Takeaway
- This study suggests that fixed-dose ibuprofen plus caffeine was not superior to ibuprofen alone or placebo in reducing acute lower back or neck pain.
Why this matters
- Due to the available evidence supporting caffeine as an analgesic adjuvant in combination with nonsteroidal anti-inflammatory drugs, it was thought that a combination of ibuprofen and caffeine could be more effective than single-agent ibuprofen for lower back or neck pain
Study design
- 635 patients with acute lower back/neck pain with pain on movement (POM) ≥5 on a 10-point numerical rating scale were randomly assigned (2:2:1) to receive oral ibuprofen 400 mg plus caffeine 100 mg (n=256), ibuprofen alone (n=253) or placebo (n=126).
- Primary outcome: change in POM triggering highest pain score at baseline (worst procedure) (POMWP) between day 1 and 2 mornings.
- Secondary outcome: POMWP area under curve (POMWPAUC) between the mornings of day 1 and 4 (POMWPAUC72h) and 6 (POMWPAUC120h).
- Funding: Boehringer Ingelheim Pharma GmbH & Co and Sanofi-Aventis.
Key results
- In ibuprofen, ibuprofen+caffeine and placebo groups, adjusted mean (standard error) reductions from baseline to the morning of day 2 were:
- POMWP:
- 1.998 (0.1042),
- 1.869 (0.1030), and
- 1.712 (0.1422), respectively.
- POMWPAUC72h:
- 4.461 (0.0942),
- 4.512 (0.0931), and
- 4.800 (0.1266), respectively.
- POMWPAUC120h:
- 3.718 (0.0992),
- 3.776 (0.0981), and
- 4.175 (0.1334), respectively.
- POMWP:
- The overall proportion of patients with treatment-emergent adverse events (AEs) was low, and no patients reported severe AEs during the treatment period.
References
References