Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study

Objective: To estimate whether combination of ibuprofen and paracetamol is more effective than ibuprofen in monotherapy, in the treatment of acute low back pain. Methods: 80 adult patients with acute low back pain were randomized into two subgroups. In the first subgroup, 40 patients were treated with ibuprofen 400mg three times a day (TID), whilst patients in the second subgroup (n= 40) were treated with a fixed-dose combination tablet of ibuprofen 200mg plus paracetamol 325mg TID, for three consecutive days. Patients were followed for another 7 days. Efficacy and tolerability of both treatment options was assessed. Results: A statistically significant decrease in pain intensity, assessed using a visual analogue scale (p < 0.001), as well as the 5-point Likert scale, was noticed in both subgroups of patients. However, intensity of pain on Day 4 was significantly lower in patients treated with combined therapy (t= 2.05, p= 0.045). Considerable improvement in mobility of the lumbar spine was noticed in both subgroups of patients (p < 0.001), but at the end of the follow up period, finger-to-floor distance was lower in patients on combined therapy (4.7cm vs. 8.3cm, t= 2.27, p= 0.03). Improvement of functional ability on Day 4 and Day 10 was significant, regardless of treatment ( p < 0.001). One patient on combined therapy and two patients on ibuprofen monotherapy reported minor gastric intolerability. Conclusion: Compared to ibuprofen monotherapy, combination of ibuprofen and paracetamol may provide faster and longer analgesia in patients with acute low back pain, with equally favorable effect on mobility and functional ability and similar tolerability.