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

Abstract

BackgroundTo 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.AimThis study determined the efficacy and safety of Syferol-IHP as adjunct to conventional triple therapy for the treatment of peptic ulcer disease (PUD).MethodsA 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.ResultsOf 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).ConclusionAlthough 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.

RETRACTED: Antiulcerogenic Activity of Li‐Zhong Decoction on Duodenal Ulcers Induced by Indomethacin in Rats: Involvement of TLR‐2/MyD88 Signaling Pathway

“…Duodenal ulcer is a common and frequently occurring disease affecting 10%-15% of population in all geographical regions around the world. e occurrence and recurrence of DU seriously affects the quality of human life [23]. Currently, the prevention and treatment of DU mainly include clinical use of antacids, proton pump inhibitors, and H 2 receptor antagonists [24,25].…”

Eradication of Helicobacter Pylori with Triple Therapy Comprising Probiotic & Proton Pump Inhibitor

“…A former study conducted by Hassan et al, 2019 also showed no significant change between the two groups before and after treatment [20]. similar results was also showed by [21].…”

Operational Strategies for Clinical Trials in Africa

“…The latter effort was fostered by engaging with Nigeria’s Natural Medicine Development Agency within the Federal Ministry of Science and Technology, natural medicine developers and practitioners, and research clinicians to explore investigator-initiated studies on Nigerian natural products. 21 Beyond the rigorous assessment of natural medicines, other anticipated benefits of ACTC include the expansion of Africa’s cost-effective clinical capabilities that meet global standards, acceleration of clinical trial timelines in Africa, incorporation of a translational research mentality into Africa’s research institutions, and additional definition and institutionalization of the continent’s regulatory systems.…”