Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial

Abstract

Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov NCT02869646. Registered on 17 August 2016.

Efficacy and underlying mechanisms of acupuncture therapy for PTSD: evidence from animal and clinical studies

“…A total of 56 studies were included, with 19 clinical studies and 37 animal studies. Two studies (Prisco et al, 2013 ; King Heather et al, 2015 ) used ear acupuncture, one study (Wu et al, 2013 ) used scalp acupuncture, one study (Yang et al, 2022 ) used CO 2 laser stimulation, one study (Feng et al, 2019 ) used TEAS, and other studies (Fang et al, 2012 ; Li, 2012 , 2014 , 2018 , 2020 ; Wang et al, 2012 , 2015 ; Hou et al, 2013a , b , 2021 ; Wang, 2013 , 2019 ; Engel et al, 2014 ; Li and Zhao, 2014 ; Zhao et al, 2014 , 2019 , 2020 ; Xie et al, 2015 ; Zheng, 2015 ; Zheng et al, 2015 ; Zhou et al, 2015 , 2019 ; Lu et al, 2016 ; Zhu et al, 2016 , 2022 ; Han, 2017 ; Li et al, 2017 , 2020a , b ; Ding, 2018 ; Oh et al, 2018 ; Zhao Y. et al, 2018 ; Zhao Z. et al, 2018 ; Chen et al, 2019 , 2020 , 2021 ; Liu et al, 2019 , 2020 ; Moiraghi et al, 2019 ; Wei et al, 2019 ; Xue et al, 2019 ; Yu et al, 2019 ; Zhang et al, 2019 ; Zhu and Lu, 2019 ; Alvear, 2021 ; Hollifield et al, 2021 ; Abanes et al, 2022 ; Lee and Pan, 2022 ; Song et al, 2022 ; Sun Y. et al, 2022 ; Zhou C. et al, 2022 ) used filiform needle (detail in…”

“…With the increasing availability of acupuncture worldwide, patients with PTSD are increasingly seeking and accepting acupuncture. Many studies have confirmed the effectiveness of acupuncture for PTSD (Yang and Zhang, 2012;Zhang, 2013;Jin et al, 2014Jin et al, , 2015Zheng et al, 2014;Zhao et al, 2015;Han et al, 2016Han et al, , 2017Grant et al, 2018;Ding et al, 2020;Song et al, 2020Song et al, , 2021Hollifield et al, 2021;Kwon et al, 2021;Li et al, 2021). Because the number of studies in the last 10 years accounts for the vast majority and is limited by research technology, there are some differences in outcomes between the long-term research and the current research, so we searched various databases from 1 January 2012 to 27 November 2022.…”

Acupuncture for Combat-Related Posttraumatic Stress Disorder

“…No extant data were available for sample size or power estimates on secondary hypotheses. A description of study methods has been published . Written informed consent was obtained.…”

“…Each of 20 items is rated from 0 (absent) to 4 (severe) and summed into a single severity score. More complete CAPS-5 scoring rules applied in this study have been published …”

“…Differences by group, also discussed below, are previously described. 33 Experimental Group: Verum Acupuncture Individual sessions were offered twice weekly, aiming for 24 sessions in a 15-week period, and reflected clinical practice with an interview (10 minutes), pulse and tongue observation (5 minutes), standard needling to elicit deqi (fullness, heaviness, aching, tingling but not sharp pain; 10 minutes), needle retention (30 minutes), and removal and conclusion (5 minutes). Participants received a standard point prescription designed in our previous work translating PTSD symptoms into traditional Chinese medicine diagnostic patterns.…”