Yonsei Med J.  2017 May;58(3):637-643. 10.3349/ymj.2017.58.3.637.

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

• Yang JH
• Suk KS
• Lee BH
• Jung WC
• Kang YM
• Kim JH
• Kim HS
• Lee HM
• Moon SH

• KMID: 2419124
• DOI: http://doi.org/10.3349/ymj.2017.58.3.637

Abstract

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.

Keyword

Chronic lower back pain; NSAIDs; aceclofenac

MeSH Terms

Administration, Oral
Adult
Aged
Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/therapeutic use
Diclofenac/administration & dosage/*analogs & derivatives/therapeutic use
Drug Administration Schedule
Female
Humans
Low Back Pain/*drug therapy
Male
Middle Aged
Pain Measurement
Prospective Studies
Quality of Life
Treatment Outcome
Anti-Inflammatory Agents, Non-Steroidal
Diclofenac

Figure

• 

  Fig. 1 Screening, randomization, and follow-up of clinical trial. CR, controlled release.

• 

  Fig. 2 (A) Change in Visual Analogue Scale (VAS) presented as mean±standard deviation. (B) Change in calculated EuroQoL 5D (EQ-5D) presented as median and interquartile range (IQR). (C) Change in Oswestry Disability Index (ODI), presented as median and IQR. Comparison between aceclofenac controlled release (CR; 200 mg once daily) and conventional aceclofenac (100 mg twice daily) showed there was significant reduction of pain and ODI score, and increase in EQ-5D for each group at 2 weeks, however, there was no difference between groups pre- and post-treatment for VAS, ODI, and EQ-5D. *p<0.05, †Non-significant.

• 

  Fig. 3 Change in each dimension (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) for EuroQoL 5D pre- to post-treatment with aceclofenac CR (200 mg once daily) and conventional aceclofenac (100 mg twice daily) over the 2 week trial. With the exception of self-care in the aceclofenac group, all dimensions showed improvement post-treatment. CR, controlled release.

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