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Aceclofenac More Tolerable, Similar Efficacy to Diclofenac for Acute Back Pain

Aceclofenac has similar effects on back pain and function and is more tolerable than diclofenac in the treatment of acute back pain, according to a recent German study.

Non-steroidal anti-inflammatory drugs (NSAIDs) are effective for short-term relief of back pain, but can cause uncomfortable gastrointestinal (GI) side effects. Newer NSAIDs such as diclofenac and aceclofenac have been developed and have decreased adverse effects on the GI tract, therefore making them more tolerable.

Diclofenac is widely used for the treatment of lower back pain, while aceclofenac has been effectively used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Preliminary studies have also indicated that aceclofenac may be effective in relieving back pain.

In a double-blind, randomised study, Manfred Schattenkirchner, MD, and Klaus A. Milachowski, MD, PhD, with the University of Munich, compared the efficacy and tolerability of the 2 drugs in patients with acute lower back pain.

The study consisted of 227 patients between the ages of 20 and 65 with localised, uncomplicated acute lumbosacral pain due to degenerative spinal disorders. Patients were randomised to receive either oral aceclofenac (100 mg twice daily) or oral diclofenac resinate (75 mg twice daily), for a maximum of 10 days or until symptoms were relieved. Visual analogue scale (VAS) pain score and improvement in functional impairment were assessed on day 4 and day 8 of treatment.

Overall, both treatment groups showed reduction in back pain and improvement in spinal function. However, aceclofenac did show some statistical superiority to diclofenac. Specifically, the VAS pain score at rest was 61.6 mm for patients receiving aceclofenac and 57.3 mm for those receiving diclofenac, with an adjusted between-group difference of 4.5 mm favouring aceclofenac.

Furthermore, progressive improvement in spinal flexibility was observed in both treatment arms, but was slightly higher in the aceclofenac group.

Both drugs showed similar numbers of patients reporting at least one adverse event, although fewer events were observed in the aceclofenac group. The most common events were those affecting the GI and no deaths or serious adverse events were reported.

Despite this, aceclofenac was more tolerable according to patient and physician evaluation. At final assessment, 50.9% of patients in the aceclofenac group rated their tolerability as 'very good' compared to 28.3% of those in the diclofenac group.

Dr. Schattenkirchner concluded from the study that the "NSAID aceclofenac is at least as effective as diclofenac resinate at lowering the level of pain in patients with acute uncomplicated low back pain suffering from degenerative spinal disorders." "Moreover, aceclofenac shows a trend towards superiority in its efficacy and tolerability compared with diclofenac resinate."
Clin Rheumatol 2003;22:2:127-135. "A double-blind, multicentre, randomised clinical trial comparing the efficacy and tolerability of aceclofenac with diclofenac resinate in patients with acute low back pain"

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