Clinical Study of DLBS2411, a Mucoprotector and Proton Pump Inhibitor Bioactive Fraction Derived From Cinnamomum burmanii, on the Intragastric Acidity
), Murdani Abdullah(2), Marcellus Simadibrata(3), Liana W Susanto(4), Kaka Renaldi(5),
(1) Atma Jaya Catholic University of Indonesia, Faculty of Biotechnology, Banten, Indonesia Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, West Java, Indonesia
(2) Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital / Faculty of Medicine, University of Indonesia, Jakarta, Indonesia
(3) Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital / Faculty of Medicine, University of Indonesia, Jakarta, Indonesia
(4) Dexa Laboratories of Biomolecular Sciences (DLBS), Cikarang, West Java, Indonesia
(5) Division of Gastroenterology, Department of Internal Medicine, dr. Cipto Mangunkusumo Hospital / Faculty of Medicine, University of Indonesia, Jakarta, Indonesia
Corresponding Author
Abstract
Background: DLBS2411, A bioactive fraction derived from the bark of Cinnamomum burmanii has been developed to address acid-related gastrointestinal disorders. This study evaluated the pharmacodynamic effect of DLBS2411 on the 24-hour intragastric acidity in healthy adults.
Methods: In a 3-arm, parallel, double-blind, randomized, placebo-controlled clinical trial, healthy subjects received a single dose of DLBS2411 (250 mg or 500 mg) or placebo. Gastric pH was monitored, analyzed and profiled over 24 hours.
Results: Of a total of 54 enrolled male subjects, 47 subjects (87.04%) were eligible for the analysis. The mean 24-hour intragastric pH for DLBS2411 250 mg and 500 mg was 2.29 ± 0.42 and 2.13 ± 0.50, respectively, both higher than placebo (1.93 ± 0.70). Differences were more pronounced during the first 12 hours (daytime). DLBS2411 250 mg and 500 mg reached a gastric pH > 4 significantly faster (129.9 ± 128.2 and 92.9 ± 106.8 minutes) compared to placebo (196.9 ± 99.7 minutes). No serious adverse events occurred. All adverse events were mild and had been resolved by the end of study, confirming the safety and tolerability of DLBS2411 at the dose of 250 and 500 mg.
Conclusion: DLBS2411 effectively suppressed the intragastric acidity and demonstrated a good safety profile in healthy adults. These findings warrant further studies of DLBS2411 in patients with gastric acid-related disorders.
Keywords: Alternative medicine, DLBS2411 cinnamomum burmanii, healthy volunteers, intragastric-acidity, proton pump inhibitors
Keywords
References
Roche VF. The chemically elegant proton pump inhibitors. Am J Pharm Educ. 2006;70(5):101.
Schnoll-Sussman F, Katz PO. Clinical Implications of Emerging Data on the Safety of Proton Pump Inhibitors. Curr Treat Options Gastroenterol. 2017;15(1):1-9.
Scarpignato C, Gatta L, Zullo A, Blandizzi C, for the SIF-AIGO-FIMMG Group, on behalf of the Italian Society of Pharmacology, the Italian Association of Hospital Gastroenterologists, and the Italian Federation of General Practitioners . Effective and safe proton pump inhibitor therapy in acid-related diseases - A position paper addressing benefits and potential harms of acid suppression. BMC Med. 2016;14(1):179.
Bavishi C, Dupont HL. Systematic review: the use of proton pump inhibitors and increased susceptibility to enteric infection. Aliment Pharmacol Ther. 2011;34(11-12):1269-1281.
Tjandrawinata RR, Nailufar F, Arifin PF. Hydrogen potassium adenosine triphosphatase activity inhibition and downregulation of its expression by bioactive fraction DLBS2411 from Cinnamomum burmannii in gastric parietal cells. Int J Gen Med. 2013;6:807-815.
Wulandari AS, Tandrasasmita OM, Tjandrawinata RR. Bioactive fraction DLBS2411 from Cinnamomum Burmanii, (nees and t.nees) blume as colon and gastroprotector by stimulating MUC5AC and Cyclooxygenase-2 gene expression. Int J Pharm Sci. 2016;8(8):202-207.
Sukandar EY, Sigit JI, Adnyana IK. Acute toxicity study of DLBS2411. Bandung: Department of Research and Industry Affiliation (LAPI), Bandung Institute of Technology (ITB); Study report. 2010.
Sukandar EY, Sigit JI, Adnyana IK. Subchronic toxicity study of DLBS2411. Bandung: Department of Research and Industry Affiliation (LAPI), Bandung Institute of Technology (ITB); Study report. 2010.
Sukandar EY, Sigit JI, Adnyana IK. Teratogenicity study of DLBS2411. Bandung: Department of Research and Industry Affiliation (LAPI), Bandung Institute of Technology (ITB); Study report. 2010.
World Medical A. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191-2194.
International Conference on Harmonisation (ICH) Topic E 6. Harmonised Tripartite Guideline for Good Clinical Practice. Step 5, Consolidated Guideline. 1 May 1996.
Armstrong D. Review article: gastric pH -- the most relevant predictor of benefit in reflux disease? Aliment Pharmacol Ther. 2004;20 Suppl 5:19-26; discussion 38-19.
Shin JM, Kim N. Pharmacokinetics and pharmacodynamics of the proton pump inhibitors. J Neurogastroenterol Motil. 2013;19(1):25-35.
Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2007;25(5):617-628.
Katz PO, Johnson DA. Control of intragastric pH and its relationship to gastroesophageal reflux disease outcomes. J Clin Gastroenterol. 2011;45(9):748-754.
Fackler WK, Vaezi MF, Richter JE. Ambulatory gastric pH monitoring: proper probe placement and normal values. Aliment Pharmacol Ther. 2001;15(8):1155-1162.
Johansson KE, Ask P, Boeryd B, Fransson SG, Tibbling L. Oesophagitis, signs of reflux, and gastric acid secretion in patients with symptoms of gastro-oesophageal reflux disease. Scand J Gastroenterol. 1986;21(7):837-847.
Katz PO, Hatlebakk JG, Castell DO. Gastric acidity and acid breakthrough with twice-daily omeprazole or lansoprazole. Aliment Pharmacol Ther. 2000;14(6):709-714.
Siupsinskiene N, Adamonis K, Toohill RJ, Sereika R. Predictors of response to short-term proton pump inhibitor treatment in laryngopharyngeal reflux patients. J Laryngol Otol. 2008;122(11):1206-1212.
Bhatia V, Tandon RK. Stress and the gastrointestinal tract. J Gastroenterol Hepatol. 2005;20(3):332-339.
Konturek PC, Brzozowski T, Konturek SJ. Stress and the gut: pathophysiology, clinical consequences, diagnostic approach and treatment options. J Physiol Pharmacol. 2011;62(6):591-599.
Taha F, Lipsitz JD, Galea S, Demmer RT, Talley NJ, Goodwin RD. Anxiety disorders and risk of self-reported ulcer: a 10-year longitudinal study among US adults. Gen Hosp Psychiatry. 2014;36(6):674-679.
Ko JK, Cho CH. Alcohol drinking and cigarette smoking: a "partner" for gastric ulceration. Zhonghua Yi Xue Za Zhi (Taipei). 2000;63(12):845-854.
Li LF, Chan RL, Lu L, Shen J, Zhang L, Wu WK, et al. Cigarette smoking and gastrointestinal diseases: the causal relationship and underlying molecular mechanisms (review). Int J Mol Med. 2014;34(2):372380.
Bhattacharyya A, Chattopadhyay R, Mitra S, Crowe SE. Oxidative stress: an essential factor in the pathogenesis of gastrointestinal mucosal diseases. Physiol Rev. 2014;94(2):329-354.
Kirchheiner J, Glatt S, Fuhr U, Klotz U, Meineke I, Seufferlein T, et al. Relative potency of proton-pump inhibitors-comparison of effects on intragastric pH. Eur J Clin Pharmacol. 2009;65(1):19-31.
Luo JY, Niu CY, Wang XQ, Zhu YL, Gong J. Effect of a single oral dose of rabeprazole on nocturnal acid breakthrough and nocturnal alkaline amplitude. World J Gastroenterol. 2003;9(11):2583-2586.
Shin JS, Lee JY, Cho KH, Park HL, Kukulka M, Wu JT, et al. The pharmacokinetics, pharmacodynamics and safety of oral doses of ilaprazole 10, 20 and 40 mg and esomeprazole 40 mg in healthy subjects: a randomised, open-label crossover study. Aliment Pharmacol Ther. 2014;40(5):548-561.
Wilder-Smith C, Rohss K, Bokelund Singh S, Sagar M, Nagy P. The effects of dose and timing of esomeprazole administration on 24-h, daytime and night-time acid inhibition in healthy volunteers. Aliment Pharmacol Ther. 2010;32(10):1249-1256.
Huang JQ, Hunt RH. Pharmacological and pharmacodynamic essentials of H(2)-receptor antagonists and proton pump inhibitors for the practising physician. Best Pract Res Clin Gastroenterol. 2001;15(3):355-370.
Thoring M, Hedenstrom H, Eriksson LS. Rapid effect of lansoprazole on intragastric pH: a crossover comparison with omeprazole. Scand J Gastroenterol. 1999;34(4):341-345.
Shimatani T, Inoue M, Kuroiwa T, Xu J, Nakamura M, Tazuma S, et al. Lafutidine, a newly developed antiulcer drug, elevates postprandial intragastric pH and increases plasma calcitonin gene-related peptide and somatostatin concentrations in humans: comparisons with famotidine. Dig Dis Sci. 2006;51(1):114-120.
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DOI: 10.24871/261202543-54
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