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1.
J Sci Food Agric ; 101(3): 863-870, 2021 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33433910

RESUMEN

BACKGROUND: Protecting the intestinal mucosa from being destroyed helps reduce the inflammation caused by acute pancreatitis (AP). In this study, whether okra pectin (OP) could attenuate the inflammation of AP through protecting the intestinal barrier was investigated. RESULTS: OP was obtained from crude okra pectin (COP) through the purification by DEAE cellulose 52 column. Supplementation with OP or COP in advance reduced the severity of AP, as revealed by lower serum amylase and lipase levels, abated pancreatic edema, attenuated myeloperoxidase activity and pancreas histology. OP or COP inhibited the production of pancreatic proinflammatory cytokines, including tumor necrosis factor-α and interleukin-6. In addition, the upregulation of AP-related proteins including ZO-1, occludin, the antibacterial peptide-defensin-1 (DEFB1) and cathelicidin-related antimicrobial peptide (CRAMP), as well as the histological examination of colon injuries, demonstrated that OP or COP provision could effectively maintain intestinal barrier function. Ultimately, dietary OP or COP supplementation could inhibit AP-induced intestinal inflammation. For the above, the effect of OP was better than COP. CONCLUSION: Dietary OP supplementation could be considered as a preventive method that effectively interferes with intestinal damage and attenuates inflammatory responses trigged by AP. © 2020 Society of Chemical Industry.


Asunto(s)
Abelmoschus/química , Ceruletida/efectos adversos , Mucosa Intestinal/efectos de los fármacos , Pancreatitis/tratamiento farmacológico , Pectinas/administración & dosificación , Extractos Vegetales/administración & dosificación , Animales , Citocinas/genética , Citocinas/inmunología , Frutas/química , Humanos , Mucosa Intestinal/inmunología , Masculino , Ratones , Ocludina/genética , Ocludina/inmunología , Pancreatitis/inducido químicamente , Pancreatitis/genética , Pancreatitis/inmunología , Pectinas/química , Extractos Vegetales/química , Factor de Necrosis Tumoral alfa/genética , Factor de Necrosis Tumoral alfa/inmunología , Proteína de la Zonula Occludens-1/genética , Proteína de la Zonula Occludens-1/inmunología
2.
Cochrane Database Syst Rev ; 1: CD013011, 2021 01 18.
Artículo en Inglés | MEDLINE | ID: mdl-33460048

RESUMEN

BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is characterized by symptoms of inattention or impulsivity or both, and hyperactivity, which affect children, adolescents, and adults. In some countries, methylphenidate is the first option to treat adults with moderate or severe ADHD. However, evidence on the efficacy and adverse events of immediate-release (IR) methylphenidate in the treatment of ADHD in adults is limited and controversial. OBJECTIVES: To evaluate the efficacy and harms (adverse events) of IR methylphenidate for treating ADHD in adults. SEARCH METHODS: In January 2020, we searched CENTRAL, MEDLINE, Embase, eight additional databases and three trial registers. We also searched internal reports on the European Medicines Agency and the US Food and Drug Administration websites. We checked citations of included trials to identify additional trials not captured by the electronic searches. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing IR methylphenidate, at any dose, with placebo or other pharmacological interventions (including extended-release formulations of methylphenidate) for ADHD in adults. Primary outcomes comprised changes in the symptoms of ADHD (efficacy) and harms. Secondary outcomes included changes in the clinical impression of severity and improvement, level of functioning, depression, anxiety and quality of life. Outcomes could have been rated by investigators or participants. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently on the characteristics of the trials, participants, interventions; outcomes and financial conflict of interests. We resolved disagreements by discussion or consulting a third review author. We obtained additional, unpublished information from the authors of one included trial that had reported efficacy data in a graph. We calculated mean differences (MDs) or standardized MDs (SMDs) with 95% confidence intervals (CIs) for continuous data reported on the same or different scales, respectively. We summarized dichotomous variables as risk ratios (RRs) with 95% CI. MAIN RESULTS: We included 10 trials published between 2001 and 2016 involving 497 adults with ADHD. Three trials were conducted in Europe and one in Argentina; the remaining trials did not report their location. The RCTs compared IR methylphenidate with placebo, an osmotic-release oral system (OROS) of methylphenidate (an extended-release formulation), an extended-release formulation of bupropion, lithium, and Pycnogenol® (maritime pine bark extract). Participants comprised outpatients, inpatients in addiction treatment, and adults willing to attend an intensive outpatient program for cocaine dependence. The duration of the follow-up ranged from 6 to 18 weeks. IR methylphenidate versus placebo We found very low-certainty evidence that, compared with placebo, IR methylphenidate may reduce symptoms of ADHD when measured with investigator-rated scales (MD -20.70, 95% CI -23.97 to -17.43; 1 trial, 146 participants; end scores; Adult ADHD Investigator Symptom Report Scale (AISRS), scored from 0 to 54), but the evidence is uncertain. The effect of IR methylphenidate on ADHD symptoms when measured with participant-rated scales was moderate, but the certainty of the evidence is very low (SMD -0.59, 95% CI -1.25 to 0.06; I2 = 69%; 2 trials, 138 participants; end scores). There is very low-certainty evidence that, compared with placebo, IR methylphenidate may reduce the clinical impression of the severity of ADHD symptoms (MD -0.57, 95% CI -0.85 to -0.28; 2 trials, 139 participants; I2 = 0%; change and end scores; Clinical Global Impression (CGI)-Severity scale (scored from 1 (very much improved) to 7 (very much worse))). There is low-certainty evidence that, compared with placebo, IR methylphenidate may slightly impact the clinical impression of an improvement in symptoms of ADHD (MD -0.94, 95% CI -1.37 to -0.51; 1 trial, 49 participants; end scores; CGI-Improvement scale (scored from 1 (very much improved) to 7 (very much worse))). There is no clear evidence of an effect on anxiety (MD -0.20, 95% CI -4.84 to 4.44; 1 trial, 19 participants; change scores; Hamilton Anxiety Scale (HAM-A; scored from 0 to 56); very low-certainty evidence) or depression (MD 2.80, 95% CI -0.09 to 5.69; 1 trial, 19 participants; change scores; Hamilton Depression Scale (HAM-D; scored from 0 to 52); very low-certainty evidence) in analyses comparing IR methylphenidate with placebo. IR methylphenidate versus lithium Compared with lithium, it is uncertain whether IR methylphenidate increases or decreases symptoms of ADHD (MD 0.60, 95% CI -3.11 to 4.31; 1 trial, 46 participants; end scores; Conners' Adult ADHD Rating Scale (scored from 0 to 198); very low-certainty evidence); anxiety (MD -0.80, 95% CI -4.49 to 2.89; 1 trial, 46 participants; end scores; HAM-A; very low-certainty evidence); or depression (MD -1.20, 95% CI -3.81 to 1.41, 1 trial, 46 participants; end scores; HAM-D scale; very low-certainty evidence). None of the included trials assessed participant-rated changes in symptoms of ADHD, or clinical impression of severity or improvement in participants treated with IR methylphenidate compared with lithium. Adverse events were poorly assessed and reported. We rated all trials at high risk of bias due to selective outcome reporting of harms and masking of outcome assessors (failure to blind outcome assessor to measure adverse events). Overall, four trials with 203 participants who received IR methylphenidate and 141 participants who received placebo described the occurrence of harms. The use of IR methylphenidate in these trials increased the risk of gastrointestinal complications (RR 1.96, 95% CI 1.13 to 2.95) and loss of appetite (RR 1.77, 95% CI 1.06 to 2.96). Cardiovascular adverse events were reported inconsistently, preventing a comprehensive analysis. One trial comparing IR methylphenidate to lithium reported five and nine adverse events, respectively. We considered four trials to have notable concerns of vested interests influencing the evidence, and authors from two trials omitted information related to the sources of funding and conflicts of interest. AUTHORS' CONCLUSIONS: We found no certain evidence that IR methylphenidate compared with placebo or lithium can reduce symptoms of ADHD in adults (low- and very low-certainty evidence). Adults treated with IR methylphenidate are at increased risk of gastrointestinal and metabolic-related harms compared with placebo. Clinicians should consider whether it is appropriate to prescribe IR methylphenidate, given its limited efficacy and increased risk of harms. Future RCTs should explore the long-term efficacy and risks of IR methylphenidate, and the influence of conflicts of interest on reported effects.


Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/tratamiento farmacológico , Estimulantes del Sistema Nervioso Central/administración & dosificación , Metilfenidato/administración & dosificación , Adulto , Antidepresivos de Segunda Generación/administración & dosificación , Ansiedad/tratamiento farmacológico , Sesgo , Bupropión/administración & dosificación , Estimulantes del Sistema Nervioso Central/efectos adversos , Depresión/tratamiento farmacológico , Sistemas de Liberación de Medicamentos , Femenino , Flavonoides/administración & dosificación , Humanos , Compuestos de Litio/administración & dosificación , Masculino , Metilfenidato/efectos adversos , Persona de Mediana Edad , Placebos/administración & dosificación , Extractos Vegetales/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Adulto Joven
3.
Phytomedicine ; 80: 153382, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33113506

RESUMEN

BACKGROUND: Although gastroprotective drugs have been used for peptic ulcer disease prevention and treatment, side effects have been observed. Finding a safe and effective treatment strategy is important. PURPOSE: Edible Trichodesma khasianum (T. khasianum) Clarke leaves are considered to protect against peptic ulcers. However, scientific evidence of this effect of T. khasianum Clarke leaves remains limited. STUDY DESIGN/METHODS: In this study, we aimed to evaluate the effect of T. khasianum Clarke leaves on ethanol-induced gastric injury and gut microbiota using RAW 264.7 cells, RGM-1 cells, and BALB/c mice, respectively. RESULT: The rosmarinic acid was identified as the major component of T. khasianum Clarke leaves extracted by 80% ethanol (80EETC). The results showed that 80EETC suppressed inflammatory mediator protein levels in LPS-induced RAW 264.7 cells. Additionally, heat shock protein expression, antiapoptotic ability, and wound healing migration capability were increased by 80EETC pretreatment in RGM-1 cells with the ethanol-induced injury. Remarkably, pretreatment with 80EETC (150 mg/kg b.w.) promoted gastric mucosal healing by decreasing oxidative stress, inflammatory response, proapoptotic protein expression, and gastric mucosa damage in ethanol-induced gastric injury in mice. Crucially, no liver or kidney toxicities were observed by 80EETC oral gavage. Moreover, 80EETC increased gut microbiota diversity and short-chain fatty acid production. CONCLUSION: Our results illustrated the remarkable gastroprotective effect by 80EETC treatment in vitro and in vivo. These findings are the first to demonstrate the powerful protective effect of T. khasianum Clarke leaves against gastric mucosal injury development.


Asunto(s)
Boraginaceae/química , Cinamatos/farmacología , Depsidos/farmacología , Mucosa Gástrica/efectos de los fármacos , Extractos Vegetales/farmacología , Sustancias Protectoras/farmacología , Administración Oral , Animales , Antiinflamatorios no Esteroideos/química , Antiinflamatorios no Esteroideos/farmacología , Antioxidantes/metabolismo , Cinamatos/análisis , Depsidos/análisis , Etanol/toxicidad , Ácidos Grasos Volátiles/metabolismo , Mucosa Gástrica/metabolismo , Mucosa Gástrica/patología , Microbioma Gastrointestinal/efectos de los fármacos , Masculino , Ratones , Ratones Endogámicos BALB C , Estrés Oxidativo/efectos de los fármacos , Úlcera Péptica/prevención & control , Extractos Vegetales/administración & dosificación , Extractos Vegetales/química , Hojas de la Planta/química , Sustancias Protectoras/química , Células RAW 264.7
4.
Food Chem ; 334: 127586, 2021 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-32707364

RESUMEN

It is unknown whether intestinal absorption of acylated anthocyanins occurs in their intact or metabolized form. In this study, with the aid of matrix-assisted laser desorption/ionization mass spectrometry (MALDI-MS) imaging, intestinal absorption of acylated anthocyanins was visually investigated. Anthocyanin extracts from purple carrots were orally administered to Sprague-Dawley rats. Acylated cyanidins were absorbed into portal and circulating blood systems in their intact form, and aglycon; cyanidin 3-O-(6-O-feruloyl-ß-d-glucopyranosyl)-(1 â†’ 6)-[ß-d-xylopyranosyl-(1 â†’ 2)]-ß-d-galactopyranoside (Cy3XFGG), and showed a high absorption of 39.3 ± 0.1 pmol/mL-plasma at 60 min after administration. MALDI-MS imaging analysis of the rat jejunum membranes showed that an organic anion transporting polypeptide (OATP) transporter was involved in Cy3XFGG transport, while deacylated anthocyanins were incorporated through both the glucose transporter 2 and OATP routes. In conclusion, acylated anthocyanin, Cy3XFGG, can be absorbed in its intact form through intestinal OATP.


Asunto(s)
Antocianinas/análisis , Antocianinas/farmacocinética , Imagen Molecular/métodos , Espectrometría de Masa por Láser de Matriz Asistida de Ionización Desorción/métodos , Acilación , Administración Oral , Animales , Antocianinas/administración & dosificación , Color , Daucus carota/química , Absorción Intestinal/efectos de los fármacos , Yeyuno/efectos de los fármacos , Yeyuno/metabolismo , Masculino , Transportadores de Anión Orgánico/metabolismo , Extractos Vegetales/administración & dosificación , Extractos Vegetales/farmacocinética , Ratas Sprague-Dawley
5.
Food Chem ; 337: 127746, 2021 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-32795856

RESUMEN

Pressurized liquid extraction was performed to obtain a phytocomplex from Lippia citriodora leaves rich in bioactive compounds. The extract was loaded in phospholipid vesicles to improve its protective effect against oxidative stress in the intestine. The phytochemicals were identified and quantified by HPLC-ESI-TOF-MS. The extract was incorporated in liposomes and penetration enhancer-containing vesicles (PEVs) modified with glucidex, a dextrin, and a biopolymer obtained from Chimaera monstrosa. The PEVs were smaller than liposomes (~150 vs 370 nm) and more stable, according to accelerated aging tests. The integrity of the vesicles in acidic or neutral pH and high ionic strength or in milk whey was assessed. The cytocompatibility of the formulations and their ability to protect Caco-2 cells against oxidative stress were confirmed in vitro and compared with two commercial extracts of L. citriodora. The results confirmed the suitability of formulations to be used in functional foods to protect the intestine from oxidative stress.


Asunto(s)
Enfermedades Gastrointestinales/tratamiento farmacológico , Lippia/química , Fosfolípidos/química , Extractos Vegetales/química , Extractos Vegetales/farmacología , Presión , Células CACO-2 , Composición de Medicamentos , Enfermedades Gastrointestinales/metabolismo , Humanos , Liposomas , Estrés Oxidativo/efectos de los fármacos , Extractos Vegetales/administración & dosificación , Extractos Vegetales/uso terapéutico , Hojas de la Planta/química
6.
Gene ; 764: 145083, 2021 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-32860902

RESUMEN

BACKGROUND/AIMS: Melamine (ML) is a common food adulterant and contaminant. Moringa oleifera is a well-known medicinal plant with many beneficial biological properties. This study investigated the possible prophylactic and therapeutic activity of an ethanolic extract of M. oleifera (MEE) against ML-induced hepatorenal damage. METHOD: Fifty male Sprague Dawley rats were orally administered distilled water, MEE (800 mg/kg bw), ML (700 mg/kg bw), MEE/ML (prophylactically) or MEE+ML (therapeutically). Hepatic aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphate (ALP) in serum were measured. Serum total bilirubin, direct bilirubin, indirect bilirubin, protein, albumin, and globulin contents were also assayed, and urea and creatinine levels were determined. Moreover, antioxidant enzyme activity of glutathione peroxidase (GPx) and catalase (CAT) in serum levels were quantified. Complementary histological and histochemical evaluation of renal and hepatic tissues was conducted, and expression of oxidative stress (GPx and CAT) and apoptosis-related genes, p53 and Bcl-2, in hepatic tissue were assessed. In parallel, transcriptional expression of inflammation and renal injury-related genes, including kidney injury molecule 1 (KIM-1), metallopeptidase inhibitor 1 (TIMP1), and tumor necrosis factor alpha (TNF-α) in the kidney tissue were determined. RESULTS: ML caused significant increases in serum levels of ALT, AST, ALP, total bilirubin, direct bilirubin, indirect bilirubin, urea, and creatinine. Further, ML treated rats showed significant reductions in serum levels of protein, albumin, globulin, GPx, and CAT. Distinct histopathological damage and disturbances in glycogen and DNA content in hepatic and renal tissues of ML treated rats were observed. KIM-1, TIMP-1, and TNF-α gene expression was significantly upregulated in kidney tissue. Also, GPx, CAT, and Bcl-2 genes were significantly downregulated, and p53 was significantly upregulated in liver tissue after ML treatment. MEE significantly counteracted the ML-induced hepatorenal damage primarily for co-exposed rats. CONCLUSION: MEE could be an effective therapeutic supplement for treatment of ML-induced hepato-renal damage, probably via modulating oxidative stress, apoptosis, and inflammation.


Asunto(s)
Enfermedad Hepática Inducida por Sustancias y Drogas/prevención & control , Moringa oleifera/química , Extractos Vegetales/administración & dosificación , Insuficiencia Renal/prevención & control , Triazinas/toxicidad , Administración Oral , Animales , Apoptosis/efectos de los fármacos , Apoptosis/genética , Apoptosis/inmunología , Moléculas de Adhesión Celular/metabolismo , Enfermedad Hepática Inducida por Sustancias y Drogas/sangre , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Modelos Animales de Enfermedad , Contaminantes Ambientales/toxicidad , Etanol/química , Contaminación de Alimentos , Regulación de la Expresión Génica/efectos de los fármacos , Humanos , Mediadores de Inflamación/sangre , Mediadores de Inflamación/metabolismo , Masculino , Estrés Oxidativo/efectos de los fármacos , Estrés Oxidativo/genética , Estrés Oxidativo/inmunología , Extractos Vegetales/química , Extractos Vegetales/aislamiento & purificación , Ratas , Insuficiencia Renal/sangre , Insuficiencia Renal/inducido químicamente , Inhibidor Tisular de Metaloproteinasa-1/metabolismo , Triazinas/administración & dosificación
7.
Medicine (Baltimore) ; 99(52): e23868, 2020 Dec 24.
Artículo en Inglés | MEDLINE | ID: mdl-33350782

RESUMEN

BACKGROUND: Diarrhea-predominant irritable bowel syndrome (IBS-D) is a kind of functional gastrointestinal disorder with obscure pathogenesis, and exploration about differential gene expression and cell heterogeneity of T lymphocytes in peripheral blood in IBS-D patients still remains unknown. Clinicians tend to use symptomatic treatment, but the efficacy is unstable and symptoms are prone to relapse. Traditional Chinese Medicine (TCM) is used frequently in IBS-D with stable and lower adverse effects. Tong-Xie-An-Chang Decoction (TXACD) has been proven to be effective in the treatment of IBS-D. However, the underlying therapeutic mechanism remains unclear. This trial aims to evaluate the clinical efficacy and safety of TXACD in IBS-D and elucidate the gene-level mechanism of IBS-D and therapeutic targets of TXACD based on single-cell sequencing technology. METHODS/DESIGN: This is a randomized controlled, double-blind, double-simulation clinical trial in which 72 eligible participants with IBS-D and TCM syndrome of liver depression and spleen deficiency will be randomly allocated in the ratio of 1:1 to two groups: the experimental group and the control group. The experimental group receives Tong-Xie-An-Chang Decoction (TXACD) and Pinaverium bromide tablets placebo; the control group receives pinaverium bromide tablets and TXACD placebo. Each group will be treated for 4 weeks. The primary outcome: the rate of IBS-Symptom Severity Score (IBS-SSS). The secondary outcomes: TCM syndrome score, adequate relief and IBS-Quality of Life Questionnaire (IBS-QOL). Mechanistic outcome is the single-cell sequencing profiling of the T lymphocytes in peripheral blood from IBS-D participants before and after the treatment and healthy individuals. DISCUSSION: This trial will prove the efficacy and safety of TXACD with high-quality evidence and provide a comprehensive perspective on the molecular mechanism of IBS-D by single-cell sequencing profiling, which makes us pinpoint specific biomarkers of IBS-D and therapeutic targets of TXACD.


Asunto(s)
Diarrea , Medicamentos Herbarios Chinos , Síndrome del Colon Irritable , Calidad de Vida , Adulto , Mezclas Complejas/administración & dosificación , Mezclas Complejas/efectos adversos , Diarrea/tratamiento farmacológico , Diarrea/etiología , Diarrea/psicología , Método Doble Ciego , Monitoreo de Drogas/métodos , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Femenino , Perfilación de la Expresión Génica/métodos , Humanos , Síndrome del Colon Irritable/sangre , Síndrome del Colon Irritable/complicaciones , Síndrome del Colon Irritable/tratamiento farmacológico , Síndrome del Colon Irritable/fisiopatología , Masculino , Medicina China Tradicional/métodos , Extractos Vegetales/administración & dosificación , Extractos Vegetales/efectos adversos , Evaluación de Síntomas , Linfocitos T , Resultado del Tratamiento
8.
Medicine (Baltimore) ; 99(51): e23523, 2020 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-33371074

RESUMEN

BACKGROUND: Radiation dermatitis is a common complication in patients with nasopharyngeal carcinoma (NPC) when treated with radiotherapy. Plant extracts have good effects on the prevention of radiation dermatitis in patients with NPC when treated with radiotherapy. However, there is insufficient comparison among the currently used plant extracts. Therefore, the purpose of this study was to explore the efficacy of different plant extracts in the prevention of radiation dermatitis in patients with NPC by Bayesian network meta-analysis. METHODS: We searched Chinese and English databases to collect all randomized controlled trials (RCT) of plant extracts for the prevention of radiation dermatitis in NPC patients who underwent radiotherapy up to October 2020. Two researchers then independently screened articles, extracted data and evaluated the quality selected literatures. All data were processed by Stata 14.0 and WinBUGS V.1.4.3. RESULTS: We applied Bayesian statistical model for network meta-analysis, ranked the effects of various plant extracts, and adopted GRADE method to explain the results. CONCLUSION: Our study is expected to provide high-quality evidence-based medicine advice for the prevention of radiation dermatitis in patients suffering from NPC undergoing radiotherapy. ETHICS AND DISSEMINATION: Ethical approval was not required for this study. The systematic review will be published in a peer-reviewed journal, presented at conferences, and will be shared on social media platforms. This review would be disseminated in a peer-reviewed journal or conference presentations. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/6SV45.


Asunto(s)
Carcinoma Nasofaríngeo/radioterapia , Neoplasias Nasofaríngeas/radioterapia , Extractos Vegetales/administración & dosificación , Radiodermatitis/prevención & control , Teorema de Bayes , Humanos , Metaanálisis en Red , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación
9.
BMJ Case Rep ; 13(12)2020 Dec 22.
Artículo en Inglés | MEDLINE | ID: mdl-33370999

RESUMEN

Juvenile respiratory laryngeal papillomatosis is a subset of a larger clinical entity of recurrent respiratory papillomatosis. It is characterised by the development of recurrent papillomata in the vocal folds. Human papillomavirus types 6 and 11 has been implicated to be the most common strain of virus associated with the formation of laryngeal papilloma. Clinical diagnosis is based on typical appearance of warty lesion on endoscopy. Surgery is the primary line of management along with adjuvant therapy like antiviral drugs and immunomodulators. Thuja occidentalis is a tree native to North America whose leaves and leaf oil have antiviral, antibacterial and antifungal properties. It has been widely used for the treatment of condylomatous skin lesions and warts. Here we discuss the outcome of thuja as an adjuvant therapy in the treatment of laryngeal papillomatosis in an 8-year-old child.


Asunto(s)
Neoplasias Laríngeas/terapia , Recurrencia Local de Neoplasia/terapia , Papiloma/terapia , Extractos Vegetales/administración & dosificación , Thuja/química , Traqueostomía , Quimioterapia Adyuvante/métodos , Niño , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Humanos , Neoplasias Laríngeas/diagnóstico , Neoplasias Laríngeas/patología , Laringoscopía , Laringe/diagnóstico por imagen , Laringe/patología , Laringe/cirugía , Masculino , Recurrencia Local de Neoplasia/diagnóstico , Papiloma/diagnóstico , Papiloma/patología , Reoperación , Resultado del Tratamiento
10.
Medicine (Baltimore) ; 99(51): e23367, 2020 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-33371067

RESUMEN

BACKGROUND: Recent experimental and clinical studies have suggested that Hwangryunhaedok-tang (HHT), an herbal formula, could improve the lipid profiles in patients with dyslipidemia. This systematic review aimed to evaluate the effectiveness and safety of HHT monotherapy or adjunctive HHT therapy with conventional lipid-lowering drugs in managing dyslipidemia. METHODS: Twelve English, Korean, Chinese, and Japanese databases were comprehensively searched from their inception to January 2020. Randomized controlled trials (RCTs) using HHT monotherapy or adjunctive HHT therapy for dyslipidemic patients were included. The primary outcome was the low-density lipoprotein cholesterol (LDL-C) level. Descriptive analyses of participant details, interventions, and outcomes were conducted and where appropriate data were available, a meta-analysis was performed and presented as a risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). The risk of bias was assessed using the Cochrane risk of bias tool and the quality of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: Nine RCTs with 536 participants were included. In comparison with lipid-lowering drugs alone, HHT as an adjunctive therapy to lipid-lowering drugs or as a monotherapy showed significantly superior (MD -1.15 mmol/L, 95% CI -1.25 to -1.05) or inferior results (MD 0.23 mmol/L, 95% CI 0.09 to 0.38), respectively, for LDL-C levels. The incidence of adverse events was significantly lower when HHT was used in addition to lipid-lowering drugs, in comparison to that with lipid-lowering drugs alone. No serious adverse events were reported in the HHT group. Most included studies showed a high risk of performance bias and the quality of evidence was rated generally "low" because of the high risk of bias and inconsistency or imprecision of the meta-analysis results. CONCLUSION: Current evidence suggests that HHT may be beneficial for patients with dyslipidemia and may reduce the adverse events associated with lipid-lowering drugs. However, due to the high risk of bias of the included studies and low quality of evidence for the main findings, no definitive conclusion could be reached. Further rigorous, high-quality, and placebo-controlled RCTs should be conducted to assess the efficacy of HHT. TRIAL REGISTRATION NUMBER: PROSPERO CRD42020164563.


Asunto(s)
Medicamentos Herbarios Chinos/uso terapéutico , Dislipidemias/tratamiento farmacológico , Hipolipemiantes/uso terapéutico , Extractos Vegetales/uso terapéutico , Glucemia , Presión Sanguínea , LDL-Colesterol/efectos de los fármacos , Comorbilidad , Quimioterapia Combinada , Medicamentos Herbarios Chinos/administración & dosificación , Medicamentos Herbarios Chinos/efectos adversos , Humanos , Hipolipemiantes/administración & dosificación , Hipolipemiantes/efectos adversos , Extractos Vegetales/administración & dosificación , Extractos Vegetales/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto
11.
Trials ; 21(1): 943, 2020 Nov 23.
Artículo en Inglés | MEDLINE | ID: mdl-33225970

RESUMEN

OBJECTIVES: Primary Objective • To assess the efficacy of herbal extracts in boosting innate immunity of patients with COVID-19 infection. Secondary Objectives • To assess the efficacy of herbal extracts in restoring respiratory health • To assess the efficacy of Cap. IP in early recovery of patients and decline in viral load • To assess the safety of herbal extracts TRIAL DESIGN: This is a single centre, randomized, 2-arm, parallel group, double blind, 1:1 ratio, controlled, exploratory trial with a study period of 30 days from the day of enrolment. PARTICIPANTS: Patients attending the COVID treatment centre at Yashwantrao Chavan Memorial Hospital, Nehrunagar, Pimpri, Pune, India were screened for their participation in the study. Patients who were known COVID-19 positive (with positive RT-PCR), eligible and willing were enrolled in the study. INTERVENTION AND COMPARATOR: The intervention in the trial has a background in 'Ayurved'. Intervention Arm: Two capsules, Investigational Product (IP) - 1 - 400mg and Investigational Product - 2 - 450mg, containing herbal extracts (a blend of water and CO2 extracts) of Shunthi (Zingiber officinale (Ginger), Vidanga (Embelia ribes), Yashtimadhu (Glycyrrhiza glabra), Haritaki (Terminalia chebula), Guduchi (Tinospora cordifolia), Shatavari (Asparagus racemosus), Aamalaki (Emblica officinalis), Pippali (Piper longum) and calcined Zinc, Shankha bhasma. Placebo Arm: Edible starch ~ 450 mg. The look and feel of IP and of Placebo boxes were very similar. Patients are to take two capsules (one each of IP-1 and IP-2) twice a day for 15 days, and from the 16th day, one capsule of IP-2 twice a day up-to day 30. Capsules are to be administered orally with plain water. The IP is to be taken with all other concomitant medicines prescribed by the treating physician/doctor. The dose of each component in the IP is very safe to administer. The investigational products are registered products with the Indian Government and have been used for more than 6 months in various health conditions but not for COVID-19. MAIN OUTCOMES: Primary Outcome: Efficacy of the herbal extracts in COVID 19 positive patients (in declining viral load: time-point: 4 days and early recovery) Secondary Outcomes: Efficacy of the herbal extracts as an immune-modulator - TH1, TH2, Th17, IL6, NK Cells and CD markers; Immunoglobulin IGG (Serum); Immunoglobulin IGM (Serum) - at 30 days. Efficacy of the investigational product in reducing sequela of the disease Safety analysis (Liver Function Test and Kidney Function Test) including serious allergic reaction of: rash, itching/swelling, severe dizziness, trouble breathing. RANDOMISATION: An alphanumeric coded set of IP/Placebo containers will be used. Participants will be automatically randomized to two groups in the ratio 1:1. BLINDING (MASKING): Participants, caregivers and investigators were blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of more than 60 and up to 75 patients were to be enrolled in the study into the two groups, considering drop-outs. 72 were enrolled with 37 into the intervention group and 35 into the placebo group. TRIAL STATUS: Protocol number: CoviQuest-01 Protocol version number: 1.2 Protocol Date: 1st July 2020 The recruitment period is completed for the trial. Date of 1st patient enrolment was 11th Aug 2020 and the last patient was enrolled on 3rd of September 2020. This is to state that it was a late submission from authors for publication of the protocol to the BMC, after enrolment in the study was over. Last Participant's last follow-up is scheduled on 5th October 2020 TRIAL REGISTRATION: The trial was prospectively registered with the CTRI (Clinical Trial Registry of India). Registration number is CTRI/2020/07/026570 . Registered on 14 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Betacoronavirus/efectos de los fármacos , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/inmunología , Inmunidad Innata/efectos de los fármacos , Extractos Vegetales/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/inmunología , Administración Oral , Betacoronavirus/genética , Estudios de Casos y Controles , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Humanos , India/epidemiología , Pandemias , Placebos/administración & dosificación , Extractos Vegetales/administración & dosificación , Neumonía Viral/epidemiología , Neumonía Viral/virología , Seguridad , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Carga Viral/efectos de los fármacos
12.
PLoS One ; 15(10): e0233938, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33095803

RESUMEN

BACKGROUND: Onion is one of the most commonly used plants in the traditional medicine for the treatment of various diseases. We recently demonstrated the anti-inflammatory properties of onion bulb extract (OBE) in reducing colitis severity in mice when administered at the same time of colitis induction. However, whether onion can reverse established colitis or even prevent its development has not been investigated. HYPOTHESIS: To test 1. whether OBE can reduce colitis severity when given either before (preventative approach) or after (treatment approach) colitis induction and if so, 2. what are the mechanisms by which onion can achieve these effects. METHODS: Colitis was induced by dextran sulfate sodium (DSS) administration using treatment and preventative approaches. The severity of the inflammation was determined by the gross and histological assessments. The colonic level/activity of pro-inflammatory molecules and immune cell markers was assessed by immunofluorescence and western blotting analysis. In vitro neutrophil superoxide release and survival was assessed by chemilumenecense and Annexin-V/7AAD assays respectively. RESULTS: OBE treatment significantly reduced colitis severity in both approaches, the colonic expression/activity profile of pro-inflammatory molecules, inhibited WKYMVm-induced superoxide release, and increased spontaneous apoptosis of neutrophils in vitro. CONCLUSIONS: OBE can be used as an effective option in the prevention and/or the treatment of established colitis.


Asunto(s)
Antiinflamatorios/administración & dosificación , Colitis/tratamiento farmacológico , Cebollas/química , Extractos Vegetales/administración & dosificación , Animales , Antiinflamatorios/química , Antiinflamatorios/farmacología , Colitis/inducido químicamente , Colitis/metabolismo , Ciclooxigenasa 2/metabolismo , Sulfato de Dextran/efectos adversos , Modelos Animales de Enfermedad , Regulación de la Expresión Génica/efectos de los fármacos , Ratones , Ratones Endogámicos BALB C , Fosforilación , Extractos Vegetales/química , Extractos Vegetales/farmacología , Proteínas Proto-Oncogénicas c-akt/metabolismo , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
13.
Medicine (Baltimore) ; 99(44): e22729, 2020 Oct 30.
Artículo en Inglés | MEDLINE | ID: mdl-33126310

RESUMEN

BACKGROUND/AIM: Proton pump inhibitor (PPI) alone is not satisfactory for the treatment of gastroesophageal reflux disease (GERD). Therefore, we investigated the efficacy of DA-5204 (Stillen 2X, 90 mg of Artemisia asiatica 95% ethanol extract per tablet) and PPI combination therapy on GERD in comparison to PPI alone. METHODS: This randomized, double-blind, placebo-controlled study randomly assigned 70 patients with endoscopically proven esophageal mucosal injury (Los Angeles classification grade A or B) into 2 groups: pantoprazole 40 mg once daily with DA-5204 twice daily (DA-5204 group) or pantoprazole 40 mg once daily with placebo twice daily (placebo group) for 4 weeks. The primary endpoint was endoscopic healing rate. The secondary endpoint was sufficient relief (≥50% reduction) of symptoms using GERD Questionnaire. RESULTS: Final analyses included 29 patients with the DA-5204 group and 30 patients with the placebo group. At weeks 4, there was no significant difference in the endoscopic healing rate between the 2 groups (DA-5204 vs placebo; 96.6% vs 93.3%; P = 1.000). However, the rate of residual minimal change was significantly lower in the DA-5204 group (5/28, 17.9%) than in the placebo group (17/28, 60.7%) (P < .001). The rates of symptom relief were not different between the DA-5204 group and the placebo group (all P > .05). CONCLUSION: Combined therapy with PPI and DA-5204 has no additional effect on the endoscopic healing rate compared to PPI alone. However, it may be beneficial in resolving minimal change.


Asunto(s)
Artemisia , Esofagitis/tratamiento farmacológico , Reflujo Gastroesofágico/tratamiento farmacológico , Extractos Vegetales/administración & dosificación , Inhibidores de la Bomba de Protones/administración & dosificación , Adulto , Anciano , Método Doble Ciego , Quimioterapia Combinada , Endoscopía del Sistema Digestivo , Esofagitis/etiología , Femenino , Reflujo Gastroesofágico/complicaciones , Humanos , Masculino , Persona de Mediana Edad , Pantoprazol/administración & dosificación , Proyectos Piloto , Resultado del Tratamiento , Adulto Joven
14.
Anim Sci J ; 91(1): e13458, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-32996238

RESUMEN

This study investigates the effect of the addition of plant-derived extracts (control, garlic extract or a combination of carvacrol, thymol, cinnamic aldehyde and eugenol oils extracts) to pig feedstuff and the reduction in salt content (NaCl or a mixture 60:40 sodium chloride:potassium lactate) on some physicochemical characteristics and consumer acceptability of dry-fermented sausages. Six different batches were formulated. The pH, color, lipid oxidation, and microbial counts were measured, and a consumer home test was performed. Both the use of a plant-derived extract and salt type affected the dry-fermented sausage characteristics. The low-salt batches presented a lower pH and higher microbial counts than the control. The salt reduction affected the color but only in the oil batches, resulting in higher L* and lower a* values. The oil batches presented the highest TBAR values (>1 mg/kg), suggesting that antioxidant compounds present into the meat were not bioavailable on the sausages or were missed during the curing process. The use of plant-derived extracts affected to consumer acceptability, whereas salt replacement did not. Oil batches scored lower than the other. From the current results, the oil extract would not be a recommended additive in pig feedstuff, especially when a low-salt strategy will be employed.


Asunto(s)
Alimentación Animal , Dieta/veterinaria , Calidad de los Alimentos , Productos de la Carne , Extractos Vegetales/administración & dosificación , Cloruro de Sodio/análisis , Porcinos , Gusto , Animales , Fenómenos Químicos , Color , Fermentación , Humanos , Concentración de Iones de Hidrógeno , Peroxidación de Lípido , Productos de la Carne/análisis
15.
Medicine (Baltimore) ; 99(38): e22228, 2020 Sep 18.
Artículo en Inglés | MEDLINE | ID: mdl-32957363

RESUMEN

INTRODUCTION: Cancer is the second leading cause of death, and the burden of cancer continues to grow globally. Research on the efficacy of combined administration of herbal medicine and anticancer drugs is also increasing. SH003 is a new herbal medicine composed of Astragalus membranaceus, Angelica gigas, and Trichosanthes kirilowii. SH003 alone up to 4800 mg daily was found to be safe. Preclinical studies have shown SH003 to have a synergistic effect with coadministration of anticancer drugs. This study aimed to determine the maximum tolerated dose of SH003 combined with docetaxel in patients with lung or breast cancer. METHODS: This is an open-label, dose-escalation study to evaluate the safety of SH003 combined with docetaxel. Patients with lung or breast cancer will be recruited. The participants will be divided into 3 groups based on SH003 daily dose (2400, 3600, and 4800 mg); the medication will be taken orally for 21 days. The traditional 3 + 3 design will be adopted for the dose escalation. Dose-limiting toxicities are defined as grade 3 or 4 adverse events according to the Common Terminology Criteria for Adverse Events. The highest dose at which no more than 1 of the 6 patients experience dose-limiting toxicity will be determined as the maximum tolerated dose of SH003 combined with docetaxel. DISCUSSION: This study investigates the safety of SH003 when combined with docetaxel. The results of this study will provide a safe dose range for conducting therapeutic exploratory trials. TRIAL REGISTRATIONS: ClinicalTrials.gov NCT04360317.


Asunto(s)
Antineoplásicos Fitogénicos/administración & dosificación , Neoplasias de la Mama/tratamiento farmacológico , Docetaxel/administración & dosificación , Neoplasias Pulmonares/tratamiento farmacológico , Extractos Vegetales/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica , Ensayos Clínicos Fase I como Asunto , Humanos , Fitoterapia
16.
Trials ; 21(1): 785, 2020 Sep 14.
Artículo en Inglés | MEDLINE | ID: mdl-32928313

RESUMEN

OBJECTIVES: 1- To compare the effectiveness of 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline and a novel solution Neem extract (Azardirachta indica) in reducing intra-oral viral load in COVID-19 positive patients. 2- To determine the salivary cytokine profiles of IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ and IL- 17 among COVID-19 patients subjected to 1% Hydrogen peroxide, 0.2% Povidone-Iodine, 2% hypertonic saline or Neem extract (Azardirachta indica) based gargles. TRIAL DESIGN: This will be a parallel group, quadruple blind-randomised controlled pilot trial with an add on laboratory based study. PARTICIPANTS: A non-probability, purposive sampling technique will be followed to identify participants for this study. The clinical trial will be carried out at the Aga Khan University Hospital (AKUH), Karachi, Pakistan. The viral PCR tests will be done at main AKUH clinical laboratories whereas the immunological tests (cytokine analysis) will be done at the Juma research laboratory of AKUH. The inclusion criteria are laboratory-confirmed COVID-19 positive patients, male or female, in the age range of 18-65 years, with mild to moderate disease, already admitted to the AKUH. Subjects with low Glasgow coma score, with a history of radiotherapy or chemotherapy, who are more than 7 days past the onset of COVID- 19 symptoms, or intubated or edentulous patients will be excluded. Patients who are being treated with any form of oral or parenteral antiviral therapy will be excluded, as well as patients with known pre-existing chronic mucosal lesions such as lichen planus. INTERVENTION AND COMPARATOR: Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene® by Aviro Health Inc./ Pyodine® by Brooks Pharma Inc.) for 20-30 seconds, thrice daily for 6 days. Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (HP® by Karachi Chemicals Products Inc./ ActiveOxy® by Boumatic Inc.) for 20-30 seconds, thrice daily for 6 days. Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated by Karachi University (chemistry department laboratories) for 20-30 seconds, thrice daily for 6 days. Group D (n=10) patients will use 2% hypertonic saline (Plabottle® by Otsuka Inc.) gargle and nasal lavage for a similar time period. Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days. For nasal lavage, a special douche syringe will be provided to each participant. Its use will be thoroughly explained by the data collection officer. After each use, the patient is asked not to eat, drink, or rinse their mouth for the next 30 minutes. MAIN OUTCOMES: The primary outcome is the reduction in the intra-oral viral load confirmed with real time quantitative PCR. RANDOMISATION: The assignment to the study group/ allocation will be done using the sealed envelope method under the supervision of Clinical Trial Unit (CTU) of Aga Khan University, Karachi, Pakistan. The patients will be randomised to their respective study group (1:1:1:1:1 allocation ratio) immediately after the eligibility assessment and consent administration is done. BLINDING (MASKING): The study will be quadruple-blinded. Patients, intervention provider, outcome assessor and the data collection officer will be blinded. The groups will be labelled as A, B, C, D or E. The codes of the intervention will be kept in lock & key at the CTU and will only be revealed at the end of study or if the study is terminated prematurely. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): As there is no prior work on this research question, so no assumptions for the sample size calculation could be made. The present study will serve as a pilot trial. We intend to study 50 patients in five study groups with 10 patients in each study group. For details, please refer to Fig. 1 for details. TRIAL STATUS: Protocol version is 7.0, approved by the department and institutional ethics committees and clinical trial unit of the university hospital. Recruitment is planned to start as soon as the funding is sanctioned. The total duration of the study is expected to be 6 months i.e. August 2020-January 2021. TRIAL REGISTRATION: This study protocol was registered at www.clinicaltrials.gov on 10 April 2020 NCT04341688 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2). Fig. 1 Flow diagram of study-participants' timeline.


Asunto(s)
Azadirachta , Betacoronavirus , Infecciones por Coronavirus , Peróxido de Hidrógeno/administración & dosificación , Pandemias , Extractos Vegetales/administración & dosificación , Neumonía Viral , Povidona Yodada/administración & dosificación , Solución Salina Hipertónica/administración & dosificación , Carga Viral , Adulto , Antiinfecciosos Locales/administración & dosificación , Betacoronavirus/efectos de los fármacos , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/terapia , Femenino , Hospitalización , Humanos , Masculino , Monitorización Inmunológica/métodos , Antisépticos Bucales/administración & dosificación , Lavado Nasal (Proceso)/métodos , Neumonía Viral/diagnóstico , Neumonía Viral/inmunología , Neumonía Viral/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Carga Viral/efectos de los fármacos , Carga Viral/métodos
17.
Trials ; 21(1): 790, 2020 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-32933552

RESUMEN

OBJECTIVES: We investigate the effects of Licorice (Glycyrrhiza glabra L.) root extract, an anti-inflammatory natural medicine, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in patients with confirmed COVID-19 that are moderately ill. TRIAL DESIGN: This is a single-center, open-label, randomized, clinical trial with parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. PARTICIPANTS: Both male and female patients with ≥18 years of age (≥ 35 kg of weight), admitted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas for treatment, screened for the following criteria. INCLUSION CRITERIA: 1. Confirmed diagnosis of SARS-CoV-2 infection (via polymerase chain reaction [PCR] and/or antibody test). 2. Presenting as moderate COVID-19 pneumonia (via chest computed tomography (CT) and/or X-ray) requiring hospitalization. 3. Hospitalized ≤48 hours. 4. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm. EXCLUSION CRITERIA: 1. Underlying diseases, including chronic heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders. 2. Severe and critical COVID-19 pneumonia. 3. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs. 4. Treatment with Investigational and antiviral therapy in a clinical study within one month before randomization. 5. History of allergy to Licorice. 6. Pregnancy and breastfeeding. INTERVENTION AND COMPARATOR: Intervention group: The standard treatment regimen for COVID-19 along with a Licorice-based herbal preparation (D-Reglis ®, Irandarouk Pharmaceutical Company, Iran) at a dose of 760 mg three times a day for a period of seven days. CONTROL GROUP: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol for a period of seven days. MAIN OUTCOMES: The recovery rate of clinical symptoms, including fever, dry cough, and tiredness, as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein, are evaluated as primary outcomes within seven days of randomization. Time to improvement of clinical and paraclinical features and length of stay in a hospital, along with the incidence of adverse reactions are also evaluated as the secondary outcomes within seven days of randomization. RANDOMIZATION: An electronic table of random numbers will be used to allocate the included participants into either control or intervention groups (in a 1:1 ratio) using the simple randomization method. BLINDING (MASKING): This is an open-label trial without blinding and placebo control. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group). TRIAL STATUS: The protocol is Version 1.0, May 31, 2020. Recruitment began July 30, 2020, and is anticipated to be completed by October 30, 2020. TRIAL REGISTRATION: This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is "IRCT20200506047323N2", https://www.irct.ir/trial/47990 . The registration date is 31 May 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Asunto(s)
Infecciones por Coronavirus , Glycyrrhiza , Pandemias , Extractos Vegetales , Raíces de Plantas , Neumonía Viral , Adulto , Antiinflamatorios/administración & dosificación , Antiinflamatorios/efectos adversos , Betacoronavirus/efectos de los fármacos , Betacoronavirus/aislamiento & purificación , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/fisiopatología , Monitoreo de Drogas/métodos , Femenino , Hospitalización , Humanos , Masculino , Extractos Vegetales/administración & dosificación , Extractos Vegetales/efectos adversos , Neumonía Viral/diagnóstico , Neumonía Viral/tratamiento farmacológico , Neumonía Viral/etiología , Neumonía Viral/fisiopatología , Ensayos Clínicos Controlados Aleatorios como Asunto , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
18.
Am J Chin Med ; 48(6): 1409-1433, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32907360

RESUMEN

Scutellaria baicalensis (SB), a herbal medicine, is commonly used to treat metabolic diseases, while Metformin (MF) is a widely used drug for type 2 diabetes. The purpose of this study was to investigate whether co-treatment of SB with MF could produce a potential therapeutic effect on high-fat and high-fructose diet (HFFD)-induced metabolic dysregulation. First, we optimized the dose of SB (100, 200, 400, and 800[Formula: see text]mg/kg) with MF (200[Formula: see text]mg/kg) in HFFD-induced C57BL6J mice. Next, the optimized dose of SB (400[Formula: see text]mg/kg) was co-administered with MF (50, 100, and 200[Formula: see text]mg/kg) in a similar animal model to find the effective combinations of SB and MF. Metabolic markers were determined in serum and tissues using different assays, histology, gene expression, and gut microbial population. The SB and MF co-treatment significantly decreased the body, liver, and VAT weights. The outcome of OGTT was improved, and the fasting insulin, HbA1c, TG, TC, LDL-c, AST, and ALT were decreased, while HDL-c was significantly increased. Histological analyses revealed maintained the integrity of liver, adipose tissue, and intestine prevented lipid accumulation in the liver and intestine and combated neuronal damage in the brain. Importantly, controlled the expression of PPAR[Formula: see text], and IL-6 genes in the liver, and expression of BDNF, Glut1, Glut3, and Glut4 genes in the brain. Treatment-specific gut microbial segregation was observed in the PCA chart. Our findings indicate that SB and MF co-treatment is an effective therapeutic approach for HFFD-induced metabolic dysregulation which is operated through the gut-liver-brain axis.


Asunto(s)
Encéfalo/metabolismo , Microbioma Gastrointestinal , Hígado/metabolismo , Enfermedades Metabólicas/tratamiento farmacológico , Enfermedades Metabólicas/metabolismo , Metformina/administración & dosificación , Metformina/farmacología , Fitoterapia , Extractos Vegetales/administración & dosificación , Extractos Vegetales/farmacología , Animales , Factor Neurotrófico Derivado del Encéfalo/genética , Factor Neurotrófico Derivado del Encéfalo/metabolismo , Dieta de Carga de Carbohidratos/efectos adversos , Dieta Alta en Grasa/efectos adversos , Modelos Animales de Enfermedad , Quimioterapia Combinada , Transportador de Glucosa de Tipo 1/genética , Transportador de Glucosa de Tipo 1/metabolismo , Interleucina-6/genética , Interleucina-6/metabolismo , Masculino , Enfermedades Metabólicas/genética , Enfermedades Metabólicas/microbiología , Ratones Endogámicos C57BL , PPAR gamma/genética , PPAR gamma/metabolismo
19.
Phytomedicine ; 78: 153307, 2020 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-32846405

RESUMEN

BACKGROUND: Current therapies for neuropathic pain are generally symptomatic and possess several side effects, limiting their prolonged usage. HYPOTHESIS/PURPOSE: Thus, it is urgent to develop novel and safe candidates for the management of this chronical condition. For this purpose, we investigated the analgesic effect of a standardized extract from Zingiber officinale Roscoe rhizomes (ZOE) obtained by CO2 supercritical extraction, in a mice model of peripheral neuropathy. We also explored the mechanism of action of ZOE and its main constituents using an in vitro model of neuroinflammation. METHODS: Peripheral mono-neuropathy was induced in mice, by spared nerve injury (SNI). The analgesic effect of ZOE after oral administration was assessed by measuring mechanical and thermal allodynia in SNI mice. The mechanism of action of ZOE and its main constituents were investigated using spinal cords samples and in an in vitro model of neuroinflammation by ELISA, western blotting and immunofluorescence techniques. RESULTS: Oral administration of ZOE 200 mg kg-1 ameliorated mechanical and thermal allodynia in SNI mice, with a rapid and a long-lasting effect. ZOE did not alter locomotor activity. In BV2 cells and spinal cord samples, ZOE, 6-gingerol and 6-shogaol reduced pERK levels, whereas ZOE and terpene fraction reduced HDAC1 protein levels, inhibited NF-κB signalling activation and decreased IL-1ß, TNF-α and IL-6 release. ZOE and each tested constituent had a positive effect on inflammation-impaired SH-SY5Y cell viability. CONCLUSIONS: The oral administration of ZOE attenuated SNI-induced neuropathic pain symptoms by reducing spinal neuroinflammation, suggesting ZOE as a novel and interesting candidate for the management of neuropathic pain.


Asunto(s)
Analgésicos no Narcóticos/farmacología , Jengibre/química , Neuralgia/tratamiento farmacológico , Extractos Vegetales/química , Extractos Vegetales/farmacología , Administración Oral , Analgésicos no Narcóticos/administración & dosificación , Analgésicos no Narcóticos/química , Animales , Citocinas/metabolismo , Modelos Animales de Enfermedad , Histona Desacetilasa 1/metabolismo , Hiperalgesia/tratamiento farmacológico , Inflamación/tratamiento farmacológico , Locomoción/efectos de los fármacos , Masculino , Ratones Endogámicos , Neuralgia/metabolismo , Extractos Vegetales/administración & dosificación , Rizoma/química , Médula Espinal/efectos de los fármacos
20.
AAPS PharmSciTech ; 21(7): 246, 2020 Aug 27.
Artículo en Inglés | MEDLINE | ID: mdl-32856115

RESUMEN

Enterococcus faecalis infections represent a health concern, mainly in oral diseases, in which treatments with chlorhexidine solution (0.2%) are often used; however, it presents high toxicity degree and several side effects. Based on this, the use of natural products as an alternative to treatment has been explored. Nonetheless, plant extracts have poor organoleptic characteristics that impair theirs in natura use. Therefore, this work aimed to evaluate the analytical profile, biological activity, and cytotoxicity in vitro of S. brasiliensis-loaded chitosan microparticles (CMSb) produced using different aspersion flow rates. The analytical fingerprint was obtained by FTIR and NIR spectra. Principal components analysis (PCA) was used to verify the similarity between the samples. The crystallinity degree was evaluated by X-ray diffraction (XRD). Phytochemical screening (PS) was performed to quantify phytocompounds. Antimicrobial activity was evaluated by minimum inhibitory concentration (MIC). Antibiofilm activity and bactericidal kinetics against E. faecalis (ATCC 29212 and MB 146-clinical isolated) were also assessed. The hemolytic potential was performed to evaluate the cytotoxicity. Data provided by FTIR, NIR, and PCA analyses revealed chemical similarity between all CMSb. Furthermore, the results from XRD analysis showed that the obtained CMSb present amorphous characteristic. Tannins and polyphenols were accurately quantified by the PS, but methodology limitations did not allow the flavonoid quantification. The low hemolytic potential assay indicates that all samples are safe. Antimicrobial assays revealed that CMSb were able to inhibit not only the E. faecalis ATCC growth but also the biofilm formation. Only one CMSb sample was able to inhibit the clinical strain. These results highlighted the CMSb antimicrobial potential and revealed this system as a promising product to treat infections caused by E. faecalis.


Asunto(s)
Anacardiaceae , Antiinfecciosos/administración & dosificación , Quitosano/administración & dosificación , Enterococcus faecalis/efectos de los fármacos , Microesferas , Extractos Vegetales/administración & dosificación , Administración Oral , Antiinfecciosos/aislamiento & purificación , Biopelículas/efectos de los fármacos , Biopelículas/crecimiento & desarrollo , Enterococcus faecalis/fisiología , Infecciones por Bacterias Grampositivas/tratamiento farmacológico , Humanos , Pruebas de Sensibilidad Microbiana/métodos , Tamaño de la Partícula , Corteza de la Planta , Extractos Vegetales/aislamiento & purificación
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