Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia.
Autor(a) principal: | |
---|---|
Data de Publicação: | 2009 |
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/6749 |
Resumo: | Fibromyalgia is a chronic painful syndrome that affects up to 5% of the population worldwide. It may be associated with sleep or mood disorders and fatigue, and progresses with functional disability. Its pathogenesis consists of disorders of central pain modulation, involvement of the descending inhibitory system and substance P hyperactivity. The drug most commonly used for treatment of this syndrome is amitriptyline, which leads to an improvement in up to 50% of cases. Patients are interested in trying alternative or complementary medicine for the treatment of fibromyalgia. Panax ginseng C.A. Meyer is an herb that has been used for hundreds of years in oriental medicine. Preclinical studies have confirmed the antinociceptive effect of its active metabolites (ginsenosides) on substance P-induced pain, demonstrating an ability to inhibit calcium channels in dorsal medullary neurons. Clinical trials have shown an improvement in quality of life and fatigue with the use of ginseng. The study had as objective to evaluate the therapeutic efficacy of the extract of P. ginseng roots in controlling pain, fatigue, sleep quality, anxiety and quality of life in fibromyalgia. Fifty-two women of 21-60 years of age, who fulfilled the inclusion criteria of the study, were selected. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effect of P. ginseng (100 mg/day) with amitriptyline (25 mg/day) and placebo. Variables evaluated were pain, fatigue, sleep quality and anxiety using a visual analogue scale (VAS); pain was evaluated using a tender points count and quality of life using the Fibromyalgia Impact Questionnaire (FIQ). The patients were evaluated at six follow-up visits and results were expressed as means ± standard error (SE) of the mean using analysis of variation (ANOVA) and Tukey s post-hoc test. Thirty-eight women with a mean age of 43 years concluded the study. There were no statistically significant differences between the three groups with respect to baseline characteristics. VAS revealed a reduction in pain in the ginseng group (p<0.0001) with an improvement ≥ 30% from the sixth week of treatment onwards, an improvement in fatigue (p<0.0001) with a reduction ≥ 25% on the sixth week and ≥ 40% on the ninth week; and an improvement in sleep (p=0.0003) with a reduction ≥ 40% in the frequency of this complaint by the 6th week of treatment. The VAS evaluation of pain, fatigue and sleep detected an improvement compared to baseline values; however, there was no statistically significant difference between the three groups. With respect to anxiety, an improvement occurred in the ginseng group compared to baseline (p<0.0001); however, amitriptyline treatment resulted in a significantly greater improvement (p<0.05). Ginseng reduced the number of tender points and improved patients quality of life, as evaluated by the FIQ, compared to baseline in both cases (p<0.0001); however, no difference was found between the groups. Treatment with ginseng resulted in an improvement in all the parameters evaluated compared to baseline; however, there was no difference between this group of patients and those using placebo and amitriptyline, and this one was more effective than placebo or ginseng in improving anxiety. The beneficial effect on all parameters evaluated suggests that further studies should be performed with larger sample sizes and/or higher doses of ginseng to evaluate this herb for future use as a complementary therapy for fibromyalgia. |
id |
UFPB_520857d1e557db52901a1e13c7b180bf |
---|---|
oai_identifier_str |
oai:repositorio.ufpb.br:tede/6749 |
network_acronym_str |
UFPB |
network_name_str |
Biblioteca Digital de Teses e Dissertações da UFPB |
repository_id_str |
|
spelling |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia.Pharmacological clinical study with roots Panax ginseng extract in the treatment of fibromyalgia.FibromialgiaPanax ginseng C. A. MeyerTratamento farmacológicoFibromyalgiaPanax ginseng C. A. MeyerPharmacological treatmentCIENCIAS BIOLOGICAS::FARMACOLOGIAFibromyalgia is a chronic painful syndrome that affects up to 5% of the population worldwide. It may be associated with sleep or mood disorders and fatigue, and progresses with functional disability. Its pathogenesis consists of disorders of central pain modulation, involvement of the descending inhibitory system and substance P hyperactivity. The drug most commonly used for treatment of this syndrome is amitriptyline, which leads to an improvement in up to 50% of cases. Patients are interested in trying alternative or complementary medicine for the treatment of fibromyalgia. Panax ginseng C.A. Meyer is an herb that has been used for hundreds of years in oriental medicine. Preclinical studies have confirmed the antinociceptive effect of its active metabolites (ginsenosides) on substance P-induced pain, demonstrating an ability to inhibit calcium channels in dorsal medullary neurons. Clinical trials have shown an improvement in quality of life and fatigue with the use of ginseng. The study had as objective to evaluate the therapeutic efficacy of the extract of P. ginseng roots in controlling pain, fatigue, sleep quality, anxiety and quality of life in fibromyalgia. Fifty-two women of 21-60 years of age, who fulfilled the inclusion criteria of the study, were selected. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effect of P. ginseng (100 mg/day) with amitriptyline (25 mg/day) and placebo. Variables evaluated were pain, fatigue, sleep quality and anxiety using a visual analogue scale (VAS); pain was evaluated using a tender points count and quality of life using the Fibromyalgia Impact Questionnaire (FIQ). The patients were evaluated at six follow-up visits and results were expressed as means ± standard error (SE) of the mean using analysis of variation (ANOVA) and Tukey s post-hoc test. Thirty-eight women with a mean age of 43 years concluded the study. There were no statistically significant differences between the three groups with respect to baseline characteristics. VAS revealed a reduction in pain in the ginseng group (p<0.0001) with an improvement ≥ 30% from the sixth week of treatment onwards, an improvement in fatigue (p<0.0001) with a reduction ≥ 25% on the sixth week and ≥ 40% on the ninth week; and an improvement in sleep (p=0.0003) with a reduction ≥ 40% in the frequency of this complaint by the 6th week of treatment. The VAS evaluation of pain, fatigue and sleep detected an improvement compared to baseline values; however, there was no statistically significant difference between the three groups. With respect to anxiety, an improvement occurred in the ginseng group compared to baseline (p<0.0001); however, amitriptyline treatment resulted in a significantly greater improvement (p<0.05). Ginseng reduced the number of tender points and improved patients quality of life, as evaluated by the FIQ, compared to baseline in both cases (p<0.0001); however, no difference was found between the groups. Treatment with ginseng resulted in an improvement in all the parameters evaluated compared to baseline; however, there was no difference between this group of patients and those using placebo and amitriptyline, and this one was more effective than placebo or ginseng in improving anxiety. The beneficial effect on all parameters evaluated suggests that further studies should be performed with larger sample sizes and/or higher doses of ginseng to evaluate this herb for future use as a complementary therapy for fibromyalgia.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - CAPESA fibromialgia é uma síndrome dolorosa crônica que afeta até 5% da população mundial. Pode associar-se com distúrbios do sono, do humor e fadiga, e cursar com incapacidade funcional. Sua patogênese envolve distúrbio de modulação central da dor, comprometimento do sistema inibitório descendente e hiperatividade da substância P. O fármaco mais utilizado na sua terapia farmacológica é a amitriptilina, com melhora em até 50% dos casos. Há muito interesse dos pacientes sobre a medicina alternativa e complementar na terapia da fibromialgia. O Panax ginseng C.A. Meyer é uma erva utilizada pela medicina oriental há centenas de anos. Estudos pré-clínicos comprovaram a ação antinociceptiva dos seus metabólitos ativos (ginsenosídeos) sobre a dor induzida pela substância P, e demonstraram sua capacidade de inibir canais de cálcio nos neurônios da região dorsal medular. Ensaios clínicos sugeriram melhora da qualidade de vida e da fadiga com uso do ginseng. O estudo teve como objetivos: avaliar a eficácia terapêutica do extrato das raízes do P. ginseng no controle da dor, fadiga, qualidade do sono e ansiedade, e qualidade de vida na fibromialgia. Foram selecionadas 52 mulheres, com idades entre 21 e 60 anos, após preencherem os critérios de inclusão para o estudo. Foi desenvolvido um ensaio clínico, randômico, duplo-cego, controlado, por 12 semanas, comparando a ação do P. ginseng (100 mg/dia) com amitriptilina (25 mg/dia) e placebo. Variáveis avaliadas: dor, fadiga, qualidade do sono e ansiedade, por escala visual analógica (EVA); dor, por contagem dos pontos dolorosos; e melhora da qualidade de vida, por meio do Fibromyalgia impact questionnaire (FIQ). As pacientes foram avaliadas em 6 visitas, e os resultados foram dados em média ± EPM, utilizando ANOVA e pós-teste de Tukey. Trinta e oito mulheres concluíram o estudo, com média de idade de 43 anos. Não houve diferença significante nas características basais médias nos três grupos. Na EVA, observou-se: redução da dor no grupo do ginseng (p<0,0001), com melhora ≥ 30% a partir da 6ª semana de terapia; melhora da fadiga (p<0,0001), com redução ≥ 25% a partir da 6ª semana, e ≥ 40% na 9ª semana; e melhora do sono (p= 0,0003), reduzindo ≥ 40% a partir da 6ª semana de terapia. Nas três variáveis avaliadas na EVA, houve melhora em relação ao período basal, mas não houve diferença entre os três grupos. Com relação à ansiedade, o ginseng mostrou-se melhor em relação ao período basal (p<0,0001), mas foi inferior à amitriptilina (p<0,05), na comparação entre os grupos. O ginseng reduziu o número de pontos dolorosos e melhorou a qualidade de vida das pacientes (FIQ), ambos em relação ao período basal (p<0,0001), mas não houve diferença entre os grupos. O ginseng foi capaz de melhorar todos os parâmetros avaliados em relação ao período basal, mas não foi diferente do placebo ou da amitriptilina, e esta foi superior ao placebo e ao ginseng na melhora da ansiedade. Sua atuação benéfica nos parâmetros avaliados sugere a realização de novos ensaios clínicos, com amostras maiores, e/ou com dose maior do ginseng, para uma futura indicação como terapia complementar na fibromialgia.Universidade Federal da ParaíbaBRFarmacologiaPrograma de Pós-Graduação em Produtos Naturais e Sintéticos BioativosUFPBDiniz, Margareth de Fátima Formiga Melohttp://lattes.cnpq.br/4173269414899195Almeida, Reinaldo Nobrega dehttp://lattes.cnpq.br/5034028656386134Andrade, Alessandra Sousa Braz Caldas de2015-05-14T12:59:41Z2018-07-21T00:24:53Z2009-11-162018-07-21T00:24:53Z2009-10-09info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/doctoralThesisapplication/pdfANDRADE, Alessandra Sousa Braz Caldas de. Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. 2009. 142 f. Tese (Doutorado em Produtos Naturais e Sintéticos Bioativos) - Universidade Federal da Paraíba, João Pessoa, 2009.https://repositorio.ufpb.br/jspui/handle/tede/6749porinfo:eu-repo/semantics/openAccessreponame:Biblioteca Digital de Teses e Dissertações da UFPBinstname:Universidade Federal da Paraíba (UFPB)instacron:UFPB2018-09-06T01:43:37Zoai:repositorio.ufpb.br:tede/6749Biblioteca Digital de Teses e Dissertaçõeshttps://repositorio.ufpb.br/PUBhttp://tede.biblioteca.ufpb.br:8080/oai/requestdiretoria@ufpb.br|| diretoria@ufpb.bropendoar:2018-09-06T01:43:37Biblioteca Digital de Teses e Dissertações da UFPB - Universidade Federal da Paraíba (UFPB)false |
dc.title.none.fl_str_mv |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. Pharmacological clinical study with roots Panax ginseng extract in the treatment of fibromyalgia. |
title |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. |
spellingShingle |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. Andrade, Alessandra Sousa Braz Caldas de Fibromialgia Panax ginseng C. A. Meyer Tratamento farmacológico Fibromyalgia Panax ginseng C. A. Meyer Pharmacological treatment CIENCIAS BIOLOGICAS::FARMACOLOGIA |
title_short |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. |
title_full |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. |
title_fullStr |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. |
title_full_unstemmed |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. |
title_sort |
Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. |
author |
Andrade, Alessandra Sousa Braz Caldas de |
author_facet |
Andrade, Alessandra Sousa Braz Caldas de |
author_role |
author |
dc.contributor.none.fl_str_mv |
Diniz, Margareth de Fátima Formiga Melo http://lattes.cnpq.br/4173269414899195 Almeida, Reinaldo Nobrega de http://lattes.cnpq.br/5034028656386134 |
dc.contributor.author.fl_str_mv |
Andrade, Alessandra Sousa Braz Caldas de |
dc.subject.por.fl_str_mv |
Fibromialgia Panax ginseng C. A. Meyer Tratamento farmacológico Fibromyalgia Panax ginseng C. A. Meyer Pharmacological treatment CIENCIAS BIOLOGICAS::FARMACOLOGIA |
topic |
Fibromialgia Panax ginseng C. A. Meyer Tratamento farmacológico Fibromyalgia Panax ginseng C. A. Meyer Pharmacological treatment CIENCIAS BIOLOGICAS::FARMACOLOGIA |
description |
Fibromyalgia is a chronic painful syndrome that affects up to 5% of the population worldwide. It may be associated with sleep or mood disorders and fatigue, and progresses with functional disability. Its pathogenesis consists of disorders of central pain modulation, involvement of the descending inhibitory system and substance P hyperactivity. The drug most commonly used for treatment of this syndrome is amitriptyline, which leads to an improvement in up to 50% of cases. Patients are interested in trying alternative or complementary medicine for the treatment of fibromyalgia. Panax ginseng C.A. Meyer is an herb that has been used for hundreds of years in oriental medicine. Preclinical studies have confirmed the antinociceptive effect of its active metabolites (ginsenosides) on substance P-induced pain, demonstrating an ability to inhibit calcium channels in dorsal medullary neurons. Clinical trials have shown an improvement in quality of life and fatigue with the use of ginseng. The study had as objective to evaluate the therapeutic efficacy of the extract of P. ginseng roots in controlling pain, fatigue, sleep quality, anxiety and quality of life in fibromyalgia. Fifty-two women of 21-60 years of age, who fulfilled the inclusion criteria of the study, were selected. A randomized, double-blind, controlled clinical trial was carried out over 12 weeks to compare the effect of P. ginseng (100 mg/day) with amitriptyline (25 mg/day) and placebo. Variables evaluated were pain, fatigue, sleep quality and anxiety using a visual analogue scale (VAS); pain was evaluated using a tender points count and quality of life using the Fibromyalgia Impact Questionnaire (FIQ). The patients were evaluated at six follow-up visits and results were expressed as means ± standard error (SE) of the mean using analysis of variation (ANOVA) and Tukey s post-hoc test. Thirty-eight women with a mean age of 43 years concluded the study. There were no statistically significant differences between the three groups with respect to baseline characteristics. VAS revealed a reduction in pain in the ginseng group (p<0.0001) with an improvement ≥ 30% from the sixth week of treatment onwards, an improvement in fatigue (p<0.0001) with a reduction ≥ 25% on the sixth week and ≥ 40% on the ninth week; and an improvement in sleep (p=0.0003) with a reduction ≥ 40% in the frequency of this complaint by the 6th week of treatment. The VAS evaluation of pain, fatigue and sleep detected an improvement compared to baseline values; however, there was no statistically significant difference between the three groups. With respect to anxiety, an improvement occurred in the ginseng group compared to baseline (p<0.0001); however, amitriptyline treatment resulted in a significantly greater improvement (p<0.05). Ginseng reduced the number of tender points and improved patients quality of life, as evaluated by the FIQ, compared to baseline in both cases (p<0.0001); however, no difference was found between the groups. Treatment with ginseng resulted in an improvement in all the parameters evaluated compared to baseline; however, there was no difference between this group of patients and those using placebo and amitriptyline, and this one was more effective than placebo or ginseng in improving anxiety. The beneficial effect on all parameters evaluated suggests that further studies should be performed with larger sample sizes and/or higher doses of ginseng to evaluate this herb for future use as a complementary therapy for fibromyalgia. |
publishDate |
2009 |
dc.date.none.fl_str_mv |
2009-11-16 2009-10-09 2015-05-14T12:59:41Z 2018-07-21T00:24:53Z 2018-07-21T00:24:53Z |
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 |
ANDRADE, Alessandra Sousa Braz Caldas de. Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. 2009. 142 f. Tese (Doutorado em Produtos Naturais e Sintéticos Bioativos) - Universidade Federal da Paraíba, João Pessoa, 2009. https://repositorio.ufpb.br/jspui/handle/tede/6749 |
identifier_str_mv |
ANDRADE, Alessandra Sousa Braz Caldas de. Ensaio farmacológico clínico com extrato das raízes do Panax ginseng C. A. Meyer no tratamento da fibromialgia. 2009. 142 f. Tese (Doutorado em Produtos Naturais e Sintéticos Bioativos) - Universidade Federal da Paraíba, João Pessoa, 2009. |
url |
https://repositorio.ufpb.br/jspui/handle/tede/6749 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
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) instacron:UFPB |
instname_str |
Universidade Federal da Paraíba (UFPB) |
instacron_str |
UFPB |
institution |
UFPB |
reponame_str |
Biblioteca Digital de Teses e Dissertações da UFPB |
collection |
Biblioteca Digital de Teses e Dissertações da UFPB |
repository.name.fl_str_mv |
Biblioteca Digital de Teses e Dissertações da UFPB - Universidade Federal da Paraíba (UFPB) |
repository.mail.fl_str_mv |
diretoria@ufpb.br|| diretoria@ufpb.br |
_version_ |
1798963940293607424 |