ImportanceCurrent interventions for posttraumatic stress disorder (PTSD) are efficacious, yet effectiveness may be limited by adverse effects and high withdrawal rates. Acupuncture is an emerging intervention with positive preliminary data for PTSD.ObjectiveTo compare verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes.Design, Setting, and ParticipantsThis was a 2-arm, parallel-group, prospective blinded randomized clinical trial hypothesizing superiority of verum to sham acupuncture. The study was conducted at a single outpatient-based site, the Tibor Rubin VA Medical Center in Long Beach, California, with recruitment from April 2018 to May 2022, followed by a 15-week treatment period. Following exclusion for characteristics that are known PTSD treatment confounds, might affect biological assessment, indicate past nonadherence or treatment resistance, or indicate risk of harm, 93 treatment-seeking combat veterans with PTSD aged 18 to 55 years were allocated to group by adaptive randomization and 71 participants completed the intervention protocols.InterventionsVerum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions.Main Outcomes and MeasuresThe primary outcome was pretreatment to posttreatment change in PTSD symptom severity on the Clinician-Administered PTSD Scale-5 (CAPS-5). The secondary outcome was pretreatment to posttreatment change in fear-conditioned extinction, assessed by fear-potentiated startle response. Outcomes were assessed at pretreatment, midtreatment, and posttreatment. General linear models comparing within- and between-group were analyzed in both intention-to-treat (ITT) and treatment-completed models.ResultsA total of 85 male and 8 female veterans (mean [SD] age, 39.2 [8.5] years) were randomized. There was a large treatment effect of verum (Cohen d, 1.17), a moderate effect of sham (d, 0.67), and a moderate between-group effect favoring verum (mean [SD] Δ, 7.1 [11.8]; t90 = 2.87, d, 0.63; P = .005) in the intention-to-treat analysis. The effect pattern was similar in the treatment-completed analysis: verum d, 1.53; sham d, 0.86; between-group mean (SD) Δ, 7.4 (11.7); t69 = 2.64; d, 0.63; P = .01). There was a significant pretreatment to posttreatment reduction of fear-potentiated startle during extinction (ie, better fear extinction) in the verum but not the sham group and a significant correlation (r = 0.31) between symptom reduction and fear extinction. Withdrawal rates were low.Conclusions and RelevanceThe acupuncture intervention used in this study was clinically efficacious and favorably affected the psychobiology of PTSD in combat veterans. These data build on extant literature and suggest that clinical implementation of acupuncture for PTSD, along with further research about comparative efficacy, durability, and mechanisms of effects, is warranted.Trial RegistrationClinicalTrials.gov Identifier: NCT02869646

中文翻译：

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针灸治疗与战斗相关的创伤后应激障碍

重要性 目前针对创伤后应激障碍 (PTSD) 的干预措施是有效的，但效果可能因不良反应和高戒断率而受到限制。针灸是一种新兴的干预措施，对于 PTSD 具有积极的初步数据。目的比较真针灸与假针灸（最少针刺）的临床和生理结果。设计、设置和参与者这是一项 2 臂、平行组、前瞻性盲法随机临床试验假设真针灸优于假针灸。该研究在加利福尼亚州长滩的 Tibor Rubin VA 医疗中心这一单一门诊地点进行，招募时间为 2018 年 4 月至 2022 年 5 月，随后进行为期 15 周的治疗期。在排除已知的 PTSD 治疗混淆因素、可能影响生物学评估、表明过去不依从或治疗抵抗或表明伤害风险的特征后，93 名 18 至 55 岁患有 PTSD 寻求治疗的退伍军人通过适应性随机化和71 名参与者完成了干预方案。干预措施 Verum 和假手术以 1 小时的疗程提供，每周两次，参与者有 15 周的时间完成最多 24 次疗程。主要结果和措施主要结果是治疗前到治疗后 PTSD 症状严重程度的变化临床医生管理的 PTSD 量表 5 (CAPS-5)。次要结果是治疗前到治疗后恐惧条件消退的变化，通过恐惧增强惊吓反应进行评估。在治疗前、治疗中和治疗后评估结果。在意向治疗 (ITT) 和治疗完成模型中对比较组内和组间的一般线性模型进行了分析。结果共有 85 名男性退伍军人和 8 名女性退伍军人（平均 [SD] 年龄，39.2 [8.5] 岁）被随机化。Verum（科恩）有很大的治疗效果d，1.17），假手术的中等效果（d, 0.67)，以及有利于 verum 的中等组间效应（平均 [SD] Δ, 7.1 [11.8]；t90= 2.87，d, 0.63;磷= .005) 在意向治疗分析中。治疗完成分析中的效果模式相似：verumd，1.53；假d, 0.86; 组间平均值 (SD) Δ, 7.4 (11.7)；t69= 2.64；d, 0.63;磷= .01)。在真实组中，治疗后恐惧增强惊吓在消退过程中的减少（即更好的恐惧消退）显着减少，但假手术组则不然，并且存在显着相关性（r= 0.31) 症状减轻和恐惧消失之间的关系。退出率较低。结论和相关性本研究中使用的针灸干预在临床上有效，并且对退伍军人的 PTSD 心理生物学产生了有利的影响。这些数据建立在现有文献的基础上，表明针灸治疗 PTSD 的临床实施，以及有关比较疗效、持久性和作用机制的进一步研究，是有必要的。试验注册ClinicalTrials.gov 标识符：NCT02869646