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1.
Front Pharmacol ; 10: 1326, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31780942

RESUMO

Introduction: Use of herbal medicines (HMs) is widespread across the world, with many people relying on HMs for their primary healthcare or using HMs in the context of a healthy life style. HMs originate from plant material and, as such, are often seen as "natural" and believed to be (relatively) safe by patients. Hepatobiliary disorders have been associated with numerous HMs. Aim: This paper aims to analyze reporting patterns for hepatobiliary disorders associated with HMs use from reports submitted to the WHO global database of individual case safety reports (ICSRs) VigiBase. Methods: A data extraction in VigiBase, the WHO international database of ICSR reports, was performed by the Uppsala Monitoring Centre on 2019-01-16. The dataset contained all ICSRs where an HM was identified with the UMC-assigned ATC code "V90: unspecified herbal and traditional medicine" and where the HM was classified as being either the suspected drug or an interacting drug, and containing at least one adverse reaction in the MedDRA® System Organ Class (SOC) Hepatobiliary Disorders (HBD). Descriptive analyses in Excel 2013® were used to determine general characteristics of the reports in the broad data set, including total number of reports, reporting country and patient characteristics. For single suspect herbal reports, reports categorized as "serious" according to CIOMS criteria (CIOMS), 2001) were extracted. Results: In total, 2,483 reports describing with at least one ADR in the SOC HBD were extracted from VigiBase. In total, 780 (31.4%) reports concern only one suspect HM. However, for 188 reports of these reports (24.1%), the single suspect herbal preparation contains more than one herbal ingredient. The 592 reports for single suspect herbal preparations described a total of 764 ADRs in the SOC HBD. Jaundice was the most reported ADR for these reports. Conclusion: Almost 2,500 reports for HMs and with at least one ADR coded to the MedDRA® SOC HBD were retrieved from VigiBase. Of the HBD SOC HM reports, around 25% concerned a single herbal species as the suspect "drug." Substantial issues with coding of the suspect herbal drugs were found. In-depth causality assessment of the cases is needed to draw conclusions on the strength of the relationships.

2.
J Gastroenterol ; 54(8): 718-729, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30919071

RESUMO

BACKGROUND: Long-term maintenance treatment of gastroesophageal reflux disease (GERD) is important to prevent relapse. Proton-pump inhibitors (PPIs) are used for both treatment and maintenance therapy of GERD. Recently, a potassium-competitive acid blocker vonoprazan was launched in Japan. We evaluated the comparative efficacy of vonoprazan and other PPIs for GERD maintenance. METHODS: A systematic literature search was performed using MEDLINE and Cochrane Central Register of Controlled Trials. Double-blind randomized controlled trials (RCTs) of PPIs, vonoprazan, and placebo for GERD maintenance published in English or Japanese were selected. Among them, studies conducted at the recommended dose and for the recommended use, and containing information on maintenance rate based on endoscopic assessment, were included. The comparative efficacies of treatments were estimated by performing a Bayesian network meta-analysis, which assessed the consistency assumption. Outcomes were number or rate of patients who maintained remission. RESULTS: Of 4001 articles identified, 22 RCTs were eligible for analysis. One study published as an abstract was hand-searched and added. The consistency hypothesis was not rejected for the analysis. The odds ratio of vonoprazan 10 mg to each PPI was 13.92 (95% credible interval [CI] 1.70-114.21) to esomeprazole 10 mg; 5.75 (95% CI 0.59-51.57) to rabeprazole 10 mg; 3.74 (95% CI 0.70-19.99) to lansoprazole 15 mg; and 9.23 (95% CI 1.17-68.72) to omeprazole 10 mg. CONCLUSIONS: The efficacy of vonoprazan in GERD maintenance treatment may be higher than that of some PPIs. However, a direct comparison of vonoprazan and PPIs is required to confirm these effects.

3.
J Gastroenterol Hepatol ; 34(8): 1316-1328, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30883868

RESUMO

BACKGROUND AND AIM: Gastroesophageal reflux disease (GERD) is a common disease caused by reflux of gastric contents to the esophagus. Proton-pump inhibitors (PPIs) are recommended as a first-line therapy to treat GERD. Recently, a new potassium-competitive acid blocker, vonoprazan, was launched in Japan. We aimed to evaluate the comparative efficacy of vonoprazan and other PPIs in healing GERD. METHODS: We used MEDLINE and the Cochrane Central Register of Controlled Trials to search the literature. Double-blind randomized controlled trials for PPIs and/or vonoprazan that were published in English or Japanese and assessed healing effects in adult GERD patients were included. To estimate the comparative efficacy of treatments, we performed a Bayesian network meta-analysis to assess the consistency assumption. RESULTS: Of 4001 articles identified in the database, 42 studies were eligible. One study was hand-searched and added to the analysis. For the main analysis of healing effects at 8 weeks, odds ratios (ORs) of vonoprazan (20 mg daily) to esomeprazole (20 mg), rabeprazole (20 mg), lansoprazole (30 mg), and omeprazole (20 mg) were 2.29 (95% credible interval, 0.79-7.06), 3.94 (1.15-14.03), 2.40 (0.90-6.77), and 2.71 (0.98-7.90), respectively. Subgroup analysis for patients with severe esophagitis at baseline showed significantly higher ORs for vonoprazan versus most of the comparator PPIs. CONCLUSIONS: This analysis shows that the GERD healing effect of vonoprazan is higher than that of rabeprazole (20 mg) but not higher than other PPIs. Subgroup analysis indicated that vonoprazan is more effective than most PPIs for patients with severe erosive esophagitis.


Assuntos
Esofagite Péptica/tratamento farmacológico , Refluxo Gastroesofágico/tratamento farmacológico , Inibidores da Bomba de Prótons/uso terapêutico , Pirróis/uso terapêutico , Sulfonamidas/uso terapêutico , Cicatrização/efeitos dos fármacos , Teorema de Bayes , Esofagite Péptica/diagnóstico , Esofagite Péptica/fisiopatologia , Refluxo Gastroesofágico/diagnóstico , Refluxo Gastroesofágico/fisiopatologia , Humanos , Metanálise em Rede , Seleção de Pacientes , Inibidores da Bomba de Prótons/efeitos adversos , Pirróis/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Indução de Remissão , Índice de Gravidade de Doença , Sulfonamidas/efeitos adversos , Fatores de Tempo , Resultado do Tratamento
4.
Expert Rev Clin Pharmacol ; 10(11): 1203-1214, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28836870

RESUMO

INTRODUCTION: In the modern antimicrobial era, the rapid spread of resistance to antibiotics and introduction of new and mutating viruses is a global concern. Combating antimicrobial resistant microbes (AMR) requires coordinated international efforts that incorporate new conventional antibiotic development as well as development of alternative drugs with antimicrobial activity, management of existing antimicrobials, and rapid detection of AMR pathogens. Areas covered: This manuscript discusses some conventional strategies to control microbial resistance. The main purpose of the manuscript is to present information on specific herbal medicines that may serve as good treatment alternatives to conventional antimicrobials for infections sensitive to conventional as well as resistant strains of microorganisms. Expert commentary: Identification of potential new antimicrobials is challenging; however, one source for potential structurally diverse and complex antimicrobials are natural products. Natural products may have advantages over other post-germ theory antimicrobials. Many antimicrobial herbal medicines possess simultaneous antibacterial, antifungal, antiprotozoal and/or antiviral properties. Herbal products have the potential to boost host resistance to infections, particularly in immunocompromised patients. Antimicrobial broad-spectrum activity in conjunction with immunostimulatory properties may help to prevent microbial resistance to herbal medicine. As part of the efforts to broaden use of herbal medicines to treat microbial infections, pre-clinical and clinical testing guidelines of these compounds as a whole should be implemented to ensure consistency in formulation, efficacy and safety.


Assuntos
Anti-Infecciosos/administração & dosagem , Fitoterapia/métodos , Preparações de Plantas/administração & dosagem , Animais , Anti-Infecciosos/farmacologia , Desenho de Fármacos , Resistência Microbiana a Medicamentos , Humanos , Hospedeiro Imunocomprometido , /microbiologia , Preparações de Plantas/farmacologia
5.
Expert Rev Clin Pharmacol ; 9(9): 1225-33, 2016 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-27232545

RESUMO

INTRODUCTION: Medicinal plants, and formulations prepared from them, have been used in China and Japan for thousands of years. Nowadays, ancient formulations of Traditional Chinese and Kampo (Japanese) Medicines coexist with Western herbal medicines (HMs) and complement each other. HMs are used for the treatment of mild and chronic diseases, as an adjunct therapy, to improve wellbeing and delay aging, or as healthy (functional) foods. AREAS COVERED: This article, a third part in a series of reviews, is focusing on history, use and regulation of the traditional and modern HMs in Japan and China. Materials available from legislative and governmental websites, PubMed and news media were used. Expert commentary: HMs are heavily regulated in both countries, often in a similar manner as conventional pharmaceutical drugs. The majority of herbal formulations are sold as over-the-counter medications supplied with leaflets describing indications and appropriate dosages for patients of different ages. Medical practitioners prescribe herbal formulations that are tailored to the needs of particular patients. Both countries had problems with adverse drug reactions and toxicity of single herbs and herbal formulations that have been investigated by authorities, and some drugs have been removed from the market.


Assuntos
Fitoterapia/métodos , Preparações de Plantas/uso terapêutico , Plantas Medicinais/química , China , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Japão , Medicina Tradicional Chinesa/efeitos adversos , Medicina Tradicional Chinesa/métodos , Medicina Kampo/efeitos adversos , Medicina Kampo/métodos , Fitoterapia/efeitos adversos , Preparações de Plantas/administração & dosagem , Preparações de Plantas/efeitos adversos
6.
J Ethnopharmacol ; 173: 318-29, 2015 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-26212021

RESUMO

ETHNOPHARMACOLOGICAL RELEVANCE: Traditional Chinese Medicine (TCM) is a popular form of ethnomedicine in the UK, and is accessed by Western, Chinese and other ethnic groups. The current regulatory regime does not effectively protect the public against poor-quality and unsafe TCMs. Understanding ethnopharmacological information on how TCM is promoted and practiced may help to inform initiatives aimed at ensuring the safe use of TCMs in the UK, and put laboratory-based ethnopharmacological investigations of TCMs in a broader context. AIM OF THE STUDY: This study aimed to examine the characteristics and practices of TCM retail outlets in London, UK, and to identify factors relevant to the safe use of TCM in the UK. MATERIALS AND METHODS: TCM retail outlets ('shops') in London, UK, were identified using a systematic approach. A structured questionnaire including questions on shop business type was used to recruit participant shops. Shops consenting to participate were visited within six weeks of providing consent. A piloted semi-structured questionnaire on shop characteristics was used for data collection following observation. The British National Formulary 53 was used to classify medical conditions/uses for TCMs promoted in the shops. Data were stored and analysed using MS Access 2003, MS Excel 2003 and SPSS 13. RESULTS: In total, 54 TCM shops in London were identified, of which 94% offered TCM consultations with a TCM practitioner. Detailed characteristics were described within 35/50 shops that gave consent to observing their premises. Most shops labelled and displayed over 150 Chinese Materia Medica (CMMs; crude materials, particularly herbs) for dispensing after consultations with a TCM practitioner. Medical conditions/uses and Patent Chinese Medicines (PCMs) were commonly promoted. In total, 794 occurrences of 205 different medical conditions/uses (median=32, QL=19, QU=48) were identified. These conditions/uses most commonly related to the following therapeutic systems: central nervous system (160/794, 20.2%); musculoskeletal and joint disease (133/794, 16.8%); obstetrics, gynaecology, and urinary-tract disorders (122/794, 15.4%); skin (102/794, 12.9%); gastrointestinal system (62/794, 7.8%). Specific conditions/uses that were frequently promoted included eczema (19/23 shops, 82.6%), arthritis (18/23, 78.3%), acne (17/23, 73.9%), obesity/weight loss/slimming (17/23, 73.9%) and psoriasis (17/23, 73.9%). Claimed conditions/uses included some serious medical conditions (e.g. diabetes, cancer and hypertension) and those focusing on vulnerable groups (e.g. children's diseases and pregnancy treatments). CONCLUSIONS: TCM shops in London, UK, typically displayed names of a wide range of medical conditions/uses for TCMs using readily understandable medical terms, implying TCM can be used to prevent or treat these conditions. However, many of these advertisements did not comply with UK regulations on medical claims for herbal medicines. Future studies should explore how these advertisements influence consumers' decisions to access TCM in the UK, practices of TCM shop staff towards the supply of TCMs in the UK, and what are the health implications at the individual and population levels.


Assuntos
Medicina Tradicional Chinesa , Comércio , Qualidade de Produtos para o Consumidor , Rotulagem de Medicamentos , Humanos , Londres
7.
Pharmacoepidemiol Drug Saf ; 21(10): 1118-24, 2012 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-22438276

RESUMO

PURPOSE: This study aimed to understand the characteristics of drug utilisation researches (DURs) using concepts of defined daily dose in China and to provide further suggestion for future DURs in China. METHODS: DURs using concepts of defined daily dose published in China were identified from China Journal Full-text Database, and in-depth data analysis was conducted for DURs published in every even-numbered year. RESULTS: In total, 2,911 DURs published between 1989 and 2009 were identified, of which 1,268 were included for further data analysis. All studies were hospital-based. Types of drugs commonly assessed in DURs were Anti-infectives for systemic use (34.1%), drugs for Nervous system (25.5%) and drugs for Alimentary tract and metabolism (14.3%). In addition, 63 DURs published in even-numbered year focusing on Chinese Herbal Medicine (CHM) were identified. Commonly used sources of defined dose were Xin Bian Yao Wu Xue/New Materia Medica (83.9%), drug information leaflets (66.8%) and Chinese Pharmacopoeia (52.0%). Common indicators used in DURs include defined daily doses (DDDs), drug utilisation index (DUI) and daily dose cost (DDC). CONCLUSION: DUR is a popular method to explore the use of both pharmaceutical drugs and CHM in China. The definition of defined daily dose and its related indicators presented in the DURs were highly varied. From this, it follows that DURs with more consistent methodology are highly needed for a thorough understanding of drug utilisation in China. Apart from DURs focusing on the hospital setting, more DURs from other health settings are needed.


Assuntos
Protocolos Clínicos/normas , Uso de Medicamentos/normas , Política Nutricional , China , Relação Dose-Resposta a Droga , Humanos
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