RESUMO
Empirically supported treatments for posttraumatic stress disorder (PTSD) exist, but research suggests these therapies are less effective, acceptable, and feasible to deliver to active duty service members (SMs) compared to civilians. Stellate ganglion block (SGB) procedure, in which a local anesthetic is injected around the cervical sympathetic chain or stellate ganglion to temporarily inhibit sympathetic nervous activity, is gaining popularity as an alternative PTSD treatment in military settings. However, it is unknown whether certain PTSD symptoms are more responsive to SGB than others. The current study involved a secondary analysis of data collected from a previous randomized controlled trial of SGB compared to sham (normal saline) injection (N = 113 SMs). PTSD symptoms were assessed via clinical interview and self-report at baseline and 8 weeks post-SGB or sham. Logistic regression analyses showed that the marked alterations in arousal and reactivity PTSD symptom cluster demonstrated the greatest symptom severity reductions after SGB, relative to sham. The reexperiencing cluster also showed pronounced response to SGB in clinician-rated but not self-reported outcomes. Post-hoc item-level analyses suggested that arousal and reactivity cluster findings were driven by reductions in hypervigilance, concentration difficulties, and sleep disturbance, whereas clinician-rated reexperiencing cluster findings were driven by reductions in physiological reactions to trauma cues, emotional reactions to trauma cues, and intrusions. Our findings align with a burgeoning literature positioning SGB as a potential novel or adjunctive PTSD treatment. Results could guide future hypothesis-driven research on mediators of therapeutic change during SGB for PTSD symptoms in SMs.
Assuntos
Bloqueio Nervoso Autônomo , Gânglio Estrelado , Transtornos de Estresse Pós-Traumáticos , Humanos , Transtornos de Estresse Pós-Traumáticos/terapia , Transtornos de Estresse Pós-Traumáticos/fisiopatologia , Gânglio Estrelado/fisiopatologia , Masculino , Adulto , Feminino , Bloqueio Nervoso Autônomo/métodos , Militares , Resultado do Tratamento , Pessoa de Meia-Idade , Nível de Alerta/fisiologia , Adulto Jovem , AutorrelatoRESUMO
BACKGROUND: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.