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What happened to Pridgeon's anti-viral?

Vic

Messages
137
Last year I heard a doctor named Pridgeon was having big success in clinical trials with an anti-viral for improving Fibromyalgia and suspected it might improve CFS as well. I was skeptical, as I don't think chronic infections are the effective cause of either CFS or Fibromyalgia (especially not FM, and I think chronic Lyme is major bullshit), but I was very curious as to how they might have worked.

http://simmaronresearch.com/2014/06...-trial-future-chronic-fatigue-syndrome-trial/

This article on simmaronresearch.com said he was hoping to present his research last November. Might be too soon to ask, but has anyone heard anything new about it?
 

Vic

Messages
137
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

So it looks like it was fairly successful. But I wonder how much of the improvement was due to pain relief from celecoxib and how effective the famciclovir actually was at eliminating the virus, assuming it was contributing.

They should have done a third group with just celecoxib IMO... Looking at that article Jonathan Edwards had the same question.
 

globalpilot

Senior Member
Messages
626
Location
Ontario
So it looks like it was fairly successful. But I wonder how much of the improvement was due to pain relief from celecoxib and how effective the famciclovir actually was at eliminating the virus, assuming it was contributing.

They should have done a third group with just celecoxib IMO... Looking at that article Jonathan Edwards had the same question.

Exactly. They should have had more endpoints in addition to pain relief, such as gastrointestinal issues, which he reported at the outset. It's a disappointment he only reported on pain.