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

SURVEY: Cognitive Impairment II

Top 3 Nutrients to Detox the Liver and Soothe Digestion

Natural Bladder Control, Go Less and Live More

Top Vitamin and Mineral Deficiencies — Are You at Risk?

Vital Molecule Increases Cellular Energy and Improves Cognitive Function

Omega Fix for Obesity: How the Right Fats Fight Fat

How Pomegranate May Protect Against Cancer

Potential of Quercetin in the Treatment of Melanoma

Trimming the spare tire: Canola oil may cut belly fat

Supplementation with vitamins C and E associated with decreased risk of cognitive impairment, dement...

 
Print Page
Email Article

Study Reports: ULTRACET Effective for Treating Fibromyalgia Pain

  [ 1338 votes ]   [ Discuss This Article ]
www.ProHealth.com • July 2, 2003


Announcement from The National Fibromyalgia Association

Orange, CA, June 12, 2003 - The National Fibromyalgia Association (NFA) announced today that a recent study published in the American Journal of Medicine reports that ULTRACET (tramadol hydrochloride/ acetaminophen) has been found to effectively reduce pain in people with fibromyalgia.

Currently there are no medications approved for the treatment of fibromyalgia in the U.S., so the study's findings provide significant hope for patient's searching for ways to effectively manage the chronic pain of this severe disorder.

Fibromyalgia (FM) is a complex chronic pain illness that can lead to significant patient disability. The fact that there is no known cause or cure for fibromyalgia challenges patients and healthcare professionals alike. It is estimated that FM affects approximately six to eight million Americans and 5% of the world's population. Patients with fibromyalgia suffer from a variety of symptoms ranging from stiffness, muscle spasms and body wide pain, fatigue and severe sleep disturbances.

The study published in the American Journal of Medicine was lead by researcher Robert M. Bennett, M.D., a pain specialist at the Oregon Health and Science University. He compared ULTRACET (37.5 mg tramadol hydrochloride/325 mg acetaminophen tablets) to placebo in 315 fibromyalgia patients. Patients who used ULTRACET experienced significantly better pain relief, as indicated by statistical analysis, than those who received placebo.

Although Ultracet has received some exposure in the medical industry, not all physicians know about it. "A lot of patients actually have to educate their doctor," notes Bennett, "but they might want to do it diplomatically," he adds.

In the U.S., ULTRACET is approved for the treatment of short-term (five days or less) management of acute pain. The efficacy of ULTRACET in treating pain is based on the value of the drug's two components-tramadol hydrochloride and acetaminophen.

About Fibromyalgia:

Fibromyalgia is a chronic pain disorder that affects people of all genders and ages. The condition is identified by widespread severe musculoskeletal pain, fatigue, and tenderness in localized areas. These areas, called "tender points," can be palpated in the head, neck, shoulder region, arms, hands, lower back, hips, thighs, and knees.

Although physicians have noted the existence of fibromyalgia symptoms in patients for centuries, it was only recognized as a medical disorder during the 1980s. The American College of Rheumatology set up diagnostic for criteria for the condition in 1990. Diagnosis is difficult as it relies on the patient's ability to rate his or her own pain and as of yet, cannot be quantified by laboratory tests. Further complicating diagnosis, fibromyalgia pain can also be accompanied by other conditions including irritable bowel syndrome, restless leg syndrome, Raynaud's syndrome and depression.

Physicians prescribe a variety of medications in an attempt to alleviate the patients' symptoms, as there is no single successful treatment for fibromyalgia. Current treatment options for pain associated with fibromyalgia include physical therapy, nonsteroidal anti-inflammatory drugs and muscle relaxants that may provide temporary relief.

Study Details

This 91-day, multi-center, outpatient, double-blind, randomized, placebo-controlled study compared ULTRACET tablets to placebo. Outcome variables included cumulative time to discontinuation (Kaplan-Meier analysis), final pain visual analog scale scores, final pain relief rating scale scores, total tender points, average myalgic scores, SF-36 Health Survey scores and Fibromyalgia Impact Questionnaire scores.

These scales were used for overall statistical analysis and to evaluate patient responses.

Of 315 patients randomized, 313 (294 women [94%], mean age 50 + 10) completed >1 post-randomization efficacy assessments (n = 156 tramadol/acetaminophen; n = 157 placebo). The Kaplan-Meier analysis of final discontinuation rates for any reason demonstrated significantly better performance with ULTRACET compared with placebo (P = 0.004). ULTRACET patients had significantly better final pain visual analog scale scores, final pain relief rating scale scores, and total Fibromyalgia Impact Questionnaire scores. SF-36 indices of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the ULTRACET patients, indicating statistically significantly higher levels of pain relief in patients taking ULTRACET than placebo.

Adverse event discontinuation occurred in 19% (29/156) of ULTRACET and 12% (18/156) of placebo patients. The most common treatment-emergent adverse events in the ULTRACET vs. placebo groups were nausea (20% vs. 12%), headache (14% vs. 10%), and pruritus (12% vs. 4%). The average dose of ULTRACET was 4.0 tablets/day (+ 1.8). ULTRACET tablets contain 37.5 mg tramadol hydrochloride and 325 mg acetaminophen.

About ULTRACET

ULTRACET combines tramadol, a leading prescription pain reliever, with acetaminophen, the most commonly recommended nonprescription pain treatment. Single-dose dental pain studies demonstrated that the ULTRACET combination of tramadol and acetaminophen provides faster onset than tramadol alone as well as longer duration and better pain relief over either medication alone.

Tramadol is a non-scheduled, centrally acting synthetic opioid analgesic. Acetaminophen is a non-opiate, non-salicylate analgesic that is often combined with other medications to enhance efficacy. ULTRACET was approved in the U.S. in August 2001.

ULTRACET is indicated for the short-term (five days or less) management of acute pain.

ULTRACET is a centrally acting analgesic that controls pain via different mechanisms of action than non-steroidal anti-inflammatory drugs (NSAIDs), the most commonly used pain medications.

ULTRACET is not an NSAID, and is not associated with potentially life-threatening gastrointestinal ulcers or bleeding that can occur with NSAIDs and the newer COX-2 NSAIDs. In addition, ULTRACET does not compromise the efficacy of certain antihypertensive agents, while NSAIDs and COX-2 NSAIDs may. ULTRACET can also be prescribed in sulfa-sensitive patients. The most frequently reported side effects with ULTRACET listed in the prescribing information are constipation (6%), somnolence (sleepiness) (6%), and increased sweating (4%).

ULTRACET should not be used concomitantly with alcohol. The use of ULTRACET in patients with liver disease is not recommended.

------------------------------------

FOR MORE INFORMATION CONTACT: Lynne Matallana, President - National Fibromyalgia Association - (714) 921-0150 - LMatallana@fmaware.org



Post a Comment

Featured Products From the ProHealth Store
FibroSleep™ Ultra EPA  - Fish Oil Energy NADH™ 12.5mg


Article Comments



Be the first to comment on this article!

Post a Comment


 
Natural Pain Relief Supplements

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%
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils

Natural Remedies

Probiotic Mint Promotes Healthy Gums & Teeth, Freshens Breath and Whitens Teeth Probiotic Mint Promotes Healthy Gums & Teeth, Freshens Breath and Whitens Teeth
Are You Obtaining the Proper Enzymes? Are You Obtaining the Proper Enzymes?
Vitamin K-2 – A Key Player in Cardiovascular and Bone Health Vitamin K-2 – A Key Player in Cardiovascular and Bone Health
Herbal Rescue for High Blood Sugar Herbal Rescue for High Blood Sugar
Herbal Inflammation Management for Whole Body Health Herbal Inflammation Management for Whole Body Health

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

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