The clinical effect of benesco™ on reflux symptoms: A double-blind randomized placebo-controlled trial

Background

Gastroesophageal reflux disease (GERD) is one of the most prevalent gastrointestinal diseases in the western world. Lifestyle modifications and proton pump inhibitors (PPIs) form the basis of the management of GERD. A subset of patients seeks for (natural) alternative therapies besides PPIs. benesco™ is an over-the-counter nutrition based on quercetin which has a presumed positive effect on esophageal barrier function. Therefore we aim to assess the effect of benesco™ on reflux symptoms.

Methods

We performed a double-blind randomized placebo-controlled trial in participants with reflux symptoms. Participants were assigned randomly (1:1) to receive 6 weeks of benesco™ (three times daily one lozenge containing 200 mg of quercetin) or placebo. The primary outcome was treatment success (≥50% reduction in Reflux Disease Questionnaire Score). Secondary outcomes included GERD-related quality of life, reflux-free days and nights, and participant-reported treatment success.

Key Results

One hundred participants were randomized. Treatment success was seen in 18 (39%) of 46 participants in the intervention group versus 21 (47%) of 45 in the placebo group (p = 0.468). In the intervention group 10 (1–21) reflux-free days were reported compared to 10 (2–25) in the placebo group (p = 0.673). In addition, 38 (34–41) versus 39 (35–42) reflux-free nights were reported (p = 0.409).

Conclusions & Inferences

In our trial benesco™ showed no significant benefit over placebo at group level.     

Quantitative MRI of skeletal muscle in a cross‐sectional cohort of patients with spinal muscular atrophy types 2 and 3

The aim of this study was to document upper leg involvement in spinal muscular atrophy (SMA) with quantitative MRI (qMRI) in a cross‐sectional cohort of patients of varying type, disease severity and age. Thirty‐one patients with SMA types 2 and 3 (aged 29.6 [7.6‐73.9] years) and 20 healthy controls (aged 37.9 [17.7‐71.6] years) were evaluated in a 3 T MRI with a protocol consisting of DIXON, T2 mapping and diffusion tensor imaging (DTI). qMRI measures were compared with clinical scores of motor function (Hammersmith Functional Motor Scale Expanded [HFMSE]) and muscle strength. Patients exhibited an increased fat fraction and fractional anisotropy (FA), and decreased mean diffusivity (MD) and T2 compared with controls (all P < .001). DTI parameters FA and MD manifest stronger effects than can be accounted for the effect of fatty replacement. Fat fraction, FA and MD show moderate correlation with muscle strength and motor function: FA is negatively associated with HFMSE and Medical Research Council sum score (τ = ?0.56 and ?0.59; both P < .001) whereas for fat fraction values are τ = ?0.50 and ?0.58, respectively (both P < .001). This study shows that DTI parameters correlate with muscle strength and motor function. DTI findings indirectly indicate cell atrophy and act as a measure independently of fat fraction. Combined these data suggest the potential of muscle DTI in monitoring disease progression and to study SMA pathogenesis in muscle.     

Changes in face-specific neural processing explain reduced cuteness and approachability of infants with cleft lip

The current study investigated whether changes in the neural processing of faces of infants with a facial abnormality – a cleft lip – mediate effects of the cleft lip on judgments of infant cuteness and approachability. Event-related potentials (ERPs) in response to pictures of faces of healthy infants and infants with a cleft lip, and ratings of cuteness and approachability of these infant faces, were obtained from 30 females. Infants with a cleft lip were rated as less attractive (less cute and approachable) than healthy infants, and both the N170 and P2 components of the ERP were of reduced amplitude in response to pictures of infants with a cleft lip. Importantly, decreased configural processing of infant faces with a cleft lip, as evidenced by reduced N170 amplitudes, mediated the reduced attractiveness ratings for infants with a cleft lip compared to healthy infants. Our findings help elucidate the mechanisms behind the less favorable responses to infants with a cleft lip, highlighting the role of face-specific rather than domain-general neural processes.     

Love withdrawal is related to heightened processing of faces with emotional expressions and incongruent emotional feedback: evidence from ERPs

Parental use of love withdrawal is thought to affect children's later psychological functioning because it creates a link between children's performance and relational consequences. To investigate whether love withdrawal is also associated with the underlying level of basic information processing in the brain, we studied event-related potentials to feedback stimuli that combined performance feedback with emotional facial expressions. We focused on the VPP (face processing) and N400 (incongruence processing). More maternal use of love withdrawal was related to more positive VPP amplitudes, larger effects of the emotional facial expression on VPP amplitude, and more negative N400 responses to incongruent combinations of feedback and facial expressions. Our findings suggest a heightened processing of faces with emotional expressions and greater sensitivity to incongruence between feedback and facial expression in individuals who experienced more love withdrawal.     

Sperm DNA integrity in relation to exposure to environmental perfluoroalkyl substances - a study of spouses of pregnant women in three geographical regions

Perfluoroalkyl substances (PFASs) can interfere with male reproductive function, but evidence in humans is limited. Six hundred four fertile men (199 from Greenland, 197 from Poland and 208 from Ukraine) were enrolled in the study. We measured four PFASs in serum (PFOS, PFOA, PFNA and PFHxS) and concurrent DNA damage in spermatozoa by sperm chromatin structure assay (SCSA) and in situ terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL) assay, apoptotic markers in semen (Fas-receptor and Bcl-xL), and reproductive hormones in serum. No association between PFASs and SCSA, apoptotic markers or reproductive hormones emerged. We observed a slight increase in SHBG and TUNEL-positivity with increased PFOA exposure in men from Greenland. Thus, consistent evidence that PFAS exposure interferes with sperm DNA fragmentation, apoptosis or reproductive hormones was not found.     

Longitudinal associations between attitudes towards binge drinking and alcohol-free drinks,and binge drinking behavior in adolescence

Alcohol attitudes are often considered an important predecessor of drinking behavior, although the literature is equivocal. Lately, attention has turned to enhancing positive cognitions on alcoholic-free drinks to discourage heavy drinking. The current study was the first to longitudinally examine associations between attitudes towards binge drinking and alcohol-free drinks and binge drinking behavior in a cross-lagged path model in Mplus. Participants were 293 adolescents (131 boys, M_age = 16.1 years) who filled in two online questionnaires with a six-month interval. Binge drinking behavior and attitudes towards binge drinking and alcohol-free drinks were all significantly correlated at both waves. The multivariate model, however, showed that only higher levels of binge drinking at T1 were prospectively related to more positive binge drinking attitudes at T2, and not vice versa. Analyses were controlled for sex, educational level, and age. Findings discard the Theory of Planned Behavior, but rather seem consistent with the Theory of Cognitive Dissonance, i.e., adolescents may adapt their cognitions to their behavior. More longitudinal research with several time points and over a longer period of time is needed to further examine the development of attitudes and drinking behavior.     

Vitamin D Concentrations at Birth and the Risk of Rheumatoid Arthritis in Early Adulthood: A Danish Population-Based Case-Cohort Study

Background: Low vitamin D in pregnancy may impair the development of the fetal immune system and influence the risk of later development of rheumatoid arthritis (RA) in the offspring. The aim was to examine whether lower 25-hydroxyvitamin D3 (25(OH)D) concentrations at birth were associated with the risk of developing RA in early adulthood. Methods: This case-cohort study obtained data from Danish registers and biobanks. Cases included all individuals born during 1981–1996 and recorded in the Danish National Patient Register with a diagnosis of RA with age >18 years at first admission. The random comparison consisted of a subset of Danish children. Vitamin D concentrations were measured in newborn dried blood. In total, 805 RA cases and 2416 individuals from the subcohort were included in the final analysis. Weighted Cox regression was used to calculate hazard ratio (HR). Results: The median (interquartile rage (IQR)) 25(OH)D concentrations among cases were 24.9 nmol/L (IQR:15.4;36.9) and 23.9 nmol/L (IQR:13.6;36.4) among the subcohort. There was no indication of a lower risk of RA among individuals in the highest vitamin D quintile compared with the lowest (HRadj.:1.21 (0.90;1.63)). Conclusion: The risk of RA in early adulthood was not associated with vitamin D concentrations at birth.