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A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia. Pridgen et al, 2017

Discussion in 'Fibromyalgia and Connective Tissue Disorders' started by dreampop, Jan 22, 2018.

  1. dreampop

    dreampop Senior Member (Voting Rights)

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    Objective
    Infections and other stressors have been implicated in the development of fibromyalgia. We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated a famciclovir + celecoxib drug combination (IMC-1), active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.

    Methods

    A total of 143 fibromyalgia patients were enrolled at 12 sites in a 16-week, double-blinded, placebo-controlled proof-of-concept trial. Randomized patients received either IMC-1 or placebo in a 1:1 ratio. Outcome measures included a 24-hour recall pain Numerical Rating Scale, the Revised Fibromyalgia Impact Questionnaire (FIQ-R), the Patient’s Global Impression of Change (PGIC) questionnaire, the Multidimensional Fatigue Inventory, the NIH Patient-Reported Outcomes Measurement Information System (PROMIS), and the Beck Depression Inventory-II conducted at baseline and weeks 6, 12, and 16 of the study.

    Results

    A significant decrease in fibromyalgia-related pain was observed for patients on IMC-1 treatment versus placebo. PGIC response rates were significantly improved with IMC-1 treatment. Overall, patient self-reported functioning, as measured by the FIQ-R, was significantly improved. Fatigue was also significantly improved as measured by the PROMIS fatigue inventory. The safety profile was encouraging. Despite the celecoxib component of IMC-1, gastrointestinal and nervous system treatment emergent adverse events were reported less frequently in the IMC-1 group, and study completion rates favored IMC-1 treatment.

    Conclusion
    IMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may represent an effective, novel treatment for fibromyalgia.

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5328426/?
     
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  2. dreampop

    dreampop Senior Member (Voting Rights)

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    I haven't seen this study discussed on PR or here, but I suspect it will be something that will simmer along, and was interested in analysis. Here are my thoughts from PR

    t's very confusing. If I read it correctly, it's +1-2 point changes over placebo on various point questionnaires, and 36% responded vs 17% for placebo. It's unclear the scale of the questionnaires, as I found different references for them (cort says it's 12 points). You have to wonder just what Celebrex alone might do.

    Without "imputation" the primary endpoint of fatigue was not statistically different. From reading the methods section, it looks like the implication is dropout were in part to blame for this, but it's not really clear.

    OFC, it should be said Pridgen has a patent and started a company around combination, I would argue cannot therefore be absolutely objective, although the study seems well designed, it's just something that needs to be noted.

    Also, participants were off all pain killers, or anything that woud reduce pain, nsaids, fibro meds.

    So, placebo recieved nothing like that stuff, but treatment recieved celebrex - a very potent anti-inflammatory. Even if it wasn't treating fibro pain, you'd expect QOL pain improvements.

    Any help clearing up this study would be appreciated!
     
    Last edited: Jan 22, 2018
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  3. Valentijn

    Valentijn Guest

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    Yes, since the Celebrex wasn't controlled for, their resulting assumptions about viral involvement are very much unwarranted. Hopefully someone will test Celebrex alone versus placebo, and/or versus the Celebrex+antiviral combo if that hasn't been done already.
     
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  4. Trish

    Trish Moderator Staff Member

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    i found these points interesting in the discussion part of the paper:

    Here's how they came to test this combination of drugs:

    And here's their rationale for not testing them separately:

    I note also that they regard it as a preliminary proof of concept trial. So presumably more trials planned if they can get funding. I wonder why it was 3 years between finishing collecting data, and getting published.
     
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  5. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    It does not prove any concept because the results can easily be put down to celecoxib on its own. The fact that in a different context celecoxib on its own did not give a significant result is not a valid reason for thinking that the present result is due to the antiviral. I suspect it took 3 years to publish because most journals would have rejected it as not properly designed.
     
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  6. ukxmrv

    ukxmrv Senior Member (Voting Rights)

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    I'd like to see a study on Celebrex alone to see what effect it has and another group taking the combo to compare exactly where the differences are (if any)

    My experience with Celebrex and an antiviral (I've tried several) is that it does have better effect for me when they are taken together.

    Celerex alone for me was the single best thing when I had a road traffic accident and was dx'ed with FM though.
     
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  7. Melanie

    Melanie Senior Member (Voting Rights)

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    I thought there were studies on Celebrex alone for Fibromyalgia over the years and it wasn't found to be terribly effective. No? Maybe they're thinking about this study was, suppress the virus and Celebrex will work on residual pain? I mean, I guess they could have done this without Celebrex to see if suppressing the virus alone helped, I don't know. On the other hand, a fixed-dose combination is a "new" drug and that makes money for him because I am sure these drugs are now generic.
     
  8. Melanie

    Melanie Senior Member (Voting Rights)

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    See my post above as I think there have been Celebrex studies in the past.
     
  9. Sue

    Sue Established Member (Voting Rights)

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    I did valtrex ( very similar to Famvir) and Celebrex . I still pulse this if fibromyalgia acts up. This combo greatly decreased my fibromyalgia pain. Glad to at least see some studies starting. I think “ ibs” and Fibromyalgia may be caused by latent viruses that get reactivated ( in my case I think it was environmental exposures) . Viruses are not mental illness that we make up due to our” false illlness beliefs. “
     
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  10. Trish

    Trish Moderator Staff Member

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    I guess to do such a trial properly there should be 4 groups all tested under the same rules and conditions and filling in the same questionnaires, so direct between group comparisons can be made. It probably is not sufficient to say past tests have shown the separate drugs to be ineffective.

    Placebo
    Drug 1
    Drug 2
    Drugs 1 and 2 combined

    This would obviously need a bigger sample.
     
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  11. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    But 'not terribly effective' is still perfectly consistent with a statistically significant effect. Testing whether a drug has some effect on pain is quite different from testing whether it has an 'adequate' effect on pain, defined in some special way for a particular study. And scales of effects cannot be compared across trials because their sensitivity will depend on the psychology of the way the patients are enrolled and informed about what the study is hoped to show. People in a trial of whether celebrex is good enough for fibromyalgia are very likely to score 'not much better'. Patients enrolled in a trial of a potential magical cure for fibromyalgia may score 'miles better' on a good day.

    As Trish says, you have to do the formal comparison within the same psychological setting.
     
  12. Sue

    Sue Established Member (Voting Rights)

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    Celebrex alone does nothing for me personally for fibromyalgia pain. I would put it with nsaids.
    Prostaglandin inhibition for myself does nothing for the fibromyalgia pain I had. Believe me I wish it did.
     
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  13. Melanie

    Melanie Senior Member (Voting Rights)

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    Well, when I said not terribly effective what I meant was not effective because I can tell you this, Celebrex and the generics would have pushed it for Fibromyalgia. They didn't which tells me it did not do anything for the Fibro pain and that may have been because there was nothing to suppress HSV-1.

    Cymbalta is what I would call "not terribly effective" but effective enough to push on patients even though it only helps 6% of them AND has horrific withdrawal symptoms. I am thinking 6% of the Fibromyalgia patients are actually misdiagnosed.
     
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