| Objective: To systematically evaluate the evidence quality of the core outcome of acupuncture in the treatment of primary depression,and to construct the core index set of acupuncture for primary depression.Methods: Study 1 A computer search of CNKI Database,Wanfang Database,CBM Database,VIP Database,Pub Med,Web of Science and Embase was used to search randomized controlled trials of acupuncture in the treatment of primary disease until July2021.Two researchers screened the literature and extracted the data according to the inclusion and exclusion criteria.Rev Man5.4 software was used for bias risk assessment and Meta analysis.Publish bias analysis,synthesize the retrieved evidence,form the evidence body of the corresponding outcome,and evaluate the evidence quality with the outcome index as a unit,mainly from five aspects: limitation,inconsistency,indirectness,inaccuracy and publication bias.The second study uses computer to search Chinese databases such as CNKI Database,Wanfang Database,CBM Database,VIP Database,and English databases such as Pub Med,Web of Science,Embase from January 1,2019 to December 31,2020.According to the results of the search and semi-structured interviews,the original core indicators list was formed,and the Delphi questionnaire was developed through the online survey platform questionnaire star.The questionnaire was distributed in two rounds.Based on Delphi’s findings,a potential core set of indicators was formed and entered into an expert consensus meeting,which was discussed and voted on anonymously by the participating experts.The final core set of indicators for clinical research on acupuncture for treatment of primary depression was formed.Results: A total of 2945 patients were included in 39 literatures.The results of Meta analysis showed that:(1)compared with the SSRIs group,the effective rate of the acupuncture group was higher [RR=1.09,95%CI(1.02,1.18),Z = 2.46,Prun0.01].(2)Compared with the SSRIs group,the score of Hamilton Depression scale in the acupuncture group was lower [MD=-1.48,95%CI(-2.75,0.21),Z =2.29,P=0.02].(3)Compared with the SSRIs group,the acupuncture combined with SSRIs group had higher effective rate[RR=1.23,95%CI(1.15,1.31),Z = 6.38(P < 0.00001)].(4)Compared with the SSRIs group,the score of Hamilton Depression scale in the acupuncture combined with SSRIs group was lower [MD=-2.76,95%CI(-3.31,2.20),Z = 9.66(P < 0.00001)].The results of GRADE quality evaluation showed that:(1)The quality of evidence of effective rates of acupuncture control SSRIs in the treatment of primary depression was high.(2)Acupuncture control SSRIs in the treatment of primary depression according to the quality of evidence formed by Hamilton Depression scale score was moderate.(3)The quality of evidence of effective rates of acupuncture combined with SSRIs compared with SSRIs in the treatment of primary depression was moderate.(4)Acupuncture combined with SSRIs compared with SSRIs in the treatment of primary depression according to the quality of evidence formed by Hamilton Depression scale score was low.Taking primary depression as an example,this study verified the construction method of core indicators of acupuncture and moxibustion clinical research.The index domains that are finally included in the core index set are therapeutic efficacy,symptoms and signs,physical and chemical examination,quality of life,health economics evaluation,safety evaluation and other indicators,a total of 7.A total of 9 outcome indicators were included in the core indicator set,including the main outcome indicators: treatment efficiency,Hamilton depression scale scores,a total of 2.Secondary outcome index: Hamilton anxiety scale score,Pittsburgh sleep quality index score,5-HT,short of 36 scale score,depression mood improvement time,side effects scale score,TCM syndrome score,a total of9 items.Conclusion:(1)Acupuncture or acupuncture combined with SSRIs can significantly reduce the score of Hamilton depression scale in patients with primary depression,and the curative effect is better than that of simple SSRIs,and the evidence quality is reliable.(2)this study formed the core index set of acupuncture in the treatment of primary depression,including 9core outcome indicators in7 types of index domain. |
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