Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
Efficacy and safety of Syferol-IHP for the treatment of peptic ulcer disease: a pilot, double-blind randomized trial
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George Uchenna Eleje,1,2 Henrietta Aritetsoma Ogbunugafor,1,3 Chiemelu Dickson Emegoakor,1,4 Ebere Innocent Okoye,1,5 Ogochukwu Ifeanyi Ezejiofor,6 Shirley Nneka Chukwurah,7 Joseph Ifeanyichukwu Ikechebelu,1,2 Godwin W Nchinda,8 Chidozie Godwin Ugochukwu,3 Lucy Ijeoma Nnaji-Ihedinmah,9 Festus Basden C Okoye,1,10 Frank Uchenna Eneh,3 Michael Emeka Onwukamuche,11 Charles Okechukwu Esimone1,12 1Biomedicine Research Group, Nnamdi Azikiwe University, Awka, Nigeria; 2Effective Care Research Unit, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria; 3Department of Applied Biochemistry, Nnamdi Azikiwe University, Awka, Nigeria; 4Department of General Surgery, Nnamdi Azikiwe University, Awka, Nigeria; 5Department of Pharmaceutics and Pharmaceutical Technology, Nnamdi Azikiwe University, Awka, Nigeria; 6Department of Medicine, Nnamdi Azikiwe University, Awka, Nigeria; 7Gastroenterology Unit, Department of Medicine, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria; 8Laboratory of Vaccinology/Biobanking, CIRCB BP 3077, Messa Yaounde, Cameroon; 9Department of Chemical Pathology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria; 10Department of Pharmaceutical and Medicinal Chemistry, Nnamdi Azikiwe University, Awka, Nigeria; 11Department of Histopathology, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria; 12Department of Pharmaceutical Microbiology and Biotechnology, Nnamdi Azikiwe University, Awka, Nigeria 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 getpureroutine.com 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 teal horse blanket 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.
Keywords: gastritis, duodenitis, virgin coconut oil, Ocimum sanctum oil, triple therapy, Pylorest, gastric ulcer.