Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial.

Importance: This is the first multisite, randomized clinical trial of stellate ganglion block (SGB) outcomes on posttraumatic stress disorder (PTSD) symptoms. Objective: To determine whether paired SGB treatments at 0 and 2 weeks would result in improvement in mean Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity scores from baseline to 8 weeks. Design, Setting, and Participants: This multisite, blinded, sham-procedure, randomized clinical trial used a 2:1 SGB:sham ratio and was conducted from May 2016 through March 2018 in 3 US Army Interdisciplinary Pain Management Centers. Only physicians performing the procedures and the procedure nurses were aware of the intervention (but not the participants or assessors); their interactions with the participants were scripted and limited to the 2 interventions. Active-duty service members on stable psychotropic medication dosages who had a PTSD Checklist-Civilian Version (PCL-C) score of 32 or more at screening were included. Key exclusion criteria included a prior SGB treatment, selected psychiatric disorders or substance use disorders, moderate or severe traumatic brain injury, or suicidal ideation in the prior 2 months. Interventions: Paired right-sided SGB or sham procedures at weeks 0 and 2. Main Outcomes and Measures: Improvement of 10 or more points on mean CAPS-5 total symptom severity scores from baseline to 8 weeks, adjusted for site and baseline total symptom severity scores (planned a priori). Results: Of 190 screened individuals, 113 (59.5%; 100 male and 13 female participants; mean [SD] age, 37.3 [6.7] years) were eligible and randomized (74 to SGB and 39 to sham treatment), and 108 (95.6% of 113) completed the study. Baseline characteristics were similar in the SGB and sham treatment groups, with mean (SD) CAPS-5 scores of 37.6 (11.2) and 39.8 (14.4), respectively (on a scale of 0-80); 91 (80.0%) met CAPS-5 PTSD criteria. In an intent-to-treat analysis, adjusted mean total symptom severity score change was -12.6 points (95% CI, -15.5 to -9.7 points) for the group receiving SGB treatments, compared with -6.1 points (95% CI, -9.8 to -2.3 points) for those receiving sham treatment (P = .01). Conclusions and Relevance: In this trial of active-duty service members with PTSD symptoms (at a clinical threshold and subthreshold), 2 SGB treatments 2 weeks apart were effective in reducing CAPS-5 total symptom severity scores over 8 weeks. The mild-moderate baseline level of PTSD symptom severity and short follow-up time limit the generalizability of these findings, but the study suggests that SGB merits further trials as a PTSD treatment adjunct. Trial Registration: ClinicalTrials.gov identifier: NCT03077919.

The impact of human immunodeficiency virus infection on obstetric hemorrhage and blood transfusion in South Africa.

BACKGROUND: Globally, as in South Africa, obstetric hemorrhage (OH) remains a leading cause of maternal mortality and morbidity. Although blood transfusion is critical to OH management, the incidence and predictors of transfusion as well as their relation to human immunodeficiency virus (HIV) infection are poorly described. STUDY DESIGN AND METHODS: A cross-sectional study was conducted of all peripartum patients at four major hospitals in South Africa (April to July 2012). Comprehensive clinical data were collected on patients who sustained OH and/or were transfused. Logistic regression was used to model risk factors for OH and transfusion. RESULTS: A total of 15,725 peripartum women were evaluated, of whom 3969 (25.2%) were HIV positive. Overall, 387 (2.5%) women sustained OH and 438 (2.8%) received transfusions, including 213 (1.4%) women with both OH and transfusion. There was no significant difference in OH incidence between HIV-positive (2.8%) and HIV-negative (2.3%) patients (adjusted odds ratio [OR], 0.95; 95% confidence interval [CI], 0.72-1.25). In contrast, the incidence of blood transfusion was significantly higher in HIV-positive (3.7%) than in HIV-negative (2.4%) patients (adjusted OR, 1.52; 95% CI, 1.14-2.03). Other risk factors for transfusion included OH, low prenatal hemoglobin, the treating hospital, lack of prenatal care, and gestational age of not more than 34 weeks. CONCLUSION: In the South African obstetric setting, the incidence of peripartum blood transfusion is significantly higher than in the United States and other high-income countries while OH incidence is similar. While OH and prenatal anemia are major predictors of transfusion, HIV infection is a common and independent contributing factor.

Protective effects of the alcohol dehydrogenase-ADH1B allele in children exposed to alcohol during pregnancy.

OBJECTIVES: To examine alcohol use for mothers with and without an ADH1B*3 allele and the moderating effects of the maternal and child ADH1B*3 allele on a broad range of infant and 7.5-year outcomes. STUDY DESIGN: Blood samples from 263 black mother/child pairs (217 mothers and 239 children) were analyzed to determine incidence of the ADH1B allele and the relation of the maternal allele to pregnancy drinking assessed at every prenatal clinic visit. Moderating effects of ADH1B were examined by dichotomizing the moderator variable and performing regression analyses on the 2 groups. RESULTS: Pregnancy drinking at conception was less frequent in the presence of the ADH1B*3 allele, and virtually no adverse effects were found in children whose mothers had at least one ADH1B*3 allele. By contrast to the maternal allele, we found no consistent pattern of greater vulnerability in children lacking the ADH1B*3 allele. CONCLUSIONS: These data are consistent with the hypothesis that the maternal ADH1B*3 allele provides some protection to the fetus from prenatal alcohol exposure.

Maternal risk factors for fetal alcohol syndrome in the Western cape province of South Africa: a population-based study.

OBJECTIVES: We defined risk factors for fetal alcohol syndrome (FAS) in a region with the highest documented prevalence of FAS in the world. METHODS: We compared mothers of 53 first-grade students with FAS (cases) with 116 randomly selected mothers of first-grade students without FAS (controls). RESULTS: Differences between case and control mothers in our study population existed regarding socioeconomic status, religiosity, education, gravidity, parity, and marital status. Mothers of children with FAS came from alcohol-abusing families in which heavy drinking was almost universal; control mothers drank little to no alcohol. Current and past alcohol use by case mothers was characterized by heavy binge drinking on weekends, with no reduction of use during pregnancy in 87% of the mothers. Twenty percent of control mothers drank during pregnancy, a rate that declined to 12.7% by the third trimester. The percentage who smoked during pregnancy was higher for case mothers than for control mothers (75.5% vs 30.3%), but the number of cigarettes smoked was low among case mothers. The incidence of FAS in offspring of relatively young women (28 years) was not explained by early drinking onset or years of drinking (mean, 7.6 years among case mothers). In addition to traditional FAS risk factors, case mothers were smaller in height, weight, head circumference, and body mass index, all anthropomorphic measures that indicate poor nutrition and second-generation fetal alcohol exposure. CONCLUSIONS: Preventive interventions are needed to address maternal risk factors for FAS.

Validation of a new biomarker of fetal exposure to alcohol.

OBJECTIVE: To test the sensitivity and specificity of fatty acid ethyl esters (FAEEs) extracted from meconium to identify alcohol-using pregnant women with a sensitive and specific methodology, gas chromatography-tandem mass spectroscopy (GC/MS/MS). Study design Twenty-seven samples of meconium were obtained from infants from the mixed race community in Cape Town, South Africa, who were enrolled in a longitudinal neurobehavioral study. Maternal alcohol use was reported prospectively during pregnancy. FAEEs were isolated from meconium and quantitated by GC/MS/MS. RESULTS: Ethyl oleate was the FAEE that correlated most strongly with maternal self-reported drinking, especially with the average ounces of absolute alcohol ingested per drinking day. Ethyl oleate was most strongly related to drinking in the second and third trimesters (Pearson r=.55 and.40, respectively). At a threshold of 1.5 average ounces of absolute alcohol ingested per drinking day, the area under the receiving operator characteristic curve was.92 (95% confidence interval, 0.74-0.97). Using a cut-off value of 32 ng/g, sensitivity was 84.2% and specificity was 83.3%. CONCLUSIONS: Ethyl oleate concentration in meconium assayed by GC/MS/MS provides a highly sensitive and specific indicator of maternal alcohol use during pregnancy.

Characteristics of mothers of children with fetal alcohol syndrome in the Western Cape Province of South Africa: a case control study.

OBJECTIVE: Factors associated with alcohol consumption during pregnancy and with fetal alcohol syndrome (FAS) births were examined as part of a larger epidemiologic study of FAS in a community in the Western Cape Province of South Africa. METHOD: Using retrospective case-control methodology, 31 mothers who had given birth to FAS children 6 to 9 years previously were compared with 31 matched controls on a variety of demographic, socioeconomic, drinking, family and maternity variables. Descriptive analyses were utilized to determine major differential characteristics between the two groups. RESULTS: In this community with a very high rate of FAS and rather uniform low socioeconomic status, the two groups were found to be comparable with respect to age, annual income, ethnic background, age of initiation of regular drinking, age at birth of the index child, gravidity and parity. However, mothers of FAS children reported initiating drinking at an earlier age, as well as reporting higher rates of heavy alcohol consumption in their extended family, current use of alcohol, drinking before and during pregnancy, and smoking of tobacco (percentage who smoke) during each trimester of the pregnancy. Mothers of FAS children had lower educational attainment and reported lower religiosity than control mothers. CONCLUSIONS: This study in South Africa draws upon the experience of mothers of 31 children with FAS to confirm many of the same high-risk variables identified in maternal risk studies in the United States and Europe. Some factors associated with less maternal alcohol abuse in this high-risk population were also identified, which may be helpful for implementing prevention in this region as well as in other developing countries.