Abstract
Cissampelos sympodialis Eichler, Menispermaceae, is widely used by Indian tribes and folk medicine to treat various inflammatory disorders, including asthma. Clinical toxicological trials were made with the tea of C sympodialis, a medicinal plant. The study took place at Lauro Wanderley Hospital/UFPB-PB, where seventeen healthy volunteers were chosen, among those six men and eleven women who orally ingested, during four weeks uninterruptedly, 150 ml of the tea, once a day. Before the first ingestion and after the last one, the participants were subjected to clinical and laboratorial tests for their overall conditions in order to analyze the toxicity of the plant. The results demonstrated that the volunteers neither experience clinical nor laboratorial alterations, as well as no significant adverse effects, apart from little change detected in their hematological tests. Nevertheless, none demonstrated any pathological conditions, just alterations of the normal human being physiology. Therefore, it is concluded that these data complement that obtained during pre-clinical studies and confirm a low toxicity of this plant.
Article PDF
Similar content being viewed by others
Avoid common mistakes on your manuscript.
References
Agra, M.F., Freitas, P.F., Barbosa-Filho, J.M., 2007a. Synopsis of the plants known as medicinal and poisonous in Northeast of Brazil. Rev. Bras. Farmacogn. 17, 114–140.
Agra, M.F., Nurit-Silva, K., Baracho, G.S., Basilio, I.J.L.D., 2007b. Estudo fama-cobotânico de folhas de Nicotiana glauca (Solanaceae). Lat. Am. J. Pharm. 26, 499–506.
Anvisa, 2010. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. Resolução RDC n° 10, de 9 de março de 2010. Dispõe sobre a notificação de drogas vegetais junto à Agência Nacional de Vigilância Sanitáriae dá outras providências. Diário Oficial da União, Brasília, DF.
Aragão, C.F.S., 2002. Desenvolvimento de metodologias analíticas para padronização de extratos de Cissampelos sympodialis Eichl(Milona). Tese de doutorado, Programa de Pós-graduação em Produtos Naturais e Sintéticos Bioativos. Universidade Federal da Paraíba, João Pessoa, 210p.
Barbosa-Filho, J.M., Agra, M.F., Thomas, G., 1997. Botanical, chemical and pharmacological investigation on C. sympodialis from Paraíba (Brazil). Cienc. Cult. 49, 386–394.
Baranowski, R., Małek, L., Prokopowicz, D., Spiewak, M., Miśko, J., 2012. Electrocardiographic diagnosis of the left ventricular hypertrophy in patients with left bundle branch block: is it necessary to verify old criteria? Cardiol. J. 19, 591–596.
Bezerra-Santos, C.R., Balestieri, F.M., Rossi-Bergmann, B., Peçanha, L.M.T., Piuvezam, M.R., 2004. Cissampelos sympodialis Eichl. (Menisperma-ceae): oral treatment decreases Ige levels and induces a Thl-skewed cytokine production in ovalbumin-sensitized mice. J. Ethnopharmacol. 95, 191–197.
Bezerra-Santos, C.R., Vieira-de-Abreu, A., Vieira, G.C., Ribeiro-Filho, J., Barbosa-Filho, J.M., Pires, A.L., Martins, M.A., Souza, H.S., Bandeira-Melo, C., Bozza, P.T., Piuvezam, M.R., 2012. Effectiveness of Cissampelos sympodialis and its isolated alkaloid warifteine in airway hyperreactivity and lung remodeling in a mouse model of asthma. Int. Immunopharmacol. 13, 148–155.
Bunchorntavakul, C., Reddy, K.R., 2013. Review article: herbal and dietary supplement hepatotoxicity. Aliment. Pharmacol. Ther. 37, 3–17.
Cardoso, E., Martins, I.S., Fornari, L., Monachini, M.C., Mansur, A.P., Caramelli, B., 2002. Alterações eletrocardiográficas e sua relação com os fatores de risco para doença isquêmica do coração em população da área metropolitana de São Paulo. Rev. Assoc. Med. Bras. 48, 231–236.
Cavalcanti, A.C., Melo, I.C.A.R., Medeiros, A.F.D., Neves, M.V.M., Pereira, A.N., Oliveira, E.J., 2013. Studies with Cissampelos sympodialis: the search towards the scientific validation of a traditional Brazilian medicine used for the treatment of asthma. Rev. Bras. Farmacogn. 23, 527–541.
CNS, 1997. Ministério da Saúde, Conselho Nacional de Saúde. Resolução n° 251, de 7 de agosto de 1997. Contempla a norma complementar para a área temática especial de novos fármacos, vacinas e testes diagnósticos. Diário Oficial da União, Brasília, DF.
CNS, 2012. Ministério da Saúde, Conselho Nacional de Saúde. Resolução n° 466, de 12 de dezembro de 2012. Aprova as normas regulamentadoras de pesquisas envolvendo seres humanos. Diário Oficial da União, Brasília, DF.
Costa, H.F., Bezerra-Santos, C.R., Barbosa- Filho, J.M., Martins, M.A., Piuvezam, M.R., 2008. Warifteine, a bisbenzylisoquinoline alkaloid, decreases immediate allergic and thermal hyperalgesic reactions in sensitized animals. Int. Immunopharmacol. 8, 519–525.
Chen, L., Zhong, N., Lai, K., 2013. Re-challenge with ovalbumin failed to induce bronchial asthma in mice with eosinophilic bronchitis. PLOS ONE 8, e75195.
De Smet, P.A., 2004. Health risks of herbal remedies: an update. Clin. Pharmacol. Ther. 76, 1–17.
Diniz, M.F.F.M., 2000. Ensaios toxicológicos pré-clínicos com as folhas de Cissampelos sympodialis Eichl (Menispermaceae). Tese de doutorado, Programa de Pós-graduação em Produtos Naturais e Sintéticos Bioativos. Universidade Federal da Paraíba, João Pessoa.
Dasgupta, A., Neighbour, H., Nair, P., 2013. Targeted therapy of bronchitis in obstructive air way diseases. Pharmacol. Ther. 140, 213–222.
Edwards, I.R., Aronson, J.K., 2000. Adverse drug reactions: definitions, diagnosis, and management. Lancet 356, 1255–1259.
Hampton, J., 2011. ECG na prática. Elsevier, Brasil.
Hoffbrand, A.V., Moss, J.E., 2013. Fundamentos em hematologia. Artmed, Porto Alegre.
Marinho, A.F., Barbosa-Filho, J.M., Oliveira, E.J., 2012. A validated method for the simultaneous quantitation of bioactive alkaloid markers in the leaf ethano-licextract of Cissampelos sympodialis Eichl: a phenological variation study. Phytochem. Anal. 23, 426–432.
Marinho, A.F., 2011. Caracterização dos marcadores, desenvolvimento e avaliação de método analítico aplicado ao estudo de sazonalidade e identificação de novos alcaloides de Cissampelos sympodialis. Tese de doutorado, Programa de Pós-graduação em Produtos Naturais e Sintéticos Bioativos. Universidade Federal da Paraíba, João Pessoa, 192p.
Matos, F.J.A., 1997. Introdução a Fitoquímica Experimental. Edições UFC, Fortaleza.
Mesia, K., Cimanga, K., Tona, L., Manpunza, M.M., Ntamabyaliro, N., Muanda, T., Muyembe, T., Totté, J., Met, T., Pieters, L., Vlientinck, A., 2011. Assessment of the short-term safety and tolerability of a quantified 80% ethanol extract from the stem bark of Naucleapobeguinii (PR 259 CT1) in healthy volunteers: a clinical phase I study. Planta Med. 77, 111–116.
Moffa, P.J., Sanches, P.C.R., 2001. Eletrocardiograma: normal e patológico. Roca, (Sério InCor) São Paulo.
Musso, A., Catellani, S., Canevali, P., Tavella, S., Vene, R., Boero, S., Pierri, I., Gobbi, M., Kunkl, A., Ravetti, J.L., Zocchi, M.R., Poggi, A., 2014. Amino bisphosphonates prevent the inhibitory effects exerted by lymph node stromal cell sonanti-tumor V8 2T lymphocytes in non-Hodgkin lymphomas. Haematologica 99, 131–139.
Owens, C., Baergen, R., Puckett, D., 2014. Online sources of herbal product information. Am. J. Med. 127, 109–115.
Paulo, P.T.C., Diniz, M.F.F.M., Medeiros, I.A., Morais, L.C.S.L., Andrade, F.B., Santos, H.B., 2009. Ensaios clínicos toxicológicos, fase I, de um fitoterápico composto (Schinus terebinthifolius Raddi, Plectranthus amboinicus Lour e Eucalyptusglobulus Labill). Rev. Bras. Farmacogn. 19, 68–76.
Piuvezam, M.R., Bezerra-Santos, C.R., Bozza, P.T., Melo, C.B., Vieira, G.C., Costa, H.F., 2012. Cissampelos sympodialis (Menispermaceae): a novel phytotherapic weapon against allergic diseases? In: Pereira, C. (Ed.), Allergic Diseases - Highlights in the Clinic, Mechanisms and Treatment. InTech, ISBN 978-953-51-0227-4, https://doi.org/10.5772/25739, Available from: http://www.intechopen.com/books/allergic-diseases-highlights-in-the-clinic-mechanisms-and-treatment/cissampelos-sympolialis-menispermaceae-a-novel-phytotherapic-weapon-against-allergic-diseases-
Ribeiro-Filho, J., Calheiros, A.S., Vieira-de-Abreu, A., Carvalho, K.I., Silva- Mendes, D., Melo, C.B., Martins, M.A., Silva- Dias, C., Piuvezam, M.R., Bozza, P.T., 2013. Toxicol. Appl. Pharmacol. 273, 19–26.
Ribeiro, S.M., Morceli, J., Gonçalves, R.S., Franco, R.J., Habermann, F., Meira, D.A., Matsubara, B.B., 2012. Accuracy of chest radiography plus electrocardiogram in diagnosis of hypertrophy in hypertension. Arq. Bras. Cardiol. 99, 825–833.
Rocha, J.D., Decoté-Ricardo, D., Redner, P., Lopes, U.C., Barbosa-Filho, J.M., Piuvezam, M.R., Arruda, L.B., Peçanha, L.M.T., 2010. Inhibitory effect of the alkaloid warifteine purified from Cissampelos sympodialis on B lymphocyte function in vitro and in vivo. Planta Med. 76, 325–330.
Spaan, A.N., Surewaard, B.C., Nijland, R., Strijp, J.A., 2013. Neutrophils versus Staphylococcus aureus: a biological tug of war. Annu. Rev. Microbiol 67, 629–650.
Sobrafo, 2011. Guia para Notificação de Reações Adversas em Oncología. In: Sociedade Brasileira de Farmacêuticos em Oncología. Conectfarma Publicações Científicas, São Paulo.
Vieira, G.C., De Lima, J.F., De Figuereido, R.C., Mascarenhas, S.R., Bezerra-Santos, C.R., Piuvezam, M.R., 2013. Inhaled Cissampelos sympodialis down-regulates airway allergic reaction by reducing lung CD3+T cells. Phytother. Res. 27, 916–925.
Zhao, J., Deng, J.W., Chen, Y.W., Li, S.P., 2013. Advanced phytochemical analysis of herbal tea in China. J. Chromatogr. A 1313, 2–23.
Author information
Authors and Affiliations
Contributions
LFBM (PhD student) main author, involved in the study design, conducted the interviews, field and laboratory work, literature review and general data collection, systematization and analysis, wrote the first draft this paper. LSNR and AIPAT, contributed to designing and following progress of the research and fieldwork. JAR and KMO, contributed to in achieving the laboratory test and data analyses. CFSA contributed to chromatographic analysis. VMVN contributed to cardiac monitoring and reports. ABL and CMBLL, contributed in writing the final version of this paper. MFFMD designed the study, supervised the laboratory work and contributed to critical reading the manuscript. All the authors have read the final manuscript and approved the submission.
Corresponding author
Ethics declarations
The authors declare no conflicts of interest.
Rights and permissions
This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
About this article
Cite this article
Mangueira, L.F.B., da Silva Nunes Ramalho, L., Lira, A.B. et al. Clinical safety evaluation of a tea containing Cissampelos sympodialis in healthy volunteers. Rev. Bras. Farmacogn. 25, 491–498 (2015). https://doi.org/10.1016/j.bjp.2015.06.009
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1016/j.bjp.2015.06.009