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      A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia

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          Abstract

          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.

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          Most cited references 22

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          The prevalence and characteristics of fibromyalgia in the general population.

          To determine the prevalence and characteristics of fibromyalgia in the general population. A random sample of 3,006 persons in Wichita, KS, were characterized according to the presence of no pain, non-widespread pain, and widespread pain. A subsample of 391 persons, including 193 with widespread pain, were examined and interviewed in detail. The prevalence of fibromyalgia was 2.0% (95% confidence interval [95% CI] 1.4, 2.7) for both sexes, 3.4% (95% CI 2.3, 4.6) for women, and 0.5% (95% CI 0.0, 1.0) for men. The prevalence of the syndrome increased with age, with highest values attained between 60 and 79 years (> 7.0% in women). Demographic, psychological, dolorimetry, and symptom factors were associated with fibromyalgia. Fibromyalgia is common in the population, and occurs often in older persons. Characteristic features of fibromyalgia--pain threshold and symptoms--are similar in community and clinic populations, but overall severity, pain, and functional disability are more severe in the clinic population.
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            Prevalence of fibromyalgia: a population-based study in Olmsted County, Minnesota, utilizing the Rochester Epidemiology Project.

            To estimate and compare the prevalence of fibromyalgia by 2 different methods in Olmsted County, Minnesota. The first method was a retrospective review of medical records of potential cases of fibromyalgia in Olmsted County using the Rochester Epidemiology Project (from January 1, 2005, to December 31, 2009) to estimate the prevalence of diagnosed fibromyalgia in clinical practice. The second method was a random survey of adults in Olmsted County using the fibromyalgia research survey criteria to estimate the percentage of responders who met the fibromyalgia research survey criteria. Of the 3,410 potential patients identified by the first method, 1,115 had a fibromyalgia diagnosis documented in the medical record by a health care provider. The age- and sex-adjusted prevalence of diagnosed fibromyalgia by this method was 1.1%. By the second method, of the 2,994 people who received the survey by mail, 830 (27.6%) responded and 44 (5.3%) met the fibromyalgia research survey criteria. The age- and sex-adjusted prevalence of fibromyalgia in the general population of Olmsted County by this method was estimated at 6.4%. To the best of our knowledge, this is the first report of the rate at which fibromyalgia is being diagnosed in a community. This is also the first report of prevalence as assessed by the fibromyalgia research survey criteria. Our results suggest that patients, particularly men, who meet the fibromyalgia research survey criteria are unlikely to have been given a diagnosis of fibromyalgia. Copyright © 2013 by the American College of Rheumatology.
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              Treatment of primary fibrositis/fibromyalgia syndrome with ibuprofen and alprazolam. A double-blind, placebo-controlled study.

              A multidimensional evaluation of 78 patients with primary fibrositis/fibromyalgia syndrome (PFS) revealed no significant relationship between clinical measures of physical discomfort and psychological measures. This observation provided evidence against the notion that the pain of PFS has a psychological etiology. The same patients were randomized into 4 groups for treatment with ibuprofen and/or alprazolam in a randomized, double-blind, double-dummy, placebo-controlled pilot trial. Clinical improvement in patient rating of disease severity and in the severity of tenderness upon palpation was most apparent in the subgroup of patients who were receiving both ibuprofen and alprazolam. An 8-week, open-label study in which 52 patients received both drugs further documented improvement in outcome measures. These data indicate that treatment with a combination of ibuprofen and alprazolam can be beneficial for some patients with PFS.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2017
                22 February 2017
                : 10
                : 451-460
                Affiliations
                [1 ]Innovative Med Concepts, LLC
                [2 ]Department of Biological Sciences, University of Alabama, Tuscaloosa, AL
                [3 ]Gendreau Consulting, LLC, Poway, CA, USA
                Author notes
                Correspondence: William L Pridgen, Innovative Med Concepts, LLC, 1837 Commons North Drive, Tuscaloosa, AL 35406, USA, Tel +1 205 366 0696, Fax +1 205 366 1451, Email tsasurgery@ 123456gmail.com
                Article
                jpr-10-451
                10.2147/JPR.S127288
                5328426
                © 2017 Pridgen et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Clinical Trial Report

                Anesthesiology & Pain management

                herpes virus, antiviral, celecoxib, famciclovir, fibromyalgia

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