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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 -
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 -
Journal of Ethnopharmacology Dec 2015Ocimum sanctum, commonly known as Holy Basil or Tulsi has been used in Ayurveda as a demulcent, stimulant, expectorant; in the treatment of bronchitis, skin infections,...
Evaluation of subacute toxicity of methanolic/aqueous preparation of aerial parts of O. sanctum in Wistar rats: Clinical, haematological, biochemical and histopathological studies.
ETHNOPHARMACOLOGICAL RELEVANCE
Ocimum sanctum, commonly known as Holy Basil or Tulsi has been used in Ayurveda as a demulcent, stimulant, expectorant; in the treatment of bronchitis, skin infections, malaria, diarrhoea, dysentery, arthritis, gastric and inflammatory disorders. We have previously shown that methanolic/aqueous extract of O. sanctum did not induce genotoxicity and other toxic effects in acute oral toxicity study. In the present report, we have performed sub-acute toxicity of methanolic/aqueous preparation of O. sanctum in Wistar rats to evaluate whether it induced any chronic toxic effects.
MATERIALS AND METHODS
In subacute toxicity study, animals received O. sanctum extract (OSE) by oral gavage at the doses of 250, 500 and 1000 mg/kg/day (n=5/group/sex) for 28 days. At the end of the study, the animals were sacrificed and evaluated for the effect of OSE on clinical, haematological, biochemical and histopathological parameters.
RESULTS
The rats treated with OSE did not show any change in body weight, food and water consumption, motor activity, sensory reactivity and foot splay measurements. There were no significant changes in haematological, pathological and biochemical parameters; and histopathology of tissues (liver, kidney, spleen, heart, and testis/ovary) among rats of either sex. OSE at a dose of 1000 mg/kg showed significant increase of Mean corpuscular hemoglobin (MCH) (19.8 ± 0.8; 18.7 ± 0.5) and mean corpuscular hemoglobin concentration (MCHC) (41.8 ± 1.1; 39.3 ± 0.7) in male and female rats in comparison to their respective controls (MCH: 17.7 ± 0.3; 17.4 ± 0.3; MCHC: 37.8 ± 0.5; 36.1 ± 0.2). Urine parameters (appearance, blood, nitrate, leucocyte, glucose, ketone, pH, protein and specific gravity) in both the male and female rats were comparable to their respective controls. In addition, no changes were observed in the vital organs of rats at macroscopic and microscopic levels.
CONCLUSIONS
Our results showed that oral administration of OSE was not toxic to male and female Wistar rats upto the highest dose tested, thereby suggesting its clinical usefulness.
Topics: Animals; Erythrocyte Indices; Female; Male; Methanol; Ocimum; Plant Components, Aerial; Plant Extracts; Rats, Wistar; Solvents; Toxicity Tests, Subacute
PubMed: 26456329
DOI: 10.1016/j.jep.2015.10.015 -
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 -
Journal of Cystic Fibrosis : Official... Jan 2016To assess whether long-term inhalation with hypertonic saline is able to halt the progression of mild CF lung disease, we analysed longitudinal data of lung clearance...
To assess whether long-term inhalation with hypertonic saline is able to halt the progression of mild CF lung disease, we analysed longitudinal data of lung clearance index (LCI) and spirometry. A total of 34 patients with mild lung disease (FEV1 ≥ 70% of predicted) had at least one LCI result before and ≥2 LCI measurements after start of hypertonic saline (HS) therapy. After a mean follow-up of 39.7 (SD 7.4) months after starting HS, LCI improved significantly from 7.89 (SD 1.35) at baseline to 6.96 (SD 1.03), and 19/34 patients had a normal LCI value at the last measurement. No decrease in mean FEV1 was observed. Thus, ventilation inhomogeneity can improve in patients with mild lung disease.
Topics: Administration, Inhalation; Adolescent; Adult; Child; Cystic Fibrosis; Demulcents; Disease Progression; Female; Humans; Male; Mucociliary Clearance; Patient Acuity; Respiratory Function Tests; Saline Solution, Hypertonic; Time; Treatment Outcome
PubMed: 26190829
DOI: 10.1016/j.jcf.2015.06.009 -
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 -
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 -
Journal of Endodontics Aug 2014This study describes a case of eye burn induced by sodium hypochlorite used as an irrigant during root canal preparation.
INTRODUCTION
This study describes a case of eye burn induced by sodium hypochlorite used as an irrigant during root canal preparation.
METHODS
A 24-year-old female endodontist was using an operating microscope during root canal treatment, and as the root canal was irrigated, the pressure cannula burst and the irrigant (3.5% sodium hypochlorite) came into direct contact with her left eye. She immediately sought ophthalmologic emergency care for pain, redness of the cornea, burning sensation, photophobia, intraocular pressure, and blurred vision. The initial treatment consisted of washing the eye with saline solution and administering analgesic and anti-inflammatory (steroid) medications. One day after the accident, a topical demulcent and hydroxypropyl medication were applied to the eyeball (conjunctiva), the eye was bandaged for 24 hours, and rest was prescribed for 7 days. Eight days later, a corneal ulcer was diagnosed, and antibiotic and anti-inflammatory (steroid) medications were used.
RESULTS
Vision was restored without any sequelae 4 weeks after the accident. The endodontist was instructed to apply control medication (Lagricel; Sophia SA, Caracas, Venezuela) for 3 months and to return for ophthalmologic follow-up every 6 months.
CONCLUSIONS
Sodium hypochlorite is an effective antibacterial irrigant indicated for the treatment of root canal infections. The tissue cytotoxicity highlights the need to inform the patient of the risk factors of accidents and enhance care with individual protection equipment for the patient and the professional during clinical procedures.
Topics: Accidents, Occupational; Analgesics, Non-Narcotic; Anti-Bacterial Agents; Anti-Inflammatory Agents; Burns, Chemical; Corneal Ulcer; Cyclopentolate; Dentists; Eye Burns; Female; Fluoroquinolones; Follow-Up Studies; Humans; Ibuprofen; Loteprednol Etabonate; Microsurgery; Moxifloxacin; Mydriatics; Occupational Diseases; Prednisolone; Root Canal Irrigants; Root Canal Preparation; Sodium Hypochlorite; Therapeutic Irrigation; Young Adult
PubMed: 25069948
DOI: 10.1016/j.joen.2014.01.026 -
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 -
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