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A Randomized, Placebo-Controlled, Double-Blinded Trial of Duloxetine

Discussion in 'Latest ME/CFS Research' started by MikeJackmin, Feb 11, 2015.

  1. MikeJackmin

    MikeJackmin Senior Member

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    A Randomized, Placebo-Controlled, Double-Blinded Trial of Duloxetine in the Treatment of General Fatigue in Patients With Chronic Fatigue Syndrome.

    Arnold LM1, Blom TJ2, Welge JA2, Mariutto E3, Heller A3.

    RESULTS:
    The improvement in the Multidimensional Fatigue Inventory general fatigue scores for the duloxetine group was not significantly greater than for the placebo group (P = 0.23; estimated difference between groups at week 12 = -1.0 [95% CI: -2.8, 0.7]). The duloxetine group was significantly superior to the placebo group on the Multidimensional Fatigue Inventory mental fatigue score, Brief Pain Inventory average pain severity and interference scores, Short Form-36 bodily pain domain, and Clinical Global Impression of Severity score. Duloxetine was generally well tolerated.

    http://www.ncbi.nlm.nih.gov/pubmed/25660434
     
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  2. Bob

    Bob

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    England (south coast)
    A small short trial. No effect on fatigue.

     
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  3. Dolphin

    Dolphin Senior Member

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    I read this. I thought the reporting in the full paper (not necessarily the abstract) seemed reasonably fair, though one could speculate that there was a tendency to favour the drug.

    The trial was funded by a drug company.
     
    Last edited: Sep 14, 2015
  4. Dolphin

    Dolphin Senior Member

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    I just counted: there were 131 instances in the Duloxetine group (n=29) versus 62 in the placebo group (n=30).

    Another way of doing it. There were 23 times adverse events were higher in the Duloxetine group versus 3 in the placebo group (I counted any within one percentage of each other as being no different: there were 3 of them). (I'm not talking about statistically significant differences, just the full list).
     
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  5. Dolphin

    Dolphin Senior Member

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    Some of the exclusions:

    So some (or a few) people who might not respond or who might have adverse reactions are excluded
     
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  6. Dolphin

    Dolphin Senior Member

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    The baseline mean SF-36 physical functioning scores for the duloxetine group was 63.1. According to the PACE Trial investigators (though not most other people) they were already "back to normal"/had normal physical functioning!
     
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  7. Dolphin

    Dolphin Senior Member

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    It took a lot of work to do this trial:

     
  8. Dolphin

    Dolphin Senior Member

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  9. Dolphin

    Dolphin Senior Member

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  10. Dolphin

    Dolphin Senior Member

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  11. Dolphin

    Dolphin Senior Member

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    2 reported weight gain in the duloxetine group versus none in the placebo group. This was a short trial (12 weeks); a longer trial might find more reports.

    Here's what Wikipedia says on adverse effects https://en.wikipedia.org/wiki/Duloxetine#Adverse_effects:

     
  12. Dolphin

    Dolphin Senior Member

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    Of the other 4 MFI subscales, there was no difference on "reduced activity" and the results were better (though none approached significance) on the other three.
     
  13. Dolphin

    Dolphin Senior Member

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    So it does look like it could be a useful drug for pain though this would need to be balanced with the side effects.
     
  14. Dolphin

    Dolphin Senior Member

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    The baseline scores for two SF-36 domains were a lot different (and the difference was statistically significant):
    Mental Health: Duloxetine: 71.0 (+/- 14.3) vs Placebo: 55.4 (+/- 20.0)
    Role Emotional: 74.1 (+/-33.8) vs 38.3 (+/- 43.1)
    (higher scores represent better results/fewer problems).

    So hard to make a fair comparison of the differential effects here.

    One possible suspicion here is about whether there was proper random allocation. Suicidality is a known possible effect with this drug (it seems) so the investigators and/or the drug company ideally wouldn't like to have any such cases from the drugs.
     
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