TY - JOUR
T1 - Low-dose cyclobenzaprine versus combination therapy with ibuprofen for acute neck or back pain with muscle spasm
T2 - A randomized trial
AU - Childers, Martin K.
AU - Borenstein, David
AU - Brown, Richard L.
AU - Gershon, Steven
AU - Hale, Martin E.
AU - Petri, Michelle
AU - Wan, George J.
AU - Laudadio, Charles
AU - Harrison, Diane D.
N1 - Funding Information:
Declaration of interest: This study (Protocol 19-401) was supported by McNeil Consumer & Specialty Pharmaceuticals.
PY - 2005/9
Y1 - 2005/9
N2 - Objective: This prospective, randomized, open-label, multicenter, community-based study was conducted to compare cyclobenzaprine 5 mg three times daily (TID) orally (CYC5) given for 7 days as monotherapy or in combination with ibuprofen 400 mg TID (CYC5/IBU400) or 800 mg TID (CYC5/ IBU800) in adults with acute neck or back pain with muscle spasm. Study design: Eligible patients were 18-65 years old, had cervical or thoracolumbar pain and spasm for ≤ 14 days, and, aside from the prescribed study medications, discontinued treatment with all analgesics, anti-inflammatory agents, and skeletal muscle relaxants during the study period. Randomization was 1:1:1 to the three treatment groups. Treatment outcome was assessed after 3 and 7 days of therapy using five patient-rated scales: spasm, pain, patient global impression of change (PGIC), medication helpfulness, and Oswestry Disability Index (ODI). Results: A total of 867 patients provided postbaseline data and were included in the intent-to-treat population (CYC5, n = 288; CYC5/ IBU400, n = 286; CYC5/IBU800, n = 293). All three treatment groups demonstrated significant improvements from baseline in PGIC, spasm, pain, ODI, and medication helpfulness (p < 0.001 for all comparisons) after 3 and 7 days of therapy. There were no significant differences in mean PGIC among groups after 3 days of therapy (p = 0.65 for treatment effect) or after 7 days of therapy (primary endpoint; p = 0.41). A PGIC responder analysis of changes from baseline showed that 88% and 93% of patients reported at least mild improvement after 3 and 7 days of therapy, respectively. All three treatments were well tolerated, with no significant differences between treatments regarding the number of adverse events (AEs) reported or number of patients reporting AEs. The most common AEs in all groups were fatigue, somnolence, dizziness, sedation, and nausea. Limitations of this study include an unblinded design and possible introduction of bias into efficacy and safety results by use of a voluntary telephone reporting system. Conclusions: This randomized, community-based clinical trial demonstrated that combination therapy with cyclobenzaprine 5 mg TID plus ibuprofen was not superior to cyclobenzaprine 5 mg TID alone in adult patients with acute neck and back pain with muscle spasm. All treatments were well tolerated.
AB - Objective: This prospective, randomized, open-label, multicenter, community-based study was conducted to compare cyclobenzaprine 5 mg three times daily (TID) orally (CYC5) given for 7 days as monotherapy or in combination with ibuprofen 400 mg TID (CYC5/IBU400) or 800 mg TID (CYC5/ IBU800) in adults with acute neck or back pain with muscle spasm. Study design: Eligible patients were 18-65 years old, had cervical or thoracolumbar pain and spasm for ≤ 14 days, and, aside from the prescribed study medications, discontinued treatment with all analgesics, anti-inflammatory agents, and skeletal muscle relaxants during the study period. Randomization was 1:1:1 to the three treatment groups. Treatment outcome was assessed after 3 and 7 days of therapy using five patient-rated scales: spasm, pain, patient global impression of change (PGIC), medication helpfulness, and Oswestry Disability Index (ODI). Results: A total of 867 patients provided postbaseline data and were included in the intent-to-treat population (CYC5, n = 288; CYC5/ IBU400, n = 286; CYC5/IBU800, n = 293). All three treatment groups demonstrated significant improvements from baseline in PGIC, spasm, pain, ODI, and medication helpfulness (p < 0.001 for all comparisons) after 3 and 7 days of therapy. There were no significant differences in mean PGIC among groups after 3 days of therapy (p = 0.65 for treatment effect) or after 7 days of therapy (primary endpoint; p = 0.41). A PGIC responder analysis of changes from baseline showed that 88% and 93% of patients reported at least mild improvement after 3 and 7 days of therapy, respectively. All three treatments were well tolerated, with no significant differences between treatments regarding the number of adverse events (AEs) reported or number of patients reporting AEs. The most common AEs in all groups were fatigue, somnolence, dizziness, sedation, and nausea. Limitations of this study include an unblinded design and possible introduction of bias into efficacy and safety results by use of a voluntary telephone reporting system. Conclusions: This randomized, community-based clinical trial demonstrated that combination therapy with cyclobenzaprine 5 mg TID plus ibuprofen was not superior to cyclobenzaprine 5 mg TID alone in adult patients with acute neck and back pain with muscle spasm. All treatments were well tolerated.
KW - Back pain
KW - Muscle relaxants
KW - Musculoskeletal pain
KW - NSAIDs
KW - Neck pain
KW - Spasm
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U2 - 10.1185/030079905X61938
DO - 10.1185/030079905X61938
M3 - Article
C2 - 16197668
AN - SCOPUS:25444452956
SN - 0300-7995
VL - 21
SP - 1485
EP - 1493
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
IS - 9
ER -