ProHealth fibromyalgia 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

The best sleeping positions for pain

VIDEO: Anxiety: 11 Things We Want You to Understand

Is There a GERD—Fibro Connection?

Beyond pain in fibromyalgia: insights into the symptom of fatigue.

Chronic Pain, Loneliness, Depression and Suicide

Stair negotiation in women with fibromyalgia: A descriptive correlational study.

Things to Do When You're Mostly Housebound

Could a Diet Reduce the Pain in Fibromyalgia? A FODMAPS Study Suggests Yes

Is a Good Night's Sleep at the Top of Your Wishlist?

When Everybody has a Plan in Life Except You

 
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
Guaifenesin FA™ FibroSleep™ Fibro Freedom™


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Guaifenesin FA™ Guaifenesin FA™
Helps the Body Eliminate Excess Calcium and Phosphates
Fibro Freedom™ Fibro Freedom™
Soothes, Strengthens & Revitalizes
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health

Natural Remedies

The Fast-Acting Solution for Healthy Digestive Function The Fast-Acting Solution for Healthy Digestive Function
Carry a Massage Therapist in Your Pocket Carry a Massage Therapist in Your Pocket
Breaking Through the Mental Fog Breaking Through the Mental Fog
A Hard-Working Molecule that May Help Ease Pain & Brighten Mood A Hard-Working Molecule that May Help Ease Pain & Brighten Mood
Guarding Against the Dangers of Vitamin D Deficiency Guarding Against the Dangers of Vitamin D Deficiency

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