Division of Gastroenterology and Hepatology, UNC Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7080, USA.
Am J Gastroenterol. 2010 Jun;105(6):1397-406. doi: 10.1038/ajg.2009.748. Epub 2010 Jan 19.
For clinical trials in functional bowel disorders (FBD), the definition of a responder, one who meets the predefined criteria for a clinical response, is needed. Factors that determine clinical response aside from treatment itself are unknown. The aim of this study was to determine what baseline and post-treatment factors affect treatment response.
Females (n=397) with FBD entering a 12-week, four-arm, randomized NIH treatment trial (desipramine (DES), CBT, pill placebo, and education) were studied at baseline and after treatment. Demographic, clinical, psychosocial, and physiological variables were considered in the analysis. A responder was defined as a patient obtaining a score>3.5 on an averaged eight-item, five-point satisfaction-with-treatment questionnaire. Baseline and post-treatment logistic regressions were performed for each treatment condition to predict the responder outcome variable.
Similar cognitive features predisposed participants to treatment response across the treatment conditions: sense of control over the condition, positive relationship with therapist or study coordinator, confidence in treatment, improvement in maladaptive cognitions, and quality of life during treatment. Demographic and clinical variables studied were not predictive. Some treatment-specific effects predicting responder status were noted, including a reduction in stool frequency with DES treatment and lack of abuse history in the placebo group.
For medication, psychological, and placebo treatment in FBD, satisfaction with treatment depends on cognitive factors of confidence in treatments, perceived control over illness and symptoms, and reduction in negative cognitions related to symptom experience. Addressing these issues among patients with FBD may enhance treatment response to a variety of treatments.
对于功能性肠病（FBD）的临床试验，需要定义一个应答者，即符合预先设定的临床应答标准的人。除治疗本身外，决定临床应答的因素尚不清楚。本研究旨在确定哪些基线和治疗后因素会影响治疗反应。
参加为期 12 周的四项 NIH 治疗试验（去甲替林（DES）、认知行为疗法（CBT）、安慰剂药丸和教育）的 FBD 女性（n=397）在基线和治疗后进行研究。分析了人口统计学、临床、心理社会和生理变量。应答者的定义为在平均八项、五分制的治疗满意度问卷中得分>3.5 的患者。对每种治疗条件进行基线和治疗后逻辑回归，以预测应答者结局变量。
类似的认知特征使参与者对各种治疗条件下的治疗反应具有倾向性：对病情的控制感、与治疗师或研究协调员的积极关系、对治疗的信心、不良认知的改善以及治疗期间的生活质量。研究的人口统计学和临床变量没有预测性。注意到一些特定于治疗的因素可以预测应答者的状态，包括 DES 治疗可减少粪便频率，安慰剂组无滥用史。
对于 FBD 的药物、心理和安慰剂治疗，治疗满意度取决于对治疗的信心、对疾病和症状的控制感以及与症状体验相关的负面认知的减少等认知因素。在 FBD 患者中解决这些问题可能会增强对各种治疗的治疗反应。
