The effect of fatty acids, vitamins, and minerals on pediatric atopic dermatitis: A systematic review.

BACKGROUND: A body of research has examined the role of fatty acid (FA), vitamin, and mineral supplementation as adjunctive treatment for atopic dermatitis (AD); however, results are conflicting and concrete recommendations are lacking. The objective of this study is to highlight the role of these nutrients in alleviating AD severity and provide the clinician with consolidated information that can be used to make recommendations to the pediatric patient and caretaker, where this topic is of high interest. METHODS: A review of the PubMed and Embase databases was conducted to identify and qualitatively analyze all randomized controlled trials, systematic reviews, and meta-analyses conducted within the last 21 years regarding use of these nutrients to alleviate symptoms of AD. Inclusion criteria include AD diagnosis, non-infant age groups, and AD severity outcomes; exclusion criteria include preventative studies, predominantly maternal or infant demographics, or nonclinical outcomes. RESULTS: Sixty-nine studies were included. Evidence regarding FA supplementation is inconclusive; however, targeting an ideal omega-3:omega-6 FA ratio may play a small role in alleviating AD symptoms. Studies results regarding vitamin/mineral supplementation are inconsistent and supplementation should not be advised unless the patient has a documented deficiency. CONCLUSION: Pediatric AD patients should lead a healthy lifestyle with an emphasis on consumption of wholesome foods. Nutritional supplementation can play a role in improving AD symptoms; however, this should be evaluated on a case-by-case basis. Limitations include heterogeneity of studies.

Relationship Between Location of Pregnancy-Related and Postpartum-Related Back Pain and Limitations of Daily Activities and Work Participation.

OBJECTIVE: The aims of this study were to (1) examine if the location of pregnancy-related back pain impacts activities of daily living and absence from work and (2) determine which types of pain were more likely to persist postpartum. METHODS: This was a secondary analysis of data from an observational cohort study. Data were collected in Ontario between 2013 and 2014. Four pain location groups were identified, including low back pain (LBP), pelvic girdle pain (PGP), combined pain, and mixed pain. Logistic regression models were used to examine the impact of pain location on activity and absence from work. Descriptive analyses explored the association between pregnancy pain location and postpartum pain patterns. RESULTS: We surveyed 305 pregnant participants and followed up with 80 of these participants up to 6 months postpartum. Data analysis showed approximately a 2-fold increase in interference with employment (outside the home) and self-grooming for those with combined pain compared to those only experiencing LBP. Respondents with PGP and combined PGP and LBP had approximately a 5-fold increased likelihood of absence from work compared to respondents with only LBP; those with a mixture of LBP and PGP had a 13-fold increase in likelihood. Approximately 50% of respondents reported being pain-free, 16% experienced lingering pain, and 38% experienced persistent pain within 6 months postpartum. Those with combined pain during pregnancy continued to have persistent pain up to 6 months postpartum. CONCLUSION: The results suggest that the location of pregnancy-related back pain is associated with interference in daily activities, an increase in absence from work, and the persistence of postpartum pain. For this cohort, back pain did not always resolve after delivery, and those experiencing pregnancy-related combined pain continued to experience symptoms postpartum.

Modifiable pre-treatment factors are associated with quality of life in women with gynaecological cancers at diagnosis and one year later: Results from the HORIZONS UK national cohort study.

OBJECTIVE: Personalised care requires the identification of modifiable risk factors so that interventions can be implemented rapidly following a gynaecological cancer diagnosis. Our objective was to determine what pre-treatment factors are associated with quality of life (QOL) at baseline (pre-treatment) and 12 months. METHODS: 1222 women with a confirmed diagnosis of endometrial, ovarian, cervical or vulvar cancer from 82 UK NHS hospitals agreed to complete questionnaires at baseline, three and 12 months. Questionnaires included measures of QOL, health, lifestyle, support and self-management. The primary outcome measure was QOL as measured by Quality of Life in Adult Cancer Survivors (QLACS). Sites provided clinical data at baseline, six and 12 months. Linear regression models were constructed to examine the association between baseline characteristics and QOL outcomes. RESULTS: QOL declined between baseline and 3 months, followed by an improvement at 12 months. Baseline (pre-treatment) factors associated with worse QOL at both baseline and 12 months were depression, anxiety, living in a more deprived area and comorbidities which limit daily activities, whereas higher self-efficacy and age of 50+ years were associated with better QOL. CONCLUSIONS: Depression, anxiety and self-efficacy are modifiable risk factors that can impact on QOL. Screening for these, and assessment of whether comorbidities limit daily activities, should be incorporated in a holistic needs assessment and interventions to improve self-efficacy should be made available. Care can then be personalised from the outset to enable all women with a gynaecological cancer the opportunity to have the best QOL.

Gender differences in authorship prior to and during the COVID-19 pandemic in research submissions to Occupational and Environmental Medicine (2017-2021).

OBJECTIVE: To explore whether the COVID-19 pandemic has impacted productivity of female academics in the field of occupational and environmental health, by examining trends in male and female authorship of submissions during and prior to the COVID-19 pandemic in Occupational and Environmental Medicine. METHODS: Administrative data on submissions between January 2017 and November 2021 were obtained through databases held at BMJ journals. Author gender was identified using an existing algorithm based on matching names to social media accounts. The number and proportion of female and male primary (first) and senior (last) authors were examined for each quarter, and the average change in share of monthly submissions from male authors in the months since the pandemic compared with corresponding months prior to the pandemic were identified using regression models estimating least squares means. RESULTS: Among 2286 (64.7%) and 2335 (66.1%) manuscripts for which first and last author gender were identified, respectively, 49.3% of prepandemic submissions were from male first authors, increasing to 55.4% in the first year of the pandemic (difference of 6.1%, 95% CI 1.3% to 10.7%), before dropping to 46.6% from April 2021 onwards. Quarterly counts identified a large increase in submissions from male authors during the first year after the onset of the pandemic, and a smaller increase from female authors. The proportion of male last authors did not change significantly during the pandemic. CONCLUSIONS: These findings suggest that there has been an increase in male productivity during the COVID-19 pandemic within the field of occupational and environmental health research that is present to a lesser extent among women.

Dietary strategies for the prevention of asthma in children.

PURPOSE OF REVIEW: This review summarizes information relating to dietary intake during pregnancy, lactation and early life that may prevent childhood asthma. This review also summarizes how future studies may be improved. RECENT FINDINGS: Recent findings from observational studies suggest that eating according to certain dietary patterns during pregnancy, such as the dietary inflammatory index, Mediterranean diet and Maternal diet index, may reduce asthma and or wheeze in the child. Vitamin D supplementation with higher doses than recommended during pregnancy may be associated with reduced early transient childhood wheezing in the offspring. Higher levels of omega-3 fatty acids in breast milk may be protective against childhood asthma. Breastfeeding infants has been shown to offer many benefits to mother and child but a direct relationship between breastfeeding and the development of asthma has not been established. During childhood, infants and children may need to reduce their intake of advanced glycation end products, increase their food intake according to the traditional Mediterranean diet and increase the diversity of foods eaten. SUMMARY: Current evidence provides limited suggestions regarding dietary changes for preventing early transient childhood wheezing. In order to harmonize methods for future data collection and reporting, it is important to harmonize relevant definitions and other important factors. The aim of the considerations described here is to enable a better comparison of future studies and provide better guidance to patients and families.

PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial.

BACKGROUND: Despite the overwhelming prevalence and health implications of obesity, it is rarely adequately addressed in a health care setting. PATHWEIGH is a pragmatic approach to weight management that uses tools built into the electronic medical record to overcome barriers and guide care. Implementation strategies are employed to facilitate adoption and use of the PATHWEIGH tools and processes. The current study will compare the effectiveness of PATHWEIGH versus standard of care (SOC) on patient weight loss in primary care and explore factors for its successful implementation. METHODS: A stepped wedge cluster randomized trial design will be used within an effectiveness-implementation hybrid study. Adult patient weight loss and weight loss maintenance will be compared in PATHWEIGH versus SOC in 57 family and internal medicine clinics in a large health system in Colorado, USA. Effectiveness will be evaluated using generalized linear mixed models to determine statistical differences in weight loss and weight loss maintenance at 6, 12, and 18 months. Patient-, provider-, and clinic-level predictors will be identified using mediator and moderator analyses. Conceptually guided by the Practical, Robust, Implementation and Sustainability Model (PRISM), a mixed methods approach including quantitative (practice surveys, use tracking) and qualitative (interviews, observations) data collection will be used to determine factors impeding and facilitating adoption, implementation, and maintenance of PATHWEIGH and evaluate specified implementation strategies. A cost analysis of the practice and system costs and resources required by PATHWEIGH relative to the reimbursement collected will be performed. DISCUSSION: The effectiveness and implementation of PATHWEIGH, and their interrelatedness, for patient weight loss are collectively the focus of the current trial. Findings from this study are expected to serve as a blueprint for available and effective weight management in primary care medical practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT04678752 . Registered on December 21, 2020.

Hydrolysed formula, delayed food introduction and fatty acids for atopic dermatitis prevention in infancy.

AIM: The role of nutrition in preventing atopic diseases including atopic dermatitis has recently gained interest in the medical community. Caregivers of infants and children at an increased risk for developing atopic dermatitis often employ exclusion diets or other measures in hopes of preventing the development of this burdensome disease. This paper reviews the current literature in regard to the role of preventative dietary measures in the context of atopic dermatitis, with a special focus on the topics of hydrolysed formula, early vs. delayed introduction of certain foods and fatty acid supplementation. METHODS: Literature pertaining to preventative dietary measures for infants at risk for atopic dermatitis was reviewed. RESULTS: Analysis of the literature suggests that hydrolysed formula should not be routinely offered to infants for prevention of atopic dermatitis. Formulas utilised should contain concentrations of polyunsaturated fatty acids similar to that in breast milk. Finally, infant caregivers should not delay or restrict introduction of food, which can be more harmful than helpful to the patient. CONCLUSION: Recommendations to caretakers providing for infants at risk for atopic dermatitis should include infant consumption of breast milk and avoid delayed introduction of foods.

Full-scale investigation of ferrous dosing in sewers and a wastewater treatment plant for multiple benefits.

This study demonstrates the full scale application of iron dosing in a metropolitan wastewater treatment plant (WWTP) and the upstream sewer system for multiple benefits. Two different dosing locations, i.e., the WWTP inlet works (Trial-1) and upstream sewer network (Trial-2) were tested in this study. Both dosing trials achieved multiple benefits such as sulfide control, phosphate removal and improved sludge dewaterability. During Trial-1, a sulfide reduction of >90% was achieved at high dosing rates (>19 kgFe ML-1) of ferrous chloride in the inlet works and in Trial-2 the in-sewer ferrous dosing had significant gas phase hydrogen sulfide (H2S) concentration reduction in the sewer network. The ferrous dosing enhanced the phosphate removal in the bioreactor up to 76% and 53 ± 2% during Trial-1 & 2, respectively. The iron ending up in the anaerobic sludge digester reduced the biogas H2S concentration by up to 36% and 45%, respectively. The dewaterability of the digested sludge was improved, with relative increases of 9.7% and 9.8%, respectively. The presence of primary clarifier showed limited impact on the downstream availability of iron for achieving the afore-mentioned multiple benefits. The iron dosing enhanced the total chemical oxygen demand removal in the primary clarifier reaching up to 49% at the high dose rates during Trial-1 and 42 ± 1% during Trial-2. This study demonstrated that multiple benefits could be achieved independent of the iron dosing location (i.e., at the WWTP inlet or in the network). Further, iron dosing at both locations enhances primary settling, beneficial for bioenergy recovery from wastewater.

EAACI position paper: Influence of dietary fatty acids on asthma, food allergy, and atopic dermatitis.

The prevalence of allergic diseases such as allergic rhinitis, asthma, food allergy, and atopic dermatitis has increased dramatically during the last decades, which is associated with altered environmental exposures and lifestyle practices. The purpose of this review was to highlight the potential role for dietary fatty acids, in the prevention and management of these disorders. In addition to their nutritive value, fatty acids have important immunoregulatory effects. Fatty acid-associated biological mechanisms, human epidemiology, and intervention studies are summarized in this review. The influence of genetics and the microbiome on fatty acid metabolism is also discussed. Despite critical gaps in our current knowledge, it is increasingly apparent that dietary intake of fatty acids may influence the development of inflammatory and tolerogenic immune responses. However, the lack of standardized formats (ie, food versus supplement) and standardized doses, and frequently a lack of prestudy serum fatty acid level assessments in clinical studies significantly limit our ability to compare allergy outcomes across studies and to provide clear recommendations at this time. Future studies must address these limitations and individualized medical approaches should consider the inclusion of specific dietary factors for the prevention and management of asthma, food allergy, and atopic dermatitis.

One-year results from the first US-based enhanced recovery after cardiac surgery (ERAS Cardiac) program.

OBJECTIVE: Our enhanced recovery after cardiac surgery (ERAS Cardiac) program is an evidence-based interdisciplinary process, which has not previously been systematically applied to cardiac surgery in the United States. METHODS: The Knowledge-to-Action Framework synthesized evidence-based enhanced recovery interventions and implementation of a designated ERAS Cardiac program. Standardized processes included (1) preoperative patient education, (2) carbohydrate loading 2 hours before general anesthesia, (3) multimodal opioid-sparing analgesia, (4) goal-directed perioperative insulin infusion, and (5) a rigorous bowel regimen. All cardiac anesthesiologists and surgeons agreed to follow the standardized pathway for adult cardiac surgery cases. The 1-year outcomes were compared between the 9 months pre- and post-ERAS Cardiac implementation using prospectively collected, retrospectively reviewed data. RESULTS: Comparing the pre- (N = 489) with the post- (N = 443) ERAS Cardiac groups, median postoperative length of stay was decreased from 7 to 6 days (P < .01). Total intensive care unit hours were decreased from a mean of 43 to 28 hours (P < .01). The incidence of gastrointestinal complications was 6.8% pre-ERAS versus 3.6% post-ERAS implementation (P < .05). Opioid use was reduced by a mean of 8 mg of morphine equivalents per patient in the first 24 hours postoperatively (P < .01). Reintubation rate and intensive care unit readmission rate were reduced by 1.2% and 1.5%, respectively (P = not significant). The incidence of hyperglycemic episodes was no different after ERAS Cardiac initiation. Patient satisfaction was 86.3% pre-ERAS versus 91.8% post-ERAS Cardiac implementation and work culture domain scores revealed increases in satisfaction across all measured indices, including patient focus, culture, and engagement. CONCLUSIONS: Initial clinical and survey data after the first year of a system-wide ERAS Cardiac program were associated with significantly improved perioperative outcomes. We believe this value-based approach to cardiac surgery can consistently result in earlier recovery, cost reductions, and increased patient/staff satisfaction.

WHO consultation on ETEC and Shigella burden of disease, Geneva, 6-7th April 2017: Meeting report.

According to the 2015 Global Burden of Disease Study, diarrhea ranked ninth among causes of death for all ages, and fourth among children under 5 years old, accounting for an estimated 499,000 deaths in this young age group. It was also the second most common cause of years lived with disability (2.39 billion YLDs). The goal of the WHO/UNICEF Integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhea (GAPPD) is to reduce deaths from diarrhea in children under 5 years of age to less than 1 per 1000 live births, by 2025. Development of new and improved vaccines against diarrheal infections is a fundamental element of the strategy towards achieving this goal. Enterotoxigenic Escherichia coli (ETEC) and Shigella are enteropathogens that cause significant global mortality and morbidity, particularly in low- and middle-income countries. In 2016, WHO's Product Development for Vaccines Advisory Committee (PDVAC) recommended that the WHO's Initiative for Vaccine Research (IVR) engage in this area, based on PDVAC's criteria of prioritizing the development of vaccines against pathogens that will address a major unmet public health need, and for which clinical candidates with a good probability of technical success are in the pipeline. As a first step, WHO's IVR convened global subject matter experts to discuss the current global ETEC and Shigella disease burden estimates, including the current understanding of the long-term indirect effects of ETEC and Shigella infection, and how these data may affect future decision making on vaccine development for both pathogens. The available global burden estimates for ETEC and Shigella differ with respect to the relative importance of these two pathogens. The mortality estimates vary between iterations published by the same group, as well as between estimates of different groups, although the uncertainty intervals are broad and overlapping. These variances are attributable to differences in the data available and incorporated in the models; the methods used to detect the pathogens; the modelling methodologies; and, to actual changes in the total number of diarrheal deaths over time. The changes in the most recently reported mortality estimates for these pathogens, as compared to previous iterations, has led to debate as to whether investment in development of stand-alone vaccines, rather than combined vaccines, is warranted from cost-effectiveness and vaccine impact perspectives. Further work will be needed to understand better the variances and uncertainties in the reported mortality estimates to support investment decision making, and ultimately policy recommendations for vaccine use. In addition, a comprehensive assessment of the value proposition for vaccines against these pathogens is needed and will be strengthened if the long-term health consequences associated with diarrhea and dysentery due to these pathogens are better defined.

Nonclinical pharmacokinetics and in vitro metabolism of H3B-6545, a novel selective ERα covalent antagonist (SERCA).

PURPOSE: H3B-6545, a novel selective estrogen receptor (ER)α covalent antagonist (SERCA) which inactivates both wild-type and mutant ERα, is in clinical development for the treatment of metastatic breast cancer. Preclinical studies were conducted to characterize the pharmacokinetics and metabolism of H3B-6545 in rat and monkeys. METHODS: The clearance and metabolic profiles of H3B-6545 were studied using rat, monkey and human hepatocytes, and reaction phenotyping was done using recombinant human cytochrome P450 enzymes. Blood stability, protein binding, and permeability were also determined in vitro. Pharmacokinetics of H3B-6545 was assessed after both intravenous and oral dosing. A nonclinical PBPK model was developed to assess in vitro-in vivo correlation of clearance. RESULTS: H3B-6545 had a terminal elimination half-life of 2.4 h in rats and 4.0 h in monkeys and showed low to moderate bioavailability, in line with the in vitro permeability assessment. Plasma protein binding was similar across species, at 99.5-99.8%. Nine metabolites of H3B-6545 were identified in hepatocyte incubations, none of which were unique to humans. Formation of glutathione-related conjugate of H3B-6545 was minimal in vitro. H3B-6545, a CYP3A substrate, is expected to be mostly cleared via hepatic phase 1 metabolism. Hepatocyte clearance values were used to adequately model the time-concentration profiles in rat and monkey. CONCLUSIONS: We report on the absorption and metabolic fate and disposition of H3B-6545 in rats and dogs and illustrate that in vitro-in vivo correlation of clearance is possible for targeted covalent inhibitors, provided reactivity is not a predominant mechanism of clearance.

Gestational nutrition 2: gene expression in sheep fetal ovaries exposed to gestational under nutrition.

A number of studies have demonstrated effects of gestational undernutrition on fetal ovarian development and postnatal female fertility. However, the mechanism underlying these effects remains elusive. Using a cohort of animals in which altered gestational nutrition affected indicators of postnatal fertility, this study applies RNAseq to fetal ovaries to identify affected genes and pathways that may underlie the relationship between gestational plane of nutrition and postnatal fertility. Pregnant ewes were exposed to either a maintenance diet or 0.6 of maintenance for the first 55 days of gestation followed by an ad libitum diet. Complementary DNA libraries were constructed from 5 to 6 fetal ovaries from each nutritional group at both days 55 and 75 of gestation and sequenced using Ion Proton. Of approximately 16,000 transcripts, 69 genes were differentially expressed at day 55 and 145 genes differentially expressed at day 75. At both gestational ages, genes expressed preferentially in germ cells were common among the differentially expressed genes. Enriched gene ontology terms included ion transport, nucleic acid binding, protease inhibitor activity and carrier proteins of the albumin family. Affected pathways identified by IPA analysis included LXR/RXR activation, FXR/RXR activation, pathways associated with nitric oxide production and citrullination (by NOS1), vitamin C transport and metabolism and REDOX reactions. The data offer some insights into potential mechanisms underlying the relationship between gestational plane of nutrition and postnatal fertility observed in these animals. In particular, the roles of nitric oxide and protease inhibitors in germ cell development are highlighted and warrant further study.

A Specifically Designed Multispecies Probiotic Supplement Relieves Seasonal Allergic Rhinitis Symptoms.

BACKGROUND: Probiotics are purported to reduce symptoms of allergic rhinitis. This study sought to determine the proportion of participants with an improvement in the mini Rhinoconjunctivitis Quality of Life Questionnaire (mRQLQ) in response to a multispecies probiotic supplement with a Simon Two-Stage design. METHODS: This study was based on a Simon Two-Stage Design for p1-p0 = 0.18 to account for seasonal variation in symptoms. Under this design, ≥10 patients are required to exhibit an improvement in quality-of-life scores to determine that there was sufficient activity for the supplement to be considered effective. Participants consumed a probiotic supplement (Ecologic® AllergyCare; probiotik®pur) twice daily for 8 weeks. The primary outcome measure was based on a change in mRQLQ scores following supplementation. Secondary outcomes include assessment of change in symptoms and medication usage with a twice-weekly symptom and medication diary, nasal congestion by rhinomanometry, and total serum Immunoglobulin E (IgE) and specific IgE for Bermuda grass. RESULTS: A total of 40 participants completed the study. A total of 25 participants (63%, 49-76%, p < 0.001; mean, 95% confidence interval, p-value) out of 40 participants had a clinically meaningful response to treatment based on assessment of mRQLQ. On average, mRQLQ scores changed from 2.83 ± 1.51 at baseline to 1.66 ± 1.36 at week 4 and 1. 38 ± 1.13 at week 8 (p < 0.01) (mean ± SD, p-value). Sum of individual symptom scores and overall symptom scores over the course of treatment was significantly reduced (p = 0.036 and p = 0.039, respectively). A moderate reduction in frequency of allergy-related medication use in the final 4 weeks of supplementation period was observed (52.5% weeks 0-4 to 41.4% weeks 4-8; average proportion of total diary responses, p = 0.085). The supplement was largely well tolerated by participants at the dose provided. CONCLUSIONS: The proportion of participants exhibiting improvement in quality-of-life metrics warrants continued investigation in the form of a phase III placebo-controlled trial.

Evasion of immunosurveillance by genomic alterations of PPARγ/RXRα in bladder cancer.

Muscle-invasive bladder cancer (MIBC) is an aggressive disease with limited therapeutic options. Although immunotherapies are approved for MIBC, the majority of patients fail to respond, suggesting existence of complementary immune evasion mechanisms. Here, we report that the PPARγ/RXRα pathway constitutes a tumor-intrinsic mechanism underlying immune evasion in MIBC. Recurrent mutations in RXRα at serine 427 (S427F/Y), through conformational activation of the PPARγ/RXRα heterodimer, and focal amplification/overexpression of PPARγ converge to modulate PPARγ/RXRα-dependent transcription programs. Immune cell-infiltration is controlled by activated PPARγ/RXRα that inhibits expression/secretion of inflammatory cytokines. Clinical data sets and an in vivo tumor model indicate that PPARγHigh/RXRαS427F/Y impairs CD8+ T-cell infiltration and confers partial resistance to immunotherapies. Knockdown of PPARγ or RXRα and pharmacological inhibition of PPARγ significantly increase cytokine expression suggesting therapeutic approaches to reviving immunosurveillance and sensitivity to immunotherapies. Our study reveals a class of tumor cell-intrinsic "immuno-oncogenes" that modulate the immune microenvironment of cancer.Muscle-invasive bladder cancer (MIBC) is a potentially lethal disease. Here the authors characterize diverse genetic alterations in MIBC that convergently lead to constitutive activation of PPARgamma/RXRalpha and result in immunosurveillance escape by inhibiting CD8+ T-cell recruitment.

The Use of a Brochure to Enable CAM-with-Chemotherapy Patient Education.

The majority of cancer patients receiving chemotherapy will consider taking complementary and alternative medicine (CAM) during their treatment. As biologically-active CAM may detrimentally interfere with chemotherapy treatment, cancer patients require evidence-based information on chemotherapy-CAM integration consequences. This study aimed to assess if the availability of a purpose-designed brochure within a cancer service aided doctors' discussions with their patients on CAM use and helped patients understand the effects of CAM during their chemotherapy treatment. Cancer care doctors consulting in an adult day unit completed a structured post-intervention feedback survey form (n = 17), and cancer patients receiving chemotherapy treatment were provided the brochure and completed the local health service consumer testing feedback form (n = 30). All cancer care doctors perceived a need for the brochure and recommended the brochure to their patients. All doctors thought the brochure made it easier for them to discuss CAM with their patients, and 59 % believed that it saved them time during patient consultations. Ninety percent of cancer patients reported the brochure had enough information to answer their CAM questions, and all patients thought the information was easy to read and understand. An evidence-based CAM-with-chemotherapy patient brochure was perceived to have enabled cancer care doctors to discuss CAM with their patients and to have answered patients' CAM questions.

Probiotics and Allergic Rhinitis: A Simon Two-Stage Design to Determine Effectiveness.

BACKGROUND: Allergic rhinitis (AR) is a chronic upper respiratory disease affecting 10-30% of the population worldwide. It associated with significant economic and medical burden. Probiotics have received attention in recent years as a novel strategy to treat infectious/immune conditions, including AR. However, substantiation of these health claims by regulatory bodies has been rejected due, in part, to inadequate clinical trial design. While randomized controlled trials are considered the gold standard for assessing clinical efficacy, such trials require a priori preclinical data on effect size, which may be a reason for the conflicting results in the probiotic and AR literature. Progressive clinical trial designs, such as the Simon Two-Stage Design, are showing promise within the area of integrative and alternative medicine, particularly in relation to probiotic supplementation, to obtain empirical data for the design of clinical trials that meet regulatory requirements. METHODS: This Phase II study uses a Simon Two-Stage Design to determine the response rate of patients with AR to a probiotic supplement. Patients will consume a multispecies probiotic twice daily for 8 weeks, and will attend an allergy clinic at the beginning and end of the intervention period for assessment. Symptom improvement following probiotic supplementation will be measured by the mini-Rhinoconjunctivitis Quality of Life Questionnaire. Secondary outcomes include twice-weekly symptom and medication diaries, objective determination of nasal congestion via Nasal Rhinomanometry, and change in frequency of medication usage. DISCUSSION: This study provides an exemplar of the value of using a progressive study design in the complementary and alternative medicine setting. A Simon Two-Stage Design was adopted to investigate whether a multispecies probiotic supplement, not yet trialed in the context of AR, has promise as a therapeutic intervention and warrants the design of larger placebo-controlled studies.

Effect of acupuncture on house dust mite specific IgE, substance P, and symptoms in persistent allergic rhinitis.

BACKGROUND: Clinical evidence suggests that acupuncture improves symptoms in persistent allergic rhinitis, but the physiologic basis of these improvements is not well understood. OBJECTIVE: A randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. METHODS: A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up. RESULTS: Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group, from 18.87 kU/L (95% CI, 10.16-27.58 kU/L) to 17.82 kU/L (95% CI, 9.81-25.83 kU/L) (P = .04). A mean (SE) statistically significant down-regulation was also seen in proinflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment from 408.74 (299.12) pg/mL to 90.77 (22.54) pg/mL (P = .04). No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (postnasal drip and sinus pain did not) and continued to improve up to 4-week follow-up. CONCLUSION: Acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Identifier: ACTRN 12610001052022.

Complementary and alternative medicine use by patients receiving curative-intent chemotherapy.

AIM: To determine which types of complementary and alternative medicine (CAM) are being used by cancer patients commencing curative-intent chemotherapy, whether the CAM taken has the potential to affect treatment efficacy, the reasons for patients' decisions to use CAM and whether these patients would like information on CAM safety with chemotherapy. METHODS: Seventy-five solid tumor malignancy patients receiving curative-intent treatment attending a cancer care day unit were interviewed about their CAM use on the day of receiving their first dose of chemotherapy. RESULTS: Sixty percent of study participants were using CAM at the start of chemotherapy treatment. Biologically active CAM assessed as having potential to interact with prescribed chemotherapy was ingested by 27% of patients, all of whom had routinely used CAM prior to cancer diagnosis. CAM was used by 51% of patients for supportive care reasons and by 28% of patients with the intention of treating their cancer. Patients' CAM decision-making was influenced by advice from family and friends, practitioners and casual acquaintances. Thirteen percent of patients were told by a CAM advice-giver not to have chemotherapy. The majority of patients (84%) would have liked to receive information on which CAM is safe to use with chemotherapy before treatment commenced. CONCLUSIONS: Patients being treated with curative intent, particularly those with a history of CAM use, may be taking biologically active CAM with potential to compromise their chemotherapy treatment. These patients want cancer-care health professionals to provide them evidence-based information on safe CAM use with chemotherapy and may be contending with alternative health advice to not have chemotherapy.