Data Suggests Taken Alone As Effective As When Taken In Combination With Ibuprofen - Large scale community-based study
shows NSAID offers no additional benefit to muscle relaxant in treatment of acute pain and muscle spasm of the back or
neck
More is not necessarily better when it comes to treating acute muscle pain and spasm of the back or neck, suggest results from the first community-based trial to evaluate the benefits of adding a non-steroidal anti inflammatory (NSAID) to treatment with a commonly prescribed muscle relaxant. According to the study, the muscle relaxant FLEXERIL 5 mg (cyclobenzaprine HCl), taken three times a day, is as effective alone as when taken in combination with ibuprofen at over-the-counter (OTC) or prescription doses.
More than 770 adult back and neck pain and muscle spasm sufferers at multiple community-based sites throughout the United States completed the randomized, multi-center, open-label one-week study, which compared thrice-daily treatment with FLEXERIL 5 mg alone or in combination with ibuprofen at over-the-counter (1,200 mg/day) or prescription doses (2,400 mg/day). Researchers shared results of the trial today at the 2004 Scientific Assembly of the American College of Emergency Physicians. A final report, including full data on all endpoints, will be completed soon.
"In clinical practice, acute muscle pain with spasm is often treated with an non-steroidal anti-inflammatory drug (NSAID) alone or in combination with a muscle relaxant," explained Martin Childers, D.O., Ph.D., associate professor, Department of Physical Medicine and Rehabilitation, School of Medicine, University of Missouri-Columbia. :The data from this study indicates that the addition of ibuprofen offers no further pain relief compared to taking FLEXERIL 5 mg alone."
About the Study
Men and women between 18 and 65 years of age with acute muscle pain with spasm of the neck or back of up to 14 days participated in the seven-day study conducted by more than 100 physicians. Patients self-reported pain intensity and muscle spasm intensity at baseline and after three and seven days of randomized treatment of FLEXERIL 5 mg three-times-a-day alone or in combination therapy with over-the-counter ibuprofen 400 mg three times a day (tid) or prescription dose ibuprofen 800 mg tid.
Results showed that all three treatments had statistically significant improvements for both spasm and pain from baseline after three and seven days of therapy. Additionally, the changes from baseline were significantly greater after one week of therapy than after three days for all three treatments for spasm and pain. This treatment duration finding was expected and consistent with previous studies. There were no statistically significant differences among the groups.
The types of adverse events observed in this study were consistent with the known safety profiles of these medications.
About FLEXERIL 5 mg
FLEXERIL 5 mg should be used for relief of painful muscle spasm along with rest and physical therapy. It should only be used for short periods of time, usually two-three weeks. FLEXERIL 5 mg is a prescription medicine and should not be taken by patients who have had a recent heart attack or have heart disease. It should not be used by people with an overactive thyroid or who are currently or have recently used MAOIs. Use of FLEXERIL 5 mg with MAOIs can result in serious health complications.
FLEXERIL 5 mg may enhance the effects of alcohol and other medicines that work on the central nervous system. In clinical studies the most common side effects were drowsiness, dry mouth and fatigue. For more information about FLEXERIL 5 mg, including full U.S. Prescribing Information, visit http://www.flexeril5mg.com or call 1-888-440-7903.
Previously published data demonstrates that the 5 mg and 10 mg strengths of FLEXERIL are comparable in their ability to provide clinically significant relief from the pain of acute musculoskeletal spasm of the back and neck, although patients taking FLEXERIL 5 mg report significantly less drowsiness than patients taking the 10 mg tablet.
More is not necessarily better when it comes to treating acute muscle pain and spasm of the back or neck, suggest results from the first community-based trial to evaluate the benefits of adding a non-steroidal anti inflammatory (NSAID) to treatment with a commonly prescribed muscle relaxant. According to the study, the muscle relaxant FLEXERIL 5 mg (cyclobenzaprine HCl), taken three times a day, is as effective alone as when taken in combination with ibuprofen at over-the-counter (OTC) or prescription doses.
More than 770 adult back and neck pain and muscle spasm sufferers at multiple community-based sites throughout the United States completed the randomized, multi-center, open-label one-week study, which compared thrice-daily treatment with FLEXERIL 5 mg alone or in combination with ibuprofen at over-the-counter (1,200 mg/day) or prescription doses (2,400 mg/day). Researchers shared results of the trial today at the 2004 Scientific Assembly of the American College of Emergency Physicians. A final report, including full data on all endpoints, will be completed soon.
"In clinical practice, acute muscle pain with spasm is often treated with an non-steroidal anti-inflammatory drug (NSAID) alone or in combination with a muscle relaxant," explained Martin Childers, D.O., Ph.D., associate professor, Department of Physical Medicine and Rehabilitation, School of Medicine, University of Missouri-Columbia. :The data from this study indicates that the addition of ibuprofen offers no further pain relief compared to taking FLEXERIL 5 mg alone."
About the Study
Men and women between 18 and 65 years of age with acute muscle pain with spasm of the neck or back of up to 14 days participated in the seven-day study conducted by more than 100 physicians. Patients self-reported pain intensity and muscle spasm intensity at baseline and after three and seven days of randomized treatment of FLEXERIL 5 mg three-times-a-day alone or in combination therapy with over-the-counter ibuprofen 400 mg three times a day (tid) or prescription dose ibuprofen 800 mg tid.
Results showed that all three treatments had statistically significant improvements for both spasm and pain from baseline after three and seven days of therapy. Additionally, the changes from baseline were significantly greater after one week of therapy than after three days for all three treatments for spasm and pain. This treatment duration finding was expected and consistent with previous studies. There were no statistically significant differences among the groups.
The types of adverse events observed in this study were consistent with the known safety profiles of these medications.
About FLEXERIL 5 mg
FLEXERIL 5 mg should be used for relief of painful muscle spasm along with rest and physical therapy. It should only be used for short periods of time, usually two-three weeks. FLEXERIL 5 mg is a prescription medicine and should not be taken by patients who have had a recent heart attack or have heart disease. It should not be used by people with an overactive thyroid or who are currently or have recently used MAOIs. Use of FLEXERIL 5 mg with MAOIs can result in serious health complications.
FLEXERIL 5 mg may enhance the effects of alcohol and other medicines that work on the central nervous system. In clinical studies the most common side effects were drowsiness, dry mouth and fatigue. For more information about FLEXERIL 5 mg, including full U.S. Prescribing Information, visit http://www.flexeril5mg.com or call 1-888-440-7903.
Previously published data demonstrates that the 5 mg and 10 mg strengths of FLEXERIL are comparable in their ability to provide clinically significant relief from the pain of acute musculoskeletal spasm of the back and neck, although patients taking FLEXERIL 5 mg report significantly less drowsiness than patients taking the 10 mg tablet.
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