PMID- 34622766
OWN - NLM
STAT- MEDLINE
DCOM- 20220128
LR  - 20220531
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 60
IP  - 1
DP  - 2022 Jan
TI  - Nocebo responses in randomized controlled trials of COVID-19 vaccines.
PG  - 5-12
LID - 10.5414/CP204028 [doi]
AB  - OBJECTIVE: The aim of this study was to evaluate the frequency and magnitude of 
      nocebo responses in -COVID-19 vaccine trials. MATERIALS AND METHODS: We performed 
      a meta-analysis of adverse effects (AEs), severe adverse effects (SAEs), 
      withdrawal due to AEs, death, and immune-mediated SAEs observed in randomized 
      controlled trials (RCTs) of COVID-19 vaccines. RESULTS: Four RCTs with a total of 
      119,110 participants (65,254 from the vaccine group and 53,856 from the placebo 
      group) were considered. The pooled estimate of AEs in the placebo and vaccine 
      groups was 16.4% (95% confidence interval (CI), 9.1 - 27.7%) and 25.3% (95% CI, 
      22.7 - 28.1%), respectively. The pooled SAE rate in the placebo and vaccine 
      groups was 0.7% (95% CI, 0.5 - 1.0%) and 0.6% (95% CI, 0.4 - 0.9%), respectively. 
      The pooled estimate of participants who withdrew from treatment due to AEs in the 
      placebo and vaccine groups was 0.3% (95% CI, 0.1 - 1.0%) and 0.2% (95% CI, 
      0.1 - 0.5%), respectively. The pooled death rate in the placebo and vaccine 
      groups was 0.02% (95% CI, 0.01 - 0.04%) and 0.01% (95% CI, 0.01 - 0.03%), 
      respectively. The pooled estimate of immune-mediated SAEs in the placebo and 
      vaccine groups was 0.01% (95% CI, 0.01 - 0.04%) and 0.02% (95% CI, 0.01 - 0.05%), 
      respectively. There were no differences observed in the pooled risk of AEs, SAEs, 
      withdrawal due to AEs, death, and immune-mediated SAEs between placebo and 
      vaccine groups. CONCLUSION: The frequency and magnitude of nocebo responses were 
      16.4% and 0.3%, respectively. Therefore, the incidence of nocebo responses was 
      high, but their magnitude was low in COVID-19 vaccine trials.
FAU - Lee, Young Ho
AU  - Lee YH
FAU - Song, Gwan Gyu
AU  - Song GG
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (COVID-19 Vaccines)
SB  - IM
MH  - COVID-19
MH  - *COVID-19 Vaccines/adverse effects
MH  - Humans
MH  - *Nocebo Effect
MH  - Randomized Controlled Trials as Topic
EDAT- 2021/10/09 06:00
MHDA- 2022/01/29 06:00
CRDT- 2021/10/08 08:42
PHST- 2021/12/20 00:00 [accepted]
PHST- 2021/10/09 06:00 [pubmed]
PHST- 2022/01/29 06:00 [medline]
PHST- 2021/10/08 08:42 [entrez]
AID - 188833 [pii]
AID - 10.5414/CP204028 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2022 Jan;60(1):5-12. doi: 10.5414/CP204028.