Background and Objectives: Dyspepsia is a common adverse event associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with lumbar spinal stenosis. Although proton pump and cyclooxygenase-2 inhibitors are potential treatment options, the optimal strategy remains unclear. This study aimed to compare the efficacy and safety of combination therapy with aceclofenac and ilaprazole versus celecoxib monotherapy for the treatment of dyspepsia caused by NSAID use in patients with lumbar spinal stenosis. Materials and Methods: This prospective, double-blind, randomized, actively controlled study was conducted at Seoul National University Bundang Hospital in South Korea from July 2020 to September 2021. The participants were randomized into one of two treatment groups: celecoxib monotherapy (control group) and combination therapy with aceclofenac and ilaprazole (test group). The primary efficacy endpoint was the mean change in the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) scores from baseline to treatment week 8. The secondary efficacy endpoint was the mean change in Short-Form-12 (SF-12) scores from baseline (week 0) to treatment week 8. Results: The study enrolled 140 patients who were randomly assigned to receive combination therapy with aceclofenac and, ilaprazole or celecoxib. In the per protocol set, the mean change in SF-LDQ scores from week 0 to week 8 was -0.51 ± 4.78 and 1.85 ± 6.70 in the combination therapy and celecoxib group, respectively (p = 0.054). SF-12 scores did not differ significantly between the two groups. Adverse events were reported in both groups, but there was no significant difference in incidence. Conclusions: Combination therapy with aceclofenac and ilaprazole can be a treatment option for NSAID-induced dyspepsia in some situations.
Keywords: NSAID 4; dyspepsia 2; llaprazole 5; lumbar spinal stenosis 1; proton pump inhibitor 3.