Publication
Fitoterapia e suplementos alimentares no cancro da mama, eventos adversos e interações com hormonoterapia: uma revisão sistemática
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Abstract(s)
Background: Aproximadamente 80% dos cancros da mama em mulheres prémenopausa são positivos para recetores hormonais de estrogénio (ER – do inglês, oestrogen receptor), recetores de progesterona (PgR – do inglês, progesterone receptor), revelando-se ser suscetível à terapia endócrina, também designada por
hormonoterapia. Os esquemas terapêuticos da hormonoterapia estão associados a regimes posológicos prolongados, geralmente, com períodos entre 5 a 10 anos, e ao aparecimento de efeitos tóxicos que podem condicionar a qualidade de vida e a saúde das doentes. O recurso a metodologias de tratamento alternativas e complementares tem sugerido benefícios na redução dos efeitos induzidos pela terapia hormonal e, por isso, a
sua utilização tem sido crescente nos doentes com cancro da mama hormono-sensíveis.
Contudo a evidência disponível sobre a segurança da combinação dessas metodologias com hormonoterapia é escassa e limitada, especialmente no que se relaciona com possíveis eventos adversos com produtos fitoterápicos e suplementos alimentares, os quais podem interferir com a farmacocinética dos fármacos.
Objetivos: Elaboração de uma revisão sistemática que reúna evidência científica de potenciais eventos adversos associados à combinação entre fitoterapia e suplementos alimentares com a hormonoterapia em doentes com cancro da mama, incluindo segurança, tolerabilidade e interferência na eficácia da mesma.
Metodologia: As bases de dados utilizadas para a pesquisa de estudos clínicos foram a Pubmed, Web of Science, Scielo e ClinicalTrials.gov. Foram incluídos estudos clínicos randomizados e não randomizados, estudos de coorte e casos-controlo, estudos observacionais sem grupos de controlo, revisões sistemáticas de estudos clínicos, metaanálises e estudos transversais.
Resultados: Da pesquisa efetuada resultaram um total de 302 artigos dos quais 19 artigos cumpriram os critérios de elegibilidade para inclusão. A revisão bibliográfica de alguns artigos excluídos resultou na inclusão de 10 artigos adicionais. No que refere a suplementos alimentares, a vitamina D3 em combinação com o cálcio, ácidos gordos essenciais, óxido de magnésio, Undaria pinnatifida (wakame) e vitamina B12 foram
suplementos usados simultaneamente com inibidores de aromatase e reportaram uma boa tolerância e segurança. Sulfato de glucosamina e sulfato de condroitina foram associados a efeitos adversos de grau menor. Em terapia com tamoxifeno, os suplementos alimentares usados foram o diindolilmetano (DIM – do inglês, diindolylmethane), óxido de magnésio, vitamina E, suplemento de soja e Yunzhi (Coriolus versicolor), sem referência a efeitos adversos significativos. Relativamente a fitoterapia, o extrato de Cimicifuga racemosa (ateia, do inglês - black cohosh) em combinação com tamoxifeno foi associado a efeitos adversos graves a menores, e a Camellia sinensis (chá verde) a efeitos de baixa severidade. Já a Salvia miltiorrhiza (danshen) não demonstrou a presença de qualquer efeito adverso. Não se verificaram alterações no perfil farmacocinético dos fármacos inibidores de aromatase na coadministração com vitamina D3 e cálcio. Contudo, a administração de vitamina E, DIM e Undaria pinnatifida (wakame) esteve associada a alterações no perfil farmacocinético do tamoxifeno e de seus metabolitos. A administração de chá verde não alterou a
farmacocinética do tamoxifeno.
Discussão: No decorrer da análise dos resultados, foram encontradas algumas inconsistências, nomeadamente em estudos efetuados sob condições idênticas e que reportaram resultados diferentes, e na avaliação de interações medicamentosas pela avaliação dos parâmetros farmacocinéticos não ter sido efetuada com a melhor qualidade metodológica de forma a evitar risco de viés.
Conclusão: A utilização de suplementos alimentares e/ou fitoterapia deve ser controlada, contínua e extensivamente avaliada através da realização de estudos clínicos adicionais.
Background: Approximately 80% of breast cancers in premenopausal women are positive for hormone receptors for estrogen and progesterone, proving to be susceptible to endocrine therapy, also called hormone therapy. Hormonotherapy therapeutic regimens are associated with prolonged dosage regimens, generally between 5 to 10 years, and the appearance of toxic effects that can affect the patient’s quality of life and health. The use of alternative and complementary treatment methodologies has suggested benefits in reducing the effects induced by hormone therapy and, therefore, its use has been increasing in patients with hormone-sensitive breast cancer. However, the available evidence on the safety of combining these methodologies with hormone therapy is scarce and limited, especially with regard to possible adverse events with herbal products and dietary supplements, which can interfere with the pharmacokinetics of drugs. Objectives: Elaboration of a systematic review that gathers scientific evidence of potential adverse events associated with the combination of herbal products and dietary supplements with hormone therapy in breast cancer patients, including safety, tolerability and interference in its efficacy. Methodology: The databases used for the research of clinical studies were Pubmed, Web of Science, Scielo and ClinicalTrials.gov. Randomized controlled clinical studies, cohort and case-control studies, observational studies without control groups, systematic reviews of clinical studies, meta-analyses and cross-sectional studies were included. Results: The search resulted in a total of 302 articles, of which 19 articles met the eligibility criteria for inclusion. The literature review of some excluded articles resulted in the inclusion of 10 additional articles. With regard to food supplements, vitamin D3 in combination with calcium, essential fatty acids, magnesium oxide, Undaria pinnatifida (wakame) and vitamin B12 were supplements used simultaneously with aromatase inhibitors and reported good tolerance and safety. Glucosamine sulfate and chondroitin sulfate were associated with minor adverse effects. In tamoxifen therapy, the dietary supplements used were diindolylmethane (DIM), magnesium oxide, vitamin E, soy supplement and Yunzhi (Coriolus versicolor), with no reference to significant adverse effects. Regarding herbal medicine, Cimicifuga racemosa (black cohosh) extract in combination with tamoxifen was associated with severe to minor adverse effects, and Camellia sinensis (green tea) with low severity effects. Salvia miltiorrhiza (danshen) did not demonstrate the presence of any adverse effects. There were no changes in the pharmacokinetic profile of aromatase inhibitor drugs in coadministration with vitamin D3 and calcium. However, the administration of vitamin E, DIM and Undaria pinnatifida (wakame) was associated with alterations in the pharmacokinetic profile of tamoxifen and its metabolites. Administration of green tea did not alter the pharmacokinetics of tamoxifen. Discussion: During the analysis of the results, some inconsistencies were found, namely in studies carried out under identical conditions and which reported different results, and in the evaluation of drug interactions by evaluating the pharmacokinetic parameters, it was not carried out with the best methodological quality in order to avoid risk of bias. Conclusion: The use of food supplements and/or herbal medicine should be controlled, continuously and extensively evaluated through further clinical studies.
Background: Approximately 80% of breast cancers in premenopausal women are positive for hormone receptors for estrogen and progesterone, proving to be susceptible to endocrine therapy, also called hormone therapy. Hormonotherapy therapeutic regimens are associated with prolonged dosage regimens, generally between 5 to 10 years, and the appearance of toxic effects that can affect the patient’s quality of life and health. The use of alternative and complementary treatment methodologies has suggested benefits in reducing the effects induced by hormone therapy and, therefore, its use has been increasing in patients with hormone-sensitive breast cancer. However, the available evidence on the safety of combining these methodologies with hormone therapy is scarce and limited, especially with regard to possible adverse events with herbal products and dietary supplements, which can interfere with the pharmacokinetics of drugs. Objectives: Elaboration of a systematic review that gathers scientific evidence of potential adverse events associated with the combination of herbal products and dietary supplements with hormone therapy in breast cancer patients, including safety, tolerability and interference in its efficacy. Methodology: The databases used for the research of clinical studies were Pubmed, Web of Science, Scielo and ClinicalTrials.gov. Randomized controlled clinical studies, cohort and case-control studies, observational studies without control groups, systematic reviews of clinical studies, meta-analyses and cross-sectional studies were included. Results: The search resulted in a total of 302 articles, of which 19 articles met the eligibility criteria for inclusion. The literature review of some excluded articles resulted in the inclusion of 10 additional articles. With regard to food supplements, vitamin D3 in combination with calcium, essential fatty acids, magnesium oxide, Undaria pinnatifida (wakame) and vitamin B12 were supplements used simultaneously with aromatase inhibitors and reported good tolerance and safety. Glucosamine sulfate and chondroitin sulfate were associated with minor adverse effects. In tamoxifen therapy, the dietary supplements used were diindolylmethane (DIM), magnesium oxide, vitamin E, soy supplement and Yunzhi (Coriolus versicolor), with no reference to significant adverse effects. Regarding herbal medicine, Cimicifuga racemosa (black cohosh) extract in combination with tamoxifen was associated with severe to minor adverse effects, and Camellia sinensis (green tea) with low severity effects. Salvia miltiorrhiza (danshen) did not demonstrate the presence of any adverse effects. There were no changes in the pharmacokinetic profile of aromatase inhibitor drugs in coadministration with vitamin D3 and calcium. However, the administration of vitamin E, DIM and Undaria pinnatifida (wakame) was associated with alterations in the pharmacokinetic profile of tamoxifen and its metabolites. Administration of green tea did not alter the pharmacokinetics of tamoxifen. Discussion: During the analysis of the results, some inconsistencies were found, namely in studies carried out under identical conditions and which reported different results, and in the evaluation of drug interactions by evaluating the pharmacokinetic parameters, it was not carried out with the best methodological quality in order to avoid risk of bias. Conclusion: The use of food supplements and/or herbal medicine should be controlled, continuously and extensively evaluated through further clinical studies.
Description
Keywords
Cancro da mama Hormonoterapia Fitoterapia Suplementos alimentares Interações medicamentosas Eventos adversos Inibidores de aromatase Tamoxifeno Breast cancer Hormone therapy Herbal medicine Dietary supplements Drug interactions Events effects Aromatase inhibitors Tamoxifen