Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study

Detalhes bibliográficos
Autor(a) principal: Yakoot,Mostafa
Data de Publicação: 2009
Outros Autores: Salaam,M. Abdel
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Arquivos de gastroenterologia (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-28032009000300007
Resumo: OBJECTIVES: To determine the efficacy and safety of "healer" cream as monotherapy in the treatment of acute and chronic anal fissure. STUDY DESIGN: A prospective, randomized, single blinded, comparative trial. METHODS: Sixty patients suffering from anal fissure were included in the study. Patients were randomly divided into three groups: group A: treated with "healer" local cream application 3 times daily; group B: treated with nitroglycerine 0.25% local cream 3 times daily; group C: treated with a lidocaine 2% cream applied locally 3 times daily. All the followings were followed up and compared between groups. (1) Visual pain analogue score after defecation; (2) severity of straining and discomfort during defecation; (3) frequency of ulcer healed at 30 days; (4) any side effects or complications. RESULTS: The pain scoring after defecation was significantly reduced in the three treatment groups. The group treated with "healer" isosorbide-di-nitrate showed the greatest reduction of the visual pain analogue score median from 9 before treatment to 3 &amp; 1 after 10 and 20 days respectively, while the median visual pain analogue score in group B treated with nitroglycerine cream was 9 reduced to 4 &amp; 2 after 10 and 20 days respectively, and the median visual pain analogue score in lidocaine group only dropped from 9 to 6 and 4, respectively. The reduction of both pain scoring and defecation scoring with "healer" was statistically significantly greater than the other two treatments by Kruskal-Wallis test, P<0.001. The number of patients experiencing complete relief and passing stools easily after 10 days was significantly higher in "healer" group, by Pearson Chi square = 22.94, P<0.001. After 30 days, the fissures were healed in 18 (90%) of 20 patients in the "healer" group and in 12 (60%) of 20 in the nitroglycerin group, while only 6 (30%) of patients treated with lidocaine cream had their fissures healed by the 30 days treatment. Chi square = 15 (P = 0.001). CONCLUSION: "Healer" is a promising effective and safe line of treatment in acute and chronic anal fissure. The characteristic pharmacokinetics of isosorbide-di-nitrate leads to a better effect than nitroglycerin in healing (more prolonged action). Also the less fast absorption than nitroglycerin leading to a smoother dose concentration curve, may be the cause that headache is less frequent and less severe in "healer" treatment versus nitroglycerin.
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spelling Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative studyFissure in anoIsosorbide dinitrateRutinOBJECTIVES: To determine the efficacy and safety of "healer" cream as monotherapy in the treatment of acute and chronic anal fissure. STUDY DESIGN: A prospective, randomized, single blinded, comparative trial. METHODS: Sixty patients suffering from anal fissure were included in the study. Patients were randomly divided into three groups: group A: treated with "healer" local cream application 3 times daily; group B: treated with nitroglycerine 0.25% local cream 3 times daily; group C: treated with a lidocaine 2% cream applied locally 3 times daily. All the followings were followed up and compared between groups. (1) Visual pain analogue score after defecation; (2) severity of straining and discomfort during defecation; (3) frequency of ulcer healed at 30 days; (4) any side effects or complications. RESULTS: The pain scoring after defecation was significantly reduced in the three treatment groups. The group treated with "healer" isosorbide-di-nitrate showed the greatest reduction of the visual pain analogue score median from 9 before treatment to 3 &amp; 1 after 10 and 20 days respectively, while the median visual pain analogue score in group B treated with nitroglycerine cream was 9 reduced to 4 &amp; 2 after 10 and 20 days respectively, and the median visual pain analogue score in lidocaine group only dropped from 9 to 6 and 4, respectively. The reduction of both pain scoring and defecation scoring with "healer" was statistically significantly greater than the other two treatments by Kruskal-Wallis test, P<0.001. The number of patients experiencing complete relief and passing stools easily after 10 days was significantly higher in "healer" group, by Pearson Chi square = 22.94, P<0.001. After 30 days, the fissures were healed in 18 (90%) of 20 patients in the "healer" group and in 12 (60%) of 20 in the nitroglycerin group, while only 6 (30%) of patients treated with lidocaine cream had their fissures healed by the 30 days treatment. Chi square = 15 (P = 0.001). CONCLUSION: "Healer" is a promising effective and safe line of treatment in acute and chronic anal fissure. The characteristic pharmacokinetics of isosorbide-di-nitrate leads to a better effect than nitroglycerin in healing (more prolonged action). Also the less fast absorption than nitroglycerin leading to a smoother dose concentration curve, may be the cause that headache is less frequent and less severe in "healer" treatment versus nitroglycerin.Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia e Outras Especialidades - IBEPEGE. 2009-09-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-28032009000300007Arquivos de Gastroenterologia v.46 n.3 2009reponame:Arquivos de gastroenterologia (Online)instname:Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologiainstacron:IBEPEGE10.1590/S0004-28032009000300007info:eu-repo/semantics/openAccessYakoot,MostafaSalaam,M. Abdeleng2009-10-28T00:00:00Zoai:scielo:S0004-28032009000300007Revistahttp://www.scielo.br/aghttps://old.scielo.br/oai/scielo-oai.php||secretariaarqgastr@hospitaligesp.com.br1678-42190004-2803opendoar:2009-10-28T00:00Arquivos de gastroenterologia (Online) - Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologiafalse
dc.title.none.fl_str_mv Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
title Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
spellingShingle Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
Yakoot,Mostafa
Fissure in ano
Isosorbide dinitrate
Rutin
title_short Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
title_full Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
title_fullStr Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
title_full_unstemmed Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
title_sort Study of efficacy and safety of a new local cream ("healer") in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study
author Yakoot,Mostafa
author_facet Yakoot,Mostafa
Salaam,M. Abdel
author_role author
author2 Salaam,M. Abdel
author2_role author
dc.contributor.author.fl_str_mv Yakoot,Mostafa
Salaam,M. Abdel
dc.subject.por.fl_str_mv Fissure in ano
Isosorbide dinitrate
Rutin
topic Fissure in ano
Isosorbide dinitrate
Rutin
description OBJECTIVES: To determine the efficacy and safety of "healer" cream as monotherapy in the treatment of acute and chronic anal fissure. STUDY DESIGN: A prospective, randomized, single blinded, comparative trial. METHODS: Sixty patients suffering from anal fissure were included in the study. Patients were randomly divided into three groups: group A: treated with "healer" local cream application 3 times daily; group B: treated with nitroglycerine 0.25% local cream 3 times daily; group C: treated with a lidocaine 2% cream applied locally 3 times daily. All the followings were followed up and compared between groups. (1) Visual pain analogue score after defecation; (2) severity of straining and discomfort during defecation; (3) frequency of ulcer healed at 30 days; (4) any side effects or complications. RESULTS: The pain scoring after defecation was significantly reduced in the three treatment groups. The group treated with "healer" isosorbide-di-nitrate showed the greatest reduction of the visual pain analogue score median from 9 before treatment to 3 &amp; 1 after 10 and 20 days respectively, while the median visual pain analogue score in group B treated with nitroglycerine cream was 9 reduced to 4 &amp; 2 after 10 and 20 days respectively, and the median visual pain analogue score in lidocaine group only dropped from 9 to 6 and 4, respectively. The reduction of both pain scoring and defecation scoring with "healer" was statistically significantly greater than the other two treatments by Kruskal-Wallis test, P<0.001. The number of patients experiencing complete relief and passing stools easily after 10 days was significantly higher in "healer" group, by Pearson Chi square = 22.94, P<0.001. After 30 days, the fissures were healed in 18 (90%) of 20 patients in the "healer" group and in 12 (60%) of 20 in the nitroglycerin group, while only 6 (30%) of patients treated with lidocaine cream had their fissures healed by the 30 days treatment. Chi square = 15 (P = 0.001). CONCLUSION: "Healer" is a promising effective and safe line of treatment in acute and chronic anal fissure. The characteristic pharmacokinetics of isosorbide-di-nitrate leads to a better effect than nitroglycerin in healing (more prolonged action). Also the less fast absorption than nitroglycerin leading to a smoother dose concentration curve, may be the cause that headache is less frequent and less severe in "healer" treatment versus nitroglycerin.
publishDate 2009
dc.date.none.fl_str_mv 2009-09-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-28032009000300007
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-28032009000300007
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/S0004-28032009000300007
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia e Outras Especialidades - IBEPEGE.
publisher.none.fl_str_mv Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia e Outras Especialidades - IBEPEGE.
dc.source.none.fl_str_mv Arquivos de Gastroenterologia v.46 n.3 2009
reponame:Arquivos de gastroenterologia (Online)
instname:Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia
instacron:IBEPEGE
instname_str Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia
instacron_str IBEPEGE
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reponame_str Arquivos de gastroenterologia (Online)
collection Arquivos de gastroenterologia (Online)
repository.name.fl_str_mv Arquivos de gastroenterologia (Online) - Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia
repository.mail.fl_str_mv ||secretariaarqgastr@hospitaligesp.com.br
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