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

Acupuncture used in clinical settings reduced symptoms of menopause

Benefits of Coconut Oil Are Undeniable

How Awesome Is Ashwagandha?

Mediterranean Herb Guards Vital Liver Functions

SURVEY RESULTS: Should Opioids Be Restricted for Chronic Illness?

CoQ10 supplementation associated with lower pro-inflammatory factors in randomized trial

Clinical trial demonstrates success of low FODMAP diet

Research Demonstrates Superiority of Krill Oil Compared to Fish Oil

Vitamin nicotinamide riboside protects mice from diabetes complications

Vitamin-mineral supplement prevents brain cell loss in recent research

 
Print Page
Email Article

Development of responder definitions for fibromyalgia clinical trials – Source: Arthritis & Rheumatism, Sep 27, 2011

  [ 6 votes ]   [ Discuss This Article ]
By Lesley M Arnold, et al. • www.ProHealth.com • September 30, 2011


Objective: To develop responder definitions for fibromyalgia clinical trials using key symptom and functional domains.

Methods:
24 candidate responder definitions were developed by expert consensus and evaluated in 12 randomized, placebo-controlled fibromyalgia trials of 4 medications.

For each definition, treatment effects of the medication compared with placebo were analyzed using the Cochran-Mantel-Haenszel test or Chi Square test.

A meta-analysis of the pooled results for the 4 medications established risk ratios to determine the definitions that best favored medication over placebo.

Results:

Two definitions performed best in the analyses.

Both definitions included 30% or greater reduction in pain and 10% or greater improvement in physical function.

They differed in that:

• One (FM30 short version) included 30% or greater improvement in sleep or fatigue,

• And the other (FM30 long version) required 30% or greater improvement in 2 of the following symptoms: sleep, fatigue, depression, anxiety, or cognition.

In the analysis of both versions, the response rate was 15% or greater for each medication and significantly greater than placebo.

The risk ratio favoring drug over placebo (95% CI) in the pooled analysis for the FM30 short version was 1.50 (1.24, 1.82), P 0.0001 or less; the FM30 long version was 1.60 (1.31, 1.96), P 0.00001 or less. [Note: a risk ratio of 1.0 would indicate no difference vs the placebo. RR’s of 1.50 and 1.60 would indicate a 50% greater response rate than placebo required with the FM30 short version and 60% greater response rate required with the FM30 long version, respectively.]

Conclusion:


Among the 24 responder definitions tested, 2 were identified as most sensitive in identifying response to treatment.

The identification of responder definitions for fibromyalgia clinical trials that include assessments of key symptom and functional domains may improve the sensitivity of clinical trials to identify meaningful improvements, leading to improved management of fibromyalgia.

Source:
Arthritis & Rheumatism, Sep 27, 2011. PMID: 21953205 by Arnold LM, Williams DA, Hudson JI, Martin SA, Clauw DJ, Crofford LJ, Wang F, Emir B, Lai C, Zablocki R, Mease PJ. University of Cincinnati College of Medicine, Cincinnati, Ohio; University of Michigan Medical School, Ann Arbor, Michigan;  Harvard Medical School/McLean Hospital, Belmont, Massachusetts; RTI-Health Solutions, Ann Arbor, Michigan; University of Kentucky, Lexington, Kentucky; Eli Lilly and Company, Indianapolis, Indiana; Pfizer, Inc., New York, New York; Jazz Pharmaceuticals, Inc., Palo Alto, California; Cypress Bioscience, Inc. San Diego, California; Swedish Medical Center, and University of Washington, Seattle, Washington, USA. [Email -
Lesley.Arnold@uc.edu]





Post a Comment

Featured Products From the ProHealth Store
Ultra ATP+, Double Strength FibroSleep™ Vitamin D3 Extreme™

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


 
All Natural Deodorants

Featured Products

Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10 Ubiquinol - A More Advanced Form of the Energy Producing Nutrient CoQ-10
The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol The Most Powerful Natural Antioxidant Discovered to Date - Hydroxytyrosol
Undenatured Type II Collagen - Chicken Soup for Your Joints Undenatured Type II Collagen - Chicken Soup for Your Joints
Herbal Rescue for High Blood Sugar Herbal Rescue for High Blood Sugar
Sunshine Vitamin Has D-lightful Health Benefits Sunshine Vitamin Has D-lightful Health Benefits

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

· Become a Wholesaler

· 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. Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map