TY - JOUR
T1 - Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain
T2 - A double-blind, randomized, placebo-controlled study
AU - Bennett, Robert M.
AU - Kamin, Marc
AU - Karim, Rezaul
AU - Rosenthal, Norman
PY - 2003/5
Y1 - 2003/5
N2 - PURPOSE: To evaluate the efficacy and safety of a combination analgesic tablet (37.5 mg tramadol/325 mg acetaminophen) for the treatment of fibromyalgia pain. METHODS: This 91-day, multicenter, double-blind, randomized, placebo-controlled study compared tramadol/acetaminophen combination tablets with placebo. The primary outcome variable was cumulative time to discontinuation (Kaplan-Meier analysis). Secondary measures at the end of the study included pain, pain relief, total tender points, myalgia, health status, and Fibromyalgia Impact Questionnaire scores. RESULTS: Of the 315 subjects who were enrolled in the study, 313 (294 women [94%], mean [± SD] age, 50 ± 10 years) completed at least one postrandomization efficacy assessment (tramadol/acetaminophen: n = 156; placebo: n = 157). Discontinuation of treatment for any reason was less common in those treated with tramadol/acetaminophen compared with placebo (48% vs. 62%, P = 0.004). Tramadol/acetaminophen-treated subjects also had significantly less pain at the end of the study (53 ± 32 vs. 65 ± 29 on a visual analog scale of 0 to 100, P <0.001), and better pain relief (1.7 ± 1.4 vs. 0.8 ± 1.3 on a scale of -1 to 4, P <0.001) and Fibromyalgia Impact Questionnaire scores (P = 0.008). Indexes of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the tramadol/acetaminophen-treated subjects. Discontinuation due to adverse events occurred in 19% (n = 29) of tramadol/acetaminophen-treated subjects and 12% (n = 18) of placebo-treated subjects (P = 0.09). The mean dose of tramadol/acetaminophen was 4.0 ± 1.8 tablets per day. CONCLUSION: A tramadol/acetaminophen combination tablet was effective for the treatment of fibromyalgia pain without any serious adverse effects.
AB - PURPOSE: To evaluate the efficacy and safety of a combination analgesic tablet (37.5 mg tramadol/325 mg acetaminophen) for the treatment of fibromyalgia pain. METHODS: This 91-day, multicenter, double-blind, randomized, placebo-controlled study compared tramadol/acetaminophen combination tablets with placebo. The primary outcome variable was cumulative time to discontinuation (Kaplan-Meier analysis). Secondary measures at the end of the study included pain, pain relief, total tender points, myalgia, health status, and Fibromyalgia Impact Questionnaire scores. RESULTS: Of the 315 subjects who were enrolled in the study, 313 (294 women [94%], mean [± SD] age, 50 ± 10 years) completed at least one postrandomization efficacy assessment (tramadol/acetaminophen: n = 156; placebo: n = 157). Discontinuation of treatment for any reason was less common in those treated with tramadol/acetaminophen compared with placebo (48% vs. 62%, P = 0.004). Tramadol/acetaminophen-treated subjects also had significantly less pain at the end of the study (53 ± 32 vs. 65 ± 29 on a visual analog scale of 0 to 100, P <0.001), and better pain relief (1.7 ± 1.4 vs. 0.8 ± 1.3 on a scale of -1 to 4, P <0.001) and Fibromyalgia Impact Questionnaire scores (P = 0.008). Indexes of physical functioning, role-physical, body pain, health transition, and physical component summary all improved significantly in the tramadol/acetaminophen-treated subjects. Discontinuation due to adverse events occurred in 19% (n = 29) of tramadol/acetaminophen-treated subjects and 12% (n = 18) of placebo-treated subjects (P = 0.09). The mean dose of tramadol/acetaminophen was 4.0 ± 1.8 tablets per day. CONCLUSION: A tramadol/acetaminophen combination tablet was effective for the treatment of fibromyalgia pain without any serious adverse effects.
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U2 - 10.1016/S0002-9343(03)00116-5
DO - 10.1016/S0002-9343(03)00116-5
M3 - Article
C2 - 12753877
AN - SCOPUS:0037716856
SN - 0002-9343
VL - 114
SP - 537
EP - 545
JO - American Journal of Medicine
JF - American Journal of Medicine
IS - 7
ER -