Electroacupuncture for Major Depression: A Pilot Study

描述（由申请人提供）：重度抑郁症是一种常见而严重的精神疾病。它与明显较低的生活质量、严重的功能损害以及因自杀或共病身体疾病而导致的过早死亡有关。在过去的50年里，已经开发出了有效和安全的治疗重度抑郁症的方法，包括抗抑郁药物疗法、心理疗法和电休克疗法。然而，许多患有抑郁症的美国人要么不接受这些常规治疗，要么没有完成适当的治疗过程。越来越多的美国抑郁症患者选择采用补充和替代疗法进行治疗。尤其是针灸，越来越多地被用于治疗抑郁症，尽管只有有限的数据支持其安全性和有效性。拟议的试点研究建立在一组传统抗抑郁治疗研究人员和一组替代医学从业人员的互补专业知识的基础上。该研究将采用随机平行组设计来比较电针（EA）和假电针（SA）治疗重度抑郁症的安全性、有效性和耐受性。在15个月的时间里，60名患有轻度或中度重度抑郁症（根据DSM-IV的定义）的成年门诊患者将被随机分配到12个EA或SA疗程，为期6周。安全性和症状改善（用汉密尔顿抑郁量表测量）将构成主要的结局指标。耐受性和功能改善将构成次要结果测量。该试点项目产生的数据将用于支持开展一项大型多中心研究的可行性，并为设计提供信息，该研究比较了两种形式的针灸与传统治疗抑郁症的疗效。

DESCRIPTION (provided by applicant): Major depression is a common and serious mental illness. It is associated with a markedly lower quality of life, significant functional impairment, and premature death due to suicide or comorbid physical illness. Over the past 50 years, effective and safe treatments for major depression have been developed, including antidepressant pharmacotherapy, psychotherapy, and electroconvulsive therapy. However, many Americans who suffer from a depressive disorder either do not accept to receive one of these conventional treatments or do not complete an adequate course of treatment. A growing number of Americans with depression are choosing to be treated with complementary and alternative therapies. Acupuncture, in particular, is increasingly being used to treat depression even though only limited data support its safety and efficacy. The proposed pilot study builds upon the complementary expertise of a group of investigators of conventional antidepressant treatments and a group of practitioners of alternative medicine. It will use a randomized parallel-group design to compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression. Over a 15-month period, 60 adult outpatients with a major depressive disorder of mild or moderate severity (as defined by the DSM-IV) will be randomized to either 12 sessions of EA or SA to be provided over 6 weeks. Safety and symptomatic improvement (as measured with the Hamilton Rating Scale for Depression) will constitute the primary outcome measures. Tolerability and functional improvement will constitute secondary outcome measures. The data generated by this pilot project will be used to support the feasibility of conducting, and inform the design of, a large multicenter study comparing the efficacy of two forms of acupuncture with a conventional treatment for depression.