Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double-blind randomized controlled exploratory and pragmatic trial.

BACKGROUND: Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological trauma. Therefore, a trauma-focused psychotherapy, such as eye movement desensitization and reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients and if its potential is boosted with the addition of MtCS. METHODS: Forty-five patients with FM and a history of traumatic events will be randomly allocated to Waiting List, EMDR + active-MtCS, or EMDR + sham-MtCS. Therapists and patients will be kept blind to MtCS conditions, and raters will be kept blind to both EMDR and MtCS. All patients will be evaluated at baseline, post-treatment, and follow-up at 6 months after post-treatment. Evaluations will assess the following variables: sociodemographic data, pain, psychological trauma, sleep disturbance, anxiety and affective symptoms, and wellbeing. DISCUSSION: This study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtCS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04084795 . Registered on 2 August 2019.

Second-trimester plasma homocysteine levels and pregnancy-induced hypertension, preeclampsia, and intrauterine growth restriction.

OBJECTIVE: The purpose of this study was to determine whether second-trimester plasma homocysteine levels are elevated among women whose pregnancies are subsequently complicated by pregnancy-induced hypertension, preeclampsia, or intrauterine growth restriction. STUDY DESIGN: Women with normal but relatively low plasma zinc levels were randomly assigned to receive zinc supplementation or placebo from 19 weeks' gestation until delivery. Plasma homocysteine concentration and plasma and erythrocyte folate levels were determined for all available stored samples (zinc group, 231/294; placebo group, 206/286) at 26 and 37 weeks' gestation. Among all women with available samples, pregnancy-induced hypertension (n = 12) or preeclampsia (n = 4) developed in 16 women, and 22 pregnancies were complicated by intrauterine growth restriction. RESULTS: Mean homocysteine levels in women with pregnancy-induced hypertension and preeclampsia were similar to those of control subjects at 26 weeks' gestation but were significantly higher at 37 weeks' gestation. Homocysteine levels were similar between women with pregnancies complicated by intrauterine growth restriction and control subjects at both time points. CONCLUSION: Second-trimester plasma homocysteine concentrations do not predict the subsequent development of pregnancy-induced hypertension, preeclampsia, and intrauterine growth restriction.

A randomized, double-blind, hemodynamic evaluation of nifedipine and labetalol in preeclamptic hypertensive emergencies.

OBJECTIVE: Our purpose was to compare the hemodynamic effects of orally administered nifedipine and intravenously administered labetalol in preeclamptic hypertensive emergencies. STUDY DESIGN: Our study was a randomized, double-blind evaluation of nifedipine and labetalol in women with preeclampsia and a systolic blood pressure >170 mm Hg or a diastolic blood pressure >105 mm Hg. Nifedipine or labetalol and placebo were given, so patients received both tablet and intravenous solution. Hemodynamic parameters at dosing and at 15, 30, 60, and 120 minutes were recorded. Outcome measures were cardiac index, systemic vascular resistance index, mean arterial pressure, and heart rate. Data were analyzed by repeated-measures analysis of variance (Friedman test) with Dunn posttests, the Mann-Whitney U test, and the chi(2) test with the Yates correction. Significance was set at P <.05. RESULTS: At dosing, the nifedipine group (n = 6) had a cardiac index of 3.08 +/- 0.51 L/min per square meter. There was a 43% increase in the cardiac index after nifedipine administration (P =.0008). There was no significant effect in the labetalol group (P =.697). There was a significant decrease in the systemic vascular resistance index after nifedipine dosing (P =.002) but no significant effect on this index after labetalol use (P =.479). The mean arterial pressure was significantly affected in both groups as follows: nifedipine, P =. 001; labetalol, P =.004. The postanalysis showed significance at 60 minutes for both. An insignificant increase in heart rate with nifedipine (P =.147) and a significant decrease with labetalol (P =. 034) were noted. CONCLUSIONS: Nifedipine increases cardiac index, whereas labetalol may not do so.

Hemodynamic effects of oral nifedipine in preeclamptic hypertensive emergencies.

OBJECTIVE: Our purpose was to evaluate the hemodynamic effects of oral nifedipine in preeclamptic hypertensive emergencies. STUDY DESIGN: A prospective observational study of the hemodynamic effects of oral nifedipine was conducted with severely preeclamptic patients receiving magnesium sulfate infusion during a hypertensive emergency. Patients were eligible for the study if systolic blood pressure was > or = 170 m Hg or the diastolic blood pressure was > or = 105 mm Hg on repeat measurements 15 minutes apart at > or = 24 weeks' gestation. Nifedipine was given with an initial dose of 10 mg orally followed by 20 mg orally every 20 minutes until systolic blood pressure was > 160 mm Hg and the diastolic blood pressure was < 100 mm Hg, or for a total of five doses. Patients were hemodynamically monitored in the lateral recumbent position by thoracic electrical bioimpedance before during, and after oral nifedipine dosing. Cardiac index, systemic vascular resistance index, mean arterial pressure, heart rate, and stroke index were all recorded at baseline and during treatment. Data were analyzed by analysis of variance for repeated measures (alpha 0.05) and paired t tests, baseline versus 15 minutes (alpha 0.01). RESULTS: Ten severely preeclamptic patients at 33.2 +/- 3.0 (mean +/- SD) weeks' gestation were enrolled in the study. Mean arterial pressure measurements taken at baseline, 0.25, 0.5, 1, and 4 hours were 133 +/- 10, 119 +/- 8, 109 +/- 8 89 +/- 12, and 100 +/- 13 mm Hg (mean +/- SD, p < 0.0001, analysis of variance repeated measures). Cardiac index increased over time (p = 0.0011, analysis of variance repeated measures). There was no significant effect on maternal heart rate or stroke index. No periodic fetal heart rate changes were noted. One patient had nausea. CONCLUSION: Oral nifedipine appears to be an effective antihypertensive agent in preeclamptic hypertensive emergencies. A steady decrease in mean arterial pressure, systemic vascular resistance, and a mirrored increase in cardiac index are noted.

Autologous blood donation with placenta previa: is it feasible?

Autologous blood donation has been recommended for patients with placenta previa. We hypothesized that premature delivery, preexisting anemia, and bleeding would limit its utilization. We reviewed the charts of all patients admitted with placenta previa between July 1, 1989, and April 30, 1992. To be eligible for autologous donation we assumed that the patient would need to be asymptomatic with a hematocrit 34% or higher at 32 weeks' gestation. Eighty-eight patients were admitted with placenta previa, 12 (14%) of whom were eligible for autologous donation. Two eligible patients required transfusion at delivery and four delivered prior to 34 weeks. Few patients with placenta previa are eligible for autologous donation and although two would have used their autologous units, twice as many may have been compromised by recent autologous donation. We conclude that autologous donation is not feasible in a majority of patients with placenta previa and is of limited usefulness in its management.

Favorable hemodynamic effects of magnesium sulfate in preeclampsia.

OBJECTIVE: Our purpose was to evaluate the hemodynamic effects of magnesium sulfate in preeclamptic and preterm labor patients. STUDY DESIGN: Fifteen preeclamptic patients at 32.4 +/- 3.3 (mean +/- SD) weeks' gestation and 11 preterm labor patients (31.3 +/- 2.8 weeks) were hemodynamically monitored in the lateral recumbent position by thoracic electrical bioimpedance (BoMed, Irvine, Calif.) before and during high-dose magnesium sulfate bolus and infusion. Cardiac index, systemic vascular resistance index, mean arterial pressure, heart rate, and stroke index were all recorded at baseline and during magnesium sulfate infusion. All patients received a standard crystalloid infusion. Data analysis continued until the patient received epidural placement or other antihypertensive therapy or was delivered. RESULTS: At baseline the systemic vascular resistance index was 2465 +/- 718 F.ohm/m2 and the cardiac index was 3.6 +/- 1.0 L/min/m2 for the preeclamptic patients. These were significantly different compared with the preterm labor patients, who had a systemic vascular resistance index of 1377 +/- 563 F.ohm/m2 and 4.6 +/- 1.2 L/min/m2. Magnesium sulfate infusion resulted in a rapid, sustained fall in systemic vascular resistance and a rise in cardiac index in the preeclamptic patient. This effect was evident at least 4 hours after initiation of the bolus and infusion. In the preterm labor patients the hemodynamic effects of magnesium sulfate were minimal and were noted only during the magnesium sulfate bolus. CONCLUSION: Magnesium sulfate infusion appears to have a prolonged hemodynamic effect in the preeclamptic patient. Sustained reduction in systemic vascular resistance and an increase in cardiac index is found in patients with preeclampsia but not in preterm labor.