Changes In Clinical Variables Research Articles

Association between body fat decrease during the first year after diagnosis and the prognosis of idiopathic pulmonary fibrosis: CT-based body composition analysis

BackgroundThe prognostic role of changes in body fat in patients with idiopathic pulmonary fibrosis (IPF) remains underexplored. We investigated the association between changes in body fat during the first year post-diagnosis and outcomes in patients with IPF.MethodsThis single-center, retrospective study included IPF patients with chest CT scan and pulmonary function test (PFT) at diagnosis and a one-year follow-up between January 2010 and December 2020. The fat area (cm2, sum of subcutaneous and visceral fat) and muscle area (cm2) at the T12-L1 level were obtained from chest CT images using a fully automatic deep learning-based software. Changes in the body composition were dichotomized using thresholds dividing the lowest quartile and others, respectively (fat area: -52.3 cm2, muscle area: -7.4 cm2). Multivariable Cox regression analyses adjusted for PFT result and IPF extent on CT images and the log-rank test were performed to assess the association between the fat area change during the first year post-diagnosis and the composite outcome of death or lung transplantation.ResultsIn total, 307 IPF patients (69.3 ± 8.1 years; 238 men) were included. During the first year post-diagnosis, fat area, muscle area, and body mass index (BMI) changed by -15.4 cm2, -1 cm2, and − 0.4 kg/m2, respectively. During a median follow-up of 47 months, 146 patients had the composite outcome (47.6%). In Cox regression analyses, a change in the fat area < -52.3 cm2 was associated with composite outcome incidence in models adjusted with baseline clinical variables (hazard ratio [HR], 1.566, P = .022; HR, 1.503, P = .036 in a model including gender, age, and physiology [GAP] index). This prognostic value was consistent when adjusted with one-year changes in clinical variables (HR, 1.495; P = .030). However, the change in BMI during the first year was not a significant prognostic factor (P = .941). Patients with a change in fat area exceeding this threshold experienced the composite outcome more frequently than their counterparts (58.4% vs. 43.9%; P = .007).ConclusionA ≥ 52.3 cm2 decrease in fat area, automatically measured using deep learning technique, at T12-L1 in one year post-diagnosis was an independent poor prognostic factor in IPF patients.

Delta radiomic patterns on serial bi-parametric MRI are associated with pathologic upgrading in prostate cancer patients on active surveillance: preliminary findings.

The aim of this study was to quantify radiomic changes in prostate cancer (PCa) progression on serial MRI among patients on active surveillance (AS) and evaluate their association with pathologic progression on biopsy. This retrospective study comprised N = 121 biopsy-proven PCa patients on AS at a single institution, of whom N = 50 at baseline conformed to the inclusion criteria. ISUP Gleason Grade Groups (GGG) were obtained from 12-core TRUS-guided systematic biopsies at baseline and follow-up. A biopsy upgrade (AS+) was defined as an increase in GGG (or in number of positive cores) and no upgrade (AS-) was defined when GGG remained the same during a median period of 18 months. Of N = 50 patients at baseline, N = 30 had MRI scans available at follow-up (median interval = 18 months) and were included for delta radiomic analysis. A total of 252 radiomic features were extracted from the PCa region of interest identified by board-certified radiologists on 3T bi-parametric MRI [T2-weighted (T2W) and apparent diffusion coefficient (ADC)]. Delta radiomic features were computed as the difference of radiomic feature between baseline and follow-up scans. The association of AS+ with age, prostate-specific antigen (PSA), Prostate Imaging Reporting and Data System (PIRADS v2.1) score, and tumor size was evaluated at baseline and follow-up. Various prediction models were built using random forest (RF) classifier within a threefold cross-validation framework leveraging baseline radiomics (Cbr), baseline radiomics + baseline clinical (Cbrbcl), delta radiomics (CΔr), delta radiomics + baseline clinical (CΔrbcl), and delta radiomics + delta clinical (CΔrΔcl). An AUC of 0.64 ± 0.09 was obtained for Cbr, which increased to 0.70 ± 0.18 with the integration of clinical variables (Cbrbcl). CΔr yielded an AUC of 0.74 ± 0.15. Integrating delta radiomics with baseline clinical variables yielded an AUC of 0.77 ± 0.23. CΔrΔclresulted in the best AUC of 0.84 ± 0.20 (p < 0.05) among all combinations. Our preliminary findings suggest that delta radiomics were more strongly associated with upgrade events compared to PIRADS and other clinical variables. Delta radiomics on serial MRI in combination with changes in clinical variables (PSA and tumor volume) between baseline and follow-up showed the strongest association with biopsy upgrade in PCa patients on AS. Further independent multi-site validation of these preliminary findings is warranted.

Twice-daily injections and multiple daily injections of insulin in toddlers with type 1 diabetes: a retrospective cohort study.

Twice-daily injections and multiple daily injections of insulin in toddlers with type 1 diabetes: a retrospective cohort study.

Effects of double intravenous furosemide administration at different doses on clinical variables, electrocardiographic indices and serum electrolytes in miniature donkeys.

The intravenous (IV) usage of diuretics such as furosemide may cause changes in clinical variables, electrocardiographic (ECG) indices and some serum electrolytes concentrations in miniature donkeys. The purpose of this study was to evaluate the effects of double intravenous (IV) administration of furosemide at different doses on the clinical variables, ECG indices and serum electrolytes levels in miniature donkeys. A total of 21 clinically and para-clinically healthy miniature donkeys with a mean age of 6.00 ± 1.00 years and weight of 95.00 ± 5.00 kg were used. The animals were randomly divided into three groups of control (normal saline) and low- (1.00 mg kg-1) and high-dose (2.00 mg kg-1) of furosemide. Two IV injections with 12-hr interval were administered in each animal. The clinical and ECG parameters were measured at 0 (baseline), 2 (T2), 24 (T24) and 48 (T48) hr after drug administration. Serum concentrations of electrolytes were measured at T0, T24 and T48. The results of this study showed no changes in clinical variables (heart rate, rectal temperature and respiratory rate) and ECG indices (amplitude and duration of P, QRS and T waves and duration of PR, QT and RR intervals) as well as no significant changes in serum electrolytes (sodium, potassium, chloride, phosphorus, calcium and magnesium) levels. Although no significant effect on clinical variables, electrolytes levels and ECG indices after double IV administration of furosemide (1.00 and 2.00 mg kg-1) in miniature donkeys was observed, absence of these effects does not mean that furosemide had no pharmacological effect.

Effects of neuronavigation-guided rTMS on serum BDNF, TrkB and VGF levels in depressive patients with suicidal ideation

BackgroundNeuronavigation-guided high-dose repetitive transcranial magnetic stimulation (rTMS) could rapidly treat depressive patients with suicidal ideation. But the mechanism of rTMS still needs to be elucidated. This study aims to investigate if rTMS improves suicidal ideation and depressive symptoms by influencing brain-derived neurotrophic factor (BDNF), tropomysin receptor kinase B (TrkB) and VGF levels. MethodsIn the present 1-week study, 59 treatment-naive depressive patients with suicidal ideation were randomly assigned to the active (n = 31) or sham (n = 28) rTMS group. The severity of suicidal ideation and depression were measured by the Beck Scale for Suicide Ideation, the Hamilton Depression Rating Scale and Montgomery–Asberg Depression Rating Scale. Fasting venous blood samples were collected at baseline and after treatment. Serum protein concentrations of BDNF, TrkB and VGF were measured by enzyme linked immunosorbent assay. ResultsWe found after treatment the levels of BDNF in the active rTMS group were higher than the sham group (p = 0.011), TrkB levels were decreased in the active group (p < 0.001), VGF levels were increased in the active group (p = 0.005). Post-treatment VGF levels in the active group were higher than the sham group (p = 0.008). However, there were no significant correlation between changes in BDNF, TrkB and VGF levels and the changes in clinical variables. LimitationsParticipants taking medication may affect the results. ConclusionsOur results suggest that the BDNF-TrkB pathway and VGF may be implicated in the mechanisms underlying neuronavigation-guided rTMS for treating depressive patients with suicidal ideation.

Identifying and analyzing sepsis states: A retrospective study on patients with sepsis in ICUs.

Sepsis accounts for more than 50% of hospital deaths, and the associated cost ranks the highest among hospital admissions in the US. Improved understanding of disease states, progression, severity, and clinical markers has the potential to significantly improve patient outcomes and reduce cost. We develop a computational framework that identifies disease states in sepsis and models disease progression using clinical variables and samples in the MIMIC-III database. We identify six distinct patient states in sepsis, each associated with different manifestations of organ dysfunction. We find that patients in different sepsis states are statistically significantly composed of distinct populations with disparate demographic and comorbidity profiles. Our progression model accurately characterizes the severity level of each pathological trajectory and identifies significant changes in clinical variables and treatment actions during sepsis state transitions. Collectively, our framework provides a holistic view of sepsis, and our findings provide the basis for future development of clinical trials, prevention, and therapeutic strategies for sepsis.

Study protocol of the PROUD48 study comparing the effects of pemafibrate and omega-3 fatty acid ethyl esters on ApoB-48 in statin-treated patients with dyslipidaemia: a prospective, multicentre, open-label, randomised, parallel group trial in Japan

IntroductionThis study will compare the lowering effects of pemafibrate and omega-3 fatty acid ethyl esters on fasting apolipoprotein B-48 (apoB-48), a surrogate marker reflecting postprandial hypertriglyceridaemia, which is a residual...

Metagenomic analysis reveals crosstalk between gut microbiota and glucose-lowering drugs targeting the gastrointestinal tract in Chinese patients with type 2 diabetes: a 6 month, two-arm randomised trial

Aims/hypothesisThe use of oral glucose-lowering drugs, particularly those designed to target the gut ecosystem, is often observed in association with altered gut microbial composition or functional capacity in individuals with type 2 diabetes. The gut microbiota, in turn, plays crucial roles in the modulation of drug efficacy. We aimed to assess the impacts of acarbose and vildagliptin on human gut microbiota and the relationships between pre-treatment gut microbiota and therapeutic responses.MethodsThis was a randomised, open-labelled, two-arm trial in treatment-naive type 2 diabetes patients conducted in Beijing between December 2016 and December 2017. One hundred participants with overweight/obesity and newly diagnosed type 2 diabetes were recruited from the Pinggu Hospital and randomly assigned to the acarbose (n=50) or vildagliptin (n=50) group using sealed envelopes. The treatment period was 6 months. Blood, faecal samples and visceral fat data from computed tomography images were collected before and after treatments to measure therapeutic outcomes and gut microbiota. Metagenomic datasets from a previous type 2 diabetes cohort receiving acarbose or glipizide for 3 months were downloaded and processed. Statistical analyses were applied to identify the treatment-related changes in clinical variables, gut microbiota and associations.ResultsNinety-two participants were analysed. After 6 months of acarbose (n=44) or vildagliptin (n=48) monotherapy, both groups achieved significant reductions in HbA1c (from 60 to 46 mmol/mol [from 7.65% to 6.40%] in the acarbose group and from 59 to 44 mmol/mol [from 7.55% to 6.20%] in the vildagliptin group) and visceral fat areas (all adjusted p values for pre–post comparisons <0.05). Both arms showed drug-specific and shared changes in relative abundances of multiple gut microbial species and pathways, especially the common reductions in Bacteroidetes species. Three months and 6 months of acarbose-induced changes in microbial composition were highly similar in type 2 diabetes patients from the two independent studies. Vildagliptin treatment significantly enhanced fasting active glucagon-like peptide-1 (GLP-1) levels. Baseline gut microbiota, rather than baseline GLP-1 levels, were strongly associated with GLP-1 response to vildagliptin, and to a lesser extent with GLP-1 response to acarbose.Conclusions/interpretationThis study reveals common microbial responses in type 2 diabetes patients treated with two glucose-lowering drugs targeting the gut differently and acceptable performance of baseline gut microbiota in classifying individuals with different GLP-1 responses to vildagliptin. Our findings highlight bidirectional interactions between gut microbiota and glucose-lowering drugs.Trial registrationClinicalTrials.gov NCT02999841FundingNational Key Research and Development Project: 2016YFC1304901.Graphical abstract

Real-Time fMRI Neurofeedback Training Changes Brain Degree Centrality and Improves Sleep in Chronic Insomnia Disorder: A Resting-State fMRI Study.

BackgroundChronic insomnia disorder (CID) is considered a major public health problem worldwide. Therefore, innovative and effective technical methods for studying the pathogenesis and clinical comprehensive treatment of CID are urgently needed.MethodsReal-time fMRI neurofeedback (rtfMRI-NF), a new intervention, was used to train 28 patients with CID to regulate their amygdala activity for three sessions in 6 weeks. Resting-state fMRI data were collected before and after training. Then, voxel-based degree centrality (DC) method was used to explore the effect of rtfMRI-NF training. For regions with altered DC, we determined the specific connections to other regions that most strongly contributed to altered functional networks based on DC. Furthermore, the relationships between the DC value of the altered regions and changes in clinical variables were determined.ResultsPatients with CID showed increased DC in the right postcentral gyrus, Rolandic operculum, insula, and superior parietal gyrus and decreased DC in the right supramarginal gyrus, inferior parietal gyrus, angular gyrus, middle occipital gyrus, and middle temporal gyrus. Seed-based functional connectivity analyses based on the altered DC regions showed more details about the altered functional networks. Clinical scores in Pittsburgh sleep quality index, insomnia severity index (ISI), Beck depression inventory, and Hamilton anxiety scale decreased. Furthermore, a remarkable positive correlation was found between the changed ISI score and DC values of the right insula.ConclusionsThis study confirmed that amygdala-based rtfMRI-NF training altered the intrinsic functional hubs, which reshaped the abnormal functional connections caused by insomnia and improved the sleep of patients with CID. These findings contribute to our understanding of the neurobiological mechanism of rtfMRI-NF in insomnia treatment. However, additional double-blinded controlled clinical trials with larger sample sizes need to be conducted to confirm the effect of rtfMRI-NF from this initial study.

Analysis of Clinical Parameters, Drug Consumption and Use of Health Resources in a Southern European Population with Alcohol Abuse Disorder during COVID-19 Pandemic.

The disruption in healthcare attention to people with alcohol dependence, along with psychological decompensation as a consequence of lockdown derived from the COVID-19 pandemic could have a negative impact on people who suffer from alcohol abuse disorder. Observational real world data pre-post study included 9966 men aged >16 years registered as having the diagnosis of alcohol abuse disorder in the electronic medical records (EMR) of the Aragon Regional Health Service (Spain). Clinical (Glutamate-oxaloacetate -GOT-, Glutamate pyruvate -GPT-, creatinine, glomerular filtration, systolic blood pressure -SBP-, diastolic blood pressure -DBP-, total cholesterol, LDL, HDL, triglycerides, and body mass index -BMI-), pharmacological (dose per inhabitant per day, DHD, of drugs used in addictive disorders, benzodiazepines and antidepressants) and health resource use variables (primary and specialized care) were considered. A Student’s t-test for matched samples was performed to analyze the changes in clinical variables between alcohol abuse disorder patients with and without COVID-19. Only creatinine and LDL showed a significant but clinically irrelevant change six months after the end of the strict lockdown. The total number of DHDs for all drugs included in the study (except for benzodiazepines), decreased. In the same way, the use of health services by these patients also decreased. The impact of COVID-19 among this group of patients has been moderate. The reorganization of health and social services after the declaration of the state of alarm in our country made possible the maintenance of care for this vulnerable population.

Efficacy, Complications, and Factors Predictive of Response to Treatment with Transvaginal Radiofrequency Ablation for Symptomatic Uterine Myomas

Transvaginal radiofrequency ablation is a minimally invasive treatment for myomas in women who wish to preserve their uterus. This study aimed to evaluate the efficacy and safety of transvaginal radiofrequency to treat myomas and to identify factors predictive of the response to treatment. Prospective case series. Virgen de las Nieves University Hospital, a tertiary center in Granada, Spain. The participants were 59 patients with myomas. Transvaginal radiofrequency ablation. The variables recorded were personal (age and type of myoma), procedure dependent (pain, need for analgesia, duration of sick leave, procedure duration, and complications), clinical (total days of menstrual bleeding and days of heavy menstrual bleeding), and score on the symptom severity scale of the Uterine Fibroid Symptom and Quality of Life Questionnaire. Myoma volume was determined by ultrasonography. Changes in clinical variables and myoma volume were analyzed 2, 6, and 12 months after the procedure. Moreover, the influence of age, initial myoma size, type of myoma, and duration of the procedure on the outcomes of treatment were analyzed. Statistically significant improvements in symptoms were seen in all variables analyzed for bleeding at 0, 2, 6, and 12 months, and a significant improvement was seen in the symptom severity scale score 12 months after the procedure. Mean myoma volume (in milliliters) was significantly lower 2, 6, and 12 months after treatment (p <.05). At 12 months, the mean reduction in myoma volume was more than 80%. Patient age and initial myoma size were identified as factors predictive of the outcomes. Transvaginal radiofrequency ablation was an effective and safe technique for the treatment of myomas. The patient's age and initial size of the myoma influenced the outcome of treatment.

One-year impact of bariatric surgery on echocardiographic markers of vascular disease: results from the prospective FatWest study

Abstract Background Aortic root plaque and aortic valve sclerosis (AVS) are known echocardiographic markers of atherosclerosis. Obesity increases the atherothrombotic risk, while large surgical weight loss improves the cardiovascular risk profile. It is unclear whether the severity of vascular disease associated with severe obesity changes after bariatric surgery. Purpose To assess the 1-year impact of bariatric surgery on aortic root wall thickness (ART) and AVS. Methods 91 severely obese patients (43±10 years, preoperative body mass index [BMI] 41.7±4.9 kg/m2, 55% hypertensive, 17% diabetic) underwent echocardiography preoperatively and 14 months after Roux-en-Y bypass surgery in the prospective FatWest (Bariatric Surgery on the West Coast of Norway) study. We measured the end-diastolic maximum ART and categorized AVS as mild, moderate or severe based on combined aortic cusp thickness and hyperechoic valve lesions. Left ventricular (LV) structural remodelling was assessed by LV mass and geometry. In 52 patients with clinical signs of obstructive sleep apnea, preoperative polysomnography data including apnea-hypopnea index and mean nightly oxygen saturation were evaluated. Results Preoperatively, 39% had mild-moderate AVS, and an average ART of 4.9±1.7mm (Figures 1–2). Presence of AVS at baseline was associated with higher LV mass, while ART was higher in men, older patients and increased with lower nightly oxygen saturation (r=−0.29, p&amp;lt;0.05). During the first preoperative 14 months, patients experienced a 12.9±3.8kg/m2 BMI and 0.6±1.9mm ART reduction, and AVS prevalence lowered by 45% (Figures 1 and 2). In backward stepwise multivariate regression analyses with adjustment for changes in clinical variables, LV mass and geometry, less ART reduction at 14 months was independently predicted by higher age, higher postoperative BMI and presence of AVS (R2 0.53, all p&amp;lt;0.05). Persistent AVS was associated with higher age and preoperative diabetes (R2 0.24, p&amp;lt;0.05). Conclusion In patients undergoing bariatric surgery, a reduction in echocardiographic markers of vascular disease was observed 1 year postoperatively, particularly in younger, non-diabetic patients. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Helse Vest Figure 1Figure 2

A Functional Connectivity Study to Investigate the Role of the Right Anterior Insula in Modulating Emotional Dysfunction in Borderline Personality Disorder.

Previous imaging studies in patients with borderline personality disorder (BPD) have detected functional brain dysfunctions. Mindfulness training may improve the symptoms of BPD, although the neural mechanisms involved remain poorly understood. This study had several key aims: a) to investigate the role of right anterior insula (rAI) functional connectivity in modulating baseline emotional status in BPD, b) to compare differences in connectivity changes after mindfulness training versus interpersonal effectiveness intervention, and c) to explore the correlation between longitudinal changes in imaging data and clinical indicators. Thirty-eight patients with BPD underwent resting-state functional magnetic resonance imaging. Participants completed self-report clinical scales and participated in a dialectical-behavioral therapy (mindfulness versus interpersonal effectiveness modules). Changes in clinical and imaging variables were evaluated longitudinally after completion of the first 10-week sessions of psychotherapeutic intervention. At baseline, the rAI was strongly connected with the other salience network nodes and anticorrelated with most core nodes of the default mode network (p < .05, corrected). The functional connectivity of the rAI correlated with emotional dysregulation and deficits in mindfulness capacities (p < .05, corrected). After completion of psychotherapeutic intervention, both groups (mindfulness and interpersonal effectiveness) showed divergent posttherapy functional connectivity changes, which were in turn associated with the clinical response. The functional connectivity of the rAI seems to play an important role in emotion dysregulation and deficits in mindfulness capacities in individuals with BPD. Psychotherapy seems to modulate this functional connectivity, leading to beneficial changes in clinical variables.

Changes in prefrontal cortex activation with exercise in knee osteoarthritis patients with chronic pain: An fNIRS study

The role of exercise on pain modulatory mechanism of the prefrontal areas is not clear. We aimed to determine the effects of exercise on functional activity of the prefrontal cortex in patients with knee osteoarthritis (OA) with chronic pain and to assess the relationships between changes in clinical variables and cortical hemodynamics with exercise via functional near-infrared spectroscopy (fNIRS). Fifteen patients with knee OA with chronic pain were included. All participants attended an exercise program 3 times a week for 6 weeks. Pain during activity was assessed by visual analogue scale (VAS). Pain catastrophization, kinesiophobia and functionality were also measured. Brain hemodynamic activity was assessed with a 47-channel fNIRS system before and after the exercise. Pain, pain catastrophization, kinesiophobia and functionality scores significantly improved (p < 0.05) while functional activity of the dorsolateral prefrontal cortex (DLPFC) during painful stimuli was significantly reduced after exercise program (p < 0.05). Change in cortical hemodynamic activity within the DLPFC was significantly correlated with change in pain perception (R = 0.54, p < 0.05) and pain catastrophization scores (R = 0.44, p < 0.05). Exercise resulted in improvements in clinical assessments of pain severity and pain catastrophization which was accompanied by alterations in prefrontal cortex activation. We provided evidence about the pain modulatory effects of exercise at cortical level which is correlated with clinical improvements in patients with chronic pain. We demonstrate the feasibility and potential of fNIRS methodology for i) elucidating the neural mechanisms underlying chronic and stimulus evoked pain, and ii) exploring the effect of treatment methods on brain functionality.

White matter microstructure and structural networks in treatment-resistant schizophrenia patients after commencing clozapine treatment: A longitudinal diffusion imaging study

This study investigates changes on white matter microstructure and neural networks after 6 months of switching to clozapine in schizophrenia patients compared to controls, and whether any changes are related to clinical variables. T1 and diffusion-weighted MRI images were acquired at baseline before commencing clozapine and after 6 months of treatment for 22 patients with treatment-resistant schizophrenia and 23 controls. The Tract-based spatial statistics approach was used to compare changes over time between groups in fractional anisotropy (FA). Changes in structural network organisation weighted by FA and number of streamlines were assessed using graph theory. Patients displayed a significant reduction of FA over time (p<0.05) compared to controls in the genu and body of the corpus callosum and bilaterally in the anterior and superior corona radiata. There was no correlation between FA change in patients and changes in clinical variables or serum level of clozapine. There was no changes in structural network organisation between groups (F(7,280)=2.80;p = 0.187). This longitudinal study demonstrated progressive focal FA abnormalities in key anterior tracts, but preserved brain structural network organisation in patients. The FA reduction was independent of any clinical measures and may reflect progression of the underlying pathophysiology of this malignant form of schizophrenia illness.

Effects of hemodialysis treatment on saliva flow rate and saliva composition during in-center maintenance dialysis: a cross-sectional study

Aim To analyze changes in saliva flow rate and clinical measures from unstimulated whole saliva (UWS) among patients undergoing hemodialysis for end-stage kidney disease (ESKD). Background Chronic hemodialysis causes changes in blood chemistry as well as dry mouth, due to removal of excess fluids. UWS is used to examine saliva flow rate as an indicator of mouth dryness. Whether UWS can be used to measure changes in clinical variables following hemodialysis has not been explored. Design A cross-sectional quantitative study. Methods Patients with ESKD were recruited by purposive sampling (n = 100) between 1 January and 30 June 2015 from a hospital in northern Taiwan. UWS was collected 1-hour pre-dialysis (T1), mid-dialysis (T2), and 1-hour post-dialysis (T3). Saliva flow rate and clinical variables were analyzed. Results Saliva flow rate increased significantly from T1 to T3 (Wald χ2 = 10.40, p < .01). Changes in saliva from T1 to T3 included decreases in blood urea nitrogen and creatinine (Wald χ2 = 97.12, p < .001 and Wald χ2 = 36.98, p < .001, respectively). The pH and osmolality also decreased (p < .001 and p < .01, respectively). Changes in electrolytes included decreases in potassium and calcium (Wald χ2 = 6.71, p < .05 and Wald χ2 = 17.64, p < .01, respectively) and increases in chloride (Wald χ2 = 17.64, p < .001). Conclusion Our findings demonstrated saliva flow rate and several saliva components were altered during hemodialysis. The total volume of saliva secretion increased following dialysis, which can reduce xerostomia. Therefore, medical personnel could provide interventions of relieving dry mouth symptoms and increasing saliva flow rate before hemodialysis treatment.

Cerebral fractional amplitude of low-frequency fluctuations may predict headache intensity improvement following acupuncture treatment in migraine patients.

To explore how baseline resting-state cerebral function predicts clinical outcomes of acupuncture treatment for migraine. One hundred migraine patients and 46 healthy subjects were recruited. Patients were randomized into the acupuncture, sham acupuncture, and waiting list groups. Resting-state functional magnetic resonance imaging data were collected at baseline and after 1 month of longitudinal acupuncture treatments. Fractional amplitude of low-frequency fluctuations (fALFF) calculations were applied to explore the associations between baseline fALFF and changes in clinical variables in the acupuncture treatment group and the waiting list group. Compared with healthy subjects, migraine patients had lower fALFF in the left rostral ventromedial medulla, right thalamus, left amygdala, and right angular gyrus. Regression analyses revealed that baseline fALFF values in the left middle frontal gyrus, left superior temporal gyrus, and middle temporal gyrus were positively associated with headache intensity changes in the acupuncture treatment group, while baseline fALFF values in the bilateral lingual gyrus and cuneus were negatively associated with headache intensity changes in this group. The baseline fALFF values of brain regions associated with cognitive pain modulation, but not migraine severity, may predict future headache intensity improvement levels in migraine patients receiving acupuncture treatment.

Pelvic Floor Biometric Changes Assessed by 4D Translabial Ultrassound in Women With Vulvodynia Submitted to Physical Therapy: A Pilot Study of a Randomized Controlled Trial

BackgroundVulvodynia is a disabling condition in which pelvic floor muscles' (PFM) hypertonicity plays an important role. AimTo evaluate biometric changes in PFM in women with vulvodynia undergoing kinesiotherapy treatment protocol (KTP). MethodsA single-blinded randomized controlled trial of 57 women with vulvodynia randomly assigned to either KTP + amitriptyline or amitriptyline alone (controls) for treatment. Four-dimensional translabial ultrasound assessed PFM regarding symphysis-levator distance at rest, anorectal angle at rest, excursion of the levator plate angle, and levator hiatal narrowing. Volunteers underwent a vaginal examination for a cotton swab test (CST), fulfillment of Friedrich criteria score and PFM power of contraction, and completed a diary of sexual pain and frequency of vaginal intercourse. Outcomes were assessed at baseline and after 8 weeks of treatment. OutcomesPrimary outcomes were differences in biometric parameters assessed by four-dimensional translabial ultrasound after treatment, between groups. Secondary outcomes were changes in clinical variables (CST, Friedrich criteria, PFM power of contraction, frequency of intercourse, and intensity of sexual pain) between groups and correlation analysis between biometric parameters and clinical variables. ResultsOnly the KTP group had statistically significant changes in biometric parameters after treatment (symphysis-levator distance: 0.22 ± 0.2, 95% CI = 0.1–0.4, P = .008; levator hiatal narrowing: −0.33 ± 0.2, 95% CI = −1 to −0.2, P = .04). Comparisons between groups showed that symphysis-levator distance (0.3, 95% CI = 0.2–0.6, P = .005) and excursion of levator plate angle (4.9, 95% CI = −0.4 to 10.1, P = .02) improved significantly after KTP treatment. Clinical variables showed greater improvement in the group treated with KTP for CST (difference of −3.7, 95% CI = −7 to −0.4, P = .01), Friedrich criteria (difference of −1.9, 95% CI = −3.2 to −0.6, P = .003), PFM power of contraction (0.3, 95% CI = 0.1–0.6, P = .05) and intensity of sexual pain (reduction of 1.7, 95% CI = −3.1 to −0.2, P = .01). Some clinical and biometric variables correlated positively, for example, frequency of vaginal intercourse and anorectal angle (P = .04; r = 0.25), or inversely, for example, pain intensity at CST and anorectal angle (P = .004, r = −0.31). Clinical ImplicationsThis study provides evidence on efficiency of a physical therapy protocol for improvement of symptoms of vulvodynia and hypertonicity changes. ConclusionThis pilot study suggests that KTP for women with vulvodynia promoted significant changes in PFM biometric measures, consistent with alterations in hypertonicity and clinical improvement.Bardin MG, Giraldo PC, Martinho N. Pelvic Floor Biometric Changes Assessed by 4D Translabial Ultrassound in Women With Vulvodynia Submitted to Physical Therapy: A Pilot Study of a Randomized Controlled Trial. J Sex Med 2020;17:2236–2246.

Impact of changes in social anxiety on social functioning and quality of life in outpatients with schizophrenia: A naturalistic longitudinal study

The prevalence of comorbid social anxiety disorder among patients with schizophrenia is currently attracting attention, and symptoms of social anxiety are reportedly associated with various clinical features. However, the contribution of social anxiety to social functioning and quality of life (QOL) over time remains obscure. The aim of this study was to examine the impact of changes in social anxiety symptoms on social functioning and QOL among outpatients with schizophrenia. Of the 207 outpatients who were eligible at baseline, 118 patients agreed with and completed a follow-up investigation at least 1 year (695.8 days on average) after the baseline study. Stepwise multiple regressions examining the change in social functioning using demographic data and changes in clinical variables as explanatory variables demonstrated that the changes in social anxiety and general psychopathology contributed to the change in the Social Functioning Scale, while the changes in clinical severity and negative symptoms contributed to the change in the Global Assessment of Functioning scale. Stepwise multiple regressions for the change in QOL demonstrated that the changes in social anxiety and depression contributed to the change in the World Health Organization QOL scale, Brief version, and the changes in social anxiety and positive symptoms contributed to the Subjective Well-being Under Neuroleptic Drug Treatment, Short Form. The results revealed that the changes in social anxiety symptoms were significantly associated with the change in functional outcome among patients with schizophrenia. Treatments targeting social anxiety seem to be key to achieving a full recovery in patients with schizophrenia.

Progression of Fatty Liver Disease in Children Receiving Standard of Care Lifestyle Advice

Nonalcoholic fatty liver disease (NAFLD) is the most common pediatric chronic liver disease. Little is known about outcomes in recognized youth. We compared paired liver biopsies from 122 of 139 children with NAFLD (74% male; 64% white; 71% Hispanic; mean age, 13 ± 3 years; age range, 8-17 years) who received placebo and standard of care lifestyle advice in 2 double-blind, randomized clinical trials within the nonalcoholic steatohepatitis (NASH) clinical research network from 2005 through 2015. We analyzed histologic changes with respect to baseline and longitudinal change in clinical variables using regression analysis. At enrollment, 31% of the children had definite NASH, 34% had borderline zone 1 NASH, 13% had borderline zone 3 NASH, and 21% had fatty liver but not NASH. Over a mean period of 1.6 ± 0.4 years, borderline or definite NASH resolved in 29% of the children, whereas 18% of the children with fatty liver or borderline NASH developed definite NASH. Fibrosis improved in 34% of the children but worsened in 23%. Any progression to definite NASH and/or in fibrosis was associated with adolescent age, and higher waist circumference, levels of alanine or aspartate aminotransferase, total and low-density lipoprotein cholesterol at baseline (<0.05), and over follow-up time, with increasing level of alanine aminotransferase, hemoglobin A1C (P<.05), gamma-glutamyl transferase and development of type 2 diabetes (P<.01). Increasing level of gamma-glutamyl transferase was also associated with reduced odds of any improvement (P= .003). One-third of children with NAFLD enrolled in placebo groups of clinical trials had histologic features of progression within 2 years, in association with increasing obesity and serum levels of aminotransferases and loss of glucose homeostasis.