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

Research output: Contribution to journalArticle

2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)637-643
Number of pages7
JournalYonsei medical journal
Volume58
Issue number3
DOIs
Publication statusPublished - 2017 May

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Low Back Pain
Clinical Trials
Safety
Therapeutics
Heartburn
Dyspepsia
Visual Analog Scale
aceclofenac
Quality of Life
Pain Management
Patient Compliance
Prescriptions
Spine
Anti-Inflammatory Agents

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Yang, Jae Ho ; Suk, Kyung Soo ; Lee, Byung Ho ; Jung, Woo Chul ; Kang, Young Mi ; Kim, Ji Hye ; Kim, Hak Sun ; Lee, Hwan Mo ; Moon, Seong Hwan. / Efficacy and safety of different aceclofenac treatments for chronic lower back pain : Prospective, randomized, single center, open-label clinical trials. In: Yonsei medical journal. 2017 ; Vol. 58, No. 3. pp. 637-643.
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title = "Efficacy and safety of different aceclofenac treatments for chronic lower back pain: Prospective, randomized, single center, open-label clinical trials",
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.",
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Efficacy and safety of different aceclofenac treatments for chronic lower back pain : Prospective, randomized, single center, open-label clinical trials. / Yang, Jae Ho; Suk, Kyung Soo; Lee, Byung Ho; Jung, Woo Chul; Kang, Young Mi; Kim, Ji Hye; Kim, Hak Sun; Lee, Hwan Mo; Moon, Seong Hwan.

In: Yonsei medical journal, Vol. 58, No. 3, 05.2017, p. 637-643.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and safety of different aceclofenac treatments for chronic lower back pain

T2 - Prospective, randomized, single center, open-label clinical trials

AU - Yang, Jae Ho

AU - Suk, Kyung Soo

AU - Lee, Byung Ho

AU - Jung, Woo Chul

AU - Kang, Young Mi

AU - Kim, Ji Hye

AU - Kim, Hak Sun

AU - Lee, Hwan Mo

AU - Moon, Seong Hwan

PY - 2017/5

Y1 - 2017/5

N2 - 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.

AB - 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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