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Randomised double-blind placebo-controlled intervention study on the nutritional efficacy of a food for special medical purposes (FSMP) and a dietary supplement in reducing the symptoms of veisalgia
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  • Published on: 3 November 2023
    No Research Ethics approval? No pre-registration? What is BMJ doing?
    • Martijn Katan, Em professor of nutrition VU University Amsterdam

    1. Nowhere in the article do I find a mention of a Research Ethics Committee or Institutional Review Board that reviewed and approved the protocol. Does this university (in Germany, of all places) allow its scientists to perform medical experiments on humans as they see fit?
    2. It is not up to the authors to decide that 'trial registration was not necessary'. Trials on humans must be pre-registered. The data analysis in this paper makes abundantly clear why medical journals demand pre-registration; Table 3 is a blatant fishing expedition without correction for multiple testing.
    3. How can BMJ publish an article that does not follow the Declaration of Helsinki and the ICMJE Guidelines?

    Conflict of Interest:
    None declared.
  • Published on: 20 October 2020
    FSMP and Versalgia
    • Jan Quinton, CEO-Scientist Phoenix Pharmaceuticals Australia Pty Ltd

    This study seems to support the growing evidence that hangovers are largely related to oxidative stress, and perhaps to large extent the increased activity of acetaldehyde. However, it is difficult to make much sense out of the data when the actual amounts of each component have not been presented. Thiamine for example, included in the vitamin and minerals group, is a potent antioxidant that has been shown to reduce the mortality of rats poisoned with acetaldehyde. Were sufficient amounts of thiamine included? Other potent antioxidants that have been shown to reduce acetaldehyde poisoning in rats and to reduce symptoms of hangover include L-cysteine. This nutrient plays a role in the generation of glutathione, the inactivation of acetaldehyde, and the protection against damage due to oxidative stress. The significance of the current manuscript without information on L-cysteine or glutathione is therefore limited.

    Conflict of Interest

    Our company manufactures a hangover treatment which contains thiamine and L-cysteine and have published a clinical trial in (ClinTrials Res 2018) that reported efficacy in hangover. This was not cited in the current paper.

    Conflict of Interest:
    None declared.