JAMA ：新冠疫苗不良反应或有2/3由反安慰剂效应导致

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JAMA Network Open：新冠疫苗不良反应或有2/3由反安慰剂效应导致

环球科学

2022/01/21

论文
论文标题：Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials: A Systematic Review and Meta-analysis
作者：Julia W. Haas, Friederike L. Bender, Sarah Ballou, John M. Kelley, Marcel Wilhelm, Franklin G. Miller, Winfried Rief, Ted J. Kaptchuk
期刊：JAMA Network Open
发表时间：2022/01/18
数字识别码：10.1001/jamanetworkopen.2021.43955
摘要：ImportanceAdverse events (AEs) after placebo treatment are common in randomized clinical drug trials. Systematic evidence regarding these nocebo responses in vaccine trials is important for COVID-19 vaccination worldwide especially because concern about AEs is reported to be a reason for vaccination hesitancy.ObjectiveTo compare the frequencies of AEs reported in the placebo groups of COVID-19 vaccine trials with those reported in the vaccine groups.Data SourcesFor this systematic review and meta-analysis, the Medline (PubMed) and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched systematically using medical subheading terms and free-text keywords for trials of COVID-19 vaccines published up to July 14, 2021.Study SelectionRandomized clinical trials of COVID-19 vaccines that investigated adults aged 16 years or older were selected if they assessed solicited AEs within 7 days of injection, included an inert placebo arm, and provided AE reports for both the vaccine and placebo groups separately. Full texts were reviewed for eligibility by 2 independent reviewers.Data Extraction and SynthesisData extraction and quality assessment were performed independently by 2 reviewers, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline and using the Cochrane risk-of-bias tool. Meta-analyses were based on random-effects models.Main Outcomes and MeasuresThe primary outcomes were the proportions of placebo recipients reporting overall, systemic, and local (injection-site) AEs as well as logarithmic odds ratios (ORs) to evaluate group differences. Outcomes were tested for significance usingztests with 95% CIs.ResultsTwelve articles with AE reports for 45 380 participants (22 578 placebo recipients and 22 802 vaccine recipients) were analyzed. After the first dose, 35.2% (95% CI, 26.7%-43.7%) of placebo recipients experienced systemic AEs, with headache (19.3%; 95% CI, 13.6%-25.1%) and fatigue (16.7%; 95% CI, 9.8%-23.6%) being most common. After the second dose, 31.8% (95% CI, 28.7%-35.0%) of placebo recipients reported systemic AEs. The ratio between placebo and vaccine arms showed that nocebo responses accounted for 76.0% of systemic AEs after the first COVID-19 vaccine dose and for 51.8% after the second dose. Significantly more vaccine recipients reported AEs, but the group difference for systemic AEs was small after the first dose (OR, −0.47; 95% CI, −0.54 to −0.40; P < .001; standardized mean difference, −0.26; 95% CI, −0.30 to −0.22) and large after the second dose (OR, −1.36; 95% CI, −1.86 to −0.86; P < .001; standardized mean difference, −0.75; 95% CI, −1.03 to −0.47).Conclusions and RelevanceIn this systematic review and meta-analysis, significantly more AEs were reported in vaccine groups compared with placebo groups, but the rates of reported AEs in the placebo arms were still substantial. Public vaccination programs should consider these high rates of AEs in placebo arms.

所属学科：
免疫学
在一项对随机、设置安慰剂对照的新冠疫苗试验的荟萃分析中，研究人员分析了12个新冠疫苗临床试验的数据，其中包括22 578名安慰剂接受者和22 802名疫苗接者，比较了接种疫苗和接受安慰剂注射的志愿者出现不良事件的概率。在第一次注射后，超过35%的安慰剂接受者有全身不良事件，其中伴有头痛或疲劳的发烧最常见。在第一次注射后，46%的疫苗接受者经历了至少一次全身不良事件。



考虑到许多不良事件也发生在安慰剂组，研究人员认为疫苗组的所有不良事件中有76%由反安慰剂效应（病人不相信治疗有效，可能会令病情恶化）引起。在第二次注射后，安慰剂组的全身不良事件下降率到32%，相比之下，接种疫苗的参与者中61%报告了全身不良事件。研究人员发现在第二次接种后，疫苗组报告的52%的不良事件由反安慰剂效应导致。研究结果发表在JAMA Network Open杂志上。


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文章标签
新冠疫苗
安慰剂
不良事件
头痛
疲劳
发烧
反安慰剂效应

https://jamanetwork.com/journals ... fullarticle/2788172

https://www.linkresearcher.com/t ... e-baaf-6e0405c003f2



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