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Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of and finding treatments for complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.
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Since it is Cox-2 they are inhibiting here, I am wondering about plain old ibuprofen?
@natasa778,
Instead of using Ibuprofen, I wonder if Naproxen would be more effective as an OTC anti-inflammatory choice because of this drug's longer plasma half life of 12 to 17 hrs. However, Celebrex would still have an edge over Naproxen in its ability to only inhibit COX-2. See, 1) http://www.rxlist.com/naprosyn-drug/clinical-pharmacology.htm and 2) http://www.ncbi.nlm.nih.gov/pubmed/15229960
1878 - A Combination of Celecoxib and Famciclovir Is Efficacious in the Treatment of Fibromyalgia: Results of a Phase IIa Randomized, Double-Blind, Placebo-Controlled Study
Monday, November 17, 2014: 4:30 PM
104 B (Boston Convention and Exhibition Center)
Presentation Number: 1878
William Pridgen1, Carol Duffy2, Judith Gendreau3 and R Michael Gendreau3, 1Innovative Med Concepts, Tuscaloosa, AL, 2University of Alabama, Tuscaloosa, AL, 3Gendreau Consulting, LLC, Poway, CA
Background/Purpose:
Fibromyalgia (FM) is a common chronic pain syndrome with symptoms that include widespread pain, fatigue, sleep disruption and cognitive impairment. It is known that infections and other types of stressors are capable of triggering the development of FM. We hypothesize that these stressors could be responsible for triggering a reactivation of latent herpesviruses, and that this reactivation could in turn lead to the central nervous system dysregulation seen in this condition. The present study was designed to evaluate an anti-viral drug combination selected for activity against herpes class viruses.
Methods:
A total of 143 patients selected using the ACR 2010 FM criteria were enrolled at 12 sites in a 16-week, double-blind, placebo-controlled trial. Patients were randomized (1:1) to receive a proprietary combination of celecoxib + famciclovir or placebo. Outcome measures included a 24-hour recall pain numeric rating scale (NRS), Fibromyalgia Impact Questionnaire (FIQ-R), Patient Global Impression of Change (PGIC), and the PROMIS fatigue short form at baseline, and after 6, 12 and 16 weeks of study participation.
Results:
The primary efficacy endpoint was change in pain from baseline. Pain reduction was evaluated using the pain NRS and the 7-day recall pain item from the FIQ-R. Change from baseline was determined using an MMRM approach with LOCF/ BOCF imputation for missing data. A significant decrease in pain was observed for patients on treatment vs. placebo at 16 weeks by both measures. The absolute change on the NRS was -1.9 units vs -1.1, comparing active to placebo (p=0.031). On the FIQ-R item, the change was -2.2 vs -0.92 (p=0.001). Key secondary endpoints included analysis of the PGIC, where a value of “1” or “2” was considered a clinical responder. Significantly improved PGIC response rates were noted at endpoint: 33.3% for active vs 19.2% in placebo patients (p=0.031). Total FIQR score change at the endpoint visit was -17.54 vs -7.87 (p=0.002), while changes in the 3 domains were 14.29 vs -5.44 (p=0.004) for Function, -4.29 vs -1.89 (p=0.003) for Overall Impact, and -16.77 vs -7.90 (p=0.004) for Symptoms. In addition, improvements in fatigue were seen at endpoint on the PROMIS fatigue (-7.62 units vs -4.15; p=0.020).
The safety profile was especially encouraging. Despite the celecoxib component, gastrointestinal and nervous system treatment emergent adverse events were reported significantly more often in the placebo treatment group (GI: 29.0% vs 42.5%; nervous system: 17.4% vs 23.3%; active to placebo), and study completion rates favored active treatment over placebo (82.6% vs. 60.8%) (largely driven by higher placebo discontinuation rates due to adverse events and lack of efficacy).
Conclusion:
A proprietary combination of famciclovir, which we postulate is inhibiting herpesvirus replication, and celecoxib, known to inhibit both herpesvirus replication and reactivation, was efficacious in treating multiple symptoms of FM. Given the simultaneous improvement in many domains and the surprising tolerability of this combination of drugs, we believe this combination warrants further study as a potential new therapy for fibromyalgia patients.
Keywords: fibromyalgia and viruses
Disclosure:W. Pridgen, Innovative Med Concepts, Innovative Med Concepts ; C. Duffy, Innovative Med Concepts, Innovative Med Concepts ;J. Gendreau, Innovative Med Concepts ; R. M. Gendreau, Innovative Med Concepts, Innovative Med Concepts.
I'm hesitant about introducing a note of negativity/caution here, but these results don't look impressive to me.Pridgen et al. said:Key secondary endpoints included analysis of the PGIC, where a value of “1” or “2” was considered a clinical responder. Significantly improved PGIC response rates were noted at endpoint: 33.3% for active vs 19.2% in placebo patients (p=0.031).
This would never do in a phase III study. I am unsure about whether or not its acceptable in a phase II study.Very underwhelming results. Subjective outcome measures. If a psychobabbler had presented these outcomes in the context of a psychological intervention, people would be (rightly) very critical.
I'm hesitant about introducing a note of negativity/caution here, but these results don't look impressive to me.
If I've understood this correctly, only an extra 14.1% of participants responded to treatment, over and above the placebo group, using this particular outcome measure. And that doesn't mean that the participants, who responded, experienced a major response or a transformation in their health.
However, the safety profile seems quite good.
http://www.google.com/url?sa=t&rct=...=awJXPkZGPUzCAI6Drju6Aw&bvm=bv.79908130,d.cGENon-Steroidal Anti-Inflammatory Drugs and Brain Inflammation: Effects on Microglial Functions
Celecoxib increases risk of stroke and cardiac events and I think has been withdrawn in UK as mentioned. If Cox-2 inhibition is needed this looks like a catch-22.
Because of the significant side effect profiles of steroidal and NSAID medications, there is a greater interest in natural compounds, such as dietary supplement and herbal remedies, which have been used for centuries to reduce pain and inflammation.[94] Many of these natural compounds also work by inhibiting the inflammatory pathways in a similar manner as NSAIDs. In addition to the COX pathway, many natural compounds act to inhibit nuclear factor-kB (NF-kB) inflammatory pathways.
NSAIDs, is that they interfere in the healing process
Aspirin shown to benefit schizophrenia treatment
Some anti-inflammatory medicines, such as aspirin, estrogen, and Fluimucil, can improve the efficacy of existing schizophrenia treatments, new research suggests. Research has shown that the immune system is linked to certain psychiatric disorders, such as schizophrenia and bipolar disorder. Research has shown that "antioxidants and anti-inflammatory drugs could not only reduce symptoms associated with the disorders but also prevent the appearance of neurobiological abnormalities and transition to psychosis if given early during brain development," experts say.
. . . Schizophrenia in particular is linked to the HLA gene system, which is found on chromosome 6 in humans. The HLA system controls many of the characteristics of the immune system.
According to lead researcher, Professor Iris Sommer (Psychiatry Department, University Medical Centre, Utrecht, Netherlands): "The picture on anti-inflammatory agents in schizophrenia has been mixed, but this analysis pulls together the data from 26 double-blind randomised controlled trials, and provides significant evidence that some (but not all) anti-inflammatory agents can improve symptoms of patients with schizophrenia. In particular, aspirin, estrogens (in women) and the common antioxidant N-acetylcysteine (fluimicil) show promising results. Other anti-inflammatory agents, including celecoxib, minocycline, davunetide, and fatty acids showed no significant effect." . . .