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Double-blinded placebo-controlled cross-over pilot trial of naltrexone to treat Gulf War Illness

Discussion in 'Other Health News and Research' started by Dolphin, Jun 10, 2018.

  1. Dolphin

    Dolphin Senior Member (Voting Rights)

    Messages:
    3,155
    [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].
     
    andypants, Inara, Robert 1973 and 7 others like this.
  2. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

    Messages:
    10,287
    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.
     
    andypants, Inara, Marky and 9 others like this.
  3. Marky

    Marky Senior Member (Voting Rights)

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    Location:
    Norway
    Dont even have to read the paper to understand that it didnt work:giggle:
     
    andypants and alktipping like this.
  4. Alvin

    Alvin Senior Member (Voting Rights)

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    3,309
    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)

    Messages:
    474
    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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    10,287
    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.
     
    Inara, Hutan, MarcNotMark and 4 others like this.

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