Lack of efficacy of @entity1443 in treating symptomatic knee osteoarthritis: a randomized, double-blind, placebo-controlled comparison trial with XXXX .

@entity1 @entity137 @entity571 @entity3522 @entity158 @entity1443
BACKGROUND: Recommendations state that @entity1443 should be used in preference to nonsteroidal anti-inflammatory drugs in the initial treatment of symptomatic @entity571 ( @entity571 ) of the hip or knee, because of lesser @entity137 and the pervasive belief that @entity1443 is not only effective in treating @entity158 but is of equal analgesic efficacy as nonsteroidal anti-inflammatory drugs. METHODS: This was a randomized, double-blind, placebo-controlled trial of @entity3522 , 75 mg twice daily, vs @entity1443 , 1000 mg 4 times daily, in 82 subjects with symptomatic @entity571 of the medial knee. @entity571 was quantitated radiographically, and subjects met stringent baseline @entity158 criteria. The primary evaluation of efficacy used the Western Ontario and McMaster Universities @entity571 Index, with evaluations at screening, baseline, and 2 and 12 weeks after treatment. Intention-to-treat analysis was used. RESULTS: Twenty-five subjects were randomized to @entity3522 , 29 to @entity1443 , and 28 to placebo. The groups were closely matched for age, sex, body mass index, prior use of @entity571 medications, baseline @entity158 , and radiographic features. At 2 and 12 weeks, clinically and statistically significant (P<.001) improvements were seen in the @entity3522 -treated group; however, no significant improvements were seen in the @entity1443 -treated group (P =.92 at 2 weeks and.19 at 12 weeks). Stratification of subjects according to baseline @entity158 , prestudy @entity571 medication, and radiographic grade showed no clear pattern of preferential response to @entity3522 , and did not reveal a subset of subjects who responded to @entity1443 . CONCLUSIONS: @entity3522 is effective in the symptomatic treatment of @entity571 of the knee, but @entity1443 is not. A review of the literature reveals that there is scanty published evidence for a therapeutic effect of @entity1443 relative to placebo in @entity1 with @entity571 of the knee, because most published studies use active comparators (ie, nonsteroidal anti-inflammatory drugs) only. The advocacy of @entity1443 use in subjects with @entity571 of the knee should be reconsidered pending further placebo-controlled studies.
