Objectives To evaluate the efficacy and safety of combination analgesic tramadol/piroxicam for the treatment of low back pain.
Methods This 2- week study took place in two REHA-Centres in Croatia. Patients took medication as needed for the treatment of acute low back pain and/or osteoarthritis pain. They were given 20 mg of piroxicam in the morning and 50 mg of tramadol every 12 h for 15 days. Patients reported maximum pain relief (VAS scale 0 to 10) and rated overall efficacy (scale 1 = poor to 5 = excellent) at the final visit. Adverse events (AEs) were monitored throughout the study.
Results A total of 70 patients from two REHA-Centres provided data. We present the analysis of age, sex and profession. Most of our patients (61%) were employed. Our patients needed therapy for osteoarthritis pain (52%), low back pain (40%) and other (osteoporosis, RA, SA) 8%. After 15 days combination tramadol/piroxicam provided pain relief (range 2,5 ? 3,5). Overall efficacy of combination was rated 35% ?very good? or ?excellent? by 20%, ?good? by 35% and ?poor? by 10% only. There were no serious or unexpected AEs. The most common AEs were: nausea 20%, constipation 18%, headache 16%, dizziness 12% and somnolence 8%.
Conclusion This study demonstrated that the combination analgesic tramadol/piroxicam is effective and well tolerated in patients with low back pain and/or ostheoarthritis.