Fallon Brian A, Ahern David K, Pavlicova Martina, Slavov Iordan, Skritskya Natalia, Barsky Arthur J
From the New York State Psychiatric Institute, New York; and Brigham and Women's Hospital, Boston.
Am J Psychiatry. 2017 Aug 1;174(8):756-764. doi: 10.1176/appi.ajp.2017.16020189. Epub 2017 Jun 29.
Prior studies of hypochondriasis demonstrated benefits for pharmacotherapy and for cognitive-behavioral therapy (CBT). This study examined whether joint treatment offers additional benefit.
Patients with DSM-IV hypochondriasis (N=195) were randomly assigned to one of four treatments-placebo, CBT, fluoxetine, or joint treatment with both fluoxetine and CBT. Evaluations assessed hypochondriasis, other psychopathology, adverse events, functional status, and quality of life. The primary analysis assessed outcome at week 24 among the intent-to-treat sample, with responders defined as having a 25% or greater improvement over baseline on both the Whiteley Index and a modified version of the Yale-Brown Obsessive Compulsive Scale for hypochondriasis (H-YBOCS-M). The Cochran-Armitage trend test assessed the hypothesized pattern of response: joint treatment > CBT or fluoxetine treatment > placebo treatment.
The predicted pattern of response was statistically significant, as shown by the following responder rates: joint treatment group, 47.2%; single active treatment group, 41.8%; and placebo group, 29.6%. Responder rates for each active treatment were not significantly different from the rate for placebo. Secondary analyses of the Whiteley Index as a continuous measure revealed that, compared with placebo, fluoxetine (but not CBT) was significantly more effective at week 24 in reducing hypochondriasis and had a significantly faster rate of improvement over 24 weeks. Fluoxetine also resulted in significantly less anxiety and better quality of life than placebo. Dropout rates did not differ between groups, and treatment-emergent adverse events were evenly distributed.
This study supports the safety, tolerance, and efficacy of fluoxetine for hypochondriasis. Joint treatment provided a small incremental benefit. Because approximately 50% of patients did not respond to the study treatments, new or more intensive approaches are needed.
先前关于疑病症的研究表明药物治疗和认知行为疗法（CBT）均有疗效。本研究旨在探讨联合治疗是否能带来额外益处。
将195例符合《精神疾病诊断与统计手册》第四版（DSM-IV）疑病症诊断标准的患者随机分配至四种治疗组之一：安慰剂组、CBT组、氟西汀组或氟西汀与CBT联合治疗组。评估内容包括疑病症症状、其他精神病理学症状、不良事件、功能状态及生活质量。主要分析在意向性治疗样本中评估第24周时的结果，将在怀特利指数（Whiteley Index）和疑病症的改良版耶鲁-布朗强迫量表（H-YBOCS-M）上较基线改善25%或更多的患者定义为有反应者。 Cochr an-Armitage趋势检验评估假设的反应模式：联合治疗组 > CBT组或氟西汀治疗组 > 安慰剂治疗组。
如下反应率表明，预测的反应模式具有统计学意义：联合治疗组为47.2%；单一活性治疗组为41.8%；安慰剂组为29.6%。各活性治疗组与安慰剂组的反应率无显著差异。将怀特利指数作为连续变量进行的次要分析显示，与安慰剂相比，氟西汀在第24周时在减轻疑病症方面显著更有效，且在24周内改善速度显著更快。氟西汀还导致焦虑显著减轻，生活质量优于安慰剂。各组间脱落率无差异，治疗中出现的不良事件分布均匀。
本研究支持氟西汀治疗疑病症的安全性、耐受性和疗效。联合治疗带来了微小的额外益处。由于约50%的患者对研究治疗无反应，需要新的或更强化的治疗方法。
