Development and evaluation of an instrument for the critical appraisal of randomized controlled trials of natural products

<p>Abstract</p> <p>Background</p> <p>The efficacy of natural products (NPs) is being evaluated using randomized controlled trials (RCTs) with increasing frequency, yet a search of the literature did not identify a widely accepted critical appraisal instrument developed specifically for use with NPs. The purpose of this project was to develop and evaluate a critical appraisal instrument that is sufficiently rigorous to be used in evaluating RCTs of conventional medicines, and also has a section specific for use with single entity NPs, including herbs and natural sourced chemicals.</p> <p>Methods</p> <p>Three phases of the project included: 1) using experts and a Delphi process to reach consensus on a list of items essential in describing the identity of an NP; 2) compiling a list of non-NP items important for evaluating the quality of an RCT using systematic review methodology to identify published instruments and then compiling item categories that were part of a validated instrument and/or had empirical evidence to support their inclusion and 3) conducting a field test to compare the new instrument to a published instrument for usefulness in evaluating the quality of 3 RCTs of a NP and in applying results to practice.</p> <p>Results</p> <p>Two Delphi rounds resulted in a list of 15 items essential in describing NPs. Seventeen item categories fitting inclusion criteria were identified from published instruments for conventional medicines. The new assessment instrument was assembled based on content of the two lists and the addition of a Reviewer's Conclusion section. The field test of the new instrument showed good criterion validity. Participants found it useful in translating evidence from RCTs to practice.</p> <p>Conclusion</p> <p>A new instrument for the critical appraisal of RCTs of NPs was developed and tested. The instrument is distinct from other available assessment instruments for RCTs of NPs in its systematic development and validation. The instrument is ready to be used by pharmacy students, health care practitioners and academics and will continue to be refined as required.</p

Effect of glucosamine supplementation on fasting and non-fasting plasma glucose and serum insulin concentrations in healthy individuals

AbstractObjective: To test the hypothesis that glucose intolerance does not occur when healthy adults consume normal, recommended dosages of glucosamine sulfate.Methods: Healthy adults (N=19) ingested 1500mg of glucosamine sulfate or placebo (double blind) each day for 12 weeks. Three-hour oral glucose tolerance tests (OGTT) were performed using 75g of dextrose. These occurred before the start of supplementation, at 6 weeks, and at the completion of supplementation (12 weeks).Results: There were no significant differences between fasted levels of serum insulin or blood glucose. Glucosamine sulfate supplementation did not alter serum insulin or plasma glucose during the OGTT. There were no significant differences within or between treatments, ages or gender. Glycated hemoglobin measurements at the three time points showed no significant change over time, within or between treatments, ages or gender. The lack of significant changes may have been due to large standard deviations in the data.Conclusion: The data suggests that glucosamine supplementation, with normal recommended dosages, does not cause glucose intolerance in healthy adults. This cannot be determined conclusively, however, until further studies are conducted using alternative types of testing

Predicting Bone Adaptation in Astronauts during and after Spaceflight

A method was previously developed to identify participant-specific parameters in a model of trabecular bone adaptation from longitudinal computed tomography (CT) imaging. In this study, we use these numerical methods to estimate changes in astronaut bone health during the distinct phases of spaceflight and recovery on Earth. Astronauts (N = 16) received high-resolution peripheral quantitative CT (HR-pQCT) scans of their distal tibia prior to launch (L), upon their return from an approximately six-month stay on the international space station (R+0), and after six (R+6) and 12 (R+12) months of recovery. To model trabecular bone adaptation, we determined participant-specific parameters at each time interval and estimated their bone structure at R+0, R+6, and R+12. To assess the fit of our model to this population, we compared static and dynamic bone morphometry as well as the Dice coefficient and symmetric distance at each measurement. In general, modeled and observed static morphometry were highly correlated (R2> 0.94) and statistically different (p p < 0.0001). The Dice coefficient and symmetric distance indicated a reasonable local fit between observed and predicted bone volumes. This work applies a general and versatile computational framework to test bone adaptation models. Future work can explore and test increasingly sophisticated models (e.g., those including load or physiological factors) on a participant-specific basis

Parasympathetic Control of the Heart. II. A Novel Interganglionic Intrinsic Cardiac Circuit Mediates Neural Control of Heart Rate

Intracardiac pathways mediating the parasympathetic control of various cardiac functions are incompletely understood. Several intracardiac ganglia have been demonstrated to potently influence cardiac rate [the sinoatrial (SA) ganglion], atrioventricular (AV) conduction (the AV ganglion), or left ventricular contractility (the cranioventricular ganglion). However, there are numerous ganglia found throughout the heart whose functions are poorly characterized. One such ganglion, the posterior atrial (PA) ganglion, is found in a fat pad on the rostral dorsal surface of the right atrium. We have investigated the potential impact of this ganglion on cardiac rate and AV conduction. We report that microinjections of a ganglionic blocker into the PA ganglion significantly attenuates the negative chronotropic effects of vagal stimulation without significantly influencing negative dromotropic effects. Because prior evidence indicates that the PA ganglion does not project to the SA node, we neuroanatomically tested the hypothesis that the PA ganglion mediates its effect on cardiac rate through an interganglionic projection to the SA ganglion. Subsequent to micro-injections of the retrograde tracer fast blue into the SA ganglion, \u3e70% of the retrogradely labeled neurons found within five intracardiac ganglia throughout the heart were observed in the PA ganglion. The neuroanatomic data further indicate that intraganglionic neuronal circuits are found within the SA ganglion. The present data support the hypothesis that two interacting cardiac centers, i.e., the SA and PA ganglia, mediate the peripheral parasympathetic control of cardiac rate. These data further support the emerging concept of an intrinsic cardiac nervous system

Scene gist categorization in pigeons

Scene gist categorization in humans is rapid and accurate and appears to be tuned to fundamental statistical regularities in the visual world. Although pigeons have been reported to form many types of categorical judgments, little research has examined scene categorization by pigeons or the underlying mechanisms of it. The present study trained eight pigeons on a scene gist categorization task using a go/no-go procedure. Four birds were trained to discriminate between two natural categories (beach vs. mountain) and four were trained to discriminate between a natural (beach) and a man-made (street) category. The birds successfully learned both categorization tasks at a similar rate and to a high degree of accuracy (>80%). During a subsequent generalization test with novel images, strong transfer of discrimination was observed with only a modest generalization decrement. Finally, the birds were trained with progressively shorter stimulus durations (beginning with the original 5-sec duration and decreasing to less than 1 sec) to determine if they could still form a discrimination with limited visual information as with humans. Decreasing durations initially negatively affected performance, but over time the pigeons recovered and formed discriminations with stimulus presentations in the 200-500 ms range. The results indicate that, like humans, pigeons can form rapid scene gist categorization judgments. However, the visual information critical for these judgments remains to be determined

Parasympathetic control of the heart. III. Neuropeptide Y-immunoreactive nerve terminals synapse on three populations of negative chronotropic vagal preganglionic neurons

The vagal postganglionic control of cardiac rate is mediated by two intracardiac ganglia, i.e., the sinoatrial (SA) and posterior atrial (PA) ganglia. Nothing is known about the vagal preganglionic neurons (VPNs) that innervate the PA ganglion or about the neurochemical anatomy of central afferents that innervate these VPNs. These issues were examined using light microscopic retrograde labeling methods and dual-labeling electron microscopic histochemical and immunocytochemical methods. VPNs projecting to the PA ganglion are found in a narrow column exclusively in the ventrolateral nucleus ambiguus (NA-VL). These neurons are relatively large (37.6 ± 2.7 μm by 21.3 ± 3.4 μm) with abundant cytoplasm and intracellular organelles, rare somatic and dendritic spines, round uninvaginated nuclei, and myelinated axons. Previous physiological data indicated that microinjections of neuropeptide Y (NPY) into the NA-VL cause negative chronotropic effects. The present morphological data demonstrate that NPY-immunoreactive nerve terminals formed 18 ± 4% of the axodendritic or axosomatic synapses and close appositions on VPNs projecting to the PA ganglion. Three approximately equal populations of VPNs in the NA-VL were retrogradely labeled from the SA and PA ganglia. One population each projects to the SA ganglion, the PA ganglion, or to both the SA and PA ganglia. Therefore, there are both shared and independent pathways involved in the vagal preganglionic controls of cardiac rate. These data are consistent with the hypothesis that the central and peripheral parasympathetic controls of cardiac rate are coordinated by multiple potentially redundant and/or interacting pathways and mechanisms