A randomized, placebo- and active-controlled, multi-country, multi-center parallel group trial to evaluate the efficacy and safety of a fixed-dose combination of 400 mg ibuprofen and 100 mg caffeine compared with ibuprofen 400 mg and placebo in patients with acute lower back or neck pain
Journal of Pain Research Sep 29, 2019
Predel HG, et al. - The efficacy of a fixed-dose combination of ibuprofen and caffeine was compared with that of ibuprofen or placebo for the treatment of acute lower back/neck pain. In this randomized trial, randomization of 635 patients was done (256 ibuprofen + caffeine: 253 ibuprofen: 126 placebo). All active treatment arms showed a reduced change in pain on movement indicating a decrease in lower back/neck pain; however, treatment effects were small vs placebo. Findings did not support the superiority of ibuprofen plus caffeine over ibuprofen alone or placebo for the treatment of acute lower back/neck pain in this setting.
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