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BMJ Open Jan 2017To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To investigate the efficacy and safety of CS1002, an over-the-counter cough treatment containing diphenhydramine, ammonium chloride and levomenthol in a cocoa-based demulcent.
DESIGN
A multicentre, randomised, parallel group, controlled, single-blinded study in participants with acute upper respiratory tract infection-associated cough.
SETTING
4 general practitioner (GP) surgeries and 14 pharmacies in the UK.
PARTICIPANTS
Participants aged ≥18 years who self-referred to a GP or pharmacist with acute cough of <7 days' duration. Participant inclusion criterion was cough severity ≥60 mm on a 0-100 mm visual analogue scale (VAS). Exclusion criteria included current smokers or history of smoking within the past 12 months (including e-cigarettes). 163 participants were randomised to the study (mean participant age 38 years, 57% females).
INTERVENTIONS
Participants were randomised to CS1002 (Unicough) or simple linctus (SL), a widely used cough treatment, and treatment duration was 7 days or until resolution of cough.
MAIN OUTCOME MEASURES
The primary analysis was intention-to-treat (157 participants) and comprised cough severity assessed using a VAS after 3 days' treatment (prespecified primary end point at day 4). Cough frequency, sleep disruption, health status (Leicester Cough Questionnaire (LCQ-acute)) and cough resolution were also assessed.
RESULTS
At day 4 (primary end point), the adjusted mean difference (95% CI) in cough severity VAS between CS1002 and SL was -5.9 mm (-14.4 to 2.7), p=0.18. At the end of the study (day 7) the mean difference in cough severity VAS was -4.2 mm (-12.2 to 3.9), p=0.31. CS1002 was associated with a greater reduction in cough sleep disruption (mean difference -11.6 mm (-20.6 to 2.7), p=0.01) and cough frequency (mean difference -8.1 mm (-16.2 to 0.1), p=0.05) compared with SL. There was greater improvement in LCQ-acute quality of life scores with CS1002 compared with SL: mean difference (95% CI) 1.2 (0.05 to 2.36), p=0.04 after 5 days' treatment. More participants prematurely stopped treatment due to cough improvement in the CS1002 group (24.4%) compared with SL (10.7%; p=0.02). Adverse events (AEs) were comparable between CS1002 (20.5%) and SL (27.6%) and largely related to the study indication. 6 participants (7%) in the CS1002 group reduced the dose of medication due to drowsiness/tiredness, which subsequently resolved. These events were not reported by participants as AEs.
CONCLUSIONS
Although the primary end point was not achieved, CS1002 was associated with greater reductions in cough frequency, sleep disruption and improved health status compared with SL.
TRIAL REGISTRATION NUMBER
EudraCT number 2014-004255-31.
Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Ammonium Chloride; Antipruritics; Cacao; Cough; Demulcents; Diphenhydramine; Drug Combinations; Female; Histamine H1 Antagonists; Humans; Male; Menthol; Middle Aged; Nonprescription Drugs; Severity of Illness Index; Single-Blind Method; Treatment Outcome; United Kingdom; Young Adult
PubMed: 28093442
DOI: 10.1136/bmjopen-2016-014112 -
Pharmacognosy Magazine Aug 2014Astragalus hamosus L. (Fabaceae) is used in herbal medicine as emollient, demulcent, phrodisiac, diuretic, laxative, and good for inflammation, ulcers, and leukoderma....
BACKGROUND
Astragalus hamosus L. (Fabaceae) is used in herbal medicine as emollient, demulcent, phrodisiac, diuretic, laxative, and good for inflammation, ulcers, and leukoderma. It is useful in treating irritation of the mucous membranes, nervous affections, and catarrh.
OBJECTIVE
Rhamnocitrin 4-β-D-galactopyranoside (RGP), isolated from A. hamosus, was investigated for its possible protective effect on different models of toxicity in vitro on sub-cellular and cellular level.
MATERIALS AND METHODS
The effects of RGP were evaluated on isolated rat brain synaptosomes, prepared by Percoll reagent and on rat hepatocytes, isolated by two-stepped collagenase perfusion.
RESULTS
In synaptosomes, RGP had statistically significant protective effect, similar to those of silymarin, on 6-hydroxy (OH)-dopamine-induced oxidative stress. These results correlate with literature data about protective effects of kempferol and rhamnocitrin on oxidative damage in rat pheochromocytoma PC12 cells. In rat hepatocytes, we investigate the effect of RGP on two models of liver toxicity: Bendamustine and cyclophosphamide. In these models, the compound had statistically significant cytoprotective and antioxidant activity, similar to those of silymarin.
CONCLUSION
According to these results, we can suggest that such cytoprotective effect of RGP might be due to an influence on bendamustine and cyclophosphamide metabolism in rat hepatocytes. In isolated rat hepatocytes, in combination with bendamustine and cyclophosphamide and in 6-OH-dopamine-induced oxidative stress in isolated rat synaptosomes, RGP, isolated from A. hamosus, was effective protector and antioxidant. The effects were closed to those of flavonoid silymarin-the classical hepatoprotector and antioxidant.
PubMed: 25298664
DOI: 10.4103/0973-1296.139778 -
Ear, Nose, & Throat Journal Dec 2023To determine the efficacy of flurbiprofen 8.75 mg lozenges for patients with laboratory-confirmed streptococcal pharyngitis both before and concomitant with antibiotics. (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To determine the efficacy of flurbiprofen 8.75 mg lozenges for patients with laboratory-confirmed streptococcal pharyngitis both before and concomitant with antibiotics.
METHODS
This post hoc analysis comprised adult participants from 2 earlier randomized, double-blind, placebo-controlled studies evaluating the analgesic efficacy of flurbiprofen 8.75 mg lozenges in acute pharyngitis. Throat swabs were obtained to diagnose streptococcal infection. Prior to and 2 hours after each dose of study medication (flurbiprofen or placebo lozenges), patients rated 3 symptoms of acute pharyngitis (sore throat pain, difficulty swallowing, and swollen throat) using visual analogue scales. Appropriate antibiotic treatment was initiated when culture results were reported. Mean changes in each pharyngeal symptom were compared over the immediate 24 hours before and during the initial 24 hours of antibiotic treatment.
RESULTS
Twenty-four patients provided both preantibiotic and concomitant antibiotic efficacy outcomes. Relief of throat pain was 93% greater in the flurbiprofen group than in the placebo group before antibiotic coadministration and 84% greater than placebo during antibiotic administration (both P < .05). Relief of difficulty swallowing was 71% greater in the flurbiprofen group than in the placebo before antibiotic administration (P = .16) and 107% greater during concomitant antibiotic administration (P = .04). Relief of the sensation of throat swelling was 295% greater with flurbiprofen than placebo before antibiotic administration (P = .008) and 70% greater during concomitant antibiotic administration (P = .06). For placebo-treated patients, relief from throat pain and difficulty swallowing were similar before and during antibiotic treatment (P > .05), indicating no benefit with antibiotic administration for these symptoms. No treatment-related discontinuations or serious adverse events were reported.
CONCLUSIONS
Irrespective of antibiotic use, flurbiprofen 8.75 mg lozenges provide well-tolerated, effective relief of pharyngeal symptoms in patients with streptococcal infection. In the 24 hours after administration, antibiotics provide no relief of throat pain or difficulty swallowing beyond the topical demulcent effects of placebo lozenges.
Topics: Adult; Humans; Flurbiprofen; Anti-Bacterial Agents; Treatment Outcome; Pharyngitis; Pain; Streptococcal Infections; Deglutition Disorders; Double-Blind Method
PubMed: 34261371
DOI: 10.1177/01455613211025754 -
Biological Trace Element Research Jun 2022Plantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a...
The Level of Cadmium Impurities in Traditional Herbal Medicinal Products with Plantago lanceolata L., folium (Ribwort Plantain Leaves) Available in Polish Pharmacies - Comprehensive Toxicological Risk Assessment Including Regulatory Point of View and ICH Q3D Elemental Impurities Guideline.
Plantago lanceolata L., folium (ribwort plantain) is an active pharmaceutical ingredient in traditional herbal medicinal products (THMP) available in pharmacies as a demulcent for the symptomatic treatment of oral or pharyngeal irritations and associated dry cough. This kind of THMP is widely applied among the European population; however, recently, voices have been heard in the public about alleged cadmium impurities. The idea of our study was a comprehensive risk assessment of the Cd impurity exposure and its effect on human health. Our assessment strategy was based on regulatory aspects (raw results versus limits set by FAO/WHO for herbal medicines) and toxicological risk assessment approach based on ICH Q3D guideline for elemental impurities in final pharmaceutical products. The cadmium was determined by electrothermal atomization atomic absorption spectrometry based on our previously described methodology. Obtained results show that all analysed THMP with P. lanceolata L., folium available in the Polish pharmacies contain cadmium impurities, but at a very low level (ranged 0.73 - 20.6 μg/L). The content of Cd in a single dose (ng/single dose) is also very low and is not a threat to patients. The estimated maximum daily exposure (ng/day) of Cd based on the 'worst-case scenario' (maximum concentrations by oral administration) meets the standards of ICH Q3D guideline (all results were below oral permitted daily exposure; PDE for Cd, i.e. < 5.0 µg/day). It can be concluded that all analysed samples of THMP with P. lanceolata L., folium should not represent any health hazard to the patients due to cadmium levels. To the best of our knowledge, this is the first study about Cd impurity level in THMP with P. lanceolata L., folium (ribwort plantain leaves) available in European pharmacies.
Topics: Cadmium; Humans; Pharmaceutical Preparations; Pharmacies; Plant Leaves; Plantago; Plants, Medicinal; Poland; Risk Assessment; Vegetables
PubMed: 34373979
DOI: 10.1007/s12011-021-02861-5 -
Pediatric Reports Jun 2013Respiratory tract infections are an important health problem because of high incidence and economic costs. The World Health Organization identifies honey as a potential...
Respiratory tract infections are an important health problem because of high incidence and economic costs. The World Health Organization identifies honey as a potential demulcent treatment for cough. The aim of this study is to determine: i) patient public perceptions towards a proposed randomized controlled trial (RCT) comparing the effects of honey to placebo for treatment of cough in children; ii) potential participation rates for proposed trial; iii) whether age and gender of parent or child impacts on proposed cough assessment tools. Forty adult participants with children age 1-6 years presenting with an upper respiratory tract infection were enrolled. They underwent a structured interview regarding the proposed trial and assessed their child's cough using two validated questionnaires. Eighty-eight percent of those recruited were willing to participate in the proposed trial. The two independently validated cough scores correlated well. A relationship between age and gender of child or parent with cough assessment score was not found. We conclude that a RCT to determine the effects of honey versus placebo is feasible. The public find the outcome measures and trial design acceptable.
PubMed: 23904963
DOI: 10.4081/pr.2013.e8 -
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 -
Clinical Ophthalmology (Auckland, N.Z.) 2015To determine whether agents which are purportedly capable of inducing encystment of Acanthamoeba can recapitulate the signal when tested in differing formulations.
PURPOSE
To determine whether agents which are purportedly capable of inducing encystment of Acanthamoeba can recapitulate the signal when tested in differing formulations.
METHODS
In accordance with the International Standard ISO 19045, Acanthamoeba castellanii ATCC 50370 trophozoites were cultured in antibiotic-free axenic medium, treated with test solutions, and encystment rates plus viability were measured via bright field and fluorescent microscopy. Test solutions included phosphate-buffered saline (PBS), borate-buffered saline, biguanide- and hydrogen peroxide (H2O2)-based biocides, propylene glycol (PG) and povidone (POV) ophthalmic demulcents, and one-step H2O2-based contact lens disinfection systems.
RESULTS
Only PBS solutions with 0.25 ppm polyaminopropyl biguanide (PAPB) and increasing concentrations of PG and POV stimulated A. castellanii encystment in a dose-dependent manner, whereas PBS solutions containing 3% H2O2 and increasing concentrations of PG and POV did not stimulate encystment. Borate-buffered saline and PBS/citrate solutions containing PG also did not stimulate encystment. In addition, no encystment was observed after 24 hours, 7 days, or 14 days of exposures of trophozoites to one-step H2O2 contact lens disinfection products or related solutions.
CONCLUSION
The lack of any encystment observed when trophozoites were treated with existing or new one-step H2O2 contact lens care products, as well as when trophozoites were exposed to various related test solutions, confirms that Acanthamoeba encystment is a complex process which depends upon simultaneous contributions of multiple factors including buffers, biocides, and demulcents.
PubMed: 26508829
DOI: 10.2147/OPTH.S88199 -
Journal of Ocular Pharmacology and... Oct 2015Hydroxypropyl guar (HPG) and hyaluronic acid (HA) have been individually shown to improve dry eye symptoms. The purpose of this in vitro study was to assess the...
PURPOSE
Hydroxypropyl guar (HPG) and hyaluronic acid (HA) have been individually shown to improve dry eye symptoms. The purpose of this in vitro study was to assess the potential benefits of a new lubricant eye drop formulation containing the demulcents propylene glycol and polyethylene glycol and an HA/HPG dual polymer in models of the human corneal epithelium.
METHODS
Cultured human corneal epithelial or corneal-limbal epithelial cells were treated with the HA/HPG dual-polymer formulation or single-polymer formulations containing either HPG or HA. Desiccation protection by cell hydration and surface retention was assessed using cell viability assays. Sodium fluorescein permeability, transepithelial resistance, and cell viability assays were conducted using pretreated cells exposed to a surfactant/detergent insult to evaluate cell and cell barrier protection. Surface lubricity was assessed in tribological experiments of pericardium-pericardium friction.
RESULTS
Hydration protection against desiccation and protection by surface retention were significantly greater with the HA/HPG formulation versus HPG or HA (P<0.001) alone and with HPG versus HA (P ≤ 0.016). Fluorescein permeability and transepithelial resistance assays demonstrated significantly better cell and barrier protection from surfactant insult with HA/HPG versus the single-polymer formulations (P ≤ 0.01). After insult, there were markedly more viable cells evident with HA/HPG compared with HPG or HA alone. HA/HPG and HPG reduced surface friction to a greater extent than HA (P ≤ 0.02) and maintained lubricity after the formulations were rinsed away.
CONCLUSIONS
HA/HPG provided effective hydration and lubrication and demonstrated prolonged retention of effect. HA/HPG may potentially promote desiccation protection and retention on the ocular surface.
Topics: Cell Survival; Cornea; Cross-Over Studies; Drug Evaluation, Preclinical; Dry Eye Syndromes; Epithelium, Corneal; Humans; Hyaluronic Acid; Lubricant Eye Drops; Polyethylene Glycols; Polysaccharides; Propylene Glycol; Surface-Active Agents; Treatment Outcome; Viscosupplements
PubMed: 26067908
DOI: 10.1089/jop.2014.0164 -
Giornale Italiano Di Nefrologia :... Feb 2016The medicinal use of herbs is a principal achievement of human ingenuity. The most renowned doctors of antiquity: Hippocrates, Dioscorides, Theophrastus, Pliny the Elder...
The medicinal use of herbs is a principal achievement of human ingenuity. The most renowned doctors of antiquity: Hippocrates, Dioscorides, Theophrastus, Pliny the Elder and Galen mentioned herbs in their works. The first printed herbal was published in Mainz in 1485. Outstanding scientists e.g. Otto Brunfels, Hieronymus Bock, Leonard Fuchs and Andreo Mattiola published herbals in the 16th century. Polish doctors also contributed to the development of herbal treatment. The first work: Of Herbs and their Potency by Stefan Falimirz, published in 1534, triggered other publications in the 16th century, the age of herbals. In 1542, Hieronymus Spiczynski published a herbal: Of Local and Overseas Herbs and their Potency. Then, in 1568, Marcin Siennik published his: Herbal, which is the Description of Local and Overseas Herbs, their Potency and Application. In 1595, Marcin of Urzedow published: The Polish Herbal, the Books of Herbs. Completed in mid-16th century, it was only published 22 years after his death. The last work discussed is Herbal Known in Latin as published in 1613 by Simon Syrenius a graduate of Ingolstadt and Padua universities and lecturer at the Academy of Krakow. The work was Europes most complete elaboration on herbal treatment. The herbs described in the herbals worked as diuretics, demulcents, analgesics, relaxants and preventives of kidney stones. Published in Polish, they are still to be found in Poland. All the works presented herein are held by the Library of the Seminary of Wloclawek, and the Ossolinski National Institute in Wroclaw.
Topics: History, 16th Century; History, 17th Century; Humans; Phytotherapy; Poland; Urologic Diseases
PubMed: 26913886
DOI: No ID Found -
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