Cognitive-behavioral therapy versus education and XXXX versus placebo for moderate to severe @entity29 .

@entity1 @entity308 @entity10081 @entity5829 @entity1989 @entity294 @entity4743 @entity29 @entity490 @entity1142 @entity1744
BACKGROUND _ AIMS: Studies of antidepressants and @entity29 ( @entity29 ) are methodologically limited. The aim of this study was to assess the clinical efficacy and safety of cognitive-behavioral therapy (CBT) against education (EDU) and @entity5829 ( @entity4743 ) against placebo ( @entity1989 ) in female @entity1 with moderate to severe @entity29 ( @entity1744 , functional @entity490 , painful @entity1142 , and unspecified @entity29 ). We also evaluated the amenability of clinically meaningful subgroups to these treatments. METHODS: This randomized, comparator-controlled, multicenter trial enrolled 431 adults from the University of North Carolina and the University of Toronto with moderate to severe symptoms of @entity29 . @entity1 received psychological (CBT vs. EDU) or antidepressant ( @entity4743 vs. @entity1989 ) treatment for 12 weeks. Clinical, physiologic, and psychosocial assessments were performed before and at the end of treatment. RESULTS: The intention-to-treat analysis showed CBT as significantly more effective than @entity10081 (P = 0.0001; responder rate, 70% CBT vs. 37% EDU; number needed to treat [NNT ], 3.1). @entity4743 did not show significant benefit over @entity1989 in the intention-to-treat analysis (P = 0.16; responder rate, 60% @entity4743 vs. 47% @entity1989 ; NNT, 8.1) but did show a statistically significant benefit in the per-protocol analysis (P = 0.01; responder rate, 73% @entity4743 vs. 49% @entity1989 ; NNT, 5.2), especially when @entity1 with nondetectable blood levels of @entity4743 were excluded (P = 0.002). Improvement was best gauged by satisfaction with treatment. Subgroup analyses showed that @entity4743 was beneficial over @entity1989 for moderate more than severe symptoms, abuse history, no @entity308 , and @entity294 -predominant symptoms; CBT was beneficial over EDU for all subgroups except for @entity308 . CONCLUSIONS: For female @entity1 with moderate to severe @entity29 , CBT is effective and @entity4743 may be effective when taken adequately. Certain clinical subgroups are more or less amenable to these treatments.
