Ear Pressure Pills For Insomnia Treatment System Evaluation

Objective:Trough comprehensive retrieval and bias evaluation and combined analysis, we want to explore efficiency and safety of seed attachment AA as an independent intervention for primary insomnia.Methods:1. Data RetrievalWe searched the Medline, Embase, PsycINFO, OVID, ProQuest, Worldcat, ICTRP, CCTCTR, and Chinese Database CBMdisc, CNKI, VIP, Wangfang Data and Wangfang Dissertation Database. Hand searching covered the core journals in this field for the past two dacades, and reference list of all studies in the full text screen round were also checked.2. Selective CriteriaAll studies that recruited adult participants with insomnia were included. Intervention method in treatment group was supposed to be AA only, while sham AA, placebo, no treatment, or western meds could be adopted in control group. The outcomes would cover at least one of the following items:effective rate, sleep parameters, sleep efficiency, scales for assessing insomnia or adverse effect.3. Data Collection and Analysis:Two evaluators were responsible for article screen and data extraction independently, the third evaluator verified all information. All disagreement were resolved by consensus. Assessment of risk bias was in accordence with Cochrane Handbook for Systematic Reviews of Interventions, then Review Manager5.2.5and GRADEprofiler3.6were adopted for Meta analysis and evidence grading.Main Results:1. Fifteen clinical trials were included, altogether1495participants aged between18～78years,809in AA group and686in control group. Their suffering of insomnia range from11days to more than10years.2. Six combined results from AA VS sham A A, placebo, or blank control comparation are as follow:effective rate [RR2.65,95%CI (0.37,18.91)], total sleep time [WMD57.15,95%CI (45.88,68.42)], sleep onset latency [WMD-9.89,95%CI (-14.37,-5.42)], number of awakening [SMD-0.79,95%CI (-1.10,-0.48)], total score on PSQI [WMD-3.41,95%CI (-3.95,-2.86)], and sleep efficiency [WMD11.86,95%CI (3.60,20.13)].3. Four combined results from AA VS Western Meds comparation are as follow: effective rate [RR1.24,95%CI (1.15,1.34]], total score on PSQI [WMD-3.41,95%CI (-3.95,-2.86)], sleep efficiency [WMD21.44,95%CI (16.30,26.58)], adverse effect [RR0.07,95%CI (0.02,0.23)].Conclusions:1. Independently use of AA resulted in lower PSQI score compared with sham AA, placebo,western meds or blank control. With the evidence ranked moderate, this outcome turned to be stable.2. Independently use of AA showed longer sleep time, better effective rate, higher sleep efficiency, shorter spleep lantency, and less awaking times compared with sham AA, placebo,western meds or blank control. But the level of evidences were low, they need to be treated with caution.3. Independently use of AA also revealed better effective rate compared with western meds.With the evidence ranked moderate, it turned to be stable.4. Compared with western meds, AA group reported better sleep efficiency, low PSQI score, and less adverse effects. As for the low evidence quality however, these results need to be treated with caution as well.