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Efficacy and Relevance of Topical Diclofenac for Osteoarthritic Pain—Reply
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In reply
The overenrollment in our trial1 resulted from an unanticipated jump in patient randomization at several large research centers, just as we were nearing the 200-patient mark. Using the day we accrued the 200th patient as a cutoff, we have now identified the first 209 randomized patients. Analysis of their data confirmed the superiority of Pennsaid (a topical 1.5% [wt/wt] diclofenac sodium solution in a carrier containing dimethyl sulfoxide [Dimethaid Health Care Ltd, Markham, Ontario]) (pain, P<.001; physical function, P<.001; patient global assessment, P = .002; mean difference between groups for pain, 2.3).
The clinically significant difference of 2 is an estimate of a reasonable, anticipated difference between treatment groups, and we plugged this number into the standard power calculation equation to adequately explore our premise: the superiority of Pennsaid. It is not, however, a literature-derived "minimal clinically important improvement."
Contrary to the writers’ implication, the effect sizes . . . [Full Text of this Article]
AUTHOR INFORMATION
Sanford H. Roth, MD;
J. Zev Shainhouse, MD
RELATED ARTICLE
Efficacy and Relevance of Topical Diclofenac for Osteoarthritic Pain
Sita M. A. Bierma-Zeinstra, Janneke N. Belo, and Siep Thomas
Arch Intern Med. 2005;165(5):588-589.
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