Qing Fei Pai Du Tang, a Chinese multi-herbal medicine formulated against COVID-19, elevates the plasma levels of IL-1β, IL-18, TNF-α, and IL-8
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Abstract
There are currently no specific vaccine or drugs proven to be effective against COVID-19. Traditional Chinese herbal medicine has been integrated into the official therapeutic protocol against COVID-19 in China. Qing Fei Pai Du Tang (QFPDT) is a Chinese multi-herbal formula newly developed and specifically optimized for the treatment of COVID-19. Therapeutic administration of QFPDT resulted in an improved cure rate in mild to critically-ill patients. However, the immunological mechanism for the efficacy of QFPDT has been poorly understood. Furthermore, the feasibility of prophylactic use in uninfected individuals remain unconfirmed. We thus examined whether the administration of QFPDT at a dose lower than recommended for therapeutic use alters hematological and/or immunological measures in healthy individuals. We found that QFPDT elevates the plasma levels of IL-1β, IL-18, TNF-α, and IL-8, which are key mediators of acute inflammatory responses to ssRNA viruses. No apparent adverse effects were observed during the trial. Our finding suggests that the pharmacological action of QFPDT is associated with the upregulation of a subset of proinflammatory cytokines despite its clinical benefits for COVID-19 patients. We should therefore be careful in its prophylactic use in uninfected individuals until we have a better understanding of the immunopharmacological action of QFPDT through further clinical studies with larger cohorts.
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SciScore for 10.1101/2020.07.13.20146175: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: All procedures were approved by the Ethics Committees of the Takanawa Clinic (approval number: 2020-2).
Consent: A signed informed consent form was obtained from each participant prior to inclusion in this study.Randomization not detected. Blinding All experimental procedures and data analyses were conducted by investigators who were blinded to the subjects’ clinical information using a de-identified dataset. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources A total of 18 healthy volunteers were enrolled (5 males, 13 females; ages 22–58 years; mean age [SD], 33.8 [10.7] years), all of whom tested … SciScore for 10.1101/2020.07.13.20146175: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: All procedures were approved by the Ethics Committees of the Takanawa Clinic (approval number: 2020-2).
Consent: A signed informed consent form was obtained from each participant prior to inclusion in this study.Randomization not detected. Blinding All experimental procedures and data analyses were conducted by investigators who were blinded to the subjects’ clinical information using a de-identified dataset. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources A total of 18 healthy volunteers were enrolled (5 males, 13 females; ages 22–58 years; mean age [SD], 33.8 [10.7] years), all of whom tested negative for IgM and IgG antibodies to SARS-CoV-2. IgGsuggested: NoneSARS-CoV-2suggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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