Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável

Detalhes bibliográficos
Autor(a) principal: Rocha, Heraldo Arcela de Carvalho
Data de Publicação: 2014
Tipo de documento: Tese
Idioma: por
Título da fonte: Biblioteca Digital de Teses e Dissertações da UFPB
Texto Completo: https://repositorio.ufpb.br/jspui/handle/tede/6818
Resumo: The irritable bowel syndrome (IBS) is defined as the presence of continuing or recurrent abdominal pain or discomfort and it is associated with altered bowel habit. Its pathophysiology involves the following aspects: genetic variables, changes in gut motility and visceral sensitivity, psychosocial factors, in addition to inflammatory and infectious processes. The treatment is based on dietary guidance and change in lifestyle. The use of drugs is indicated in symptomatic stages of IBS. The growing interest of patients for complementary and alternative medicine has been observed in recent years. Panax ginseng C.A. Meyer has been used for centuries in oriental medicine. Experimental studies have demonstrated the antinociceptive action of this herbal medicine on calcium and sodium channels, as well as on primary sensory neurons. The study aimed to: conduct phase II clinical trial with Panax ginseng CA Meyer in patients with IBS; contribute to the study of the pharmacological effects of Panax ginseng C.A. Meyer; evaluate the therapeutic efficacy of Panax ginseng C.A. Meyer in abdominal pain control in patients with IBS; and observe the adverse effects. Twenty-six patients were selected by means of the inclusion criteria for the study and they were divided into two groups. A clinical double-blind, randomized, prospective and experimental trial was conducted for eight weeks, comparing the action of dry extract of Panax ginseng (300 mg / day) with trimebutine (600 mg / day). Abdominal pain was assessed using the Likert scale. Patients were assessed at four visits and the results were analyzed using the Mann-Whitney and Friedman tests, with a significance level of p < 0.05. Twenty- four patients completed the study, being 87.50% female and mean age of 47.41 years. There was a relative homogeneity among patients with regard to sex, age and duration of symptoms. All patients, before beginning treatment with Panax ginseng and trimebutine, had negative scores for the Likert scale values. There was improvement in abdominal pain, through this scale, in patients who used Panax ginseng. This group started from a median basal of -5 to 2.5, 3 and 5 in the 1st, 4th and 8th weeks of treatment, respectively, with a statistically significant difference. Similar results were achieved in the group that used the trimebutine. The only adverse effect observed was the occurrence of headache in two patients (16.66%) in the group that used the herbal. Panax ginseng C.A. Meyer was effective in the control of abdominal pain in IBS patients, analogous to trimebutine, and may be used in future studies, with the prospect of a phase III clinical trial.
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spelling Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritávelPhase II clinical trial with Panax ginseng C. A. Meyer in the treatment of irritable bowel syndromeSíndrome do intestino irritávelPanax ginseng C. A. MeyerTratamento farmacológicoIrritable bowel syndromePanax ginseng C. A. MeyerPharmacological treatmentCIENCIAS BIOLOGICAS::FARMACOLOGIAThe irritable bowel syndrome (IBS) is defined as the presence of continuing or recurrent abdominal pain or discomfort and it is associated with altered bowel habit. Its pathophysiology involves the following aspects: genetic variables, changes in gut motility and visceral sensitivity, psychosocial factors, in addition to inflammatory and infectious processes. The treatment is based on dietary guidance and change in lifestyle. The use of drugs is indicated in symptomatic stages of IBS. The growing interest of patients for complementary and alternative medicine has been observed in recent years. Panax ginseng C.A. Meyer has been used for centuries in oriental medicine. Experimental studies have demonstrated the antinociceptive action of this herbal medicine on calcium and sodium channels, as well as on primary sensory neurons. The study aimed to: conduct phase II clinical trial with Panax ginseng CA Meyer in patients with IBS; contribute to the study of the pharmacological effects of Panax ginseng C.A. Meyer; evaluate the therapeutic efficacy of Panax ginseng C.A. Meyer in abdominal pain control in patients with IBS; and observe the adverse effects. Twenty-six patients were selected by means of the inclusion criteria for the study and they were divided into two groups. A clinical double-blind, randomized, prospective and experimental trial was conducted for eight weeks, comparing the action of dry extract of Panax ginseng (300 mg / day) with trimebutine (600 mg / day). Abdominal pain was assessed using the Likert scale. Patients were assessed at four visits and the results were analyzed using the Mann-Whitney and Friedman tests, with a significance level of p < 0.05. Twenty- four patients completed the study, being 87.50% female and mean age of 47.41 years. There was a relative homogeneity among patients with regard to sex, age and duration of symptoms. All patients, before beginning treatment with Panax ginseng and trimebutine, had negative scores for the Likert scale values. There was improvement in abdominal pain, through this scale, in patients who used Panax ginseng. This group started from a median basal of -5 to 2.5, 3 and 5 in the 1st, 4th and 8th weeks of treatment, respectively, with a statistically significant difference. Similar results were achieved in the group that used the trimebutine. The only adverse effect observed was the occurrence of headache in two patients (16.66%) in the group that used the herbal. Panax ginseng C.A. Meyer was effective in the control of abdominal pain in IBS patients, analogous to trimebutine, and may be used in future studies, with the prospect of a phase III clinical trial.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPESA síndrome do intestino irritável (SII) é definida pela presença de dor ou desconforto abdominal contínuo ou recorrente, estando associada com alterações do hábito intestinal. Sua fisiopatologia envolve os seguintes aspectos: variáveis genéticas, alterações da motilidade intestinal e da sensibilidade visceral, fatores psicossociais, além de processos inflamatórios e infecciosos. O tratamento é baseado em orientação dietética e na mudança do estilo de vida. O uso de fármacos é indicado nas fases sintomáticas da SII. Tem sido observado o crescente interesse dos pacientes pela medicina alternativa e complementar, nos últimos anos. O Panax ginseng C.A. Meyer é utilizado há séculos pela medicina oriental. Estudos experimentais demonstraram a ação antinociceptiva desse fitoterápico sobre os canais de cálcio e de sódio, assim como sobre os neurônios sensoriais primários. O estudo teve como objetivos: realizar ensaio clínico de fase II com o Panax ginseng C.A. Meyer em pacientes com SII; contribuir para o estudo dos efeitos farmacológicos do Panax ginseng C.A. Meyer; avaliar a eficácia terapêutica do Panax ginseng C.A. Meyer no controle da dor abdominal em pacientes com SII; observar os efeitos adversos. Foram selecionados vinte e seis pacientes, através de critérios de inclusão para a pesquisa, sendo divididos em dois grupos. Foi realizado um estudo clínico, duplo cego, randômico, prospectivo e experimental por oito semanas, comparando a ação do extrato seco do Panax ginseng (300 mg/dia) com a trimebutina (600 mg/dia). A dor abdominal foi avaliada através da escala de Likert. Os pacientes foram avaliados em quatro consultas e os resultados foram analisados através dos testes de Mann-Whitney e Friedman, com nível de significância quando p<0,05. Vinte e quatro pacientes concluíram o estudo, sendo 87,50% do sexo feminino e média de idade de 47,41 anos. Ocorreu uma relativa homogeneidade nos grupos de estudo no que se refere ao sexo, idade e duração dos sintomas. Todos os pacientes, antes do início dos tratamentos com Panax ginseng e trimebutina, apresentavam os valores negativos para os escores na escala de Likert. Houve melhora da dor abdominal, nos pacientes que utilizaram o Panax ginseng. Esse grupo partiu de uma mediana basal de -5 para 2,5, 3 e 5, na 1ª., 4ª. e 8ª. semanas de tratamento, respectivamente, com diferença estatisticamente significativa. O efeito adverso observado foi a ocorrência de cefaleia em dois pacientes (16,66%), no grupo que usou o fitoterápico. O Panax ginseng C.A. Meyer foi eficaz no controle da dor abdominal em pacientes com SII, de modo análogo à trimebutina, podendo ser utilizado em novos estudos, com a perspectiva de um ensaio clínico de fase III.Universidade Federal da Paraí­baBRFarmacologiaPrograma de Pós-Graduação em Produtos Naturais e Sintéticos BioativosUFPBDiniz, Margareth de Fátima Formiga Melohttp://lattes.cnpq.br/4173269414899195Rocha, Heraldo Arcela de Carvalho2015-05-14T13:00:02Z2018-07-21T00:26:00Z2014-10-222018-07-21T00:26:00Z2014-02-14info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisapplication/pdfROCHA, Heraldo Arcela de Carvalho. Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável. 2014. 87 f. Tese (Doutorado em Produtos Naturais e Sintéticos Bioativos) - Universidade Federal da Paraí­ba, João Pessoa, 2014.https://repositorio.ufpb.br/jspui/handle/tede/6818porinfo:eu-repo/semantics/openAccessreponame:Biblioteca Digital de Teses e Dissertações da UFPBinstname:Universidade Federal da Paraíba (UFPB)instacron:UFPB2018-09-06T02:34:18Zoai:repositorio.ufpb.br:tede/6818Biblioteca Digital de Teses e Dissertaçõeshttps://repositorio.ufpb.br/PUBhttp://tede.biblioteca.ufpb.br:8080/oai/requestdiretoria@ufpb.br|| diretoria@ufpb.bropendoar:2018-09-06T02:34:18Biblioteca Digital de Teses e Dissertações da UFPB - Universidade Federal da Paraíba (UFPB)false
dc.title.none.fl_str_mv Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
Phase II clinical trial with Panax ginseng C. A. Meyer in the treatment of irritable bowel syndrome
title Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
spellingShingle Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
Rocha, Heraldo Arcela de Carvalho
Síndrome do intestino irritável
Panax ginseng C. A. Meyer
Tratamento farmacológico
Irritable bowel syndrome
Panax ginseng C. A. Meyer
Pharmacological treatment
CIENCIAS BIOLOGICAS::FARMACOLOGIA
title_short Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
title_full Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
title_fullStr Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
title_full_unstemmed Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
title_sort Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável
author Rocha, Heraldo Arcela de Carvalho
author_facet Rocha, Heraldo Arcela de Carvalho
author_role author
dc.contributor.none.fl_str_mv Diniz, Margareth de Fátima Formiga Melo
http://lattes.cnpq.br/4173269414899195
dc.contributor.author.fl_str_mv Rocha, Heraldo Arcela de Carvalho
dc.subject.por.fl_str_mv Síndrome do intestino irritável
Panax ginseng C. A. Meyer
Tratamento farmacológico
Irritable bowel syndrome
Panax ginseng C. A. Meyer
Pharmacological treatment
CIENCIAS BIOLOGICAS::FARMACOLOGIA
topic Síndrome do intestino irritável
Panax ginseng C. A. Meyer
Tratamento farmacológico
Irritable bowel syndrome
Panax ginseng C. A. Meyer
Pharmacological treatment
CIENCIAS BIOLOGICAS::FARMACOLOGIA
description The irritable bowel syndrome (IBS) is defined as the presence of continuing or recurrent abdominal pain or discomfort and it is associated with altered bowel habit. Its pathophysiology involves the following aspects: genetic variables, changes in gut motility and visceral sensitivity, psychosocial factors, in addition to inflammatory and infectious processes. The treatment is based on dietary guidance and change in lifestyle. The use of drugs is indicated in symptomatic stages of IBS. The growing interest of patients for complementary and alternative medicine has been observed in recent years. Panax ginseng C.A. Meyer has been used for centuries in oriental medicine. Experimental studies have demonstrated the antinociceptive action of this herbal medicine on calcium and sodium channels, as well as on primary sensory neurons. The study aimed to: conduct phase II clinical trial with Panax ginseng CA Meyer in patients with IBS; contribute to the study of the pharmacological effects of Panax ginseng C.A. Meyer; evaluate the therapeutic efficacy of Panax ginseng C.A. Meyer in abdominal pain control in patients with IBS; and observe the adverse effects. Twenty-six patients were selected by means of the inclusion criteria for the study and they were divided into two groups. A clinical double-blind, randomized, prospective and experimental trial was conducted for eight weeks, comparing the action of dry extract of Panax ginseng (300 mg / day) with trimebutine (600 mg / day). Abdominal pain was assessed using the Likert scale. Patients were assessed at four visits and the results were analyzed using the Mann-Whitney and Friedman tests, with a significance level of p < 0.05. Twenty- four patients completed the study, being 87.50% female and mean age of 47.41 years. There was a relative homogeneity among patients with regard to sex, age and duration of symptoms. All patients, before beginning treatment with Panax ginseng and trimebutine, had negative scores for the Likert scale values. There was improvement in abdominal pain, through this scale, in patients who used Panax ginseng. This group started from a median basal of -5 to 2.5, 3 and 5 in the 1st, 4th and 8th weeks of treatment, respectively, with a statistically significant difference. Similar results were achieved in the group that used the trimebutine. The only adverse effect observed was the occurrence of headache in two patients (16.66%) in the group that used the herbal. Panax ginseng C.A. Meyer was effective in the control of abdominal pain in IBS patients, analogous to trimebutine, and may be used in future studies, with the prospect of a phase III clinical trial.
publishDate 2014
dc.date.none.fl_str_mv 2014-10-22
2014-02-14
2015-05-14T13:00:02Z
2018-07-21T00:26:00Z
2018-07-21T00:26:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/doctoralThesis
format doctoralThesis
status_str publishedVersion
dc.identifier.uri.fl_str_mv ROCHA, Heraldo Arcela de Carvalho. Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável. 2014. 87 f. Tese (Doutorado em Produtos Naturais e Sintéticos Bioativos) - Universidade Federal da Paraí­ba, João Pessoa, 2014.
https://repositorio.ufpb.br/jspui/handle/tede/6818
identifier_str_mv ROCHA, Heraldo Arcela de Carvalho. Ensaio clínico de fase II com Panax ginseng C. A. Meyer no tratamento da síndrome do intestino irritável. 2014. 87 f. Tese (Doutorado em Produtos Naturais e Sintéticos Bioativos) - Universidade Federal da Paraí­ba, João Pessoa, 2014.
url https://repositorio.ufpb.br/jspui/handle/tede/6818
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language por
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eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade Federal da Paraí­ba
BR
Farmacologia
Programa de Pós-Graduação em Produtos Naturais e Sintéticos Bioativos
UFPB
publisher.none.fl_str_mv Universidade Federal da Paraí­ba
BR
Farmacologia
Programa de Pós-Graduação em Produtos Naturais e Sintéticos Bioativos
UFPB
dc.source.none.fl_str_mv reponame:Biblioteca Digital de Teses e Dissertações da UFPB
instname:Universidade Federal da Paraíba (UFPB)
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reponame_str Biblioteca Digital de Teses e Dissertações da UFPB
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repository.name.fl_str_mv Biblioteca Digital de Teses e Dissertações da UFPB - Universidade Federal da Paraíba (UFPB)
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