Estudo comparativo, randomizado para avaliar a eficÃcia terapÃutica da Mentha crispa e do secnidazol no tratamento da tricomonÃase / Trichomoniasis is a non-viral sexually transmitted disease most common in the world. The current treatment of this disease includes the use of several drugs, including herbal remedies formulated with Mentha crispa have also been used as protozoan The aim of this study was to evaluate the efficacy and safety of herbal medicine containing Mentha crispa in patients with vaginal trichomoniasis. The study was a randomized clinical trial, parallel and opened. It included 60 female volunteers, 35 from Fortaleza - Ceara and 25 from Sinop - Mato Grosso, who had stool examination of vaginal discharge positive for trichomoniasis. Patients were randomly distributed in two treatment groups, the Mentha crispa group and the Secnidazole group. Both groups were composed of 30 volunteers, in which, respectively, 2 tablets of 12 mg of herbal Giamebil and 2 tablets 1000mg Secnidal  were orally administered in single dose. The clinical trial consisted of three steps: pretreatment, treatment and post-treatment. To significance level of 5%, no difference was found between the groups (P = 0.6120), because the proportion of volunteers with no T.vaginalis in the Secnidazole group was 96.67% and the proportion found in the Mentha crispa group was 90.00%. Secondary endpoints for the evaluation of the effectiveness of Mentha crispa in the treatment of trichomoniasis were the improvement of clinical complaints: vaginal discharge, unpleasant odor, genital burning, dysuria, dyspareunia, pelvic pain and itching. It has not been demonstrated statistically significant difference (P = 0 , 4583) between the treatments in the proportion of patients who reported no such complaints. The drugs were considered well tolerated, as no voluntary needed additional pharmacological intervention in order to control or eradicate such discomfort. Therefore, adverse events were assessed as being mild, manifesting itself only once and having spontaneous remission. However, adverse effects were significantly higher (P = 0.0006) in the Secnidazole group (66.67%) than those found in the Mentha crispa group (20.00%). Adverse events reported by volunteers Secnidazole group were nausea (16.67%), the unpleasant odor in the urine (3.33%) and metallic taste, that was cited by 50% of patients and it showed a statistically significant difference between the treatment groups (P <0.001). The referred events by the volunteers of the Mentha crispa group were: epigastric pain, nausea, vomiting and headache reported by 3.33%, while unpleasant taste was mentioned by 6.67%. No signs of clinical toxicity was observed during treatment. This trial concluded that the herbal medicine containing Mentha crispa showed efficacy and safety when used orally at a dose of 24mg, presenting itself as an alternative therapy safe, effective, accessible and with quality for treatment in patients with trichomoniasis.

Description

CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior / TricomonÃase à a doenÃa sexualmente transmissÃvel nÃo-viral mais comum no mundo. O tratamento atual dessa patologia compreende o uso de vÃrios fÃrmacos, inclusive fitoterÃpicos formulados com Mentha crispa tambÃm tÃm sido empregados como antiprotozoÃrios. O objetivo desse estudo foi avaliar a eficÃcia terapÃutica e a seguranÃa do fitoterÃpico contendo Mentha crispa (GiamebilÂ) em pacientes com tricomonÃase vaginal. O estudo realizado foi um ensaio clÃnico do tipo randomizado, paralelo e aberto com 60 voluntÃrias do sexo feminino, sendo 35 procedentes de Fortaleza/Cearà e 25 da cidade de Sinop/Mato Grosso, que apresentaram exame parasitolÃgico positivo da secreÃÃo vaginal para tricomonÃase. As pacientes foram distribuÃdas aleatoriamente em dois grupos de tratamento, o grupo Mentha crispa e o grupo Secnidazol, ambos compostos de 30 voluntÃrias, os quais foram administrados por via oral, respectivamente, 2 comprimidos de 12 mg de Giamebil e 2 comprimidos de 1000 mg de SecnidalÂ, em dose Ãnica. O ensaio clÃnico foi constituÃdo de trÃs etapas: prÃ-tratamento, tratamento e pÃs-tratamento. Ao nÃvel de significÃncia de 5%, nÃo se constatou diferenÃa estatÃstica entre os grupos (P=0,6120), pois a proporÃÃo de voluntÃrias com ausÃncia de T.vaginalis no grupo Secnidazol foi de 96,67% e a verificada no grupo Mentha crispa foi de 90,00%. Os desfechos secundÃrios para a avaliaÃÃo da eficÃcia da Mentha crispa no tratamento da tricomonÃase foram a melhora das queixas clÃnicas: corrimento vaginal, odor desagradÃvel, ardor genital, disÃria, dispareunia, prurido e dor pÃlvica. NÃo foi demonstrada diferenÃa estatisticamente significante (P=0,4583) entre os tratamentos em relaÃÃo à proporÃÃo de pacientes que relataram ausÃncia dessas queixas. Os medicamentos foram considerados bem tolerados, pois nenhuma voluntÃria necessitou intervenÃÃo farmacolÃgica adicional no intuito de controlar ou debelar tal desconforto. Portanto, os eventos adversos foram avaliados como sendo de intensidade leve, manifestando-se uma Ãnica vez e com remissÃo espontÃnea. Entretanto, os efeitos adversos foram significativamente maiores (P = 0,0006) no grupo Secnidazol (66,67%) do que os verificados no grupo Mentha crispa (20,00%). Os eventos adversos relatados pelas voluntÃrias do grupo Secnidazol foram: nÃusea (16,67%), odor desagradÃvel na urina (3,33%) e gosto metÃlico, sendo que esse citado por 50% das pacientes evidenciou diferenÃa estatisticamente significante entre os grupos de tratamento (P <0,001). Os eventos referidos pelas voluntÃrias do grupo Mentha crispa foram: epigastralgia, nÃusea, vÃmito e cefalÃia referidos por 3,33%, enquanto gosto desagradÃvel foi mencionado por 6,67%. Nenhum sinal de toxicidade clÃnica foi observado no perÃodo de tratamento. O presente ensaio clÃnico concluiu que o fitoterÃpico contendo Mentha crispa apresentou eficÃcia terapÃutica e seguranÃa quando empregado por via oral na dose Ãnica de 24mg, apresentando-se como uma alternativa terapÃutica segura, eficaz, acessÃvel e de qualidade para o tratatamento de pacientes com tricomonÃase. / Trichomoniasis is a non-viral sexually transmitted disease most common in the world. The current treatment of this disease includes the use of several drugs, including herbal remedies formulated with Mentha crispa have also been used as protozoan The aim of this study was to evaluate the efficacy and safety of herbal medicine containing Mentha crispa in patients with vaginal trichomoniasis. The study was a randomized clinical trial, parallel and opened. It included 60 female volunteers, 35 from Fortaleza - Ceara and 25 from Sinop - Mato Grosso, who had stool examination of vaginal discharge positive for trichomoniasis. Patients were randomly distributed in two treatment groups, the Mentha crispa group and the Secnidazole group. Both groups were composed of 30 volunteers, in which, respectively, 2 tablets of 12 mg of herbal Giamebil and 2 tablets 1000mg Secnidal  were orally administered in single dose. The clinical trial consisted of three steps: pretreatment, treatment and post-treatment. To significance level of 5%, no difference was found between the groups (P = 0.6120), because the proportion of volunteers with no T.vaginalis in the Secnidazole group was 96.67% and the proportion found in the Mentha crispa group was 90.00%. Secondary endpoints for the evaluation of the effectiveness of Mentha crispa in the treatment of trichomoniasis were the improvement of clinical complaints: vaginal discharge, unpleasant odor, genital burning, dysuria, dyspareunia, pelvic pain and itching. It has not been demonstrated statistically significant difference (P = 0 , 4583) between the treatments in the proportion of patients who reported no such complaints. The drugs were considered well tolerated, as no voluntary needed additional pharmacological intervention in order to control or eradicate such discomfort. Therefore, adverse events were assessed as being mild, manifesting itself only once and having spontaneous remission. However, adverse effects were significantly higher (P = 0.0006) in the Secnidazole group (66.67%) than those found in the Mentha crispa group (20.00%). Adverse events reported by volunteers Secnidazole group were nausea (16.67%), the unpleasant odor in the urine (3.33%) and metallic taste, that was cited by 50% of patients and it showed a statistically significant difference between the treatment groups (P <0.001). The referred events by the volunteers of the Mentha crispa group were: epigastric pain, nausea, vomiting and headache reported by 3.33%, while unpleasant taste was mentioned by 6.67%. No signs of clinical toxicity was observed during treatment. This trial concluded that the herbal medicine containing Mentha crispa showed efficacy and safety when used orally at a dose of 24mg, presenting itself as an alternative therapy safe, effective, accessible and with quality for treatment in patients with trichomoniasis.

Links & Downloads

1. http://www.teses.ufc.br/tde_busca/arquivo.php?codArquivo=4054

Tags

FitoterÃpico

Mentha crispa

Trichomoniasis

Clinical Trials

Efficacy

Drug

phytoterapic

Mentha crispa

FARMACOLOGIA

Additional Fields

Identifer	oai:union.ndltd.org:IBICT/oai:www.teses.ufc.br:3167
Date	25 January 2010
Creators	PacÃfica Pinheiro Cavalcanti
Contributors	Maria Elisabete Amaral de Moraes, JanaÃna Serra Azul Monteiro Evangelista, Gilmara Silva de Melo Santana, SilvÃnia Maria Mendes Vasconcelos, Mirna Marques Bezerra
Publisher	Universidade Federal do CearÃ, Programa de PÃs-GraduaÃÃo em Farmacologia, UFC, BR
Source Sets	IBICT Brazilian ETDs
Language	Portuguese
Detected Language	English
Type	info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/doctoralThesis
Format	application/pdf
Source	reponame:Biblioteca Digital de Teses e Dissertações da UFC, instname:Universidade Federal do Ceará, instacron:UFC
Rights	info:eu-repo/semantics/openAccess