Post-traumatic stress disorder (PTSD) is a significant public health problem, affecting approximately 7% of the general population and 13–18% of the combat Veteran population. The first study using acupuncture for PTSD in a civilian population showed large pre- to post-treatment effects for an empirically developed verum protocol, which was equivalent to group cognitive behavior therapy and superior to a wait-list control. The primary objective of this study is to determine both clinical and biological effects of verum acupuncture for combat-related PTSD in treatment-seeking US Veterans. This is a two-arm, parallel-group, prospective randomized placebo-controlled clinical trial. The experimental condition is verum acupuncture and the placebo control is sham (minimal) acupuncture in 1-h sessions, twice a week for 12 weeks. Ninety subjects will provide adequate power and will be allocated to group by an adaptive randomization procedure. The primary outcome is change in PTSD symptom severity from pre- to post-treatment. The secondary biological outcome is change from pre- to post-treatment in psychophysiological response, startle by electromyographic (EMG) eyeblink. Assessments will be conducted at pre-, mid-, post-, and 1-month post-treatment, blind to group allocation. Intent-to-treat analyses will be conducted. The study results will be definitive because both clinical and biological outcomes will be assessed and correlated. Issues such as the number needed for recruitment and improvement, use of sham acupuncture, choice of biological measure, and future research need will be discussed. ClinicalTrials.gov NCT02869646 . Registered on 17 August 2016.

中文翻译：

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针灸治疗创伤后应激障碍：随机对照临床试验的试验开发和方法学方法

创伤后应激障碍 (PTSD) 是一个重大的公共卫生问题，影响了大约 7% 的普通人群和 13-18% 的退伍军人人群。在平民人群中使用针灸治疗 PTSD 的第一项研究表明，经验开发的 verum 方案在治疗前和治疗后都有很大的影响，这相当于群体认知行为治疗，优于等待名单控制。本研究的主要目的是确定真针灸对寻求治疗的美国退伍军人与战斗相关的 PTSD 的临床和生物学影响。这是一项双臂、平行组、前瞻性随机安慰剂对照临床试验。实验条件是真针灸，安慰剂对照是假（最小）针灸，每次 1 小时，每周两次，持续 12 周。九十名受试者将提供足够的权力，并将通过自适应随机化程序分配到组中。主要结果是 PTSD 症状严重程度从治疗前到治疗后的变化。次要生物学结果是心理生理反应从治疗前到治疗后的变化，由肌电图 (EMG) 眨眼引起。评估将在治疗前、治疗中、治疗后和治疗后 1 个月进行，对分组分配不知情。将进行意向治疗分析。研究结果将是确定的，因为临床和生物学结果都将被评估和关联。将讨论招募和改进所需的数量、假针灸的使用、生物测量的选择以及未来的研究需求等问题。ClinicalTrials.gov NCT02869646。2016 年 8 月 17 日注册。