Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders
Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders
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DOI：
10.1016/s0016-5085(03)00669-3
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发表时间：
2003-07-01
期刊：
影响因子：
29.4
通讯作者：
Bangdiwala, SI
中科院分区：
文献类型：
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作者：
Drossman, DA;Toner, BB;Bangdiwala, SI
背景与目的：抗抑郁药和心理治疗在功能性肠病（FBD）中的研究在方法学上是有限的。本研究的目的是评估认知行为疗法（CBT）对抗教育（EDU）和地西帕明（DES）对抗安慰剂（PLA）对中重度FBD（肠易激综合征、功能性腹痛、疼痛性便秘和未明确FBD）女性患者的临床疗效和安全性。我们还评估了有临床意义的亚组对这些治疗的适应性。方法：这项随机、对照、多中心试验招募了来自北卡罗来纳大学和多伦多大学的431名患有中度至重度FBD症状的成年人。参与者接受心理（CBT vs EDU）或抗抑郁（DES vs PLA）治疗12周。在治疗前和治疗结束时进行临床、生理和社会心理评估。结果：意向治疗分析显示CBT明显比EDU更有效（P = 0.0001；应答率，70% CBT vs 37% EDU；所需治疗人数[NNT]， 3.1）。在意向治疗分析中，DES没有显示出明显优于PLA的益处（P = 0.16；应答率，60% DES vs 47% PLA； NNT, 8.1），但在按方案分析中确实显示出统计学上显著的益处（P = 0.01；应答率，73% DES vs 49% PLA； NNT, 5.2），特别是当排除血液中检测不到DES水平的参与者时（P = 0.002）。改善最好通过对治疗的满意度来衡量。亚组分析显示，对于中度症状多于重度症状、滥用史、无抑郁和腹泻为主症状的患者，DES优于PLA；除抑郁症外，CBT在所有亚组中均优于EDU。结论：对于女性中重度FBD患者，CBT是有效的，DES在适当的情况下可能有效。某些临床亚组或多或少适合这些治疗。
Background & Aims: Studies of antidepressants and psychological treatments in functional bowel disorders (FBD) 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 desipramine (DES) against placebo (PLA) in female patients with moderate to severe FBD (irritable bowel syndrome, functional abdominal pain, painful constipation, and unspecified FBD). 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 FBD. Participants received psychological (CBT vs. EDU) or antidepressant (DES vs. PLA) 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 EDU (P = 0.0001; responder rate, 70% CBT vs. 37% EDU; number needed to treat [NNT], 3.1). DES did not show significant benefit over PLA in the intention-to-treat analysis (P = 0.16; responder rate, 60% DES vs. 47% PLA; NNT, 8.1) but did show a statistically significant benefit in the per-protocol analysis (P = 0.01; responder rate, 73% DES vs. 49% PLA; NNT, 5.2), especially when participants with nondetectable blood levels of DES were excluded (P = 0.002). Improvement was best gauged by satisfaction with treatment. Subgroup analyses showed that DES was beneficial over PLA for moderate more than severe symptoms, abuse history, no depression, and diarrhea-predominant symptoms; CBT was beneficial over EDU for all subgroups except for depression. Conclusions: For female patients with moderate to severe FBD, CBT is effective and DES may be effective when taken adequately. Certain clinical subgroups are more or less amenable to these treatments.