Activate Now
 
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

Patient Insights into the Design of Technology to Support a Strengths-Based Approach to Health Care.

Greater intake of dietary omega-3 fatty acids associated with lower risk of diabetic retinopathy

SURVEY: Weight Management & Chronic Illness

Japanese green tea consumers have reduced risk of dementia

Do Nothing, Accomplish Everything! The Connection Between Breathing and Healing

Nature Heals

Best Herbs to Help With Insomnia

Meet the ProHealth Editors

Choline: Why You Should Eat Your Egg Yolks and Take Krill

Calcium, vitamin D supplementation associated improved stroke recovery

 
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
Ultra ATP+, Double Strength Optimized Curcumin Longvida® Energy NADH™ 12.5mg

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
Natural Pain Relief Supplements

Featured Products

FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium

Natural Remedies

Block food Cravings At Their Molecular Root Block food Cravings At Their Molecular Root
The Curcumin Revolution: 'Golden' Ticket to Better Health The Curcumin Revolution: 'Golden' Ticket to Better Health
More Weight Loss than Any Other Discovery in Supplement History More Weight Loss than Any Other Discovery in Supplement History
The New Dual Activation Pain Relief Cream The New Dual Activation Pain Relief Cream
Coenzyme Q10 - The Energy Maker Coenzyme Q10 - The Energy Maker

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 AND SAVE 15% NOW*
Be the first to know about new products, special discounts and the latest health news. *New subscribers only

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

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map