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

• Published in: Clinical and experimental gastroenterology Vol. 12; pp. 21 - 30
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: New Zealand Dove Medical Press Limited 01.01.2019; Taylor & Francis Ltd; Dove Medical Press
• Subjects: Amoxicillin; Analysis; Care and treatment; Clinical trials; Coconut oil; Double-blind studies; Drug therapy, Combination; duodenitis; Endoscopy; Fatty acids; gastritis; Gastroenterology; Gastrointestinal diseases; Health risk assessment; Infections; Medical research; Medicine; ocimum sanctum oil; Original Research; Peptic ulcer; peptic ulcer disease; Pharmaceuticals; Rabeprazole; syferol; Teaching hospitals; triple therapy; Ulcers; virgin coconut oil; Nigeria; triple therapy; duodenitis; Ocimum sanctum oil; Pylorest; gastric ulcer; gastritis; virgin coconut oil
• ISSN: 1178-7023; 1178-7023
• DOI: 10.2147/CEG.S178179

To our knowledge, there is no prior randomized study on the utility of Syferol-IHP (blend of virgin coconut oil and oil) when coadministered with a triple therapy schedule. This study determined the efficacy and safety of Syferol-IHP as adjunct to conventional triple therapy for the treatment of peptic ulcer disease (PUD). 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 . Secondary outcome measures were the disappearance of epigastric pain, gastritis, and duodenitis. Analysis was by intention-to-treat. 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, =0.048) but not for duodenal ulcer (RR=0.400, 95% CI=0.07-2.37, =0.241). eradication was 100% with Syferol-IHP vs 50% with placebo ( =0.066). Epigastric pain (reduction to 16.2% vs 43.5%; =0.021), gastritis (reduction to 13.5% vs 39.1%; = 0.024), and duodenitis (reduction to 0% vs 8.7%; =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, =0.937) and laboratory parameters were not significantly different pre- and posttherapies ( >0.05, for both groups). 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.