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

Affiliations
  • 1Department of Orthopedic Surgery, Yonsei University College of Medicine, Seoul, Korea. shmoon@yuhs.ac
  • 2Department of Orthopedic Surgery, Catholic-Kwandong University College of Medicine, International St. Mary's Hospital, Incheon, Korea.

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.


Reference

1. Witt CM, Pach D, Reinhold T, Wruck K, Brinkhaus B, Mank S, et al. Treatment of the adverse effects from acupuncture and their economic impact: a prospective study in 73,406 patients with low back or neck pain. Eur J Pain. 2011; 15:193–197. PMID: 20609604.
2. Andrade NS, Flynn JP, Bartanusz V. Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge. Spine J. 2013; 13:1698–1704. PMID: 24012430.
Article
3. Chaparro LE, Furlan AD, Deshpande A, Mailis-Gagnon A, Atlas S, Turk DC. Opioids compared with placebo or other treatments for chronic low back pain: an update of the Cochrane Review. Spine (Phila Pa 1976). 2014; 39:556–563. PMID: 24480962.
4. Cawston H, Davie A, Paget MA, Skljarevski V, Happich M. Efficacy of duloxetine versus alternative oral therapies: an indirect comparison of randomised clinical trials in chronic low back pain. Eur Spine J. 2013; 22:1996–2009. PMID: 23686477.
Article
5. Schattenkirchner M, Milachowski KA. A double-blind, multicentre, randomised clinical trial comparing the efficacy and tolerability of aceclofenac with diclofenac resinate in patients with acute low back pain. Clin Rheumatol. 2003; 22:127–135. PMID: 12740678.
Article
6. Li J, Mansmann UR. Modeling of non-steroidal anti-inflammatory drug effect within signaling pathways and miRNA-regulation pathways. PLoS One. 2013; 8:e72477. PMID: 23967306.
Article
7. Day RO, Graham GG. Non-steroidal anti-inflammatory drugs (NSAIDs). BMJ. 2013; 346:f3195. PMID: 23757736.
Article
8. Bae SK, Kim SH, Lee HW, Seong SJ, Shin SY, Lee SH, et al. Pharmacokinetics of a new once-daily controlled-release formulation of aceclofenac in Korean healthy subjects compared with immediate-release aceclofenac and the effect of food: a randomized, open-label, three-period, crossover, single-centre study. Clin Drug Investig. 2012; 32:111–119.
9. Legrand E. Aceclofenac in the management of inflammatory pain. Expert Opin Pharmacother. 2004; 5:1347–1357. PMID: 15163279.
Article
10. Pareek A, Chandurkar N, Chandanwale AS, Ambade R, Gupta A, Bartakke G. Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone. Eur Spine J. 2009; 18:1836–1842. PMID: 19421791.
Article
11. Trelle S, Reichenbach S, Wandel S, Hildebrand P, Tschannen B, Villiger PM, et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011; 342:c7086. PMID: 21224324.
Article
12. Vestergaard P, Hermann P, Jensen JE, Eiken P, Mosekilde L. Effects of paracetamol, non-steroidal anti-inflammatory drugs, acetylsalicylic acid, and opioids on bone mineral density and risk of fracture: results of the Danish Osteoporosis Prevention Study (DOPS). Osteoporos Int. 2012; 23:1255–1265. PMID: 21710339.
Article
13. Pareek A, Chandurkar N, Gupta A, Sirsikar A, Dalal B, Jesalpura B, et al. Efficacy and safety of aceclofenac-cr and aceclofenac in the treatment of knee osteoarthritis: a 6-week, comparative, randomized, multicentric, double-blind study. J Pain. 2011; 12:546–553. PMID: 21277837.
Article
14. Ogon M, Krismer M, Söllner W, Kantner-Rumplmair W, Lampe A. Chronic low back pain measurement with Visual Analogue Scales in different settings. Pain. 1996; 64:425–428. PMID: 8783305.
Article
15. Johnsen LG, Hellum C, Nygaard OP, Storheim K, Brox JI, Rossvoll , et al. Comparison of the SF6D, the EQ5D, and the Oswestry Disability Index in patients with chronic low back pain and degenerative disc disease. BMC Musculoskelet Disord. 2013; 14:148. PMID: 23622053.
Article
16. Whynes DK, McCahon RA, Ravenscroft A, Hodgkinson V, Evley R, Hardman JG. Responsiveness of the EQ-5D health-related quality-of-life instrument in assessing low back pain. Value Health. 2013; 16:124–132. PMID: 23337223.
Article
17. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980; 66:271–273. PMID: 6450426.
18. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000; 25:2940–2952. PMID: 11074683.
Article
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