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United European Gastroenterology Journal Oct 2019Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
BACKGROUND
Irritable bowel syndrome (IBS) is highly prevalent and presents a clinical challenge. Gelsectan is a medical device containing xyloglucan (XG), pea protein and tannins (PPT) from grape seed extract, and xylo-oligosaccharides (XOS), which act together to protect and reinforce the intestinal barrier.
OBJECTIVE
The objective of this study is to evaluate the efficacy and safety of XG + PPT + XOS in patients with diarrhoea-predominant IBS (IBS-D).
METHODS
In this double-blind study, 60 patients were randomly assigned to receive XG + PPT + XOS or placebo for 28 days, then crossed over to the alternative treatment. Patients were followed for 60 days.
RESULTS
At Day 28, a significantly higher proportion of patients starting treatment with XG + PPT + XOS than placebo (87 vs 0%; = 0.0019) presented normal stools (Bristol Stool Form Scale type 3-4). At Day 56, a significantly higher proportion of patients who crossed over to XG + PPT + XOS than placebo (93% vs 23%; = 0.0001) presented normal stools. In the group allocated to receive XG + PPT + XOS after placebo, benefits of XG + PPT + XOS were maintained during follow-up. Subjective assessments of abdominal pain, bloating, quality of life and general health indicated significant improvement with XG + PPT + XOS over placebo. There were no related adverse events.
CONCLUSION
XG + PPT + XOS effectively controlled diarrhoea and alleviated clinical symptoms in patients with IBS-D, and was well tolerated.
Topics: Abdominal Pain; Adult; Cross-Over Studies; Demulcents; Diarrhea; Double-Blind Method; Drug Therapy, Combination; Equipment Design; Female; Follow-Up Studies; Glucans; Humans; Irritable Bowel Syndrome; Male; Oligosaccharides; Pea Proteins; Placebos; Prebiotics; Prevalence; Quality of Life; Romania; Safety; Treatment Outcome; Xylans
PubMed: 31662866
DOI: 10.1177/2050640619862721 -
PloS One 2019Stroke patients are at high risk of developing pneumonia, which is major cause of post-stroke mortality. Proton pump inhibitors and H2 receptor antagonists are...
Stroke patients are at high risk of developing pneumonia, which is major cause of post-stroke mortality. Proton pump inhibitors and H2 receptor antagonists are anti-ulcer drugs, which may predispose to the development of pneumonia by suppression of the gastric acid with bactericidal activity. Unlike proton pump inhibitors and H2 receptor antagonists, mucoprotective agents have gastroprotective effects with no or less anti-acid property. We aimed to investigate effects of the acid-suppressive medications (proton pump inhibitors and H2 receptor antagonists) and mucoprotective agents on risk for post-stroke pneumonia using the National Health Insurance Service-National Sample Cohort in Korea. This retrospective cohort study included 8,319 patients with acute ischemic stroke. Use of proton pump inhibitors, H2 receptor antagonists, and mucoprotective agents (rebamipide, teprenone, irsogladine, ecabet, polaprezinc, sofalcone, sucralfate, and misoprostol) after stroke were determined based on the prescription records, which were treated as time-dependent variables. Primary outcome was the development of post-stroke pneumonia. During the mean follow-up period of 3.95 years after stroke, 2,035 (24.5%) patients had pneumonia. In the multivariate time-dependent Cox regression analyses (adjusted hazard ratio [95% confidence interval]), there was significantly increased risk for pneumonia with use of proton pump inhibitors (1.56 [1.24-1.96]) and H2 receptor antagonists (1.40 [1.25-1.58]). In contrast to the proton pump inhibitors and H2 receptor antagonists, use of mucoprotective agents did not significantly increase the risk for pneumonia (0.89 [0.78-1.01]). In conclusion, the treatment with proton pump inhibitors and H2 receptor antagonists was associated with increased risk for pneumonia in stroke patients. Clinicians should use caution in prescribing the acid-suppressive medications for the stroke patients at great risk for pneumonia.
Topics: Aged; Anti-Ulcer Agents; Cohort Studies; Demulcents; Female; Gastric Acid; Histamine H2 Antagonists; Humans; Male; Middle Aged; Pneumonia; Proton Pump Inhibitors; Republic of Korea; Retrospective Studies; Risk Factors; Stroke
PubMed: 31067267
DOI: 10.1371/journal.pone.0216750 -
Optometry and Vision Science : Official... Mar 2019Microblepharon exfoliation improved eyelid signs and tear film characteristics after a single in-office treatment in symptomatic contact lens wearers. (Randomized Controlled Trial)
Randomized Controlled Trial
SIGNIFICANCE
Microblepharon exfoliation improved eyelid signs and tear film characteristics after a single in-office treatment in symptomatic contact lens wearers.
PURPOSE
The purpose of this study was to assess the effect of two eyelid hygiene treatments-microblepharon exfoliation and a hypoallergenic foam cleanser (LidHygenix)-on clinical signs of the eyelids, meibomian glands, and tear film in contact lens discomfort.
METHODS
A randomized, interventional, unmasked, crossover trial was conducted on 30 experienced daily-wear soft contact lens wearers. Assessment of clinical signs of the eyelid margin, meibomian gland morphology and secretion, and tear film biophysical properties was performed (baseline 1), and participants were randomly assigned to receive one of the two treatments (microblepharon exfoliation or foam cleansing using LidHygenix) as a single in-office procedure. Symptoms were evaluated using the Contact Lens Dry Eye Questionnaire-8 immediately after treatment, and assessment of all the study variables was repeated at the follow-up visit 7 to 10 days after treatment. After 28 to 30 days of washout, participants returned for reassessment of the study variables (baseline 2) and were crossed over to receive the alternate treatment. Follow-up was repeated 7 to 10 days after the second treatment.
RESULTS
Seven to 10 days after treatment with microblepharon exfoliation, symptomatic wearers showed significant improvement in anterior blepharitis (mean difference, 0.60; P = .04), lid wiper staining (0.50; P = .06), and lid-parallel conjunctival folds (0.68, P = .02) along with orifice capping (median difference, 0.65; P < .001), foam (0.90; P < .001), secretion volume (0.69; P < .001), quality (0.74; P < .001), and expressibility (0.49; P = .002), which were also clinically significant changes. However, in tear properties, significant improvements were observed in tear volume (LidHygenix, -1.25 mm; microblepharon exfoliation, -1.62 mm), break-up time (-0.14 seconds; -0.14 seconds), tear evaporation rate without contact lenses (21.52 g m h; 45.43 g m h), and lipid layer thickness (-20.61 nm; -25.13 nm) after both treatments but in symptomatic lens wearers only (P < .05).
CONCLUSIONS
Microblepharon exfoliation improved eyelid signs and tear film characteristics in symptomatic contact lens wearers after a single in-office treatment.
Topics: Adolescent; Adult; Conjunctiva; Contact Lenses, Hydrophilic; Cross-Over Studies; Demulcents; Dry Eye Syndromes; Eyelid Diseases; Female; Humans; Hygiene; Male; Meibomian Gland Dysfunction; Ophthalmic Solutions; Prospective Studies; Surveys and Questionnaires; Young Adult
PubMed: 30801507
DOI: 10.1097/OPX.0000000000001354 -
Journal of Gastroenterology and... Dec 2018Currently, it is still unclear whether adding a mucoprotective agent to a proton pump inhibitor (PPI) results in better outcomes compared with using a PPI alone in...
BACKGROUND
Currently, it is still unclear whether adding a mucoprotective agent to a proton pump inhibitor (PPI) results in better outcomes compared with using a PPI alone in patients with post-gastric endoscopic submucosal dissection (ESD) ulcers. This study aimed to examine the efficacy of PPI alone versus combination treatment in healing of post-gastric ESD ulcers, as well as on delayed bleeding and amount of blood transfused.
METHODS
A systematic search of MEDLINE, EMBASE, Cochrane, and ISI Web of knowledge databases, up until May 2017, for randomized trials comparing PPI alone versus PPI plus a mucoprotective drug in achieving ulcer healing in patients undergoing gastric ESD was performed. The primary outcome is scarring stage on endoscopic assessment at 4 or 8 weeks after gastric ESD.
RESULTS
From an initial 3071 citations, eight articles (n = 953 lesions from 934 patients) were analyzed. Patients receiving combination treatment achieved a scarring stage significantly more often than those on a PPIs alone at 4 or 8 weeks after ESD, (risk ratio = 1.36, 95% CI; 1.06-1.75). No study reported amount of blood transfused. There were no significant between treatment-group differences in terms of delayed bleeding (risk ratio = 0.58, 95% CI; 0.17-1.99). Neither location of ulcer nor Helicobacter pylori infection was related to ulcer scarring stage.
CONCLUSION
The limited evidences suggested combination treatment may be more effective in accelerating the process of ulcer healing in patients undergoing gastric ESD than the use of PPI alone, but does not appear to alter delayed bleeding risk.
Topics: Aged; Blood Transfusion; Demulcents; Drug Therapy, Combination; Endoscopic Mucosal Resection; Female; Gastroscopy; Humans; Male; Middle Aged; Peptic Ulcer Hemorrhage; Protective Factors; Proton Pump Inhibitors; Risk Factors; Stomach Ulcer; Time Factors; Treatment Outcome; Wound Healing
PubMed: 29870582
DOI: 10.1111/jgh.14305 -
Expert Review of Gastroenterology &... Jan 2018The intestinal barrier controls the absorption of nutrients and water whilst helping to prevent the entry of toxins and pathogenic micro-organisms from the lumen into... (Review)
Review
The intestinal barrier controls the absorption of nutrients and water whilst helping to prevent the entry of toxins and pathogenic micro-organisms from the lumen into the tissues. Deficiencies in the barrier are associated with various gastrointestinal and extra digestive disorders. Areas covered: This review provides an overview of the relationship between increased intestinal permeability and disease, and considers the role of mucosal protectants (mucoprotectants) in restoring normal intestinal barrier function, with a particular focus on diarrheal disorders. Expert commentary: Impairment of the intestinal barrier characterizes a variety of diseases, and there is ongoing interest in the development of pharmacological approaches targeting the reduction of intestinal permeability. These include corticosteroids, aminosalicylates and anti-tumor necrosis factor-α (TNF-α), which act by reducing inflammation; probiotics, which modulate the production of mucin and epithelial tight junction proteins; and mucoprotectants, which form a protective film over the epithelium. Recently, preclinical and clinical data highlight, the ability of new mucoprotectants, such as gelatin tannate and xyloglucan, to protect the intestinal mucosa and to exert anti-diarrheal effects. In the future the ability of these substances to enhance the intestinal barrier may extend their use in the management of a variety of gastro-intestinal diseases associated with 'leaky gut'.
Topics: Demulcents; Diarrhea; Gelatin; Glucans; Humans; Inflammatory Bowel Diseases; Intestinal Absorption; Intestinal Mucosa; Permeability; Tannins; Treatment Outcome; Xylans
PubMed: 28946778
DOI: 10.1080/17474124.2018.1378573 -
Drug Development and Industrial Pharmacy Jan 2018Research to measure the chemical characterization of alginate rafts for good raft performance and ascertain how formulation can affect chemical parameters.
OBJECTIVE
Research to measure the chemical characterization of alginate rafts for good raft performance and ascertain how formulation can affect chemical parameters.
SIGNIFICANCE
A selection of alginate formulations was investigated all claiming to be proficient raft formers with significance between products established and ranked.
METHODS
Procedures were selected which demonstrated the chemical characterization allowing rafts to effectively impede the reflux into the esophagus or in severe cases to be refluxed preferentially into the esophagus and exert a demulcent effect, with focus of current research on methods which complement previous studies centered on physical properties. The alginate content was analyzed by a newly developed HPLC method. Methods were used to determine the neutralization profile and the acid neutralization within the raft determined along with how raft structure affects neutralization.
RESULTS
Alginate content of Gaviscon Double Action (GDA) within the raft was significantly superior (p < .0001) to all competitor products. The two products with the highest raft acid neutralization capacity were GDA and Rennie Duo, the latter product not being a raft former. Raft structure was key and GDA had the right level of porosity to allow for longer duration of neutralization.
CONCLUSION
Alginate formulations require three chemical reactions to take place simultaneously: transformation to alginic acid, sodium carbonate reacting to form carbon dioxide, calcium releasing free calcium ions to bind with alginic acid providing strength to raft formation. GDA was significantly superior (p <.0001) to all other comparators.
Topics: Alginates; Aluminum Hydroxide; Antacids; Calcium Carbonate; Carbonates; Drug Combinations; Electric Impedance; Esophagus; Gastroesophageal Reflux; Glucuronic Acid; Hexuronic Acids; Humans; Magnesium; Silicic Acid; Sodium Bicarbonate
PubMed: 28836872
DOI: 10.1080/03639045.2017.1371737 -
Biomaterials Jul 2017Transplanted islets suffer hypoxic stress, which leads to nonspecific inflammation. This is the major cause of islet graft failure during the early stage of intrahepatic...
Transplanted islets suffer hypoxic stress, which leads to nonspecific inflammation. This is the major cause of islet graft failure during the early stage of intrahepatic islet transplantation. Although bilirubin has shown potent anti-oxidative and anti-inflammatory functions, its clinical applications have been limited due to its insolubility and short half-life. To overcome this problem, novel amphiphilic bilirubin nanoparticles are designed. Hydrophilic poly(ethylene glycol) (PEG) is conjugated to the hydrophobic bilirubin molecule. Then, the PEG-bilirubin conjugates form nanoparticles via self-assembly, i.e., so-called to BRNPs. BRNPs can protect islet cells not only from chemically induced oxidative stress by scavenging reactive oxygen species molecules, but also from activated macrophages by suppressing cytokine release. Importantly, in vivo experiments demonstrate that BRNP treatment can dramatically and significantly prolong islet graft survival compared to bilirubin treatment. In addition, immunohistochemical analysis shows BRNPs have potent anti-oxidative and anti-inflammatory capabilities. Collectively, novel BRNPs can be a new potent remedy for successful islet transplantation.
Topics: Animals; Bilirubin; Demulcents; Diabetes Mellitus; Inflammation; Islets of Langerhans; Male; Mice; Mice, Inbred BALB C; Nanoparticles; Polyethylene Glycols; RAW 264.7 Cells; Rats; Rats, Sprague-Dawley; Reactive Oxygen Species; Transplantation, Heterologous
PubMed: 28448818
DOI: 10.1016/j.biomaterials.2017.04.029 -
Molecules (Basel, Switzerland) Apr 2017(Linn.) is a medicinal plant from China and Korea that has been traditionally used to control inflammation, to stop bedwetting and as a mouthwash in cases of bleeding...
(Linn.) is a medicinal plant from China and Korea that has been traditionally used to control inflammation, to stop bedwetting and as a mouthwash in cases of bleeding gums. Its flowers are employed medicinally for their emollient, demulcent and diuretic properties, which make them useful in chest complaints. Furthermore, a flower extract decoction is used to improve blood circulation, for the treatment of constipation, dysmenorrhoea, haemorrhages, etc. However, the possible mechanisms of the immune-stimulatory effect remains to be elucidated. Therefore, we investigated the role of flower (ARF) extracts in the immune-stimulatory effect of macrophages and the underlying mechanisms of action. ARF water extract (ARFW) could dose-dependently increase NO production and cytokines (IL-6 and TNF-α). We also found that ARFW significantly increased the expression of iNOS and COX-2 proteins in RAW264.7 cells. Consistent with these results, MAPK protein (JNK, ERK, p38) expression levels were induced after treatment with ARFW. Additionally, ARFW showed a marked increase in the phosphorylation level of IκBα and subsequent IκBα degradation allowing NF-κB nuclear translocation. These results suggest that the immune-stimulatory effect of flower extracts is mediated through the translocation of NF-κB p65 subunit into the nucleus from the cytoplasm and subsequent activation of pro-inflammatory cytokines (IL-6 and TNF-α) and other mediators (iNOS and COX-2), which occurs mainly through MAPK signalling pathway. Thus, we suggest that ARFW could be considered as a potential therapeutic agent useful in the development of immune-stimulatory compounds.
Topics: Adjuvants, Immunologic; Althaea; Animals; Cell Survival; Cyclooxygenase 2; Drug Evaluation, Preclinical; Flowers; Lipopolysaccharides; MAP Kinase Signaling System; Mice; Nitric Oxide Synthase Type II; Plant Extracts; RAW 264.7 Cells
PubMed: 28441343
DOI: 10.3390/molecules22050679 -
Evidence-based Complementary and... 2017(moghat) is used as a nutritive and demulcent drink. This study was performed to investigate the antiproliferative effects of moghat root extract (MRE) and its...
(moghat) is used as a nutritive and demulcent drink. This study was performed to investigate the antiproliferative effects of moghat root extract (MRE) and its apoptotic mechanism in hepatocellular carcinoma (HCC) cells, HepG2 and Hep3B. MTT assay, morphological changes, apoptosis enzyme linked immunosorbent assay, caspase and apoptotic activation, flow cytometry, and immunoblot analysis were employed. The IC of MRE for HepG2 (910 ± 6 g/ml) and for Hep3B (1510 ± 5 g/ml) induced significant growth-inhibitory effects against HCC cells, with no cytotoxic effect on normal hepatocytes. MRE treatment induced apoptotic effects to HepG2 cells in a caspase-dependent manner and via upregulating p53/p21 and PCNA. The upregulation of p21 was controlled by p53 expression in HepG2 but not in Hep3B despite upregulation of Bax protein in both cell lines. Interestingly, p21 may be a remarkable switch to G1 arrest in HepG2 cells, but not in Hep3B cells. In addition, Fas- and mitochondria-mediated pathways were found to be involved in MRE-induced apoptosis in Hep3B cells. The GC-MS analysis of MRE revealed two major constituents of pharmaceutical importance: the flavonoid apigenin (17.04%) and the terpenoid squalene (11.32%). The data presented in this paper introduces as a promising nontoxic herb with therapeutic potential for HCC. To the authors' knowledge, the present study provides the first report on the anticancer activity of MRE on HCC cells.
PubMed: 28421122
DOI: 10.1155/2017/7218562 -
Romanian Journal of Morphology and... 2016The skin burns are an issue of great interest and seriousness in the public health domain, by their destructive features. Natural medicinal products are extensively used...
UNLABELLED
The skin burns are an issue of great interest and seriousness in the public health domain, by their destructive features. Natural medicinal products are extensively used from ancient times, in ethnopharmacology, for the treatment of skin injuries (burns, wounds, ulcerations) due to the local modulation of the cellular response, in terms of emollient, demulcent, astringent, anti-inflammatory, antimicrobial, epithelizing, wound-healing, immunomodulatory and antioxidant effects.
AIM
Histological and immunohistochemical assessment of antiseptic, anti-inflammatory, astringent and cicatrizing effects of Scutellariae (altissimae, galericulatae, hastifoliae) herba extracts administered in the form of 20% topical preparations (cold-creams), in experimental model of third degree skin burns, at Wistar rats. Caffeic acid and chlorogenic acid derivatives were identified in all herbal samples. The most active was the cold-cream with 20% Scutellariae hastifoliae herba soft extract, promoting the neoangiogenesis vessels and granulation tissue. Flavonoids, tannins and polyphenol carboxylic acids are the main active principles responsible for antiseptic, anti-inflammatory, astringent and cicatrizing effects of herbal extracts. Beeswax, from the formulation of cold-creams, acts as emollient, epithelizing, cicatrizing and biostimulator.
Topics: Animals; Biological Products; Burns; Immunohistochemistry; Models, Theoretical; Plant Extracts; Rats; Rats, Wistar; Scutellaria; Skin
PubMed: 28174795
DOI: No ID Found