Efficacy and Safety of Piroxicam Beta-Cyclodextrin Sachets for Treating Chronic Low Back Pain: A Randomized, Parallel, Active-Controlled Trial

Abstract

Background: The clinical effects of the sachet form of piroxicam beta-cyclodextrin have been studied for their efficacy against acute or osteoarthritic pain in Western populations, but studies are sparse for chronic low back pain. We evaluated the effects of the sachet form on local Asian people with chronic backache, compared with conventional piroxicam tablets. Methods: Forty-seven eligible patients were randomized into a sachet treatment group (n=24) and a tablet treatment group (n=23). Both groups received dosages of 20 mg per day orally for 28 days. Efficacy was evaluated using a pain score and a disability index. Results: The efficacy of the two application methods was compared based on 42 patients included in the per-protocol population. The sachet-form drugs showed greater improvement than tablets in lowering the pain score by 1.93 units. This mode of delivery also showed a greater improvement in the patients’ disability index. Sachet application produced 12.5% of adverse incidences versus 19% for tablets, with no statistically significant difference. Conclusion: Piroxicam betacyclodextrin sachets extended the spectrum of analgesic activity for the treatment of these patients with chronic low back pain and provided a low incidence of side effects.