tetano
Editor, Senior Moderator
Psychiatry Clin Neurosci
. 2023 Aug 30.
doi: 10.1111/pcn.13592. Online ahead of print. Placebo effects on all-cause mortality of COVID-19 patients in randomized controlled trials of interleukin-6 antagonists: a systematic review and network meta-analysis
Ping-Tao Tseng[SUP] #[/SUP][SUP] 1 2 3 4 [/SUP], Bing-Syuan Zeng[SUP] #[/SUP][SUP] 5 1 [/SUP], Trevor Thompson[SUP] 6 [/SUP], Brendon Stubbs[SUP] 7 8 9 [/SUP], Po-Ren Hsueh[SUP] 10 11 [/SUP], Kuan-Pin Su[SUP] 12 13 14 [/SUP], Yen-Wen Chen[SUP] 3 [/SUP], Tien-Yu Chen[SUP] 15 16 [/SUP], Yi-Cheng Wu[SUP] 17 [/SUP], Pao-Yen Lin[SUP] 18 19 [/SUP], Andre F Carvalho[SUP] 20 [/SUP], Chih-Wei Hsu[SUP] 19 [/SUP], Dian-Jeng Li[SUP] 21 [/SUP], Ta-Chuan Yeh[SUP] 15 [/SUP], Cheuk-Kwan Sun[SUP] 22 23 [/SUP], Yu-Shian Cheng[SUP] 2 24 [/SUP], Yow-Ling Shiue[SUP] 1 4 [/SUP], Chih-Sung Liang[SUP] #[/SUP][SUP] 25 26 [/SUP], Yu-Kang Tu[SUP] #[/SUP][SUP] 27 28 [/SUP]
Affiliations
Aim: Many randomised controlled trials (RCTs) have investigated the use of interleukin-6 (IL-6) antagonists for the treatment of coronavirus disease 2019 (COVID-19), yielding inconsistent results. This network meta-analysis (NMA) aimed to identify the source of these inconsistent results by re-assessing whether participants treated with standard of care (SoC) plus placebo group have different all-cause mortality from those treated with SoC alone and to re-evaluate the efficacy of IL-6 antagonists in the treatment of COVID-19.
Methods: We conducted a systematic search for relevant RCTs from the inception of electronic databases through September 1[SUP]st[/SUP] , 2022. The primary outcome was all-cause mortality. The secondary outcomes were the incidences of major medical events, secondary infections, all-cause discontinuation, and serious adverse events.
Results: The results of NMA of 33 RCTs showed that patients with COVID-19 treated with SoC plus placebo had lower odds of all-cause mortality than those who received SoC alone (odds ratio=0.75, 95% confidence interval=0.58 to 0.97). This finding remained consistent after excluding studies with no incident deaths. In addition, when we consider the impact of the widely-promoted COVID-19 vaccination and newly-developed anti-viral treatment strategy, the results from the analysis of RCT published in 2021 and 2022 remained similar.
Conclusion: These findings suggest the potential influence of placebo effects on the treatment outcomes of COVID-19 in RCTs. When evaluating the efficacy of treatment strategies for COVID-19, it is crucial to consider the use of placebo in the design of clinical trials. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; coronavirus disease 2019; interleukin-6; network meta-analysis; placebo effect.
. 2023 Aug 30.
doi: 10.1111/pcn.13592. Online ahead of print. Placebo effects on all-cause mortality of COVID-19 patients in randomized controlled trials of interleukin-6 antagonists: a systematic review and network meta-analysis
Ping-Tao Tseng[SUP] #[/SUP][SUP] 1 2 3 4 [/SUP], Bing-Syuan Zeng[SUP] #[/SUP][SUP] 5 1 [/SUP], Trevor Thompson[SUP] 6 [/SUP], Brendon Stubbs[SUP] 7 8 9 [/SUP], Po-Ren Hsueh[SUP] 10 11 [/SUP], Kuan-Pin Su[SUP] 12 13 14 [/SUP], Yen-Wen Chen[SUP] 3 [/SUP], Tien-Yu Chen[SUP] 15 16 [/SUP], Yi-Cheng Wu[SUP] 17 [/SUP], Pao-Yen Lin[SUP] 18 19 [/SUP], Andre F Carvalho[SUP] 20 [/SUP], Chih-Wei Hsu[SUP] 19 [/SUP], Dian-Jeng Li[SUP] 21 [/SUP], Ta-Chuan Yeh[SUP] 15 [/SUP], Cheuk-Kwan Sun[SUP] 22 23 [/SUP], Yu-Shian Cheng[SUP] 2 24 [/SUP], Yow-Ling Shiue[SUP] 1 4 [/SUP], Chih-Sung Liang[SUP] #[/SUP][SUP] 25 26 [/SUP], Yu-Kang Tu[SUP] #[/SUP][SUP] 27 28 [/SUP]
Affiliations
- PMID: 37646204
- DOI: 10.1111/pcn.13592
Aim: Many randomised controlled trials (RCTs) have investigated the use of interleukin-6 (IL-6) antagonists for the treatment of coronavirus disease 2019 (COVID-19), yielding inconsistent results. This network meta-analysis (NMA) aimed to identify the source of these inconsistent results by re-assessing whether participants treated with standard of care (SoC) plus placebo group have different all-cause mortality from those treated with SoC alone and to re-evaluate the efficacy of IL-6 antagonists in the treatment of COVID-19.
Methods: We conducted a systematic search for relevant RCTs from the inception of electronic databases through September 1[SUP]st[/SUP] , 2022. The primary outcome was all-cause mortality. The secondary outcomes were the incidences of major medical events, secondary infections, all-cause discontinuation, and serious adverse events.
Results: The results of NMA of 33 RCTs showed that patients with COVID-19 treated with SoC plus placebo had lower odds of all-cause mortality than those who received SoC alone (odds ratio=0.75, 95% confidence interval=0.58 to 0.97). This finding remained consistent after excluding studies with no incident deaths. In addition, when we consider the impact of the widely-promoted COVID-19 vaccination and newly-developed anti-viral treatment strategy, the results from the analysis of RCT published in 2021 and 2022 remained similar.
Conclusion: These findings suggest the potential influence of placebo effects on the treatment outcomes of COVID-19 in RCTs. When evaluating the efficacy of treatment strategies for COVID-19, it is crucial to consider the use of placebo in the design of clinical trials. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; coronavirus disease 2019; interleukin-6; network meta-analysis; placebo effect.