Aceclofenac is as safe and effective as tenoxicam in the treatment of ankylosing spondylitis: a 3 month multicenter comparative trial. Spanish Study Group on Aceclofenac in Ankylosing Spondylitis

J Rheumatol. 1996 Jul;23(7):1194-9.


Objective: To compare in a 3 month, multicenter, double blind, parallel study the efficacy and safety of a nonsteroidal antiinflammatory drug, aceclofenac, 100 mg bid orally, with that of tenoxicam, 20 mg orally at bedtime, in the treatment of adult patients with active ankylosing spondylitis (AS).

Methods: A total of 273 patients (135 in the aceclofenac group and 138 in the tenoxicam group) entered the study. Eight efficacy variables were assessed: morning stiffness, visual analog pain scale, control of additional paracetamol, modified Schöber's test, C7 line-iliac crest distance, lateral flexion of the spine, thoracic expansion, and occiput-wall distance.

Results: Seven of the 8 variables improved significantly in both groups, with no differences between the 2 groups in any variable at the end of the study. Six percent of patients taking aceclofenac and 5% of patients taking tenoxicam withdrew because of unsatisfactory therapeutic action. Forty-two adverse events possibly or probably related to treatment were observed in the aceclofenac group and 37 in the tenoxicam group. However, only 2.2% of patients in the aceclofenac group and 1.4% in the tenoxicam group withdrew for this reason.

Conclusion: Aceclofenac and tenoxicam are similar in terms of safety and effectiveness; and aceclofenac, 100 mg orally twice daily, is a safe, effective, and convenient treatment for active AS.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Diclofenac / administration & dosage
  • Diclofenac / adverse effects
  • Diclofenac / analogs & derivatives*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Participation
  • Piroxicam / administration & dosage
  • Piroxicam / adverse effects
  • Piroxicam / analogs & derivatives*
  • Placebos
  • Spondylitis, Ankylosing / drug therapy*
  • Surveys and Questionnaires


  • Anti-Inflammatory Agents, Non-Steroidal
  • Placebos
  • Piroxicam
  • Diclofenac
  • aceclofenac
  • tenoxicam