Department of Psychiatry and EMGO Institute, VU University Medical Center, Academic Outpatient Clinic for Anxiety Disorders, GGZinGeest, Amsterdam, The Netherlands.
Psychother Psychosom. 2012;81(6):366-74. doi: 10.1159/000339369. Epub 2012 Sep 6.
To compare the effectiveness of second-step treatment with cognitive therapy (CT) versus fluvoxamine in patients with obsessive-compulsive disorder (OCD) who are nonresponsive to exposure in vivo with response prevention (ERP).
A 12-week randomized controlled trial at an outpatient clinic in the Netherlands comparing CT with fluvoxamine in OCD. Of 118 subjects with OCD treated with 12 weeks of ERP, 48 appeared to be nonresponders (Y-BOCS improvement score of less than one third). These nonresponders were randomized to CT (n = 22) or fluvoxamine (n = 26). The main outcome measure was the Y-BOCS severity scale. Statistical analyses were conducted in the intention-to-treat sample (n = 45) on an 'as randomized basis' and in the per-protocol sample (n = 30). Due to selective dropout in the fluvoxamine group, two additional sensitivity analyses were performed.
Complete data could be obtained from 45 subjects (94%) after 12 weeks. Fifty percent of the patients refused fluvoxamine after randomization compared to 13% who refused CT [χ(2)(1) = 7.10; p = 0.01]. CT as a second-step treatment did not appear to be effective in this sample of nonresponders. Fluvoxamine was significantly superior to CT in the intention-to-treat sample, in the per-protocol sample and in the two separately defined samples in which the sensitivity analyses were performed.
OCD patients who are nonresponsive to ERP may benefit more from a switch to treatment with an antidepressant instead of switching to CT. In clinical practice, it may be important to motivate this subgroup of patients to undergo psychopharmacological treatment, as this may improve their outcome considerably.
比较认知疗法（CT）与氟伏沙明对暴露和反应预防（ERP）治疗无效的强迫症（OCD）患者的第二阶段治疗效果。
荷兰一家门诊诊所进行的为期 12 周的随机对照试验，比较了 CT 与氟伏沙明在 OCD 中的应用。在接受 12 周 ERP 治疗的 118 例 OCD 患者中，有 48 例患者似乎无反应（Y-BOCS 改善评分不到三分之一）。这些无反应者被随机分为 CT 组（n=22）或氟伏沙明组（n=26）。主要观察指标为 Y-BOCS 严重程度量表。在意向治疗样本（n=45）中进行了统计分析，在“按随机分组”和“按方案分析”两种情况下进行。由于氟伏沙明组选择性脱落，因此进行了另外两项敏感性分析。
12 周后，45 例（94%）患者可获得完整数据。与拒绝 CT 的 13%相比，50%的患者在随机分组后拒绝氟伏沙明[χ(2)(1)=7.10；p=0.01]。在这个无反应者样本中，CT 作为第二阶段治疗似乎无效。氟伏沙明在意向治疗样本、按方案分析样本和进行了两项单独定义的敏感性分析样本中均明显优于 CT。
对 ERP 无反应的 OCD 患者可能从换用抗抑郁药治疗中获益更多，而不是换用 CT。在临床实践中，重要的是要激励这组亚患者接受精神药理学治疗，因为这可能会大大改善他们的预后。
