Phase 1, placebo-controlled, dose escalation trial of chicory root extract in patients with osteoarthritis of the hip or knee

<p>Abstract</p> <p>Background</p> <p>Extracts of chicory root have anti-inflammatory properties <it>in vitro </it>and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial was to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives were to assess effects on the signs and symptoms of this disorder.</p> <p>Methods</p> <p>Individuals greater than 50 years of age with OA of the hip or knee were eligible for trial entry. A total of 40 patients were enrolled in 3 cohorts and were treated with escalating chicory doses of 600 mg/day, 1200 mg/day and 1800 mg/day for 1 month. The ratio of active treatment to placebo was 5:3 in cohorts 1 and 2 (8 patients) each and 16:8 in cohort 3 (24 patients). Safety evaluations included measurement of vital signs and routine lab tests at baseline and the end of the treatment period. Efficacy evaluations at baseline and final visits included self-assessment questionnaires and measurement of the 25-foot walking time.</p> <p>Results</p> <p>In the highest dose cohort, 18 patients who completed treatment per protocol were analyzed for efficacy. In this group, 13 patients showed at least 20% improvement in the defined response domains of pain, stiffness and global assessment: 9 of 10 (90%) patients randomized to active treatment with chicory and 4 of 8 (50%) patients randomized to placebo (P = 0.06). In general, the treatment was well-tolerated. Only one patient who was treated with the highest dose of chicory had to discontinue treatment due to an adverse event.</p> <p>Conclusions</p> <p>The results of this pilot study suggest that a proprietary bioactive extract of chicory root has a potential role in the management of OA and merits further investigation. Clinicaltrials.gov identifier: NCT 01010919.</p

The state of the Martian climate

60°N was +2.0°C, relative to the 1981–2010 average value (Fig. 5.1). This marks a new high for the record. The average annual surface air temperature (SAT) anomaly for 2016 for land stations north of starting in 1900, and is a significant increase over the previous highest value of +1.2°C, which was observed in 2007, 2011, and 2015. Average global annual temperatures also showed record values in 2015 and 2016. Currently, the Arctic is warming at more than twice the rate of lower latitudes

Chronic Alterations in Joint Flexibility Associated with Aerobic Dance Instruction of College Age Females

The purposes of this study were (1) to determine if three selected aerobic dance related conditions would result in chronic alterations of flexibility of college women and (2) to compare flexibility measures of college age females during a semester of aerobic dance instruction. Subjects were sixty-three college women enrolled in aerobic dance, bowling, and archery classes. Eight flexibility measures were obtained during the third and eleventh weeks of the experimental period. Data were analyzed by a factor analysis the Pearson Product Moment Correlation, and eight oneway analyses of covariance. Conclusions of the investigation were (1) a program of aerobic dance alone is not sufficient to promote flexibility, and (2) supplemental flexibility activities of ten minutes duration used with aerobic dance training are beneficial in increasing hip flexion

Differences in Symptom Clusters Identified Using Ratings of Symptom Occurrence vs. Severity in Lung Cancer Patients Receiving Chemotherapy

ContextAn important question in symptom clusters research is whether the number and types of symptom clusters vary based on the specific dimension of the symptom experience used to create the clusters.ObjectivesGiven that lung cancer patients undergoing chemotherapy (CTX) report an average of 14 co-occurring symptoms and studies of symptom clusters in these patients are limited, the purpose of this study, in lung cancer patients undergoing CTX (n&nbsp;=&nbsp;145), was to identify whether the number and types of symptom clusters differed based on whether symptom occurrence rates or symptom severity ratings were used to create the clusters.MethodsA modified version of the Memorial Symptom Assessment Scale was used to assess for the occurrence and severity of 38 symptoms, one week after the administration of CTX. Exploratory factor analysis was used to extract the symptom clusters.ResultsBoth the number and types of symptom clusters were relatively similar using symptom occurrence rates or symptom severity ratings. Five symptom clusters were identified using both symptom occurrence rates and severity ratings (i.e., sickness behavior, lung cancer specific, psychological, nutritional, and epithelial). Across these two dimensions, the specific symptoms within each of the symptom clusters were relatively similar.ConclusionsIdentification of symptom clusters in patients with lung cancer may assist with the development of more targeted symptom management interventions. Future studies are warranted to determine if symptom clusters change over a cycle of CTX in patients with lung cancer

Co-occuring symptoms in older oncology patients with distinct attentional function profiles

PurposeEvaluate how subgroups of older adults with distinct attentional function profiles differ on the severity of nine common symptoms and determine demographic and clinical characteristics and symptom severity scores associated with membership in the low and moderate attentional function classes.MethodsThree subgroups of older oncology outpatients were identified using latent profile analysis based on Attentional Function Index (AFI) scores. Symptoms were assessed prior to the second or third cycle of CTX. Logistic regressions evaluated for associations with attentional function class membership.ResultsFor trait anxiety, state anxiety, depression, sleep disturbance, morning fatigue, and evening fatigue scores, differences among the latent classes followed the same pattern (low &gt; moderate &gt; high). For morning and evening energy, compared to high class, patients in low and moderate classes reported lower scores. For pain, compared to moderate class, patients in low class reported higher scores. In the logistic regression analysis, compared to high class, patients with lower income, higher comorbidity, higher CTX toxicity score, and higher levels of state anxiety, depression, and sleep disturbance were more likely to be in low AFI class. Compared to high class, patients with higher comorbidity and trait anxiety and lower morning energy were more likely to be in moderate AFI class.ConclusionsConsistent with the hypothesis that an increased risk for persistent cognitive decline is likely related to a variety of physical and psychological factors, for six of the nine symptoms, a "dose response" effect was observed with higher symptom severity scores associated with a progressive decline in attentional function

Distinct Physical Function Profiles in Older Adults Receiving Cancer Chemotherapy.

ContextAlthough physical function is an important patient outcome, little is known about changes in physical function in older adults receiving chemotherapy (CTX).ObjectivesIdentify subgroups of older patients based on changes in their level of physical function; determine which demographic and clinical characteristics were associated with subgroup membership; and determine if these subgroups differed on quality-of-life (QOL) outcomes.MethodsLatent profile analysis was used to identify groups of older oncology patients (n&nbsp;=&nbsp;363) with distinct physical function profiles. Patients were assessed six times over two cycles of CTX using the Physical Component Summary score from the Short Form 12. Differences, among the groups, in demographic and clinical characteristics and QOL outcomes were evaluated using parametric and nonparametric tests.ResultsThree groups of older oncology patients with distinct functional profiles were identified: Well Below (20.4%), Below (43.8%), and Above (35.8%) normative Physical Component Summary scores. Characteristics associated with membership in the Well Below class included the following: lower annual income, a higher level of comorbidity, being diagnosed with depression and back pain, and lack of regular exercise. Compared with the Above class, patients in the other two classes had significantly poorer QOL outcomes.ConclusionAlmost 65% of older oncology patients reported significant decrements in physical function that persisted over two cycles of CTX. Clinicians can assess for those characteristics associated with poorer functional status to identify high-risk patients and initiate appropriate interventions