Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials.
OBJECTIVE
Nonsteroidal anti-inflammatory drugs are a mainstay for medical treatment of chronic lower back pain (CLBP). Increased dose intervals for medication have been associated with increased patient adherence to prescriptions. The purpose of this clinical trial was to compare the efficacy and safety of a once daily dose of aceclofenac controlled release (CR) and a twice daily dose of aceclofenac for CLBP management.


METHODS
A prospective, randomized, single center, open-label clinical trial was performed to compare the efficacy and safety of aceclofenac CR (200 mg once daily) to aceclofenac dose (100 mg twice daily). Fifty patients in each group were enrolled for the study. The primary end point was Visual Analogue Scale (VAS) change at baseline to that at 2 weeks after medication and safety profiles. Also, change in quality of life measured by EuroQoL 5D (EQ-5D) and Oswestry Disability Index (ODI) functional score for the lumbar spine were also assessed.


RESULTS
Within groups at pre- and post-treatment, there were significant VAS reductions for aceclofenac CR and aceclofenac (p=0.028). EQ-5D increased significantly in both groups (p=0.037). ODI scores decreased significantly in both groups (p=0.012). However, there were no significant differences between aceclofenac CR and aceclofenac at pre- and post-treatment. Patients with aceclofenac CR showed significant increases in heartburn and indigestion and adverse gastrointestinal effects, compared to aceclofenac.


CONCLUSIONS
In patients with CLBP, aceclofenac CR and aceclofenac demonstrated significant symptomatic pain relief, improvement in quality of life and functional scores. Aceclofenac CR slightly increased gastrointestinal adverse effects, such as heartburn and indigestion.
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Jae Ho
JH
Yang
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Kyung Soo
KS
Suk
Department of Orthopedic Surgery, Catholic-Kwandong University College of Medicine, International St. Mary's Hospital, Incheon, Korea.
Byung Ho
BH
Lee
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Woo Chul
WC
Jung
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Young Mi
YM
Kang
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Ji Hye
JH
Kim
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Hak Sun
HS
Kim
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea.
Hwan Mo
HM
Lee
Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea. shmoon@yuhs.ac.
Seong Hwan
SH
Moon
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000627:therapeutic use; D004008:Diclofenac / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004008:Diclofenac; C056498:aceclofenac
Chronic lower back pain; NSAIDs; aceclofenac