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Research News Briefs

September 16, 2003

Study Reports: ULTRACET Effective for Treating Fibromyalgia Pain

The National Fibromyalgia Association (NFA) announced on June 12, 2003 that a recent study reports that ULTRACET (tramadol hydrochloride/acetaminophen) has been found to effectively reduce pain in people with fibromyalgia. The study, published in the American Journal of Medicine, was led by researcher Robert M. Bennett, M.D., a pain specialist at the Oregon Health and Science University. In the 91-day, multi-center, outpatient, double-blind, randomized, placebo-controlled study, Dr. Bennett 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. 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.

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 Dr. 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. (Source: Announcement from The National Fibromyalgia Association by Lynne Matallana, President. Website: http://www.fmaware.org.)

Lactic Acid Bacteria Helps CFS?

Research at the CFS-FM Integrative Care Centre in Toronto, Canada showed that patients with CFS have marked alterations in microbial flora, including lowered levels of bifidobacteria and small intestinal bacterial overgrowth (SIBO). The researchers cited other studies that indicated that CFS patients are under increased oxidative stress, have a type 2 helper cell dominated cytokine profile, frequently report allergies, have altered essential fatty acid (EFA) status and may have malabsorption of certain micronutrients. The researchers proposed that lactic acid bacteria (LAB) have the potential to influence the immune system in CFS patients by supporting T helper cell 1 driven cellular immunity and may decrease allergies.

In addition, LAB are strong antioxidants, may improve EFA status, can enhance absorption of micronutrients by protecting the intestinal epithelial barrier, and have been used to treat SIBO. For these reasons, the researchers concluded that LAB may have a therapeutic role in the treatment of CFS. (Source: Logan AC, Venket Rao A, Irani D. Med Hypotheses 2003 Jun;60(6):915-23.)

Collagen and Muscle Pathology in FM Patients

Muscle biopsies were obtained from 27 female fibromyalgia (FM) patients, and from eight age-matched female control subjects. Amino acids were determined by HPLC and electron microscopy was performed.

The FM patients had lower hydroxyproline and lower total concentration of the major amino acids of collagen than the controls. No significant difference was seen in the concentration of the major amino acids of myosin or of total protein. Electron microscopy showed no significant differences between FM patients and controls although atrophied muscle fibrils occurred in FM patients only, but frequencies were not significantly different. It was concluded that the fibromyalgia patients studied had a significantly lower amount of intramuscular collagen. This may lower the threshold for muscle micro-injury and thereby result in non-specific signs of muscle pathology. (Source: Rheumatology (Oxford). 2003 Jul 16. Gronemann ST, Ribel-Madsen S, Bartels EM, Danneskiold-Samsoe B, Bliddal H.)

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