Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War Illness, 2018, Brewer et al

Discussion in ''Conditions related to ME/CFS' news and research' started by Dolphin, Jun 10, 2018.

  1. Dolphin

    Dolphin Senior Member (Voting Rights)

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    [I'm not impressed with the way the abstract for this study is written]


    https://www.tandfonline.com/doi/full/10.1080/21641846.2018.1477034

    Original Articles
    Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War Illness
    Kori L. Brewer, Allison Mainhart & William J. Meggs
    Received 01 Apr 2018, Accepted 11 May 2018, Published online: 09 Jun 2018


    [​IMG]ABSTRACT
    Background: 30% of Gulf War veterans developed Gulf War Illness (GWI) with chronic fatigue, pain, and neuropsychological disabilities.

    Purpose: To assess the efficacy of low-dose naltrexone to treat GWI.

    Methods: A double-blinded, placebo-controlled crossover trial of naltrexone 4.5 mg/day was conducted. The Clinical global impression scale (CGIS), visual analogue scales (VAS), SF-36 Health Survey, and the Connors Continuous Performance Test assessed treatment response. ClinicalTrials.gov registry Identifier is NCT02206490.

    Results: Thirty-seven participants completed the protocol. 100% had upper airway inflammation on examination. 88% were overweight or obese. The CGIS detected improvement in 38% of patients (n = 14) (responders), with 6 of these patients reporting much improvement. Non-responders were rated as showing no change from baseline (n = 18; 49%), or were rated minimally worse (n = 5; 13%). On the SF-36 Health Survey, responders showed significantly less disability than non-responders with respect to emotional limitations (p = 0.01) as well as greater improvement on VAS scales for confusion (p < 0.01), vertigo (p = 0.03) and depression (p = 0.05). All enrolled participants had detectable levels of naltrexone in their serum at the end of the treatment period, with values ranging from 1.5to 18 ng/ml. Anecdotally, some subjects and their spouses felt that naltrexone should be continued after the study ended.

    Conclusion: This pilot trial suggests low-dose naltrexone may be effective for some with GWI. Further study and consideration of other doses is needed.

    KEYWORDS: Gulf War illness, naltrexone, chronic fatigue, chronic pain, neuropsychological disabilities

    Additional information
    Funding
    This work was supported by the United States Department of Defense Congressionally Directed Medical Research Program [grant number W81XWH-09-2-0065].
     
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  2. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    I agree. It is so disappointing that editors agree to publish abstracts like this. This abstract fails to give the expected results of the study - the comparison of test and control outcomes. As such it should be rejected for publication. It is as simple as that.
     
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  3. Marky

    Marky Senior Member (Voting Rights)

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    Dont even have to read the paper to understand that it didnt work:giggle:
     
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  4. Alvin

    Alvin Senior Member (Voting Rights)

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    I'm overtired and may not be seeing it but what is wrong with the abstract?
    Also only having 37 patients involved is not a great sample size to make inferences from.
     
    Inara likes this.
  5. Sid

    Sid Senior Member (Voting Rights)

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    Shocking stuff. The reviewers were asleep on this one. Or completely incompetent.
     
  6. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    It shows that the people who did better did better than the people who didn't do so well. That is not a very useful conclusion.
     
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