Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis

Matthys, H; Eisebitt, Reinhard; Seith, Bettina; Heger, Marianne

doi:10.1078/1433-187x-00308

Cited by 91 publications

(99 citation statements)

References 18 publications

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“…Several clinical studies (Chuchalin et al, 2005;Matthys et al, 2003;Matthys et al, 2007a;Matthys, Hereg, 2007b) have also proven the efficacy of Eps 7630 for treating bronchitis.…”

Section: Pharmacological Activitiesmentioning

confidence: 99%

“…No adverse effects have been reported in patients older than 12 years old, noting that the extract of P. sidoides is well tolerated in therapeutic doses (Tsyrkunov, 1989;Kolodziej et al, 1997apud Alonso, 2004Correia et al, 1984apud Alonso, 2004Anderson et al, 1992;Edenharder et al, 1995apud Alonso, 2004Heil, Reitermann, 1994apud Alonso, 2004Matthys et al, 2003;Schotz et al, 2007).…”

Section: Adverse Effectsmentioning

confidence: 99%

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Evaluation of medicine package inserts: a study of two cases of Pelargonium sidoides D.C. phytomedicines

Linhares

Oliveira

Silva

2010

Braz. J. Pharm. Sci.

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In order for a phytotherapeutic drug be approved and sold in Brazil, it must be registered with the National Sanitary Surveillance Agency (ANVISA), where the quality, safety and efficacy of the product are carefully appraised. In addition, the drug must also meet a number of criteria one of which is the adequacy of the package inserts. Therefore, the aim of this study was to appraise the package inserts of all phytotherapeutic drugs produced using a standardized extract of Pelargonium sidoides, which were registered and available from Brazilian pharmacies. This checking was to ascertain whether these inserts fulfilled the requirements stipulated by RDC 140/03. The information required under RDC 140/03 was appraised through a previously devised standard form. Evaluation of the package inserts revealed that neither of the two brands fully met the requirements of the legislation. Manufacturer 'A' met only 37.0% of the requirements satisfactorily, while 16.0% of the information was considered unsatisfactory and 47.0% of the information was absent. Regarding manufacturer 'B', 64.2% of the analyzed requirements were considered satisfactory, while 16.0% were considered unsatisfactory and 19.8% of the information was absent. A package insert should contain information about medicine for consumers, pharmacists and doctors. However, the results obtained in this study showed that the information presented in the package insert of both medicines was unsatisfactory, and in many cases, violates the legislation.Uniterms: Medicines/formulation of package inserts. Phytotherapeutic drugs. Package inserts/evaluation. Pelargonium sidoides.Para que um medicamento fitoterápico seja comercializado no Brasil, este deve ser registrado junto à ANVISA, onde são avaliados todos os aspectos referentes à qualidade, segurança e eficácia do produto, além de verificar se estes atendem alguns requisitos, sendo um deles a adequação da bula. Por esta razão, neste estudo foram avaliadas as bulas de todos os fitoterápicos elaborados à base do extrato padronizado de Pelargonium sidoides, registrados e disponíveis no mercado brasileiro, com o intuito de verificar se estas atendem aos requisitos exigidos pela RDC 140/03. No presente trabalho, as informações exigidas pela RDC 140/03 foram avaliadas através de um formulário padrão previamente elaborado. Após avaliação das bulas pode ser verificado que nenhuma das duas marcas atendia por completo as exigências da legislação, sendo que o fabricante "A" atendeu apenas 37,0% dos requisitos exigidos de forma satisfatória, enquanto 16,0% das informações foram consideradas insatisfatórias e em 47,0% as informações estavam ausentes. Com relação ao fabricante "B", 64,2% dos itens analisados foram considerados satisfatórios, enquanto 16,0% foram considerados insatisfatório e em 19,8% as informações estavam ausentes. A bula deveria conter informações sobre o medicamento para consumidores, farmacêuticos e médicos, no entanto, os resultados obtidos neste estudo mostram que as informações apresentadas nas bulas foram ...

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“…Several clinical studies (Chuchalin et al, 2005;Matthys et al, 2003;Matthys et al, 2007a;Matthys, Hereg, 2007b) have also proven the efficacy of Eps 7630 for treating bronchitis.…”

Section: Pharmacological Activitiesmentioning

confidence: 99%

Section: Adverse Effectsmentioning

confidence: 99%

Evaluation of medicine package inserts: a study of two cases of Pelargonium sidoides D.C. phytomedicines

Linhares

Oliveira

Silva

2010

Braz. J. Pharm. Sci.

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“…The BSS in the literature: The symptoms and findings assessed in the BSS were first described in 1996 by Haidvogl et al 13 and Dome et al 14 Later on, in 1999 and 2002, Blochin et al 15 and Golovatiouk et al, 16 used the full scale, but the term "BSS" was introduced in the scientific literature in 2003 by Matthys et al 17 and has since been used in many further publications e.g. [18][19][20][21][22][23][24][25][26][27][28][29] Recently, a review of all trials employing the BSS until April 2012 was published.…”

Section: Clinical Psychometric Measures For Acute Bronchitismentioning

confidence: 99%

“…One study was subdivided into two sections (study 17 ), because one part was performed in Germany with German doctors and patients and the other in Ukraine with Ukrainian doctors and patients. Possibly the different backgrounds of history and native language could exert different influences on the results.…”

Section: Studies Patients and Study Designsmentioning

confidence: 99%

“…All eligible studies were conducted with EPs 7630. [17][18][19][20][21][22][23][24] Planning, execution and analysis of these clinical trials were carried out in accordance with the national regulations, the Declaration of Helsinki and the ICH-Guideline for Good Clinical Practice. The study protocols and other required study documents were submitted to the respective independent ethics committee and regulatory authorities for approval.…”

Section: Studies Patients and Study Designsmentioning

confidence: 99%

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The BSS - A Valid Clinical Instrument to Measure the Severity of Acute Bronchitis

Lehrl¹,

Matthys²,

Kamin³

et al. 2014

JLPRR

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Pneumococcal conjugate vaccines for preventing vaccine-type invasive pneumococcal disease and pneumonia with consolidation on x-ray in children under two years of age

Lucero

Dulalia

Parreno

et al. 2004

Cochrane Database of Systematic Reviews

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Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis

Cited by 91 publications

References 18 publications

Evaluation of medicine package inserts: a study of two cases of Pelargonium sidoides D.C. phytomedicines

Evaluation of medicine package inserts: a study of two cases of Pelargonium sidoides D.C. phytomedicines

The BSS - A Valid Clinical Instrument to Measure the Severity of Acute Bronchitis

Pneumococcal conjugate vaccines for preventing vaccine-type invasive pneumococcal disease and pneumonia with consolidation on x-ray in children under two years of age

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