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

Abstract

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 inten sity, 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 mobili - ty and functional ability and similar tolerability.