-treat analysis(ITT).1.Comparison of baseline demographic and clinical characteristicsBoth demographic(gender,age,educational background,and occupation)and clinical(course of disease,TCM syndrome,tongue&pulse features;ISI,PSQI,and PSQI component subscores)characteristics were comparable among these groups.2.Overall efficacy comparisonIn the treatment group,5 patients(13.88%)were cured,15(41.67%)responded obviously,13(36.11%)responded,and 3(8.33%)did not respond to treatment;the total response rate was 91.67%.In the control group,none of the patients(0%)were cured,2(5.56%)responded obviously,8(22.22%)responded,and 26(72.22%)did not respond to treatment;the total response rate was only 27.78%.The difference between the two groups was statistically significant.Among the four subgroups,the coarse needle treatment group had a significantly higher total response rate compared with the other three groups.No statistically significant difference was observed between the fine needle control group and coarse needle control group.3.Comparison of the ISI scoreIn all groups,the ISI total score was significantly reduced at all post-treatment time points compared with their baseline scores.Inter-group comparison showed that,significantly greater reductions in the ISI total score were noted in the treatment group compared with the control group;and the coarse needle treatment group had the greatest reduction in the ISI total score.There was no significant difference between the coarse needle control group and fine needle control group.Similar results were obtained when the ISI subscores were compared among these groups.4.Comparison of the PSQI total scoreAfter 4 weeks of treatment,the PSQI total score was significantly reduced from baseline in all groups,but the reduction was significantly greater in the treatment group compared with the control group.5.Comparison of the PSQI component subscoresAt week 4,the differences in all PSQI component subscores were statistically significant between the treatment group and the control group(P<0.05)except component V(P>0.05).The PSQI score tended to decrease over time in all groups,but the reduction was more obvious in the treatment group than the control group.The greatest reduction was observed in the coarse needle treatment group,with statistically significant differences when compared with the other three subgroups.6.SafetyOne patient in the control group experienced mild post-acupuncture hematoma,which was resolved quickly.The incidence of adverse events was comparable among these groups(P>0.05).Conclusion1.Balance acupuncture is effective in the treatment of primary insomnia,whose efficacy can be observed as early as week 1,and be maintained at least through week 4.2.Balance acupuncture using coarse needle seems to be superior to the use of fine needle in treating primary insomnia. |
PDF Full Text Request