The PHEM-B toolbox of methods for incorporating the influences on Behaviour into Public Health Economic Models.

BACKGROUND: It is challenging to predict long-term outcomes of interventions without understanding how they work. Health economic models of public health interventions often do not incorporate the many determinants of individual and population behaviours that influence long term effectiveness. The aim of this paper is to draw on psychology, sociology, behavioural economics, complexity science and health economics to: (a) develop a toolbox of methods for incorporating the influences on behaviour into public health economic models (PHEM-B); and (b) set out a research agenda for health economic modellers and behavioural/ social scientists to further advance methods to better inform public health policy decisions. METHODS: A core multidisciplinary group developed a preliminary toolbox from a published review of the literature and tested this conceptually using a case study of a diabetes prevention simulation. The core group was augmented by a much wider group that covered a broader range of multidisciplinary expertise. We used a consensus method to gain agreement of the PHEM-B toolbox. This included a one-day workshop and subsequent reviews of the toolbox. RESULTS: The PHEM-B toolbox sets out 12 methods which can be used in different combinations to incorporate influences on behaviours into public health economic models: collaborations between modellers and behavioural scientists, literature reviewing, application of the Behaviour Change Intervention Ontology, systems mapping, agent-based modelling, differential equation modelling, social network analysis, geographical information systems, discrete event simulation, theory-informed statistical and econometric analyses, expert elicitation, and qualitative research/process tracing. For each method, we provide a description with key references, an expert consensus on the circumstances when they could be used, and the resources required. CONCLUSIONS: This is the first attempt to rigorously and coherently propose methods to incorporate the influences on behaviour into health economic models of public health interventions. It may not always be feasible or necessary to model the influences on behaviour explicitly, but it is essential to develop an understanding of the key influences. Changing behaviour and maintaining that behaviour change could have different influences; thus, there could be benefits in modelling these separately. Future research is needed to develop, collaboratively with behavioural scientists, a suite of more robust health economic models of health-related behaviours, reported transparently, including coding, which would allow model reuse and adaptation.

Systematic Review and Meta-Analyses Assessment of the Clinical Efficacy of Bismuth Subsalicylate for Prevention and Treatment of Infectious Diarrhea.

BACKGROUND: A large number of studies have evaluated the pharmacology, safety, and/or efficacy of bismuth subsalicylate for the relief of common gastrointestinal symptoms, diarrhea and vomiting due to acute gastroenteritis. In addition, short-term (48 h) medication with bismuth subsalicylate is known to be effective against infectious gastroenteritis such as travelers' diarrhea. AIMS: Previous studies have documented the bacteriostatic/bactericidal effects of bismuth subsalicylate against a variety of pathogenic gastrointestinal bacteria. However, meta-analyses of the clinical efficacy of bismuth subsalicylate for both prevention and treatment of travelers' diarrhea have not yet been published. METHODS: A total of 14 clinical studies (from 1970s to 2007) comprised the core data used in this assessment of efficacy of bismuth subsalicylate against infectious (including travelers') diarrhea. These studies allowed for statistical meta-analyses regarding prevention (three travelers' diarrhea studies) and treatment of infectious diarrhea (11 studies [five travelers' diarrhea]). RESULTS: The results show that subjects treated with bismuth subsalicylate for up to 21 days have 3.5 times greater odds of preventing travelers' diarrhea compared with placebo (95% CI 2.1, 5.9; p < 0.001). In addition, subjects with infectious diarrhea treated with bismuth subsalicylate had 3.7 times greater odds of diarrhea relief (recorded on diaries as subjective symptomatic improvement) compared to those receiving placebo (95% CI 2.1, 6.3; p < 0.001). CONCLUSIONS: This systematic review and meta-analysis suggests that bismuth subsalicylate can be beneficial for those at risk or affected by food and waterborne diarrheal disease such as traveler's (infectious) diarrhea, and may decrease the risk of inappropriate antibiotic utilization.

Diaper dermatitis prevalence and severity: Global perspective on the impact of caregiver behavior.

OBJECTIVES: To compare prevalence and severity of diaper dermatitis (DD) in infants and toddlers (babies) across three countries (China, USA, and Germany), including diapered skin measures and caregiver practices. METHODS: A cross-sectional study of 1791 babies (~600 from each country) was recruited at each clinical site. Based on regional toilet-training habits, exclusively diaper-wearing infants were recruited between ages 2-8 months in China and 2-18 months in the USA and Germany. DD was measured, as well as skin pH, transepidermal water loss (TEWL), and relative humidity (RH) in the diapered region. Caregiver habits were collected via a questionnaire and included information on hygienic practices. RESULTS: Diaper dermatitis was highest in the perianal area, followed by the intertriginous, genital, and buttock regions. In general, DD was significantly lower in babies in China, highest in Germany, and intermediate in the USA. This rank ordering of DD by geography was also observed in baby age 2-8 months. The lower DD observed in China was associated with lower skin pH and TEWL on diapered skin and decreased RH in the diaper. Chinese caregivers had the highest rate of prophylactic topical product usage, the most robust cleaning of the diapered area, lack of cleansing after urine-only diaper changes, and Chinese infants spent the least time in an overnight diaper. CONCLUSIONS: These data suggest caregiver behaviors including prophylactic use of topical products, thorough cleaning after stooling and reduced time in an overnight diaper are associated with less DD, lower superficial skin pH, and enhanced skin barrier.

The impact of diaper design on mitigating known causes of diaper dermatitis.

BACKGROUND: Diapers play a critical role in infant health. In addition to providing sanitary methods of disposing of urine and feces, they can also directly impact skin health. Prolonged exposure to wetness and fecal matter has been shown to be a key driver of diaper dermatitis. This study sought to evaluate how diaper construction can affect absorption of stool. METHODS: Methods included laboratory testing of stool absorbency as well as an at-home diaper evaluation study, which examined a diaper's ability to keep fecal matter from the skin. Breastfed infant stool was given special consideration, as its properties make it difficult to contain. RESULTS: Laboratory results demonstrated that a meshlike aperture diaper was better able to absorb fecal matter. The at-home diaper evaluation study confirmed that a meshlike aperture diaper design resulted in fewer instances of stool being present on skin during diaper changes. CONCLUSION: Diapers with a meshlike aperture topsheet may represent a better way to mitigate known causes of diaper dermatitis through their superior ability to absorb fecal matter.

Satiety effects of psyllium in healthy volunteers.

Controlling hunger between meals is a challenge for many individuals. This manuscript comprises 2 sequential clinical trials investigating the effects of psyllium (Metamucil) on satiety, both using a randomized, double-blind, placebo-controlled cross-over design. The first study determined the effects of 3.4 g, 6.8 g, and 10.2 g of psyllium taken before breakfast and lunch for 3 days. The second study determined the effects of 6.8 g (taken before breakfast and lunch on Days 1 and 2 and before breakfast on Day 3) on the satiety of participants receiving an energy restricted meal in the morning (breakfast) for 3 days. Efficacy endpoints were mean inter-meal hunger, desire to eat, and Satiety Labeled Intensity Magnitude Visual Analog Scale scores. In Study 1, all 3 psyllium doses resulted in directional or statistically significant mean reductions in hunger and desire to eat, and increased fullness between meals compared to placebo, with both higher doses better than placebo or 3.4 g. The 6.8 g dose provided more consistent (p ≤ 0.013) satiety benefits versus placebo. In Study 2, satiety was assessed similarly to Study 1. A significant (p ≤ 0.004) decrease in the 3-day mean hunger and desire to eat, as well as an increase in fullness for psyllium relative to placebo was observed. Most adverse events were mild gastrointestinal symptoms and were similar for psyllium compared to placebo. These results indicate that psyllium supplementation contributes to greater fullness and less hunger between meals.

Study on percutaneous penetration of representative cosmetic ingredients in a baby wipe product in an in vitro diaper rash skin model.

Studying percutaneous penetration of various cosmetic ingredients through intact and compromised skin can provide insight on quantitative exposure assessment for baby products intended for diapered skin. We developed an in vitro model (tape-stripped human skin) designed to achieve the Trans-Epidermal Water Loss values measured in babies with various degrees of diaper dermatitis. Six reference compounds showed the impact of physicochemical properties on absorption through this "diaper rash" skin model. Under simulated diaper conditions, dermal absorption of cosmetic ingredients (phenoxyethanol, sodium benzoate, benzyl alcohol, disodium EDTA, and propylene glycol) was different, but <100%. Additionally, the effect of diaper rash on dermal absorption of well-absorbed ingredients (phenoxyethanol, sodium benzoate, and benzyl alcohol) was limited (enhancement of 1.1-1.3), while the enhancement for moderately absorbed compounds (disodium EDTA and propylene glycol) was 1.8-3.3. Absorption via skin with "diaper rash" is specific to individual ingredients and exposure conditions, so a fixed uncertainty factor is not appropriate for safety assessment. The data support that the default 100% dermal absorption commonly used in first-tier risk assessments for diapered skin is conservative. This diaper rash skin model provides a practical tool of estimating absorption of various ingredients in baby products intended for diapered skin.

Psyllium is a natural nonfermented gel-forming fiber that is effective for weight loss: A comprehensive review and meta-analysis.

BACKGROUND: Psyllium is a natural, predominantly soluble fiber that forms a viscous gel when hydrated and is not digested or fermented. In the small intestine, psyllium gel increases chyme viscosity, slowing the degradation and absorption of nutrients. Psyllium has a significant effect in patients with metabolic syndrome and type-2 diabetes on glycemic control, while lowering serum cholesterol in hypercholesterolemic patients. Some randomized controlled studies have shown that psyllium also facilitates weight loss in overweight and obese participants. OBJECTIVES: A comprehensive review and meta-analysis assessing psyllium's impact on body weight, body mass index (BMI), and waist circumference in overweight and obese participants. DATA SOURCES: A comprehensive search was performed (Medline, Scopus, Cochrane Database) through March 21, 2022, using search terms to identify randomized, controlled, clinical studies designed to assess weight loss in overweight and obese participants over at least 2 months. Data were analyzed using the inverse variance method with random effects models. CONCLUSIONS: Six studies meeting inclusion criteria were identified (total n = 354). The meta-analysis showed that psyllium, dosed just before meals (mean dose 10.8 g/day, mean duration 4.8 months), was effective for decreasing body weight (MD = -2.1 kg [95% confidence interval [CI]: -2.6 to -1.6]; p < .001), BMI (MD = -0.8 kg/m 2 [95% CI: -1.0 to -0.6]; p < .001) and waist circumference (MD = -2.2 cm [95% CI: -2.9 to -1.4]; p < .001) in overweight and obese populations. IMPLICATIONS FOR PRACTICE: Gel-forming nonfermented psyllium fiber, dosed just before meals, is effective in facilitating weight loss in overweight and obese participants.

Understanding the impact funding cuts on Environmental and regulatory services and gastrointestinal infections: a longitudinal ecological study.

Background: Gastrointestinal (GI) infections result in 17 million cases annually, with foodborne illness costing the National Health Service (NHS) £60m per year. The burden of GI infection is unequally distributed, with greater impact in more socioeconomically disadvantaged groups and areas. Local authorities (LA) provide vital services that protect public health and wellbeing. The impact of funding cuts to local services and their effect on public health is an area of concern. Environmental and regulatory (ER) services are responsible for roles such as food safety and infectious disease control. This study aims to understand the impact of local funding cuts on ER and GI infection outcomes. Methods: We will conduct an ecological longitudinal study in England from 2010-2019 at the LA level to examine how changes in ER expenditure overtime have impacted ER and GI infection outcomes. Data will be gathered on food hygiene enforcement, food hygiene compliance levels, GI infection hospitalisation, NHS 111 calls relating to GI infection symptoms, GI infection pathogen data, deprivation, and population density. Measures will be aggregated to LA level and statistical analysis will be carried out. Ethics and dissemination: University of Liverpool Ethics committee have confirmed ethical approval will not be required. All data will be aggregated and anonymised, therefore only data sharing agreements will be required. Findings will be disseminated to the stakeholder group in addition to outputs through conferences and publications. These findings will help understand impact of key services on public health and should inform government and public health policy and strategy.

Laxative effects of wheat bran and psyllium: Resolving enduring misconceptions about fiber in treatment guidelines for chronic idiopathic constipation.

BACKGROUND: Treatment guidelines for chronic idiopathic constipation (CIC) recommend an "increase in fiber intake" as a first-line therapy, but most epidemiologic studies fail to support an association between a high-fiber diet and a reduced risk of constipation. Furthermore, randomized controlled clinical studies show that most isolated fibers (e.g., supplements) are not different from placebo for a laxative effect, and several may be constipating. OBJECTIVES: The objective of this review was to compare the effects of two isolated fibers, coarse wheat bran and psyllium, on stool output and stool water content in patients with CIC. This review will also address misconceptions about fiber that are perpetuated by treatment guidelines. DATA SOURCES: A comprehensive literature review was conducted with the use of the Scopus, SciFinder, and PubMed scientific databases, limited to the previous 50 years (1968-2018; latest date included, December 31, 2018). CONCLUSIONS: In patients with CIC, nonfermented gel-forming psyllium was 3.4 times more effective than insoluble wheat bran for increasing stool output. Both psyllium and coarse wheat bran increased stool water content, a stool-softening effect, but finely ground wheat bran decreased stool water content, a stool-hardening effect. IMPLICATIONS FOR PRACTICE: It is a misconception that dietary fiber and all isolated fibers provide a laxative effect in patients with CIC. Our analysis suggests that treatment guidelines for CIC should make specific evidence-based recommendations as it pertains to fiber. To do otherwise takes the risk of perpetuating myth and misunderstanding and depriving patients of an effective therapy for CIC. A generic recommendation to "increase fiber intake" is akin to a recommendation to "increase pill intake" without regard to therapeutic or adverse effects.

Evaluation of the Impact of 2 Disposable Diapers in the "Natural" Diaper Category on Diapered Skin Condition.

The demand for natural infant care products, including diapers, has increased. However, few disposable diapers have been able to provide the performance caregivers desire while also incorporating ingredients consistent with the "natural" category. In an examiner-blinded clinical study, the performance of a new cotton-enhanced diaper with high-performance materials was compared with an existing natural diaper offering. A total of 131 infants wore 1 of the 2 diapers for a 4-week period. Diaper performance was assessed based on skin marking assessments, scored by a trained grader, and incidence of diaper dermatitis. Skin grading for diaper dermatitis was assessed at 4 sites in the diaper area. The new diaper offering was associated with less skin marking and significantly less diaper rash at the genitals and intertriginous regions versus the comparator. These data suggest that the new diaper provided significant improvement in both skin marking and prevalence of diaper rash.

The effects of high concentration tooth whitening bleaches on microleakage of Class V composite restorations.

OBJECTIVE: To explore the effects of high-concentration hydrogen peroxide bleaching agents on the microleakage of composite restorations. METHODS: In 60 extracted human molars, Class V restorations were prepared with Scotchbond 1/Filtek Z250 composite. Teeth were randomly divided into four groups: (1) no bleaching; (2) bleaching with 14% hydrogen peroxide gel from Crest Whitestrips; (3) bleaching with 20% carbamide peroxide gel from Opalescence PF 20; and (4) bleaching with 38% hydrogen peroxide gel Opalescence Xtra Boost. Bleaching procedures were carried out at 37 degrees C for 21 days/42 hours (2); seven days/42 hours (3); one day/45 minutes (4). Varnish was applied on the apical portion of the teeth only, excluding the restoration, prior to immersion in a 0.1% rhodamin-B-isothiocyanate solution for 24 hours at 37 degrees C. After rinsing, specimens were embedded in methacrylate blocks, and sectioned with a water-cooled microtome with three restoration cuts positioned centrally parallel to the long axis of the tooth. Microleakage was evaluated at the occlusal margins of the Class V restorations using a stereo microscope, separate for dentin and enamel margins. RESULTS: Over 90% of enamel margins exhibited no microleakage following cycling. Bleaching agents had almost no effect on numerical averages. Eighty-eight percent of the dentin margins were free of microleakage for the non-treated control group. Bleaching treatments collectively had slight numerical reductions to around 80%. The statistical evaluation (Kruskal-Wallis-test) showed no significant difference in microleakage between groups for enamel or dentin. CONCLUSION: Bleaching with the materials tested had no influence on microleakage of Filtek Z250 composite bonded with Scotchbond 1.

Characterizing Exclusively Breastfed Infant Stool via a Novel Infant Stool Scale.

Analysis of stool has long been a diagnostic tool across a number of disease states. Currently, there are two stool scales in clinical use, the Bristol Stool Scale and the Amsterdam Infant Stool Scale. However, the existing categorizations for stool may not sufficiently cover the broad range of stool output for exclusively breastfed infants. The Bristol Stool Scale is not age specific to cover children who are not toilet trained and the Amsterdam Infant Stool Scale, though developed for children who are not toilet trained, does not sufficiently cover the wide variety of consistencies of exclusively breastfed infant stools. Through a robust understanding of exclusively breastfed infant stool characteristics, a new stool scale has been developed. It is proposed that this stool scale may better assist in observing and recording exclusively breastfed infant stool in a more accurate manner, which may aid in diagnostic capabilities.

Improving Diaper Performance for Extremely Low-Birth-Weight Infants.

BACKGROUND: Extremely low-birth-weight (ELBW) infants face significant diapering challenges compared with their full-term peers, due to immature musculature, nervous system, and skin development. Advances in medical care have increased an ELBW infant's rate of survival, which creates a growing need for diapers to better serve these infants. Aim of research. The objective of this study was to identify and confirm the requirements for optimal diaper performance from the neonatal intensive care unit nurses' perspective, as well as to assess in-hospital performance to determine if new features improved key developmental care parameters. METHOD: Two surveys were shared among nurses to address study objectives. Study 1 (N = 151) was designed for neonatal intensive care unit nurses to identify key requirements for ELBW diapers and rate the performance of existing ELBW diapers. Study 2 (N = 99) assessed in-hospital performance of the test diaper compared with the usual diaper, under normal usage conditions. Findings/results. The majority of nurses agreed that ELBW diapers must fit appropriately between the legs so that hips and legs are not spread apart and that ELBW diapers need to be flexible between the legs for positioning. Of the nurses-infant pair responses, 93% ( P < .0001) preferred the test ELBW diaper over their usual diaper. CONCLUSION: Findings suggest that nurses should be included in the product design process to ensure both their needs and the needs of an infant are being met. Nurses are considering how diaper features may affect both acute and long-term medical outcomes and this information provides necessary guidance to diaper manufacturers and designers when developing better-performing diapers.

A 24-hour dental plaque prevention study with a stannous fluoride dentifrice containing hexametaphosphate.

Recently, a novel antibacterial fluoride dentifrice containing stannous fluoride and sodium hexametaphosphate (CrestPRO-HEALTH) was introduced. A digital plaque image analysis (DPIA) technique was used to quantify in situ plaque formation in a population carrying out a phased intervention protocol that included: (1) an initial treatment regimen including toothbrushing with standard sodium fluoride dentifrice in conventional bid brushing, (2) a second treatment regimen where a modified hygiene regimen was applied using standard sodium fluoride dentifrice including a period of 24 hours of non-brushing, and (3) a third treatment regimen where the 24-hour non-brushing regimen was continued using the antimicrobial stannous fluoride/sodium hexametaphosphate dentifrice. The quantitative evaluation of plaque formation was assessed in morning measurements following either standard evening hygiene (treatment period 1) or 24 hours since brushing (treatment periods 2 and 3). Post-brushing plaque measurements were also taken in each treatment regimen. Sixteen subjects completed all three treatment regimens with no side effects or oral complaints. Morning plaque coverage in treatment period 1 was 13.3%. Plaque coverage significantly increased in treatment period 2 when pre-bedtime brushing was discontinued, with 24-hour growth covering 18.4% of the dentition. Intervention of the antimicrobial stannous fluoride/hexametaphosphate dentifrice in treatment period 3 provided significant inhibition of plaque regrowth over 24 hours (15.2% coverage, a 17% reduction vs. sodium fluoride dentifrice control). These results support the strong retention and lasting antimicrobial efficacy of high stabilized stannous fluoride/sodium hexametaphosphate dentifrices.

Efficacy of a high bioavailable cetylpyridinium chloride mouthrinse over a 24-hour period: a plaque imaging study.

PURPOSE: To evaluate the antiplaque benefits of a 0.07% high bioavailable, alcohol-free cetylpyridium chloride (CPC) rinse used after toothbrushing versus toothbrushing alone. METHODS: A digital plaque image analysis technique was used to quantify in situ plaque formation in a subject population carrying out modified hygiene using standard fluoridated dentifrice or standard dentifrice augmented with 30 seconds mouthrinsing with an alcohol-free mouthrinse containing 700 ppm CPC. RESULTS: Comparison of plaque formation 24 hours following "last hygiene" revealed that brushing followed by CPC mouthrinse use provided a statistically significant decrease in plaque coverage on teeth averaging 42% as compared with brushing only. Moreover, toothbrushing with a standard dentifrice in the morning resulted in 34% less plaque when subjects used the CPC mouthrinse 24 hours prior to examination. CLINICAL SIGNIFICANCE: These results support the strong retention and lasting antiplaque efficacy of high bioavailable CPC mouthrinse and suggest that the plaque biofilms formed during CPC use are susceptible to more efficient debridement.

Comparative clinical trial of two antigingivitis mouthrinses.

PURPOSE: To compare the safety and the antiplaque and antigingivitis efficacy of two oral rinses. METHODS: A randomized, double-blind, parallel groups, single-center study was conducted to evaluate the safety and efficacy of a high bioavailable, alcohol-free 0.07% cetylpyridinium chloride (CPC) rinse (Crest Pro-Health Rinse) and a positive control rinse containing essential oils (EO) and 21.6% ethyl alcohol (Cool Mint Listerine). Seventy-eight healthy adults were enrolled in a modified experimental gingivitis clinical trial. Four weeks before the baseline visit, subjects received a prophylaxis and were instructed to brush twice daily in a manner to approach optimum gingival health. At the end of the 4-week period, subjects were randomly assigned to treatment and instructed to use 20 ml of their assigned product for 30 seconds after brushing twice daily during a 21-day treatment phase. Plaque removal by brushing was prevented during the treatment phase for one mandibular quadrant (experimental gingivitis region) by means of a specially-manufactured tooth shield. Safety and efficacy measurements were obtained at baseline and at the end-of-treatment using the Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), and Modified Quigley-Hein Plaque Index (MQH). At all visits, an oral soft tissue examination was performed for each subject. The efficacy data obtained in the experimental gingivitis region were analyzed with analysis of covariance. RESULTS: Seventy-five subjects completed the study and were included in the data analyses. No statistically significant differences were detected between the two treatment groups for MGI, GBI or MQH measures. Results were similar for shielded interproximal sites. Both treatments were well-tolerated. CLINICAL SIGNIFICANCE: This randomized, controlled comparative clinical trial demonstrated that rinsing twice daily with the experimental alcohol-free 0.07% CPC rinse provides antiplaque and antigingivitis efficacy similar to that of the positive control EO rinse, a recognized antiplaque and antigingivitis mouthrinse that contains alcohol.

A 6-month clinical study assessing the safety and efficacy of two cetylpyridinium chloride mouthrinses.

PURPOSE: To evaluate the effects of two experimental cetylpyridinium chloride (CPC) mouthrinses containing 0.075% and 0.10% CPC on the development of gingivitis and plaque versus a placebo control over a period of 6 months. METHODS: This was a randomized, single center, parallel group, double blind, positive and placebo controlled clinical trial. A 0.12% chlorhexidine rinse served as the positive control for validation of the methodology. At the beginning of the trial, 366 subjects were balanced and randomly assigned to treatment groups. Subjects received a dental prophylaxis and began rinsing twice a day with 15 ml of their assigned mouthwash for 30 seconds after brushing their teeth. Subjects were assessed for gingivitis and gingival bleeding by the Löe-Silness Gingival Index method and plaque by the Turesky modification of Quigley Hein Plaque Index at baseline and after 3 and 6 months of product use. Oral soft tissue health was also assessed. RESULTS: After 3 and 6 months, subjects rinsing with either 0.075% or 0.10% CPC had significantly (P< 0.0001) less gingivitis, gingival bleeding, and plaque, on average, than those on placebo. The 6-month mean reductions in gingivitis, gingival bleeding, and plaque for the 0.075% and 0.10% CPC rinses versus placebo were 23%, 30% and 17%, and 20%, 27% and 19%, respectively. There was no statistically significant difference in efficacy between the two CPC mouthrinses. Reductions at 3 months were similar to those seen at 6 months. Significant benefits were observed with chlorhexidine, thereby validating the study. CLINICAL SIGNIFICANCE: This study clearly demonstrates that CPC mouthrinses formulated to deliver therapeutic benefits when used twice daily can significantly prevent the development of gingivitis, gingival bleeding, and plaque over a 6-month period.

A 6-month clinical trial to study the effects of a cetylpyridinium chloride mouthrinse on gingivitis and plaque.

PURPOSE: To evaluate the effects of a novel mouthrinse containing 0.07% high bioavailable cetylpyridinium chloride (Crest Pro-Health Rinse) on the development of gingivitis and plaque versus a placebo control over a period of 6 months. METHODS: This was a randomized, 6-month, placebo-controlled, parallel groups, double blind, single center clinical trial. One hundred thirty-nine generally healthy adults with mild-to-moderate gingivitis were enrolled in the study. Subjects were given Modified Gingival Index (MGI), Gingival Bleeding Index (GBI) and Modified Quigley-Hein Plaque Index (MQH) examinations followed by a dental prophylaxis. Subjects were then randomly assigned to either the cetylpyridinium chloride (CPC) rinse or placebo rinse and instructed to begin rinsing twice a day with 20 ml of their assigned mouthrinse for 30 seconds after brushing their teeth. Subjects were assessed for MGI, GBI and MQH scores after 3 and 6 months of product use. Oral hard and soft tissue examinations were also performed at all visits. RESULTS: 124 subjects were evaluable at Month 3 and 119 at Month 6. After 6 months, subjects rinsing with the CPC rinse showed 15.4% less gingival inflammation, 33.3% less gingival bleeding, and 15.8% less plaque relative to the placebo group. All reductions were highly statistically significantly different (P< 0.01). Results were similar at 3 months. Both treatments were well-tolerated. CLINICAL SIGNIFICANCE: This study demonstrates that the Crest Pro-Health 0.07% CPC mouthrinse provided significant antiplaque and antigingivitis benefits when used twice daily for 6 months as an adjunct to toothbrushing.

Antibacterial and antiplaque effects of a novel, alcohol-free oral rinse with cetylpyridinium chloride.

Antimicrobial agents are commonly incorporated into hygiene products for the treatment and prevention of plaque and gingivitis. Recently, a new alcohol-free rinse containing 0.07% cetylpyridinium chloride (CPC) in a high bioavailable matrix (Crest Pro-Health Rinse) was introduced to provide antiplaque and antigingivitis benefits. This paper reviews results from an in vitro pre-clinical study and an in vivo clinical study evaluating the antibacterial and antiplaque benefits of this CPC rinse technology. In the in vitro experiment, a no-alcohol 0.065% high bioavailable CPC prototype rinse was evaluated for its hostility against a broad range of microorganisms commonly associated with plaque and gingivitis. The rinse demonstrated greater than 99% germ kill for all organisms tested individually as well as in whole saliva. The benefit of this antibacterial action on plaque inhibition was assessed in a clinical trial. A double-blinded, 3-period, 6-sequence crossover study was conducted evaluating the antiplaque effect of the novel 0.07% high bioavailable, alcohol-free CPC rinse versus a positive control (Listerine Cool Mint containing essential oils) and a negative control (placebo CPC rinse). A modification of the Addy 4-day plaque model was used for this evaluation. Plaque was measured at baseline (Day 1) of each treatment period and at Day 4 using the Turesky modification of Quigley-Hein index. During the treatment period, subjects brushed only their lingual surfaces twice daily for up to 60 seconds. Following brushing, subjects used 20 mls of the mouthrinse product for 30 seconds in the morning and evening. Fifty-five subjects completed the study. For non-brushed sites, both the essential oils and CPC rinse exhibited a 25% reduction in plaque vs. placebo after four days of product usage, which was statistically significant (p < 0.0001). Both treatments also exhibited a statistically significant benefit versus placebo (p<0.0001) for brushed sites (>38% plaque reduction). These data support the antibacterial action of the high bioavailable, alcohol-free CPC rinse and demonstrate antiplaque effects for Crest Pro-Health Rinse that are "at least as good as" the leading essential oils antiseptic, making it well-suited for a broad range of patients, particularly those who are sensitive to products containing alcohol.

Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus.

BACKGROUND: A number of health benefits are associated with intake of soluble, viscous, gel-forming fibers, including reduced serum cholesterol and the attenuation of postprandial glucose excursions. OBJECTIVE: We assess the effects of psyllium, which is a soluble, gel-forming, nonfermented fiber supplement, on glycemic control in patients who were being treated for type 2 diabetes mellitus (T2DM) and in patients who were at risk of developing T2DM. DESIGN: A comprehensive search was performed of available published literature (Scopus scientific database) and clinical records stored by Procter & Gamble with the use of key search terms to identify clinical studies that assessed the glycemic effects of psyllium in nondiabetic, pre-T2DM, and T2DM patients. RESULTS: We identified 35 randomized, controlled, clinical studies that spanned 3 decades and 3 continents. These data were assessed in 8 meta-analyses. In patients with T2DM, multiweek studies (psyllium dosed before meals) showed significant improvement in both the fasting blood glucose (FBG) concentration (-37.0 mg/dL; P < 0.001) and glycated hemoglobin (HbA1c) [-0.97% (-10.6 mmol/mol); P = 0.048]. Glycemic effects were proportional to baseline FBG; no significant glucose lowering was observed in euglycemic subjects, a modest improvement was observed in subjects with pre-T2DM, and the greatest improvement was observed in subjects who were being treated for T2DM. CONCLUSIONS: These data indicate that psyllium would be an effective addition to a lifestyle-intervention program. The degree of psyllium's glycemic benefit was commensurate with the loss of glycemic control. Because the greatest effect was seen in patients who were being treated for T2DM, additional studies are needed to determine how best to incorporate psyllium into existing prevention and treatment algorithms with concomitant hypoglycemic medications.