Haag S, Senf W, Tagay S, Langkafel M, Braun-Lang U, Pietsch A, Heuft G, Talley N J, Holtmann G
Department of Gastroenterology and Hepatology, and Clinic for Psychosomatic Medicine and Psychotherapy, University Hospital Essen, Essen, Germany.
Aliment Pharmacol Ther. 2007 Apr 15;25(8):973-86. doi: 10.1111/j.1365-2036.2007.03277.x.
In a prospective randomized, controlled trial, to compare the long-term outcome of intensive medical therapy (with or without cognitive-behavioural or muscle relaxation therapy) vs. standard medical therapy in patients with refractory functional dyspepsia (FD), referred to a tertiary referral medical center.
A total of 100 consecutive FD patients were allocated to a standardized symptom-oriented 4 month therapy (SMT, n = 24), intensive medical therapy (IMT, medical therapy with testing-for and targeting-of abnormalities of motor-and-sensory function, n = 28) or IMT plus psychological interventions (either progressive-muscle relaxation (IMT-MR, n = 20) or cognitive-behavioural therapy (IMT-CBT, n = 28). The symptom intensity (SI) and health-related quality-of-life (HRQoL) after 12 months were prespecified primary outcome parameters.
After 12 months, significantly greater improvement of SI occurred in patients with IMT-all (with or without psychological interventions) compared with SMT (P < 0.025 vs. IMT-all). IMT, IMT-MR and IMT-CBT alone also resulted in significantly better improvement of the primary outcome parameters (P all < 0.025 vs. SMT). HRQoL significantly improved in all groups with intensive medical therapy but not standard medical therapy. Differences between intensive medical therapy-all and standard medical therapy were not significant. Concomitant anxiety and depression was improved significantly by IMT-CBT (vs. SMT) but not other treatments.
In FD patients with refractory symptoms, intensified medical management involving function testing and psychological intervention yields superior long-term-outcomes. Additional CBT may be effective for the control of concomitant anxiety and depression.
在一项前瞻性随机对照试验中,比较强化药物治疗(联合或不联合认知行为疗法或肌肉放松疗法)与标准药物治疗对难治性功能性消化不良(FD)患者的长期疗效,这些患者均转诊至一家三级转诊医疗中心。
总共100例连续的FD患者被分配接受标准化的以症状为导向的4个月治疗(SMT,n = 24)、强化药物治疗(IMT,针对运动和感觉功能异常进行检测和靶向治疗的药物治疗,n = 28)或IMT加心理干预(渐进性肌肉放松疗法(IMT-MR,n = 20)或认知行为疗法(IMT-CBT,n = 28)。12个月后的症状强度(SI)和健康相关生活质量(HRQoL)是预先设定的主要结局参数。
12个月后,与SMT相比,接受IMT(无论有无心理干预)的患者SI改善更为显著(与所有IMT组相比,P < 0.025)。单独的IMT、IMT-MR和IMT-CBT也使主要结局参数得到了显著更好的改善(与SMT相比,P均< 0.025)。所有强化药物治疗组的HRQoL均显著改善,而标准药物治疗组未改善。强化药物治疗组与标准药物治疗组之间的差异不显著。IMT-CBT(与SMT相比)可显著改善伴发的焦虑和抑郁,而其他治疗则无此效果。
对于有难治性症状的FD患者,涉及功能检测和心理干预的强化药物管理可产生更好的长期疗效。额外的认知行为疗法可能对控制伴发的焦虑和抑郁有效。