Efficacy and tolerability of orally administered tramadol/dexketoprofen fixed-dose combination compared to diclofenac/thiocolchicoside in acute low back pain: experience from an Italian, single-centre, observational study
Stefano Meloncelli, Marco Divizia, Giorgio Germani
Abstract
OBJECTIVES: To compare the analgesic efficacy and tolerability of tramadol/dexketoprofen 75/25 mg (TRAM/DKP) versus diclofenac/thiocolchicoside 75/4 mg (DIC/THIO) in patients with moderate-to-severe acute low back pain (LBP). METHODS: = 38), both given every 12 h for 5 days. The primary endpoint was the change from baseline in pain intensity (PI) at pre-specified post-dose time points (t day1, t day3, t day7) and compared between the two treatments. Additional endpoints, all evaluated at day 7, included: the sum of PI difference (SPID), percentage of responders in terms of PI reduction versus baseline and change from baseline in Douleur Neuropathique (DN4) score. Tolerability and safety were also assessed. RESULTS: < .0001)]. Both treatments were well tolerated. CONCLUSIONS: Orally administered TRAM/DKP 75/25 mg can be a valuable and effective option in patients with acute LBP.