Correction to: Immunogenic Yeast-Based Fermentation Product Reduces Allergic Rhinitis-Induced Nasal Congestion: A Randomized, Double-Blind, Placebo-Controlled Trial.

The article ''Immunogenic Yeast-Based Fermentation Product Reduces Allergic Rhinitis-Induced Nasal Congestion: A Randomized, Double-Blind, Placebo-Controlled Trial'', written by Mark A. Moyad, Larry E. Robinson, Julie M. Kittelsrud, Stuart G. Reeves, Susan E. Weaver, Aireen I. Guzman, Mark E. Bubak was originally published electronically on the publisher's internet portal (currently Springer-Link) on 12 August, 2009.

Anti-inflammatory properties of a dried fermentate in vitro and in vivo.

The aim of this study was to document anti-inflammatory properties of a dried fermentate derived from Saccharomyces cerevisiae (EpiCor(®)), hereafter referred to as dried fermentate in vitro using cell-based bioassays, and in vivo using a skin irritation model in healthy humans. In vitro testing involved parallel assessment of primary human polymorphonuclear (PMN) cell formation of reactive oxygen species (ROS) and migration toward the inflammatory mediator Leukotriene B4. In vivo evaluation used a single-blind placebo-controlled design, where dermal histamine-induced inflammation was used as a model for the complex intercellular signals involved in the initiation, escalation, and resolution of the inflammatory response. Microvascular blood perfusion was evaluated using noninvasive laser Doppler probes applied to the inner forearms of 12 healthy human subjects, where parallel sites were treated with either dried fermentate or saline (placebo). Subjective scores of dermal irritation were also collected. Treatment of PMN cells in vitro resulted in reduced ROS formation and migratory activity toward Leukotriene B4. Clinical results demonstrated significantly reduced microvascular inflammatory responses to histamine-induced skin inflammation, and significantly reduced subjective scores of irritation at the inflamed sites treated with dried fermentate compared with the sites treated with placebo (P<.05). Treatment of inflammatory cells in vitro with dried fermentate resulted in reduced inflammatory responses. This was confirmed in vivo, suggesting that the dried fermentate facilitates the resolution of inflammatory responses. The effects using a topical skin model suggest that similar events may happen when the dried fermentate is introduced across mucosal membranes after consumption.

A dried yeast fermentate selectively modulates both the luminal and mucosal gut microbiota and protects against inflammation, as studied in an integrated in vitro approach.

EpiCor, derived from Saccharomyces cerevisiae, has been shown to have immunomodulating properties in human clinical trials and in vitro. However, the underlying mechanisms behind its immune protection via the gut remain largely unknown. Therefore, the aim of this study was to use an integrated in vitro approach to evaluate the metabolism of EpiCor by the intestinal microflora, its modulating effect on the gut microbiota, and its anti-inflammatory activity on human-derived cell lines. Using the SHIME model, in combination with a mucus adhesion assay, has shown that low doses of EpiCor have a prebiotic-like modulatory effect on the luminal- and mucosa-associated microbiota. These include gradual changes in general community structure, reduction of potential pathogens, quantitative increase in lactobacilli, and qualitative modulation of bifidobacteria. Moreover, by combination of the SHIME with Caco-2 cells and Caco-2/THP1 cocultures, a significant decrease in pro-inflammatory cytokines was observed at the end of the treatment period.

A dried yeast fermentate prevents and reduces inflammation in two separate experimental immune models.

Diverse and significant benefits against cold/flu symptoms and seasonal allergies have been observed with a dried fermentate (DF) derived from Saccharomyces cerevisiae (EpiCor) in multiple published randomized trials. To determine if DF may influence other immune conditions, two separate animal studies were conducted. Study 1 examined the ability of DF to prevent or reduce inflammation when given orally for 14 days to rats prior to receiving 1% carrageenan (localized inflammation model). DF significantly (P < 0.05) reduced swelling at all time points (1, 2, 3, 6, 12, and 24 hours) versus the control. Edema severity and PGE2 levels were reduced by approximately 50% and 25% (P < 0.05), respectively. Study 2 examined the ability of DF to treat established inflammation induced by type-2 collagen in mice over 4 weeks (autoimmune arthritis model). Significantly reduced arthritis scores, antibody response to type-2 collagen, and interferon-gamma levels were observed compared to controls (all parameters P < 0.05). DF favorably impacts multiple acute and potentially chronic immunologic inflammatory control mechanisms and should be further tested in clinical trials.

A novel approach to hospital palliative care: an expanded role for counselors.

BACKGROUND: A large tertiary hospital in central Georgia has found a novel approach to hospital palliative care. APPROACH: It is unique in that the approach has a strong counseling base in providing the palliative service, rather than major reliance on advance practice nurses or palliative physicians. The Medical Center of Central Georgia employs master's prepared counselors who spend the hours needed to assist families in making difficult end-of-life decisions. MODEL: Using a family systems therapy approach, these counselors have developed the Transitions and Palliative Care Therapy Model, which has proved to be a successful means of providing the services. The model includes the "7 Core Components of Communication and Decision Making," which gives the counselors actual interventions to use in working through these complex cases. OUTCOMES: The growth of the program over 7 years is staggering with the outcomes far exceeding even the predicted volume from the Center to Advance Palliative Care. CONCLUSIONS: The model has the counselor at the heart of the team, keeping the communication open and flowing. The Transitions and Palliative Care Therapy Model has become an accepted standard of practice at Medical Center of Central Georgia and continues to be a successful means of managing the most complex cases in the hospital.

Immunogenic yeast-based fermentate for cold/flu-like symptoms in nonvaccinated individuals.

BACKGROUND: The common cold has a profound impact on employee attendance and productivity. Seasonal influenza is responsible for approximately 200,000 hospitalizations and 36,000 deaths per year in the United States alone. Over-the-counter medication efficacy has been questioned, and seasonal vaccination compliance issues abound. Our previously reported randomized trial of an oral fermentation product found an adjuvant benefit for vaccinated individuals in terms of a significantly reduced incidence and duration of cold and flu-like symptoms. METHODS: A concurrent 12-week, randomized, double-blind, placebo-controlled clinical trial of 116 subjects with no recent history of seasonal influenza vaccination was conducted. Participants received once-daily supplementation with 500 mg of a dried modified Saccharomyces cerevisiae oral fermentate (EpiCor) or placebo. Clinical outcome measurements included periodic interval-based in-clinic examinations and serologic analysis at baseline, 6 weeks, and 12 weeks. Participants utilized a standardized self-report symptom diary. RESULTS: Subjects receiving the intervention experienced a statistically significant reduction in the incidence (p = 0.01), a nonsignificant reduction in duration (p = 0.10), and no impact on the severity (p = 0.90) of colds or flu-like symptoms, but a more favorable safety profile compared with subjects receiving placebo. CONCLUSIONS: This nutritional-based fermentate appeared to be safe and efficacious in a unique at-risk population and should receive more clinical research as a potential method to reduce the incidence of cold and flu-like symptoms, in individuals with and without a history of influenza vaccination.

Immunogenic yeast-based fermentation product reduces allergic rhinitis-induced nasal congestion: a randomized, double-blind, placebo-controlled trial.

INTRODUCTION: Allergic rhinitis (AR) impacts around 25% of the worldwide population. However, cost, safety, and a high dissatisfaction rate with numerous conventional medications continues to be an issue in the largest patient surveys, due primarily to a lack of efficacy on nasal congestion. Our previously published randomized trial demonstrated a significant reduction in cold and flu-like symptoms, and a secondary potential observation of a decrease in nasal congestion with an oral yeast-derived compound; therefore, the objective of this study was to test the effects of this same product on nasal congestion and other notable AR symptoms. METHODS: A 12-week, randomized, double-blind, placebo-controlled clinical trial of 96 healthy subjects with a recent clinically documented history of seasonal allergies and AR was conducted. Participants received once-daily supplementation with 500 mg of a dried, modified Saccharomyces cerevisiae oral fermentation product (EpiCor, Embria Health Sciences, Ankeny, Iowa, USA) or placebo during the 12-week period of the highest recorded concentrations of total pollen counts for this Midwest geographic area. Clinical outcome measurements included in-clinic examinations, validated questionnaire and standard diary, and serologic analysis at baseline, 6 and 12 weeks. RESULTS: During the highest pollen count period (weeks 1-6), EpiCor significantly reduced the mean severity of specific AR symptoms, including a significant reduction in nasal congestion (P=0.04), rhinorrhea (P=0.005), and a nonsignificant reduction in ocular discharge symptoms. A significantly (P=0.04) reduced total number of days with nasal congestion (12.5 fewer days) favored EpiCor compared with placebo, as did the nasal congestion section of the quality of life questionnaire (P=0.04). Subjects receiving the intervention also experienced significantly (P=0.03) higher salivary IgA levels. Adverse events were similar to placebo. CONCLUSION: This yeast-derived product appeared to be safe and efficacious, and should receive more clinical research with and without standard medications to reduce the impact of seasonal allergies, especially AR-induced nasal congestion.

Lessons learned from the 2007-2008 cold and flu season: what worked and what was worthless.

The 2007-2008 cold and flu season had a feeble beginning but a dramatic end. Most states in the U.S. were reporting their highest number of flu cases well into February and March. It is concerning that not only the public but health care professionals have not embraced widespread vaccination because approximately 200,000 hospitalizations and 36,000 deaths a year continue to make this condition one of the leading preventable causes of morbidity and mortality. The real question that needs to be asked next year is who should not be vaccinated rather than who needs to be vaccinated. Preventive measures with soap and water and 62% ethyl alcohol hand gels continue to make sense, whereas the antibacterial soaps seem to provide no added protection and theoretically increase the risk of bacterial resistance. A few dietary supplements garnered some attention. Among products with clinical research, an oral 500 mg qd immunogenic fermentate (Epicor) reduced the risk and duration of cold and flu symptoms in subjects vaccinated for seasonal influenza. Two novel prescription medications (zanamivir [Relenza], and oseltamivir [Tamiflu]) are available for the prevention and/or treatment of influenza and also have demonstrated minimal resistance compared to the older medications. These FDA-approved medications should receive more attention because of their overall effectiveness in treating the flu during the first stages of the disease process.

Effects of a modified yeast supplement on cold/flu symptoms.

A yeast-based product (EpiCor, a dried Saccharomyces cerevisiae fermentate) was compared to placebo to determine effects on the incidence and duration of cold and flu-like symptoms in healthy subjects recently vaccinated for seasonal influenza. In a 12-week, randomized, double-blind, placebo-controlled clinical trial, 116 participants received daily supplementation with 500 mg of EpiCor or placebo for 12 weeks. Data collected included periodic in-clinic examinations and serologic evaluations at baseline, 6- and 12-weeks. Subjects also utilized a standardized self-report symptom diary during the study. Participants receiving the yeast-based product had significantly fewer symptoms and significantly shorter duration of symptoms when compared with subjects taking a placebo.

Cholesterol, cholesterol-lowering agents/statins, and urologic disease: Part IV--is vitamin E phosphate or another unique type of this vitamin the last chance for these supplements?

Vitamin E, once the highly espoused heart healthy paradigm of the dietary supplement world, has now been touted by many experts to be either heart unhealthy or simply ineffective based on the results of past and recent randomized trials in cardiovascular medicine. Natural and synthetic vitamin E supplements, especially in large dosages, have been the concern. Researchers have embarked on testing a variety of other novel forms of vitamin E, such as vitamin E phosphate and other forms of vitamin E, to determine safety issues as well as the impact on cardiovascular disease (CVD) risk markers and end-points. Until vitamin E demonstrates meaningful changes in some of the accepted markers of CVD prevention, it will be difficult to espouse their use specifically for these and other conditions.