Topical diclofenac versus oral ibuprofen:: A double blind, randomized clinical trial to demonstrate efficacy and tolerability in patients with activated osteoarthritis of the finger joints (Heberden and/or Bouchard arthritis).

Introduction: This double-blind, randomized study has been carried out to assess the efficacy and tolerability of topical diclofenac emulgel versus oral ibuprofen in activated osteoarthritis of the finger joints (Heberden and/or Bouchard arthritis). Patients and Methods: A total of 321 patients were randomly assigned to one of the treatment groups and received either diclofenac emulgel (verum) and ibuprofen placebo-tablets or diclofenac emulgel-placebo and ibuprofen tablets (verum). A 10 cm ribbon of ointment was applied 4 times daily and tablets (400 mg ibuprofen) were taken 3 times daily. Primary efficacy criterion was the response rate defined as an improvement in pain intensity of at least 40 % on a 100 mm visual analogue scale. Secondary efficacy criteria were as follows: disease activity, pain at rest, pain on movement, morning stiffness, grip strength and quality of life. Results: Applying a final lower equivalence limit of 5 %, the topical therapy was at least equally effective to the oral ibuprofen therapy with regard to the response rate (p = 0.007). A comparable improvement in all secondary parameters could also be shown for both treatment regimens. Both therapies were well tolerated. However, the number of patients with severe events was higher in the ibuprofen group (n = 9) than in the diclofenac group (n = 4). Furthermore, 21 patients discontinued the study prematurely due to adverse events with a similarly striking numerical relation: 5 (3%) from the diclofenac group, 16 (10%) from the ibuprofen group. This is again paralleled by the causal relationship of the events: only 2 patients with these events were considered related to diclofenac, however, 13 (8,3 %) patients were ascribed to ibuprofen. Most of these patients with adverse events comprised gastrointestinal complaints [1 in the diclofenac group, 8 (5 %) in the ibuprofen group]. Conclusion: A 21-day topical treatment of activated osteoarthritis of the finger joints (Heberden and/or Bouchard arthritis) with diclofenac is at least as effective as systemic treatment with ibuprofen. Its tolerability seems to be superior to systemic ibuprofen therapy with respect to gastrointestinal safety and to events leading to discontinuation of treatment.