S-T Chang1, L-C Chen, C-C Chang, H-Y Chu, K-C Tsai. 1. Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan. stchang@ms87.url.com.tw
Abstract
BACKGROUND: The clinical effects of piroxicam-beta-cyclodextrin (PBC) in sachet form have been surveyed in patients with osteoarthritic or acute pain in western countries, but scarcely studied in those with chronic low back pain (LBP), and never investigated in the field of postural sway. The aim of this study was to evaluate the clinical effects of PBC in sachet form prescribed in patients with chronic backache in local Asian when compared with those of plain piroxicam. METHODS: After randomized allocation and experimental exclusion, a total of 42 eligible patients were randomized into two groups, the sachet group (n = 23) and the piroxicam tablet group (n = 19). Both groups were administered the same dosage, orally per day (daily dose = 20 mg). The duration of trial was 28 days. Efficacy was assessed with pain score, disability index and postural sway. RESULTS: The patients in sachet group showed greater improvement in pain score and disability index than those who took piroxicam tablets. There were significantly lower sway velocity and intensity at almost all different conditions than baseline profiles in both groups (P < 0.05). However, there was no significant difference of sway velocity and intensity in the piroxicam tablets group with regard to eyes open or eyes closed in 20 degrees dorsiflexion. CONCLUSIONS:Piroxicam-beta-cyclodextrin (PBC) sachet may have greater improvement in the treatment of chronic LBP and possess the extended effects on postural abnormality relevant to chronic LBP.
RCT Entities:
BACKGROUND: The clinical effects of piroxicam-beta-cyclodextrin (PBC) in sachet form have been surveyed in patients with osteoarthritic or acute pain in western countries, but scarcely studied in those with chronic low back pain (LBP), and never investigated in the field of postural sway. The aim of this study was to evaluate the clinical effects of PBC in sachet form prescribed in patients with chronic backache in local Asian when compared with those of plain piroxicam. METHODS: After randomized allocation and experimental exclusion, a total of 42 eligible patients were randomized into two groups, the sachet group (n = 23) and the piroxicam tablet group (n = 19). Both groups were administered the same dosage, orally per day (daily dose = 20 mg). The duration of trial was 28 days. Efficacy was assessed with pain score, disability index and postural sway. RESULTS: The patients in sachet group showed greater improvement in pain score and disability index than those who took piroxicam tablets. There were significantly lower sway velocity and intensity at almost all different conditions than baseline profiles in both groups (P < 0.05). However, there was no significant difference of sway velocity and intensity in the piroxicam tablets group with regard to eyes open or eyes closed in 20 degrees dorsiflexion. CONCLUSIONS:Piroxicam-beta-cyclodextrin (PBC) sachet may have greater improvement in the treatment of chronic LBP and possess the extended effects on postural abnormality relevant to chronic LBP.