■目前对创伤后应激障碍(PTSD)的干预措施是有效的,然而,有效性可能受到不利影响和高退出率的限制。针灸是一种新兴的干预措施,对PTSD有积极的初步数据。
■比较针刺和假针刺(最小针刺)对临床和生理结果的影响。
■这是一个双臂,平行组,前瞻性盲法随机临床试验假设verum优于假针刺。这项研究是在一个单独的门诊地点进行的,长滩的TiborRubinVA医疗中心,加州,招募时间为2018年4月至2022年5月,随后为15周的治疗期.在排除了已知的PTSD治疗困惑的特征之后,可能会影响生物学评估,表示过去的不依从性或治疗抵抗,或者表明有伤害的风险,93名18至55岁患有PTSD的寻求治疗的退伍军人通过适应性随机分组,71名参与者完成了干预方案。
■Verum和假作为1小时的课程提供,每周两次,参与者被给予15周的时间来完成多达24个疗程。
■主要结果是根据临床医生管理的PTSD量表-5(CAPS-5)对PTSD症状严重程度的治疗前变化。次要结果是治疗前对治疗后恐惧条件灭绝的变化,通过恐惧增强的惊吓反应来评估。结果在预处理时进行评估,中期治疗,和后处理。在意向治疗(ITT)和治疗完成模型中分析了与组内和组间比较的一般线性模型。
■共有85名男性和8名女性退伍军人(平均[SD]年龄,39.2[8.5]年)随机分组。有很大的治疗效果(科恩d,1.17),虚假(d,0.67),和中等的群体间效应有利于verum(平均值[SD]Δ,7.1[11.8];t90=2.87,d,0.63;P=0.005)在意向治疗分析中。在治疗完成的分析中,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;P=0.01)。在灭绝期间,对治疗后减少恐惧增强的惊吓有明显的预处理(即,恐惧消失更好),而不是假手术组,症状减轻与恐惧消失之间存在显着相关性(r=0.31)。提款率很低。
■本研究中使用的针灸干预在临床上是有效的,并且有利地影响了战斗退伍军人的PTSD的心理生物学。这些数据建立在现有文献的基础上,表明针灸治疗创伤后应激障碍的临床实施,随着对比较疗效的进一步研究,耐用性,和作用机制,是有保证的。
■ClinicalTrials.gov标识符:NCT02869646。
UNASSIGNED: Current 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.
UNASSIGNED: To compare verum acupuncture with sham acupuncture (minimal needling) on clinical and physiological outcomes.
UNASSIGNED: This 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.
UNASSIGNED: Verum and sham were provided as 1-hour sessions, twice weekly, and participants were given 15 weeks to complete up to 24 sessions.
UNASSIGNED: The 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.
UNASSIGNED: A 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.
UNASSIGNED: The 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.
UNASSIGNED: ClinicalTrials.gov Identifier: NCT02869646.