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.

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.

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.

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.

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.

Evidence-based treatment of frequent heartburn: the benefits and limitations of over-the-counter medications.

PURPOSE: This review summarizes the pharmacological effects of over-the-counter (OTC) heartburn drugs, and the implications for treating frequent heartburn. DATA SOURCES: PubMed and SCOPUS were searched across all years to identify well-controlled, randomized clinical studies that assessed mechanism of action and efficacy. CONCLUSIONS: Antacids can transiently neutralize acid in the esophagus, but do not significantly affect gastric pH or prevent subsequent heartburn episodes. Histamine-2 receptor antagonists (H2 RAs) rapidly develop tolerance with repeat dosing, and exhibit an analgesic effect that may provide heartburn relief while leaving the esophagus exposed to acid. Proton pump inhibitors (PPIs) provide a sustained inhibition of gastric acid production, and are superior to antacids and H2 RAs for control of gastric acid and treatment of frequent heartburn. IMPLICATIONS FOR PRACTICE: When recommending therapies for frequent heartburn, it is of particular importance to understand the strengths and weaknesses of available OTC medications. Antacids and H2 RAs are not recommended for treatment of frequent heartburn, while OTC PPIs are both indicated for, and effective for, treatment of frequent heartburn. A PPI dose of 20 mg is optimal for empiric treatment of frequent heartburn, and consistent with the 2013 treatment guidelines established by the American College of Gastroenterology (ACG) for treatment with a minimum effective dose.

Fecal excretion of Bifidobacterium infantis 35624 and changes in fecal microbiota after eight weeks of oral supplementation with encapsulated probiotic.

Certain randomized, placebo-controlled trials of oral supplementation with B. infantis 35624 have demonstrated the amelioration of symptoms of irritable bowel syndrome. Potential GI colonization by B. infantis 35624 or effects of supplementation on resident GI microbiota may pertain to these clinical observations. In this study, fecal excretion of B. infantis 35624 before, during and after 8 weeks of daily treatment was compared in subjects with IBS who received either the encapsulated oral supplement (n = 39) or placebo (n = 37) and in healthy subjects who received the supplement (n = 41). Secondarily, changes in assessed fecal microbiota and IBS symptoms were determined. Supplementation significantly increased fecal B. infantis 35624 excretion vs. placebo in IBS subjects; excretion in healthy subjects receiving supplement was quantitatively similar. Fecal levels of the probiotic declined and approached baseline once dosing ceased, documenting that colonization is transient. Although supplementation increased numbers of B infantis 35624 within the GI tract, limited changes in 10 other fecal taxa were observed either in healthy subjects or those with IBS. No impact on IBS symptoms was observed. Detection of bacterial DNA in fecal samples suggests that the probiotic is able to survive transit through the GI tract, although strain selective culture techniques were not performed to confirm viability of B. infantis 35624 in the feces. Continuous probiotic administration was necessary to maintain steady-state transit. Given the complex spectrum of GI microbiota, however, monitoring perturbations in selected taxa may not be not a useful indicator of probiotic function.

Gingival transcriptome patterns during induction and resolution of experimental gingivitis in humans.

BACKGROUND: To our knowledge, changes in the patterns of whole-transcriptome gene expression that occur during the induction and resolution of experimental gingivitis in humans were not previously explored using bioinformatic tools. METHODS: Gingival biopsy samples collected from 14 subjects during a 28-day stent-induced experimental gingivitis model, followed by treatment, and resolution at days 28 through 35 were analyzed using gene-expression arrays. Biopsy samples were collected at different sites within each subject at baseline (day 0), at the peak of gingivitis (day 28), and at resolution (day 35) and processed using whole-transcriptome gene-expression arrays. Gene-expression data were analyzed to identify biologic themes and pathways associated with changes in gene-expression profiles that occur during the induction and resolution of experimental gingivitis using bioinformatic tools. RESULTS: During disease induction and resolution, the dominant expression pathway was the immune response, with 131 immune response genes significantly up- or downregulated during induction, during resolution, or during both at P <0.05. During induction, there was significant transient increase in the expression of inflammatory and oxidative stress mediators, including interleukin (IL)-1 alpha (IL1A), IL-1 beta (IL1B), IL8, RANTES, colony stimulating factor 3 (CSF3), and superoxide dismutase 2 (SOD2), and a decreased expression of IP10, interferon inducible T-cell alpha chemoattractant (ITAC), matrix metalloproteinase 10 (MMP10), and beta 4 defensin (DEFB4). These genes reversed expression patterns upon resolution in parallel with the reversal of gingival inflammation. CONCLUSIONS: A relatively small subset (11.9%) of the immune response genes analyzed by array was transiently activated in response to biofilm overgrowth, suggesting a degree of specificity in the transcriptome-expression response. The fact that this same subset demonstrates a reversal in expression patterns during clinical resolution implicates these genes as being critical for maintaining tissue homeostasis at the biofilm-gingival interface. In addition to the immune response pathway as the dominant response theme, new candidate genes and pathways were identified as being selectively modulated in experimental gingivitis, including neural processes, epithelial defenses, angiogenesis, and wound healing.

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.

Pharmacodynamic and pharmacokinetic effects in gingival crevicular fluid from re-dosing during brushing.

The IntelliClean System from Sonicare and Crest combines a rechargeable sonic power toothbrush and a novel liquid toothpaste into one integrated system, providing the opportunity to re-dose with toothpaste during the brushing cycle. The purpose of this study was to investigate cleaning effects from in-mouth re-dosing with toothpaste during the brushing cycle vs conventional bolus dosing. This was a randomized, examiner-blind, six-period, crossover clinical study. Eighteen adult subjects used an experimental integrated system employing either a re-dosing regimen (2 doses at the start of brushing with 1 additional in-mouth dose during the last 30 seconds of brushing [2+1]) or a conventional regimen (2 doses at the start of brushing only [2+0]). Gingival crevicular fluid (GCF) was sampled at the final brushing quadrant from a preselected site in the gingival sulcus using filter strips at baseline and at 4, 15, and 120 minutes postbrushing. Mean change from baseline in the concentrations of total facultative anaerobes (TFAs) and gram-negative anaerobes (GNAs) in the GCF at 120 minutes posttreatment were modeled separately using general linear mixed models. Area under the curve of surfactant (sodium dodecyl sulfate [SDS]) in GCF over 2 hours postbrushing was calculated and modeled using an analysis of variance model. All hypotheses were tested 2-sided at the 5% significance level. Relative to the conventional regimen, the re-dosing (2+1) regimen produced a significantly greater reduction in log10 (TFA colony-forming units [CFU]/microL GCF) after brushing, 0.99+/-0.12 vs 0.65+/-0.12 (mean change +/- standard error), and a significantly greater reduction in log10 (GNA CFU/microL GCF) after brushing, 0.75 +/-0.14 vs 0.45 +/- 0.14. The re-dosing regimen led to significantly more SDS in GCF relative to the conventional regimen over the 2-hour time period. Re-dosing of liquid toothpaste during the brushing cycle with the IntelliClean System leads to a significantly increased cleaning effect, as defined by a reduced bacterial count in GCF, and significantly higher levels of surfactant in the GCF up to 2 hours after the brushing event.

Initial color change and color retention with a hydrogen peroxide bleaching strip.

PURPOSE: A randomized, double blind clinical trial was conducted to evaluate initial color improvement and post-treatment color retention following vital bleaching with a strip-based tooth whitening system. MATERIALS AND METHODS: After balancing for baseline color, 57 healthy adults were randomized to either whitening strips with a 5.3% hydrogen peroxide bleaching gel (Crest Whitestrips) or placebo strips without hydrogen peroxide. Maxillary and mandibular anterior teeth were treated twice daily for 30 minutes each over a 2-week period, and efficacy was measured objectively by comparing digital images of teeth collected at baseline, end-of-treatment (Week 2) and 6 months after treatment (Month 6). RESULTS: The whitening strip group experienced a highly significant (P< 0.0001) reduction in yellow of -2.0 deltab* units versus baseline and -1.95 deltab* units versus placebo, with similar results noted for the other color parameters in the study. Most of the initial color change remained at 6 months post-treatment, with the whitening strip group continuing to demonstrate highly significant (P< 0.0001) improvements in tooth color relative to baseline and placebo. Age was found to significantly contribute to initial color improvement, with younger subjects experiencing a greater initial reduction in yellowness compared to older participants, but not to post-treatment color retention. The whitening strips were well tolerated, with minor tooth sensitivity and oral irritation representing the most common findings during treatment. There were no persistent or new treatment-related adverse events during the 6-month monitoring period.

Overview of a professional tooth-whitening system containing 6.5% hydrogen peroxide whitening strips.

Professionally dispensed, at-home tooth whitening began with 10% carbamide peroxide gels applied to the dentition with custom-made trays. In the 1990s, higher-concentration carbamide peroxide gels were introduced to achieve faster results. Today, 15% and 20% carbamide peroxide gels are commonly used. Recently, a new vital tooth-whitening technique that uses a flexible strip rather than a tray to apply a 5.3% hydrogen peroxide whitening gel was introduced. The new strip-based product was shown to provide whitening equivalent to a 10% carbamide peroxide tray with half the wear time. In addition, the strip eliminated the need to custom fabricate trays for each patient. This article provides an overview of a professionally distributed strip-based whitening system and reviews some of the clinical data which supports the efficacy of the product. This new whitening system includes 42 mandibular and 42 maxillary strips at a higher concentration of 6.5% hydrogen peroxide. In addition, the system also includes a novel dual-action whitening dentifrice to prevent future staining postbleaching and an extrasoft toothbrush. Clinically, the professionally distributed strip-based whitening system provided 96% more efficacy than a popular carbamide plus hydrogen peroxide (equivalent to 10% carbamide peroxide) tray system and 52% more whitening than the 5.3% hydrogen peroxide strip system.