ADJUNCTIVE ACUPUNCTURE TO TREAT BIPOLAR DEPRESSION

精神疾病的补充和替代疗法越来越受欢迎，尽管缺乏严格的科学数据来解决其安全性，耐受性或有效性。这项拟议的研究为评估针灸治疗情绪障碍的文献增加了一个虽小但不断增长的群体。主要目的是评估针灸治疗与精神药理学单独结合的可行性和疗效。这项研究将重复以前NIMH资助的研究中设计的针灸诊断和治疗方法。评估受试者对针灸治疗的期望的作用。根据临床结果，患者将被随机分为针灸加稳定药物组（ACUP N=15）或非特异性针灸加稳定药物组（NS ACUP N=15）。与针灸师的临床接触对两组来说是相同的（12个疗程，8周）。病人、评分员和精神科医生将对小组分配视而不见。纳入标准现在要求中度（相对于轻度）抑郁症纳入研究，以尽量减少研究混淆，如自发改善。安全措施和程序已得到加强，以保持学习成果的保留。针灸患者将每周与RA和精神科医生会面，完成评分（IDS-C、CGI-BP、YMRS、GAF），并评估副作用和症状严重程度。我们将纳入符合入组标准但拒绝针灸干预的患者的对照组（TAU）。这些受试者将继续接受药物治疗，回顾性图表审核将使我们能够确定该样本中单独药物治疗的预期变化程度。虽然临床试验已经解决了针灸治疗单相抑郁症的疗效，但存在一个独特的机会，可以为针灸治疗双相情感障碍抑郁症状的研究带来类似的严谨性。这一建议的一个优势是它复制了其他研究人员在重度抑郁症针灸研究中开发和使用的方法。如果针灸在治疗双相情感障碍方面显示出疗效，将提出进一步的研究来评估其在维持和预防方面的效用。

Complementary and alternative therapies for psychiatric disorders are increasingly popular despite the lack of rigorous scientific data addressing their safety, tolerability, or efficacy. The proposed study adds to a small but growing body of literature to evaluate acupuncture in the treatment of mood disorders. The primary aims are to evaluate the feasibility and efficacy of acupuncture treatment in conjunction with psychopharmacology alone. The study will replicate methods of acupuncture diagnosis and treatment designed in a previous NIMH- funded study. The role of subjects' expectancies for acupuncture treatment will be evaluated. Patients will be randomized to either acupuncture plus stable medications (ACUP N=15) on clinical outcome or non-specific acupuncture plus stable medications (NS ACUP N=15). Clinical contact with an acupuncturist will be equivalent for both groups (12 sessions, 8 weeks). Patients, raters, and psychiatrists will be blind to group assignment. The criteria for inclusion now require moderate (vs. mild) depression for study entry to minimize study confounds such as spontaneous improvement. Safety measures and procedures to maintain study retention have been strengthened. Acupuncture patients will meet weekly with an RA and psychiatrist to complete ratings (IDS-C, CGI-BP, YMRS, GAF) and to assess side effects and symptom severity. We will include a comparison group (TAU) of patients who met entry criteria but refused the acupuncture intervention. Those subjects will continue to receive pharmacological treatment, and retrospective chart audit will allow us to determine the degree of change expected from medication treatment alone in this sample. While clinical trials have addressed the efficacy of acupuncture treatment for unipolar depression, a unique opportunity exists to bring similar rigor to the study of acupuncture for depressive symptoms in bipolar disorder. A strength of this proposal is its replication of methodology developed and used by other researchers in a study of acupuncture in MDD. Should acupuncture demonstrate efficacy in the treatment of bipolar disorder, further studies will be proposed to evaluate its utility for maintenance and prevention.