1. Guest, the 'News in Brief' for the week beginning 12th July 2021 is here.
    Dismiss Notice
  2. Welcome! To read the Core Purpose and Values of our forum, click here.
    Dismiss Notice
  3. Contribute to feedback on the CDC Evidence Review, for more details click here
    Dismiss Notice

Effect of Galantamine Hydrobromide in Chronic Fatigue Syndrome A Randomized Controlled Trial, 2004, Blacker et al.

Discussion in 'BioMedical ME/CFS Research' started by Michiel Tack, Jun 13, 2021.

  1. Michiel Tack

    Michiel Tack Senior Member (Voting Rights)

    Messages:
    2,490
    Likes Received:
    24,100
    Location:
    Belgium
    (Note that this is an old study from 2004)

    Abstract

    Context: There is no established pharmacological treatment for the core symptoms of chronic fatigue syndrome (CFS). Galantamine hydrobromide, an acetyl cholesterone inhibitor, has pharmacological properties that might benefit patients with CFS.

    Objective: To compare the efficacy and tolerability of galantamine hydrobromide in patients with CFS.

    Design, setting, and patients: Randomized, double-blind trial conducted June 1997 through July 1999 at 35 outpatient centers in the United Kingdom (n = 17), United States (n = 14), the Netherlands (n = 2), Sweden (n = 1), and Belgium (n = 1) involving 434 patients with a clinical diagnosis of CFS (modified US Centers for Disease Control and Prevention criteria).

    Interventions: A total of 89 patients were randomly assigned to receive 2.5 mg of galantamine hydrobromide; 86 patients, 5.0 mg; 91 patients, 7.5 mg; and 86 patients, 10 mg (these patients received medicine in the tablet form 3 times per day); a total of 82 patients received matching placebo tablets 3 times per day.

    Main outcome measures: The primary efficacy variable was the global change on the Clinician Global Impression Scale after 4, 8, 12, and 16 weeks of treatment. Secondary outcomes were changes in core symptoms of CFS on the Chalder Fatigue Rating Scale, the Fibromyalgia Impact Questionnaire, and the Pittsburgh Sleep Quality Index; changes in quality of life on the Nottingham Health Profile; and assessment of plasma-free cortisol levels and cognitive performance on a computer-based battery of tests.

    Results: After 16 weeks, there were no statistically significant differences between any of the galantamine or placebo groups in clinical condition on the Clinician Global Impression Scale, or for any of the secondary end points. Exploratory regression analysis failed to detect any consistent prognostic factor that might have influenced the primary or any secondary outcome measures.

    Conclusion: This trial did not demonstrate any benefit of galantamine over placebo in the treatment of patients with CFS.

    https://jamanetwork.com/journals/jama/fullarticle/199392
     
  2. Michiel Tack

    Michiel Tack Senior Member (Voting Rights)

    Messages:
    2,490
    Likes Received:
    24,100
    Location:
    Belgium
    This is apparently the largest drug trial ever done in ME/CFS patients. It tested the use of galantamine (an acetyl-cholinesterase inhibitor that is used to treat cognitive decline in for example Alzheimer's) at 4 different doses against a placebo.

    434 ME/CFS participated in the trial in multiple centers around the world (including Belgium). Unfortunately, no positive effect was found for any of the doses of galantamine.

    I had never heard of the trial. Does anyone know more about it and the driving forces behind it?
     
    cfsandmore, Joh, Ariel and 9 others like this.
  3. Hutan

    Hutan Moderator Staff Member

    Messages:
    14,549
    Likes Received:
    60,779
    Location:
    New Zealand
    Thanks for posting the trial @Michiel Tack.

    Certainly a lot of effort was put into it, and it seems to have been well done.

    Some of the baseline data is interesting and potentially useful, given that it comes from a large and geographically diverse sample. See for example this finding for cognitive function:

     
  4. Hutan

    Hutan Moderator Staff Member

    Messages:
    14,549
    Likes Received:
    60,779
    Location:
    New Zealand
    This was interesting re placebo response rates:
    I expect placebo response rates depend on how strongly the treatment is 'sold'.

    This study may be useful when explaining the issues with subjective outcomes in unblinded trials with inadequate controls.
     
    alktipping, Ariel, Trish and 7 others like this.
  5. James Morris-Lent

    James Morris-Lent Senior Member (Voting Rights)

    Messages:
    897
    Likes Received:
    6,653
    Location:
    United States
    Isn't there still some interest in pyridostigmine? This result would seem to make that less plausible as these drugs both act by increasing acetylcholine activity.

    Seems to be a pretty impressive trial that has flown under the radar.
     
  6. adambeyoncelowe

    adambeyoncelowe Senior Member (Voting Rights)

    Messages:
    2,317
    Likes Received:
    16,841
    This study was also included in the current (draft) NICE pharma evidence review, if that helps.
     
    Last edited: Jun 14, 2021
    Michelle, alktipping, Ariel and 6 others like this.
  7. MSEsperanza

    MSEsperanza Senior Member (Voting Rights)

    Messages:
    1,695
    Likes Received:
    12,046
    Location:
    betwixt and between
    And may be also for arguing that there exist useful objective measures to assess cognitive performance, e.g. response speed? (see Hutan's post before the one I quoted.)

    @Snow Leopard @Woolie @Jonathan Edwards @Carolyn Wilshire

    (Discussion on that topic here. )
     
    Last edited: Jun 14, 2021
  8. Michiel Tack

    Michiel Tack Senior Member (Voting Rights)

    Messages:
    2,490
    Likes Received:
    24,100
    Location:
    Belgium
    Seems that the study was funded by a pharmaceutical company. It reads:
    Some of the researchers involved in the study: Behan in the UK, Van der Meer in the Netherlands, De Meirleir in Belgium, Klimas in the US etc. Michael Sharpe was on the Data Monitoring Committee.
     
  9. Hutan

    Hutan Moderator Staff Member

    Messages:
    14,549
    Likes Received:
    60,779
    Location:
    New Zealand

Share This Page