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

Christopher Reist,Tyler Smith,Kala Carrick,Andrea Gory Munoz,Seth Norrholm,Estate Sokhadze,An-Fu Hsiao,Besa Smith,Teresa Calloway,Tanja Jovanovic,Karen Cocozza,Michael Hollifield

doi:10.1186/s13063-021-05394-3

Abstract

BackgroundPost-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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT02869646. Registered on 17 August 2016.

Highlights

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 known randomized controlled clinical trial (RCCT) using acupuncture and a traditional Chinese medicine (TCM) approach for PTSD was published in 2007 [7], showing verum acupuncture was superior to a wait-list control and equivalent to group cognitive behavior therapy (CBT)
A paper describing protocol development and methodology for that study was published in 2006 [8]. These novel findings led to a broader adoption of acupuncture practice for PTSD in the Veterans Administration Hospitals and across the USA [9] as well as further research regarding the use of acupuncture for PTSD [10,11,12,13]

Summary

Introduction

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. A paper describing protocol development and methodology for that study was published in 2006 [8] These novel findings led to a broader adoption of acupuncture practice for PTSD in the Veterans Administration Hospitals and across the USA [9] as well as further research regarding the use of acupuncture for PTSD [10,11,12,13]. Reported research outcomes since the first publication have generally supported the efficacy of acupuncture for PTSD, though methodological limitations inhibit strong supportive consensus [15]

Objectives

Methods

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Conclusion