Search Results (6)

Chronic pancreatitis (CP) is a rare but debilitating condition with an 8-fold increased risk of developing pancreatic cancer. In addition to the symptoms that come from the loss of endocrine and exocrine function in CP, the management of chronic pain is problematic. We previously showed that the CCK-receptor antagonist called proglumide could decrease inflammation, acinar-ductal metaplasia, and fibrosis in murine models of CP. We hypothesized that proglumide would be safe and diminish pain caused by CP. A Phase 1 open-labeled safety study was performed in subjects with clinical and radiographic evidence of CP with moderate to severe pain. After a 4-week observation period, the subjects were treated with proglumide in 400 mg capsules three times daily (1200 mg per day) by mouth for 12 weeks, and then subjects returned for a safety visit 4 weeks after the discontinuation of the study medication. The results of three pain surveys (Numeric Rating Scale, COMPAT-SF, and NIH PROMIS) showed that the patients had significantly less pain after 12 weeks of proglumide compared to the pre-treatment observation phase. Of the eight subjects in this study, two experienced nausea and diarrhea with proglumide. These side effects resolved in one subject with doses reduced to 800 mg per day. No abnormalities were noted in the blood chemistries. A blood microRNA blood biomarker panel that corresponded to pancreatic inflammation and fibrosis showed significant improvement. We conclude that proglumide is safe and well tolerated in most subjects with CP at a dose of 1200 mg per day. Furthermore, proglumide therapy may have a beneficial effect by decreasing pain associated with CP. Full article

Inadequate sleep is a global health concern. Sleep is multidimensional and complex; new multi-ingredient agents are needed. This study assessed the comparative effects of two multi-ingredient supplements on sleep relative to placebo. Adults (N = 620) seeking better sleep were randomly assigned to receive one of three study products. Sleep A (contained lower (0.35 mg THC and higher levels of botanicals (75 mg each hops oil and valerian oil), Sleep B (contained higher THC (0.85 mg) and lower botanicals (20 mg each hops oil and valerian oil) or placebo) for 4 weeks. Sleep disturbance was assessed at baseline and weekly using NIH’s Patient-Reported Outcomes Measurement Information System (PROMIS™) Sleep Disturbance SF 8A survey. Anxiety, stress, pain, and well-being were assessed using validated measures at baseline and weekly. A linear mixed-effects regression model was used to assess the change in health outcome score between active product groups and the placebo. There was a significant difference in sleep disturbance, anxiety, stress, and well-being between Sleep A and placebo. There was no significant difference in any health parameter between Sleep B and placebo. Side effects were mild or moderate. There were no significant differences in the frequency of side effects between the study groups. A botanical blend containing a low concentration of THC improved sleep disturbance, anxiety, stress, and well-being in healthy individuals that reported better sleep as a primary health concern. Full article

Introduction: This study evaluated the impact of the Build Our Kids’ Success (BOKS) after-school program on children’s physical activity (PA) and well-being during the COVID-19 pandemic. Methods: Program leaders, children, and their parents were recruited from after-school programs in Nova Scotia, Canada, that delivered BOKS programming in Fall 2020. After participating, Grade 4–6 children (n = 14) completed the Physical Literacy Assessment for Youth Self (PLAYself), Physical Activity Questionnaire for Older Children (PAQ-C), the Physical Activity Enjoyment Scale (PACES), and 5 National Institutes of Health (NIH) Patient-Reported Outcomes Measures Information System (PROMIS) scales. Children (n = 7), parents (n = 5), and program leaders (n = 3) completed interviews, which were analyzed for themes inductively. Results: The average PAQ-C score was 2.70 ± 0.48, PLAYself was 68.23 ± 13.12, and PACES was 4.22 ± 0.59 (mean ± SD). NIH PROMIS scores were below standard means (cognitive function, family relationships) or within normal limits (peer relationships, positive affect, and life satisfaction). A thematic analysis of interviews revealed that children’s PA levels were impacted by the pandemic and that BOKS positively impacted children’s physical well-being and integrated well with school-based activities. Conclusions: Participation in BOKS provided an overall positive experience and may have mitigated COVID-19-related declines in PA in well-being. The results of this evaluation can inform future physically-active after-school programming. Full article

Children’s physical activity participation declined during the COVID-19 pandemic, and these negative changes could lead to longer-term impacts on children’s cognitive, social, and emotional health. Purpose: To determine parent/caregivers’ perceptions of their children’s cognitive function, peer and family relationships, life satisfaction, physical activity, sleep, positive affect, and global health, before and after participating in the Build Our Kids’ Success (BOKS) programming at after-school programs in Fall 2020. Methods: Parents of children participating in the BOKS programming at after-school programs in Nova Scotia, Canada, were recruited. At baseline, 159 parents completed the National Institutes of Health (NIH) Patient-Reported Outcomes Measures Information System (PROMIS) parent-proxy questionnaire, and 75 parents completed the measures at follow-up. Independent t-tests were used to determine if there were differences between baseline and follow-up Parent Proxy Questionnaire data. Results: All NIH PROMIS outcome variables at baseline and follow-up were within normal limits (Adjusted T-Scores: 46.67 ± 7.15 to 50.04 ± 7.13). There were no significant differences in life satisfaction (t(188) = −1.05, p = 0.30), family relationships (t(189) = 0.31, p = 0.76), cognitive function (t(199) = −1.16, p = 0.25), peer relationships (t(192) = −1.86, p = 0.06), positive affect (t(195) = 0.25, p = 0.81), global health (t(216) = −0.43, p = 0.67), physical activity (t(202) = 0.787, p = 0.732), sleep disturbance (t(193) = 1.72, p = 0.087), or psychological stress (t(196) = 1.896, p = 0.059), from baseline to follow-up. Conclusions: Parent-proxy questionnaires suggested that the BOKS programming had a protective effect on children’s health behaviours and cognitive, social, and emotional health as values remained within normal limits and were not impacted by the public health restrictions during the second wave of the COVID-19 pandemic in Nova Scotia. Full article

This study examined the biopsychosocial characteristics of chronic low back pain (CLBP) in an understudied but increasingly larger part of the population: the elderly (i.e., 65 years and older). A new innovative physical functioning measure (postural control, which is a proxy for the common problem of slips and falls in the elderly) was part of this biopsychosocial evaluation. Also, the National Institutes of Health (NIH)-developed Patient-Reported Outcome Measurement Information System (PROMIS) was also part of this comprehensive evaluation. Two demographically-matched groups of elderly participants were evaluated: one with CLBP (n = 24); and the other without (NCLBP, n = 24). Results revealed significant differences in most of these measures between the two groups, further confirming the importance of using a biopsychosocial approach for future studies of pain and postural control in the elderly. Full article

Modern health services now strive for individualized treatment. This approach has been enabled by the increase in knowledge derived from neuroscience and genomics. Substance use disorders are no exception to individualized treatment even though there are no gene-specific medications yet available. What is available is the ability to quickly and precisely assess and monitor biopsychosocial variables known to vary during addiction recovery and which place addicts at increased risk of relapse. Monitoring a broad spectrum of biopsychosocial health enables providers to address diverse genome-specific changes that might trigger withdrawal from treatment or recovery relapse in time to prevent that from occurring. This paper describes modern measurement tools contained in the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) and the NIH Toolbox and suggests how they might be applied to support recovery from alcohol and other substance use disorders in both pharmacological and abstinence-oriented modalities of care. Full article