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Efficacy and Safety of Different Aceclofenac Treatments for Chronic Lower Back Pain: Prospective, Randomized, Single Center, Open-Label Clinical Trials

 Jae-Ho Yang  ;  Kyung-Soo Suk  ;  Byung-Ho Lee  ;  Woo-Chul Jung  ;  Young-Mi Kang  ;  Ji-Hye Kim  ;  Hak-Sun Kim  ;  Hwan-Mo Lee  ;  Seong-Hwan Moon 
 YONSEI MEDICAL JOURNAL, Vol.58(3) : 637-643, 2017 
Journal Title
Issue Date
Administration, Oral ; Adult ; Aged ; Anti-Inflammatory Agents, Non-Steroidal/administration & dosage* ; Anti-Inflammatory Agents, Non-Steroidal/therapeutic use ; Diclofenac/administration & dosage ; Diclofenac/analogs & derivatives* ; Diclofenac/therapeutic use ; Drug Administration Schedule ; Female ; Humans ; Low Back Pain/drug therapy* ; Male ; Middle Aged ; Pain Measurement ; Prospective Studies ; Quality of Life ; Treatment Outcome
Chronic lower back pain ; NSAIDs ; aceclofenac
PURPOSE: 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. MATERIALS AND 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. CONCLUSION: 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.
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1. College of Medicine (의과대학) > Yonsei Biomedical Research Center (연세의생명연구원) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Orthopedic Surgery (정형외과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Young Mi(강영미) ORCID logo https://orcid.org/0000-0002-7686-6316
Kim, Ji Hye(김지혜)
Kim, Hak Sun(김학선) ORCID logo https://orcid.org/0000-0002-8330-4688
Moon, Seong Hwan(문성환)
Suk, Kyung Soo(석경수) ORCID logo https://orcid.org/0000-0003-0633-2658
Yang, Jae Ho(양재호) ORCID logo https://orcid.org/0000-0001-7421-2805
Lee, Hwan Mo(이환모) ORCID logo https://orcid.org/0000-0002-5405-3832
Jung, Woo Chul(정우철)
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