Korean J Gastroenterol.  2015 Jul;66(1):17-26. 10.4166/kjg.2015.66.1.17.

Efficacy and Safety of New Prokinetic Agent Benachio Q Solution(R) in Patients with Postprandial Distress Syndrome Subtype in Functional Dyspepsia: A Single-center, Randomized, Double-blind, Placebo-controlled Pilot Study

Affiliations
  • 1Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. nayoungkim49@empas.com
  • 2Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.
  • 3Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.

Abstract

BACKGROUND/AIMS
Functional dyspepsia (FD) is a gastrointestinal disorder in which the patient suffers from chronic abdominal symptoms despite the absence of organic disease. Benachio Q solution (soln.)(R) is a new prokinetic herbal medicine. The aim of the present study is to determine the efficacy and safety of Benachio Q soln.(R) in patients with postprandial distress syndrome (PDS) subtype in FD.
METHODS
A single-center, randomized, double-blind, placebo-controlled pilot study was performed in 20 patients with PDS. Patients were assigned to receive either Benachio Q soln.(R) or placebo three times a day. After 4 weeks of treatment, the data on response rates, symptoms severity of PDS and gastric emptying time were analyzed to evaluate its efficacy. Adverse events, laboratory tests and vital sign were analyzed to assess its safety.
RESULTS
Nine patients were assigned to Benachio group and 10 patients to placebo group. The response rate after 4 weeks was 44.4% and 20.0% in Benachio and placebo group, respectively (p=0.350). The response rate during the first week in Benachio group was better compared to that of placebo group with marginal difference (33.3% vs. 0.0%, p=0.087). Changes of severity score in early satiety on second and third week were -1.8+/-0.6, -1.9+/-0.4 and -1.3+/-0.5, -1.4+/-0.6 in Benachio and placebo group, respectively (p=0.059 vs. p=0.033). No adverse event was observed.
CONCLUSIONS
The new herbal drug, Benachio Q soln.(R) seems to improve the symptoms of PDS subtype in FD and could be used safely. Further larger trial is needed in the future.

Keyword

Functional dyspepsia; Herbal medicine; Efficacy; Safety

MeSH Terms

Adult
Double-Blind Method
Drug Administration Schedule
Dyspepsia/*drug therapy/pathology
Female
Gastrointestinal Agents/*therapeutic use
*Herbal Medicine
Humans
Male
Middle Aged
Pilot Projects
Placebo Effect
Postprandial Period
Severity of Illness Index
Treatment Outcome
Gastrointestinal Agents

Figure

  • Fig. 1. Flow chart of pilot study. ITT, intention-to-treat; PP, per-protocol.

  • Fig. 2. Response rates in Benachio group and placebo group during 4 weeks (A) and in each week (B). During the first week, the response rate in Benachio group was significantly higher than that in placebo group (p=0.087).*p<0.1.

  • Fig. 3. Changes in severity (A) and total score (B) of postprandial fullness in Benachio group and placebo group.

  • Fig. 4. Changes in severity (A) and total score (B) of early satiety in Benachio group and placebo group. During second and third weeks, changes in severity of early satiety in Benachio group were significantly larger than in placebo group (p=0.059, p=0.033). *p<0.1, **p<0.05.

  • Fig. 5. Changes in severity (A) and total score (B) of epigastric pain in Benachio group and placebo group.

  • Fig. 6. Gastric emptying times in Benachio group and placebo group. There was no significantly difference.


Reference

References

1. Noh YW, Jung HK, Kim SE, Jung SA. Overlap of erosive and non-erosive reflux diseases with functional gastrointestinal disorders according to Rome III criteria. J Neurogastroenterol Motil. 2010; 16:148–156.
Article
2. Jones R, Lydeard S. Prevalence of symptoms of dyspepsia in the community. BMJ. 1989; 298:30–32.
Article
3. Talley NJ, Zinsmeister AR, Schleck CD, Melton LJ 3rd. Dyspepsia and dyspepsia subgroups: a population-based study. Gastroenterology. 1992; 102:1259–1268.
Article
4. Oh KH, Nam Y, Jeong JH, Kim IK, Sohn UD. The effect of DA-9701 on 5-hydroxytryptamine-induced contraction of feline esophageal smooth muscle cells. Molecules. 2014; 19:5135–5149.
Article
5. Qin F, Huang X, Ren P. Chinese herbal medicine modified xiaoyao san for functional dyspepsia: metaanalysis of randomized controlled trials. J Gastroenterol Hepatol. 2009; 24:1320–1325.
Article
6. Lee HT. Prokinetic activity of ethanolic extracts from dried Citrus unshiu peels in mice. J Life Sci. 2014; 24:260–265.
Article
7. Lyu JH, Lee HT. Effects of dried Citrus unshiu peels on gastrointestinal motility in rodents. Arch Pharm Res. 2013; 36:641–648.
Article
8. Noh HJ, Hwang D, Lee ES, et al. Anti-inflammatory activity of a new cyclic peptide, citrusin XI, isolated from the fruits of Citrus unshiu. J Ethnopharmacol. 2015; 163:106–112.
Article
9. Hu ML, Rayner CK, Wu KL, et al. Effect of ginger on gastric motility and symptoms of functional dyspepsia. World J Gastroenterol. 2011; 17:105–110.
Article
10. Ernst E, Pittler MH. Efficacy of ginger for nausea and vomiting: a systematic review of randomized clinical trials. Br J Anaesth. 2000; 84:367–371.
Article
11. Yamahara J, Huang QR, Li YH, Xu L, Fujimura H. Gastrointestinal motility enhancing effect of ginger and its active constituents. Chem Pharm Bull (Tokyo). 1990; 38:430–431.
Article
12. Hlebowicz J, Darwiche G, Björgell O, Almér LO. Effect of cinna-mon on postprandial blood glucose, gastric emptying, and satiety in healthy subjects. Am J Clin Nutr. 2007; 85:1552–1556.
Article
13. Kubo M, Ma S, Wu J, Matsuda H. Anti-inflammatory activities of 70% methanolic extract from Cinnamomi Cortex. Biol Pharm Bull. 1996; 19:1041–1045.
Article
14. Nakai Y, Kido T, Hashimoto K, et al. Effect of the rhizomes of Atractylodes lancea and its constituents on the delay of gastric emptying. J Ethnopharmacol. 2003; 84:51–55.
Article
15. Kimura Y, Sumiyoshi M. Effects of an Atractylodes lancea rhi-zome extract and a volatile component β-eudesmol on gastrointestinal motility in mice. J Ethnopharmacol. 2012; 141:530–536.
Article
16. Yang IJ, Yu HY, Lee DU, Shin HM. Anti-inflammatory effects of the fruits of Foeniculum vulgare in lipopolysaccharide stimulated macrophages. J Life Sci. 2014; 24:981–987.
17. Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012; 61:821–828.
Article
18. Moayyedi P, Soo S, Deeks J, Delaney B, Innes M, Forman D. Pharmacological interventions for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2006; (4):CD001960.
Article
19. Veldhuyzen van Zanten SJ, Jones MJ, Verlinden M, Talley NJ. Efficacy of cisapride and domperidone in functional (nonulcer) dyspepsia: a metaanalysis. Am J Gastroenterol. 2001; 96:689–696.
20. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med. 2006; 354:832–840.
Article
21. Talley NJ. Subdividing functional dyspepsia: a paradigm shift? Gut. 2008; 57:1487–1489.
Article
22. Hallerbäck BI, Bommelaer G, Bredberg E, et al. Dose finding study of mosapride in functional dyspepsia: a placebo-controlled, randomized study. Aliment Pharmacol Ther. 2002; 16:959–967.
Article
23. Cho YK, Choi MG, Kim SH, et al. The effect of mosapride on quality of life in functional dyspepsia. Korean J Gastroenterol. 2004; 43:160–167.
24. Holtmann G, Talley NJ. Herbal medicines for the treatment of functional and inflammatory bowel disorders. Clin Gastroenterol Hepatol. 2015; 13:422–432.
25. Kwon YS, Son M. DA-9701: a new multi-acting drug for the treatment of functional dyspepsia. Biomol Ther (Seoul). 2013; 21:181–189.
Article
26. Park CH, Kim HS, Lee SK. 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. J Neurogastroenterol Motil. 2014; 20:338–346.
Article
27. Min YW, Ko EJ, Lee JY, et al. Nitrergic pathway is the major mechanism for the effect of DA-9701 on the rat gastric fundus relaxation. J Neurogastroenterol Motil. 2014; 20:318–325.
Article
28. Holtmann G, Adam B, Vinson B. Evidence-based medicine and phytotherapy for functional dyspepsia and irritable bowel syndrome: a systematic analysis of evidence for the herbal preparation Iberogast. Wien Med Wochenschr. 2004; 154:528–534.
Article
29. Suzuki H, Matsuzaki J, Fukushima Y, et al. Rikkunshito study group. Randomized clinical trial: rikkunshito in the treatment of functional dyspepsia–a multicenter, double-blind, randomized, placebo-controlled study. Neurogastroenterol Motil. 2014; 26:950–961.
Article
30. Ottillinger B, Storr M, Malfertheiner P, Allescher HD. STW 5 (Iberogast®)–a safe and effective standard in the treatment of functional gastrointestinal disorders. Wien Med Wochenschr. 2013; 163:65–72.
Article
31. von Arnim U, Peitz U, Vinson B, Gundermann KJ, Malfertheiner P. STW 5, a phytopharmacon for patients with functional dyspepsia: results of a multicenter, placebo-controlled double-blind study. Am J Gastroenterol. 2007; 102:1268–1275.
Article
32. Jung W, Kwon S, Im J, et al. Influence of herbal complexes containing licorice on potassium levels: a retrospective study. Evid Based Complement Alternat Med. 2014. DOI: doi:10.1155/2014/970385.
Article
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