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Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial

BACKGROUND: To our knowledge, there is no prior randomized study on the utility of Syferol-IHP (blend of virgin coconut oil and Ocimum sanctum oil) when coadministered with a triple therapy schedule. AIM: This study determined the efficacy and safety of Syferol-IHP as adjunct to conventional triple...

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Autores principales: Eleje, George Uchenna, Ogbunugafor, Henrietta Aritetsoma, Emegoakor, Chiemelu Dickson, Okoye, Ebere Innocent, Ezejiofor, Ogochukwu Ifeanyi, Chukwurah, Shirley Nneka, Ikechebelu, Joseph Ifeanyichukwu, Nchinda, Godwin W, Ugochukwu, Chidozie Godwin, Nnaji-Ihedinmah, Lucy Ijeoma, Okoye, Festus Basden C, Eneh, Frank Uchenna, Onwukamuche, Michael Emeka, Esimone, Charles Okechukwu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6338118/
https://www.ncbi.nlm.nih.gov/pubmed/30679917
http://dx.doi.org/10.2147/CEG.S178179
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author Eleje, George Uchenna
Ogbunugafor, Henrietta Aritetsoma
Emegoakor, Chiemelu Dickson
Okoye, Ebere Innocent
Ezejiofor, Ogochukwu Ifeanyi
Chukwurah, Shirley Nneka
Ikechebelu, Joseph Ifeanyichukwu
Nchinda, Godwin W
Ugochukwu, Chidozie Godwin
Nnaji-Ihedinmah, Lucy Ijeoma
Okoye, Festus Basden C
Eneh, Frank Uchenna
Onwukamuche, Michael Emeka
Esimone, Charles Okechukwu
author_facet Eleje, George Uchenna
Ogbunugafor, Henrietta Aritetsoma
Emegoakor, Chiemelu Dickson
Okoye, Ebere Innocent
Ezejiofor, Ogochukwu Ifeanyi
Chukwurah, Shirley Nneka
Ikechebelu, Joseph Ifeanyichukwu
Nchinda, Godwin W
Ugochukwu, Chidozie Godwin
Nnaji-Ihedinmah, Lucy Ijeoma
Okoye, Festus Basden C
Eneh, Frank Uchenna
Onwukamuche, Michael Emeka
Esimone, Charles Okechukwu
author_sort Eleje, George Uchenna
collection PubMed
description BACKGROUND: To our knowledge, there is no prior randomized study on the utility of Syferol-IHP (blend of virgin coconut oil and Ocimum sanctum oil) when coadministered with a triple therapy schedule. AIM: This study determined the efficacy and safety of Syferol-IHP as adjunct to conventional triple therapy for the treatment of peptic ulcer disease (PUD). METHODS: A pilot double-blind randomized trial was conducted in patients with confirmed diagnosis (endoscopy-guided biopsy) of PUD. Eligible patients were randomized to Pylorest (a three-in-one tablet containing rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg) and Syferol-IHP for 2 weeks, followed by rabeprazole and Syferol-IHP for 2 weeks or Pylorest and placebo for 2 weeks, followed by rabeprazole and placebo for 2 weeks. Repeat endoscopy-guided biopsy and histology were done 4 weeks posttherapy. Primary outcome measures were the healing of ulcer and eradication of Helicobacter pylori. Secondary outcome measures were the disappearance of epigastric pain, gastritis, and duodenitis. Analysis was by intention-to-treat. RESULTS: Of the 63 patients enrolled, 60 patients had complete evaluation, with 37 patients receiving Pylorest and Syferol-IHP and 23 patients receiving Pylorest and Placebo. Healing of the PUD in favor of Pylorest and Syferol-IHP was significantly higher for gastric ulcer (RR=0.000, 95% CI=undefined, P=0.048) but not for duodenal ulcer (RR=0.400, 95% CI=0.07–2.37, P=0.241). H. pylori eradication was 100% with Syferol-IHP vs 50% with placebo (P=0.066). Epigastric pain (reduction to 16.2% vs 43.5%; P=0.021), gastritis (reduction to 13.5% vs 39.1%; P = 0.024), and duodenitis (reduction to 0% vs 8.7%; P=0.327) were observed in the Syferol-IHP and Pylorest vs placebo and Pylorest groups, respectively. Adverse events (RR=0.971, 95% CI=0.46–2.04, P=0.937) and laboratory parameters were not significantly different pre- and posttherapies (P>0.05, for both groups). CONCLUSION: Although both treatment arms were equally safe, co-administration of Syferol-IHP and triple therapy is more efficacious than triple therapy alone for treating PUD. Pan African Clinical trial registry identifier number is PACTR201606001665364.
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spelling pubmed-63381182019-01-24 Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial Eleje, George Uchenna Ogbunugafor, Henrietta Aritetsoma Emegoakor, Chiemelu Dickson Okoye, Ebere Innocent Ezejiofor, Ogochukwu Ifeanyi Chukwurah, Shirley Nneka Ikechebelu, Joseph Ifeanyichukwu Nchinda, Godwin W Ugochukwu, Chidozie Godwin Nnaji-Ihedinmah, Lucy Ijeoma Okoye, Festus Basden C Eneh, Frank Uchenna Onwukamuche, Michael Emeka Esimone, Charles Okechukwu Clin Exp Gastroenterol Original Research BACKGROUND: To our knowledge, there is no prior randomized study on the utility of Syferol-IHP (blend of virgin coconut oil and Ocimum sanctum oil) when coadministered with a triple therapy schedule. AIM: This study determined the efficacy and safety of Syferol-IHP as adjunct to conventional triple therapy for the treatment of peptic ulcer disease (PUD). METHODS: A pilot double-blind randomized trial was conducted in patients with confirmed diagnosis (endoscopy-guided biopsy) of PUD. Eligible patients were randomized to Pylorest (a three-in-one tablet containing rabeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg) and Syferol-IHP for 2 weeks, followed by rabeprazole and Syferol-IHP for 2 weeks or Pylorest and placebo for 2 weeks, followed by rabeprazole and placebo for 2 weeks. Repeat endoscopy-guided biopsy and histology were done 4 weeks posttherapy. Primary outcome measures were the healing of ulcer and eradication of Helicobacter pylori. Secondary outcome measures were the disappearance of epigastric pain, gastritis, and duodenitis. Analysis was by intention-to-treat. RESULTS: Of the 63 patients enrolled, 60 patients had complete evaluation, with 37 patients receiving Pylorest and Syferol-IHP and 23 patients receiving Pylorest and Placebo. Healing of the PUD in favor of Pylorest and Syferol-IHP was significantly higher for gastric ulcer (RR=0.000, 95% CI=undefined, P=0.048) but not for duodenal ulcer (RR=0.400, 95% CI=0.07–2.37, P=0.241). H. pylori eradication was 100% with Syferol-IHP vs 50% with placebo (P=0.066). Epigastric pain (reduction to 16.2% vs 43.5%; P=0.021), gastritis (reduction to 13.5% vs 39.1%; P = 0.024), and duodenitis (reduction to 0% vs 8.7%; P=0.327) were observed in the Syferol-IHP and Pylorest vs placebo and Pylorest groups, respectively. Adverse events (RR=0.971, 95% CI=0.46–2.04, P=0.937) and laboratory parameters were not significantly different pre- and posttherapies (P>0.05, for both groups). CONCLUSION: Although both treatment arms were equally safe, co-administration of Syferol-IHP and triple therapy is more efficacious than triple therapy alone for treating PUD. Pan African Clinical trial registry identifier number is PACTR201606001665364. Dove Medical Press 2019-01-15 /pmc/articles/PMC6338118/ /pubmed/30679917 http://dx.doi.org/10.2147/CEG.S178179 Text en © 2019 Eleje et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Eleje, George Uchenna
Ogbunugafor, Henrietta Aritetsoma
Emegoakor, Chiemelu Dickson
Okoye, Ebere Innocent
Ezejiofor, Ogochukwu Ifeanyi
Chukwurah, Shirley Nneka
Ikechebelu, Joseph Ifeanyichukwu
Nchinda, Godwin W
Ugochukwu, Chidozie Godwin
Nnaji-Ihedinmah, Lucy Ijeoma
Okoye, Festus Basden C
Eneh, Frank Uchenna
Onwukamuche, Michael Emeka
Esimone, Charles Okechukwu
Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
title Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
title_full Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
title_fullStr Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
title_full_unstemmed Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
title_short Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
title_sort efficacy and safety of syferol-ihp for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6338118/
https://www.ncbi.nlm.nih.gov/pubmed/30679917
http://dx.doi.org/10.2147/CEG.S178179
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