Drossman Douglas A, Toner Brenda B, Whitehead William E, Diamant Nicholas E, Dalton Chris B, Duncan Susan, Emmott Shelagh, Proffitt Valerie, Akman Donna, Frusciante Karen, Le Terry, Meyer Kim, Bradshaw Barbara, Mikula Kristi, Morris Carolyn B, Blackman Carlar J, Hu Yuming, Jia Huanguang, Li Jim Z, Koch Gary G, Bangdiwala Shrikant I
UNC Center for Functional GI and Motility Disorders, Division of Digestive Diseases, University of North Carolina at Chapel Hill, 27599-7080, USA.
Gastroenterology. 2003 Jul;125(1):19-31. doi: 10.1016/s0016-5085(03)00669-3.
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.
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.
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.
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.
关于抗抑郁药及心理治疗在功能性肠病（FBD）中的研究在方法上存在局限性。本研究旨在评估认知行为疗法（CBT）与健康教育（EDU）、地昔帕明（DES）与安慰剂（PLA）相比，对中度至重度FBD（肠易激综合征、功能性腹痛、便秘型肠易激综合征及未特定的FBD）女性患者的临床疗效及安全性。我们还评估了具有临床意义的亚组对这些治疗的可接受性。
这项随机、对照、多中心试验纳入了来自北卡罗来纳大学和多伦多大学的431名有中度至重度FBD症状的成年人。参与者接受了为期12周的心理治疗（CBT与EDU）或抗抑郁治疗（DES与PLA）。在治疗前及治疗结束时进行了临床、生理和社会心理评估。
意向性分析显示CBT比EDU显著更有效（P = 0.0001；缓解率，CBT为70%，EDU为37%；需治疗人数[NNT]，3.1）。在意向性分析中，DES未显示出比PLA有显著益处（P = 0.16；缓解率，DES为60%，PLA为47%；NNT，8.1），但在符合方案分析中显示出统计学上的显著益处（P = 0.01；缓解率，DES为73%，PLA为49%；NNT，5.2），尤其是排除DES血药浓度检测不到的参与者后（P = 0.002）。治疗满意度最能衡量改善情况。亚组分析显示，对于中度而非重度症状、有滥用史、无抑郁及以腹泻为主的症状，DES比PLA更有益；对于除抑郁外的所有亚组，CBT比EDU更有益。
对于中度至重度FBD女性患者，CBT有效，充分服用时DES可能有效。某些临床亚组对这些治疗的接受程度或多或少有所不同。
