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Combining paracetamol 1000 mg and ibuprofen 300 mg delivers comparable pain relief and safety to high-dose ibuprofen 600 mg monotherapy for acute low back pain.
A phase IV randomized study reports comparable overall effectiveness, safety, and tolerability with paracetamol + ibuprofen vs. ibuprofen alone for non-specific low back pain (LBP) management.
This open-label study, led by Michal Harasymczuk et al., evaluated paracetamol 1000 mg + ibuprofen 300 mg administered three times daily (TID) against ibuprofen 600 mg TID. Eligible volunteers were adults with moderate-to-severe non-specific LBP, defined by a visual analog scale (VAS) score of at least 40 mm. The modified intention-to-treat (m-ITT) population included 171 patients: 83 received the combination therapy, and 88 received ibuprofen monotherapy.
Women represented 60.2% of the combination group and 55.7% of the ibuprofen group. The mean ages were 42.8 and 43.3 years, respectively. The primary endpoint was the Sum of Pain Intensity Differences over days 0–3 (SPID 0–3 days), which assessed alteration in pain intensity during the initial treatment period. The m-ITT analysis exhibited no prominent difference between the two groups in the primary endpoint (SPID 0–3 days).
Overall effectiveness, safety, and tolerability were comparable with combination therapy and ibuprofen monotherapy. The per-protocol analysis showed a reduction in clinical pain with combination therapy. At visit 1, the Clinical Global Impression–Improvement (CGI-I) scale exhibited a higher proportion of patients reporting improvement with combination therapy. The Patients’ Global Impression of Change (PGIC) results also favored combination therapy, although the difference did not reach statistical significance (Table 1).
The findings favor paracetamol + ibuprofen TID as a treatment option for acute moderate-to-severe non-specific LBP, with overall effectiveness, safety, and tolerability comparable to ibuprofen 600 mg TID. The favorable CGI-I result and numerical trend in PGIC suggest potential benefits in perceived improvement, but these secondary findings require cautious interpretation.
Journal of Clinical Medicine
Effectiveness and Safety of the Combination of Paracetamol 1000 mg and Ibuprofen 300 mg Versus Ibuprofen 600 mg in Monotherapy in Acute Low Back Pain: Results from a Phase IV Randomized Study
Michal Harasymczuk et al.
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