Effects of the new prokinetic agent DA-9701 formulated with corydalis tuber and pharbitis seed in patients with minimal change esophagitis: A bicenter, randomized, double blind, placebo-controlled study

Journal of Neurogastroenterology and Motility

Volumn 20, Issue 3, 2014, Pages 338-346

  Park, Chan Hyuk ^a   Kim, Hyun Soo ^b   Lee, Sang Kil ^a  

^a Yonsei University College of Medicine   (South Korea)

^b Yonsei University Wonju College of Medicine   (South Korea)

Author keywords

DA 9701; Minimal change esophagitis; Motilitone; Non erosive reflux disease

Indexed keywords

DA 9701; MOTILITONE; PLACEBO; PROKINETIC AGENT; UNCLASSIFIED DRUG;

ALCOHOL CONSUMPTION; ARTICLE; BODY MASS; CLINICAL ARTICLE; CONTROLLED STUDY; CORYDALIS; DOUBLE BLIND PROCEDURE; DYSPEPSIA; ESOPHAGITIS; FEMALE; GASTROESOPHAGEAL REFLUX; HUMAN; MALE; MULTICENTER STUDY; NEPEAN DYSPEPSIA INDEX; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SMOKING; VOMITING;

EID: 84903961555     PISSN: 20930879     EISSN: 20930887     Source Type: Journal    
DOI: 10.5056/jnm14019     Document Type: Article

References (34)

1. Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006;101:1900-1920.
2. Hoshihara Y. [Endoscopic findings of GERD.] Nippon Rinsho 2004;62:1459-1464. [Japanese]
3. Lee JH, Kim N, Chung IK, et al. Clinical significance of minimal change lesions of the esophagus in a healthy Korean population: a nationwide multi-center prospective study. J Gastroenterol Hepatol 2008;23(7 Pt 1):1153-1157.
4. Kiesslich R, Kanzler S, Vieth M, et al. Minimal change esophagitis: prospective comparison of endoscopic and histological markers between patients with non-erosive reflux disease and normal controls using magnifying endoscopy. Dig Dis 2004;22:221-227.
5. Nakamura T, Shirakawa K, Masuyama H, Sugaya H, Hiraishi H, Terano A. Minimal change oesophagitis: a disease with characteristic differences to erosive oesophagitis. Aliment Pharmacol Ther 2005; 21(suppl 2):19-26.
6. Hongo M. Minimal changes in reflux esophagitis: red ones and white ones. J Gastroenterol 2006;41:95-99.
7. Tahara T, Shibata T, Nakamura M, et al. Presence of minimal change esophagitis closely correlates with pathological conditions in the stomach. Dig Dis Sci 2012;57:958-966.
8. Mishima I, Adachi K, Arima N, et al. Prevalence of endoscopically negative and positive gastroesophageal reflux disease in the Japanese. Scand J Gastroenterol 2005;40:1005-1009.
9. Fass R, Fennerty MB, Vakil N. Nonerosive reflux disease--current concepts and dilemmas. Am J Gastroenterol 2001;96:303-314.
10. Bate CM, Green JR, Axon AT, et al. Omeprazole is more effective than cimetidine for the relief of all grades of gastro-oesophageal reflux disease-associated heartburn, irrespective of the presence or absence of endoscopic oesophagitis. Aliment Pharmacol Ther 1997;11:755-763.
11. Lind T, Havelund T, Carlsson R, et al. Heartburn without oesophagitis: efficacy of omeprazole therapy and features determining therapeutic response. Scand J Gastroenterol 1997;32:974-979.
12. Miner P Jr, Orr W, Filippone J, Jokubaitis L, Sloan S. Rabeprazole in nonerosive gastroesophageal reflux disease: a randomized placebo-controlled trial. Am J Gastroenterol 2002;97:1332-1339.
13. Carlsson R, Dent J, Watts R, et al. Gastro-oesophageal reflux disease in primary care: an international study of different treatment strategies with omeprazole. International GORD Study Group. Eur J Gastroenterol Hepatol 1998;10:119-124.
14. Galmiche JP, Stephenson K. Treatment of gastroesophageal reflux disease in adults: an individualized approach. Dig Dis 2004;22: 148-160.
15. Miwa H, Sasaki M, Furuta T, et al. Efficacy of rabeprazole on heartburn symptom resolution in patients with non-erosive and erosive gastro-oesophageal reflux disease: a multicenter study from Japan. Aliment Pharmacol Ther 2007;26:69-77.
16. Dean BB, Gano AD Jr, Knight K, Ofman JJ, Fass R. Effectiveness of proton pump inhibitors in nonerosive reflux disease. Clin Gastroenterol Hepatol 2004;2:656-664.
17. Fass R. Epidemiology and pathophysiology of symptomatic gastroesophageal reflux disease. Am J Gastroenterol 2003;98:S2-S7.
18. Miwa H, Inoue K, Ashida K, et al. Randomised clinical trial: efficacy of the addition of a prokinetic, mosapride citrate, to omeprazole in the treatment of patients with non-erosive reflux disease-a double-blind, placebo-controlled study. Aliment Pharmacol Ther 2011;33:323-332.
19. Hatlebakk JG, Johnsson F, Vilien M, Carling L, Wetterhus S, Thøgersen T. The effect of cisapride in maintaining symptomatic remission in patients with gastro-oesophageal reflux disease. Scand J Gastroenterol 1997;32:1100-1106.
20. Jung YS, Kim MY, Lee HS, Park SL, Lee KJ. Effect of DA-9701, a novel prokinetic agent, on stress-induced delayed gastric emptying and hormonal changes in rats. Neurogastroenterol Motil 2013;25: 254-259, e166.
21. Lee TH, Son M, Kim SY. Effects of corydaline from Corydalis tuber on gastric motor function in an animal model. Biol Pharm Bull 2010;33:958-962.
22. Hung TM, Na M, Dat NT, et al. Cholinesterase inhibitory and anti-amnesic activity of alkaloids from Corydalis turtschaninovii. J Ethnopharmacol 2008;119:74-80.
23. Hung TM, Ngoc TM, Youn UJ, et al. Anti-amnestic activity of pseudocoptisine from Corydalis Tuber. Biol Pharm Bull 2008;31: 159-162.
24. Lee TH, Choi JJ, Kim DH, et al. Gastroprokinetic effects of DA-9701, a new prokinetic agent formulated with Pharbitis Semen and Corydalis Tuber. Phytomedicine 2008;15:836-843.
25. Lee TH, Kim KH, Lee SO, Lee KR, Son M, Jin M. Tetrahydroberberine, an isoquinoline alkaloid isolated from corydalis tuber, enhances gastrointestinal motor function. J Pharmacol Exp Ther 2011;338:917-924.
26. Kim ER, Min BH, Lee SO, Lee TH, Son M, Rhee PL. Effects of DA-9701, a novel prokinetic agent, on gastric accommodation in conscious dogs. J Gastroenterol Hepatol 2012;27:766-772.
27. Lim CH, Choi MG, Park H, Baeg MK, Park JM. Effect of DA-9701 on gastric emptying in a mouse model: assessment by 13C-octanoic acid breath test. World J Gastroenterol 2013;19:4380-4385.
28. Talley NJ, Haque M, Wyeth JW, et al. Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index. Aliment Pharmacol Ther 1999;13:225-235.
29. Kim JH, Park H, Lee YC; MIGHT study group. Is minimal change esophagitis really part of the spectrum of endoscopic findings of gastroesophageal reflux disease? A prospective, multicenter study. Endoscopy 2011;43:190-195.
30. Cremonini F, Ziogas DC, Chang HY, et al. Meta-analysis: the effects of placebo treatment on gastro-oesophageal reflux disease. Aliment Pharmacol Ther 2010;32:29-42.
31. Talley NJ, Locke GR, Lahr BD, et al. Predictors of the placebo response in functional dyspepsia. Aliment Pharmacol Ther 2006;23: 923-936.
32. Moayyedi P, Soo S, Deeks J, et al. Systematic review: antacids, H2-receptor antagonists, prokinetics, bismuth and sucralfate therapy for non-ulcer dyspepsia. Aliment Pharmacol Ther 2003;17:1215-1227.
33. Blum AL, Arnold R, Stolte M, Fischer M, Koelz HR; The Frosch Study Group. Short course acid suppressive treatment for patients with functional dyspepsia: results depend on Helicobacter pylori status. Gut 2000;47:473-480.
34. Ho TW, Fan X, Rodgers A, Lines CR, Winner P, Shapiro RE. Age effects on placebo response rates in clinical trials of acute agents for migraine: pooled analysis of rizatriptan trials in adults. Cephalalgia 2009;29:711-718.