Farabaugh Amy, Mischoulon David, Fava Maurizio, Wu Shirley L, Mascarini Alessandra, Tossani Eliana, Alpert Jonathan E
Depression Clinical and Research Program, Massachusetts General Hospital, MA WAC 812, USA.
Int Clin Psychopharmacol. 2005 Mar;20(2):87-91. doi: 10.1097/00004850-200503000-00004.
The 17-item Hamilton Rating Scale for Depression (HAMD-17) Anxiety/Somatization factor includes six items: Anxiety (psychic), Anxiety (somatic), Somatic Symptoms (gastrointestinal), Somatic Symptoms (general), Hypochondriasis and Insight. This study examines the relationship between early changes (defined as those observed between baseline and week 1) in these HAMD-17 Anxiety/Somatization Factor items and treatment outcome among major depressive disorder (MDD) patients who participated in a study comparing the antidepressant efficacy of a standardized extract of hypericum with both placebo and fluoxetine. Following a 1-week, single-blind washout, patients with MDD diagnosed by the Structured Clinical Interview for DSM-IV (SCID) were randomized to 12 weeks of double-blind treatment with hypericum extract (900 mg/day), fluoxetine (20 mg/day) or placebo. The relationship between early changes in HAMD-17 anxiety/somatization factor items and treatment outcome was assessed separately for patients who received study treatment (hypericum or fluoxetine) versus placebo with a logistic regression method. One hundred and thirty-five patients (female 57%, mean age=37.3+/-11.0 years; mean baseline HAMD-17=19.7+/-3.2 years) were randomized to double-blind treatment and were included in the intent-to-treat (ITT) analyses. After adjusting for baseline HAMD-17 scores and for multiple comparisons with the Bonferroni correction, patients who remitted (HAMD-17 score <8) after study treatment had significantly greater early improvement in Somatic Symptoms (General) scores than non-remitters. No other significant differences in early changes were noted for the remaining items between remitters versus non-remitters who received active treatment. For patients treated with placebo, early change was not predictive of remission for any of the items after Bonferroni correction. In conclusion, the presence of early improvement on the HAMD-17 item concerning fatigue and general somatic symptoms is significantly predictive of achieving remission at endpoint with active study treatment but not with placebo.
17项汉密尔顿抑郁量表（HAMD - 17）的焦虑/躯体化因子包含六个条目：焦虑（精神性）、焦虑（躯体性）、躯体症状（胃肠道）、躯体症状（一般性）、疑病和自知力。本研究探讨了参与一项比较金丝桃标准化提取物与安慰剂及氟西汀抗抑郁疗效研究的重度抑郁症（MDD）患者中，HAMD - 17焦虑/躯体化因子条目的早期变化（定义为基线至第1周观察到的变化）与治疗结局之间的关系。在为期1周的单盲洗脱期后，通过DSM - IV结构化临床访谈（SCID）诊断为MDD的患者被随机分为接受金丝桃提取物（900毫克/天）、氟西汀（20毫克/天）或安慰剂的12周双盲治疗。采用逻辑回归方法，分别评估接受研究治疗（金丝桃或氟西汀）的患者与接受安慰剂的患者中，HAMD - 17焦虑/躯体化因子条目早期变化与治疗结局之间的关系。135名患者（女性占57%，平均年龄 = 37.3±11.0岁；平均基线HAMD - 17 = 19.7±3.2岁）被随机分配至双盲治疗组，并纳入意向性分析（ITT）。在对基线HAMD - 17评分进行校正以及采用Bonferroni校正进行多重比较后，研究治疗后缓解（HAMD - 17评分 < 8）的患者在躯体症状（一般性）评分上的早期改善显著大于未缓解者。在接受活性治疗的缓解者与未缓解者之间，其余条目在早期变化方面未观察到其他显著差异。对于接受安慰剂治疗的患者，经Bonferroni校正后，早期变化对任何条目均无缓解预测作用。总之，HAMD - 17中关于疲劳和一般躯体症状条目的早期改善显著预测了接受活性研究治疗而非安慰剂时在终点达到缓解。
