ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Inflammation Disrupts Memory - What Can You Do to Protect Your Brain?

All About Ginkgo Biloba: Benefits of This Timeless Herbal Supplement

Yarrow Oil: Here's Why It Deserves a Place in Your First-Aid Kit

Trial Finds Reduction in Depressive Symptoms Following Magnesium Supplementation

Artificial sweeteners linked to risk of weight gain, heart disease and other health issues

Carnitine deficiency suggested as contributor to autism

Vitamin D supplement use associated with lower risk of breast cancer

Hop Oil: A Safe Sleep Aide

White Camphor Oil: The Purest Camphor Oil

Lutein — An Important Nutrient for Eye and Brain Health

 
Print Page
Email Article

12-center trial of Ampligen treatment for severe ME/CFS reports positive results

  [ 67 votes ]   [ Discuss This Article ]
www.ProHealth.com • March 15, 2012


Article:
A double-blind, placebo-controlled, randomized, clinical trial of the TLR-3 agonist Rintatolimod [Ampligen®] in severe cases of Chronic Fatigue Syndrome
– Source: PloS One, Mar 14, 2012

By David R Strayer, Daniel L Peterson, et al.

[Note: To read the full text of this landmark open access article free, click HERE and download the PDF. Rintatolimod (aka Ampligen) was designated an “Orphan Drug” for CFS by the FDA, for the purpose of this trial.]

Abstract:
Background: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a severely debilitating disease of unknown pathogenesis consisting of a variety of symptoms including severe fatigue.

The objective of the study was to examine the efficacy and safety of a TLR-3 agonist, rintatolimod (Poly I: C12U), in patients with debilitating CFS/ME.

Methods and Findings: A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV rintatolimod versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites.

The primary endpoint was the intra-patient change from baseline at Week 40 in exercise tolerance (ET).

Secondary endpoints included concomitant drug usage, the Karnofsky Performance Score (KPS), Activities of Daily Living (ADL), and Vitality Score (SF 36).

Subjects receiving rintatolimod [Ampligen] for 40 weeks improved intra-patient placebo-adjusted exercise tolerance 21.3% (p = 0.047) from baseline in an intention-to-treat analysis.

Correction for subjects with reduced dosing compliance increased placebo-adjusted exercise tolerance improvement to 28% (p = 0.022).

• The improvement observed represents approximately twice the minimum considered medically significant by regulatory agencies.

• The rintatolimod cohort vs. placebo also reduced dependence on drugs commonly used by patients in an attempt to alleviate the symptoms of CFS/ME (p = 0.048).

• Placebo subjects crossed-over to receive rintatolimod [Ampligen] demonstrated an intra-patient improvement in exercise tolerance performance at 24 weeks of 39% (p = 0.04). Rintatolimod at 400 mg twice weekly was generally well-tolerated.

Conclusions/Significance: Rintatolimod [Ampligen] produced objective improvement in exercise tolerance and a reduction in CFS/ME related concomitant medication usage as well as other secondary outcomes.

Trial Registration: ClinicalTrials.gov NCT00215800
 
Source: PloS One, Mar 14, 2012. Strayer DR, Carter WA, Stouch BC, Stevens SR, Bateman L, Cimoch PJ, Lapp CW, Peterson DL, Chronic Fatigue Syndrome AMP-516 Study Group, Mitchell WM. Hemispherx Biopharma, Inc., Philadelphia, Pennsylvania; BCS Consulting, Philadelphia; University of the Pacific, Stockton, California; Fatigue Consultation Clinic, Salt Lake City, Utah; Center for Special Immunology, Fountain Valley, California; Hunter-Hopkins Center, Charlotte, North Carolina; Sierra Internal Medicine Associates, Incline Village, Nevada; Vanderbilt University School of Medicine, Nashville, Tennessee, USA.





Post a Comment

Featured Products From the ProHealth Store
Optimized Curcumin Longvida® Vitamin D3 Extreme™ FibroSleep™


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

SAD? Coping with Seasonal Affective Disorder SAD? Coping with Seasonal Affective Disorder
Natural Relief for Soreness, Pain and Swelling - Putting Out the Fire Natural Relief for Soreness, Pain and Swelling - Putting Out the Fire
The Super Antioxidant for Brain, Joint and Heart Health The Super Antioxidant for Brain, Joint and Heart Health
Three-Step Strategy to Reverse Mitochondrial Aging Three-Step Strategy to Reverse Mitochondrial Aging
Vitamin E: Super Antioxidant We Only Thought We Knew Vitamin E: Super Antioxidant We Only Thought We Knew

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map