LAS VEGAS, NV—A meta-analysis presented at PAINWeek 2012 of two standard single over-the-counter (OTC) doses of immediate-release ibuprofen showed that 400 mg provided significantly better overall pain relief compared with 200 mg over a 6-hour period. Both doses of ibuprofen provided significantly better overall pain relief compared with placebo over the 6-hour period.
Drs. Shyamalie Jayawardena and Paul Butkerait, from Pfizer Consumer Healthcare, Madison, NJ, reported the results of their analysis at PAINWeek 2012. The researchers designed the meta-analysis to investigate the analgesic dose-response relationship between 200 mg and 400 mg doses of immediate-release ibuprofen in oral surgery studies. The researchers noted that current OTC dosing instructions for ibuprofen state that adults and children >12 years may take 1 tablet (200 mg) every 4–6 hours while symptoms persist or for up to 10 days. If pain does not respond to 1 tablet, 2 tablets (40 0mg) may be used (maximum 6 tablets/day).
To compare the efficacy of the two OTC doses, the researchers used Total Pain Relief scores over 6 hours (TOTPAR6), the maximum labeled dosing interval for OTC ibuprofen. Pain relief was measured using a categorical scale from 0 (no pain relief) to 4 (complete pain relief) at prespecified time points. A separate analysis was conducted for each comparison (400 mg vs. placebo, 200 mg vs. placebo, and 400 mg vs. 200 mg), using only those studies that concurrently evaluated the doses being compared.
The search identified 931 clinical studies, and 38 unique studies were included in the meta-analysis. Of these, 13 evaluated 200 mg ibuprofen, 32 evaluated 400 mg ibuprofen, and seven evaluated both 200- and 400-mg doses of ibuprofen. The pooled estimate for the treatment difference for the 400mg (n=2,890) vs. placebo (n=1,486) comparison was 9.58 (95% CI; 8.80–10.36). The pooled estimate for the treatment difference for the 200mg (n=1,036) vs. placebo (n=653) comparison was 6.89 (95% CI; 5.42–8.35). Both the 400mg and 200mg vs. placebo comparisons were statistically significant (P<0.001). For the 400mg (n=716) vs. 200mg (n=714) comparison, the pooled estimate for the treatment difference was 1.39 (95% CI; 0.41–2.37). This comparison was also statistically significant (P=0.013). Both the 400-mg and 200-mg doses of ibuprofen were well tolerated across all studies and the incidence of adverse events was similar for both doses.
In conclusion, the study investigators’ results were confirmed by data from the seven studies that simultaneously evaluated both doses of ibuprofen. The results of this meta-analysis are consistent with other reports in the literature on the efficacy and safety of OTC ibuprofen for pain relief following oral surgery.