ProHealth health Vitamin and Natural Supplement Store and Health
Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help

|
|
|
|
 
Print Page
Email Article

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

  [ 6 votes ]   [ Post a Comment ]
By Lesley M Arnold, et al. • www.ProHealth.com • September 30, 2011

previous article next article

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]



previous article
  Rating 5 (6 votes) next article




DISCUSS THIS ARTICLE   (0 existing comments) Post a Comment 




[ Be the first to comment on this article ]




 
Free Chronic Fatigue Syndrome and Fibromyalgia Newsletters
Subscribe to
Our FREE
Newsletter
Subscribe Now!
Receive up-to-date ME/CFS & Fibromyalgia treatment and research news
 Privacy Guaranteed  |  View Archives

Save on Your Next Order

Featured Products
Vitamin D3 5000 IU Vitamin D3 5000 IU
Give your body a boost with the sunshine vitamin
Omega 3-6-9 Omega 3-6-9
All three EFAs in one convenient form
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Natural Resveratrol Natural Resveratrol
Powerful Antioxidant Support + Positive Anti-aging Effects
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Most Viewed Articles
What's the Hidden Cause Behind YOUR Fibromyalgia Flares? [more]

Pridgen Reports Fibromyalgia Antiviral Trial Results “Very Positive”: Predicts New Approach Will Be ... [more]

How to Limit or Minimize Your Fibromyalgia Flare [more]

VIDEO: IACFS/ME Conference - Summary of Research by Dr. Komaroff [more]

Mitochondrial Dysfunction, Post-Exertional Malaise and CFS/ME [more]

The Devil Is In The Details – A Herpes Simplex Virus Inquiry For Fibromyalgia and Chronic Fatigue Sy... [more]

Sympathetic Nervous System Dysfunction in FIbromyalgia and Overlapping Conditions [more]

Review of Nutritional Supplements Used for ME/CFS and FM [more]

FREE: Stop Feeding Yourself PAIN Guide [more]

Sympathetic nervous system dysfunction in fibromyalgia, chronic fatigue syndrome, irritable bowel sy... [more]


FIBROMYALGIA RESOURCES
What is Fibromyalgia?
Fibromyalgia 101
Fibromyalgia Symptoms
Fibromyalgia Treatments
| CFS RESOURCES
What is CFS?
ME/CFS 101
ME/CFS Symptoms
ME/CFS Treatments
| FORUMS
Fibromyalgia
ME/CFS
ADVANCED MEDICAL LABS
WHOLESALE  |  AFFILIATES
GUARANTEE
CONTACT US
PRIVACY
RSS
SITE MAP
ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus
Credit Card Processing