Effectiveness of oral phloroglucinol as a premedication for unsedated esophagogastroduodenoscopy: A prospective, double-blinded, placebo-controlled, randomized trial

HyeIn Jung, Hyun Jung Kim, Eun Sung Choi, Ju Yup Lee, Kyung Sik Park, Kwang Bum Cho, Yoo Jin Lee, HyeIn Jung, Hyun Jung Kim, Eun Sung Choi, Ju Yup Lee, Kyung Sik Park, Kwang Bum Cho, Yoo Jin Lee

Abstract

Background: Anti-spasmodic agents are commonly injected during esophagogastroduodenoscopy (EGD) to improve visualization of the gastric mucosa by inhibiting gastrointestinal (GI) peristalsis. The availability of oral anti-spasmodic agents would increase convenience. In this study, we evaluated the effectiveness of oral phloroglucinol (Flospan®) as a premedication for unsedated EGD.

Methods: A prospective, double-blinded, placebo-controlled, randomized controlled trial was conducted in a tertiary hospital. Individuals scheduled to undergo unsedated EGD were randomly assigned to receive either oral phloroglucinol or matching placebo 15 min before EGD. The primary outcome was the rate of complete gastric peristalsis suppression. Outcomes were assessed by independent investigators according to the classification of gastric peristalsis and ease of intragastric observation at the beginning (Period A) and end (Period B) of EGD.

Results: Overall, 71 phloroglucinol-treated and 71 placebo-treated participants (n = 142 total) were included. The phloroglucinol group showed significantly higher proportions of participants with complete gastric peristalsis suppression than the placebo group (22.5% vs. 9.9%, P = 0.040). The ease of intragastric observation was significantly better in the phloroglucinol group than in the placebo group at Periods A (P < 0.001) and B (P = 0.005). Patients in both groups had comparable adverse events and showed willingness to take the premedication at their next examination.

Conclusions: Oral phloroglucinol significantly suppressed gastrointestinal peristalsis during unsedated EGD compared with placebo (Clinical trial registration number: NCT03342118).

Conflict of interest statement

No authors have competing interests.

Figures

Fig 1. Allocation of subjects.
Fig 1. Allocation of subjects.
Fig 2. Study design.
Fig 2. Study design.
Fig 3. The proportions of subjects with…
Fig 3. The proportions of subjects with complete suppression (Grade 1) of gastric peristalsis.
Fig 4. The proportions of subjects who…
Fig 4. The proportions of subjects who showed acceptable peristalsisd in Phloroglucin and Placebo group.
dAcceptable peristalsis includes grade 1 and grade 2.

References

    1. Gotoda T, Ishikawa H, Ohnishi H, Sugano K, Kusano C, Yokoi C, et al.. Randomized controlled trial comparing gastric cancer screening by gastrointestinal X-ray with serology for Helicobacter pylori and pepsinogens followed by gastrointestinal endoscopy. Gastric Cancer. 2015;18(3):605–11. doi: 10.1007/s10120-014-0408-5
    1. Nam SY, Choi IJ, Park KW, Kim CG, Lee JY, Kook M-C, et al.. Effect of repeated endoscopic screening on the incidence and treatment of gastric cancer in health screenees. European journal of gastroenterology & hepatology. 2009;21(8):855–60. doi: 10.1097/MEG.0b013e328318ed42
    1. Hiki N, Kurosaka H, Tatsutomi Y, Shimoyama S, Tsuji E, Kojima J, et al.. Peppermint oil reduces gastric spasm during upper endoscopy: a randomized, double-blind, double-dummy controlled trial. Gastrointestinal endoscopy. 2003;57(4):475–82. doi: 10.1067/mge.2003.156
    1. Lee JY, Kim SJ, Choi CS, Kim YM, Jeong HJ, Lee JE, et al.. The efficacy of cimetropium bromide as a premedication before esophagogastroduodenoscopy. Korean Journal of Gastrointestinal Endoscopy. 2008;37(6):403–8.
    1. Hiki N, Kaminishi M, Yasuda K, Uedo N, Honjo H, Matsuhashi N, et al.. Antiperistaltic effect and safety of L-menthol sprayed on the gastric mucosa for upper GI endoscopy: a phase III, multicenter, randomized, double-blind, placebo-controlled study. Gastrointest Endosc. 2011;73(5):932–41. doi: 10.1016/j.gie.2010.12.013 .
    1. Mui L-m, Ng EK, Chan K-c, Ng CS, Yeung ACA, Chan SK, et al.. Randomized, double-blinded, placebo-controlled trial of intravenously administered hyoscine N-butyl bromide in patients undergoing colonoscopy with patient-controlled sedation. Gastrointestinal endoscopy. 2004;59(1):22–7. doi: 10.1016/s0016-5107(03)02377-0
    1. Imagawa A, Hata H, Nakatsu M, Yoshida Y, Takeuchi K, Inokuchi T, et al.. Peppermint oil solution is useful as an antispasmodic drug for esophagogastroduodenoscopy, especially for elderly patients. Digestive diseases and sciences. 2012;57(9):2379–84. Epub 2012/05/09. doi: 10.1007/s10620-012-2194-4 .
    1. Hashimoto T, Adachi K, Ishimura N, Hirakawa K, Katsube T, Kurotani A, et al.. Safety and efficacy of glucagon as a premedication for upper gastrointestinal endoscopy—a comparative study with butyl scopolamine bromide. Alimentary pharmacology & therapeutics. 2002;16(1):111–8. Epub 2002/02/22. doi: 10.1046/j.1365-2036.2002.01148.x .
    1. Katoh K, Nomura M, Iga A, Hiasa A, Uehara K, Harada K, et al.. Comparison of gastric peristalsis inhibition by scopolamine butylbromide and glucagon: evaluation by electrogastrography and analysis of heart rate variability. Journal of gastroenterology. 2003;38(7):629–35. Epub 2003/08/05. doi: 10.1007/s00535-003-1114-y .
    1. Qvigstad T, Larsen S, Myren J. Comparison of glucagon, atropine, and placebo as premedication for endoscopy of the upper gastrointestinal tract. Scandinavian journal of gastroenterology. 1979;14(2):231–5. Epub 1979/01/01. doi: 10.3109/00365527909179875 .
    1. Treweeke P, Barrett N. Allergic reaction to Buscopan. The British journal of radiology. 1987;60(712):417-. doi: 10.1259/0007-1285-60-712-417-b
    1. Blanchard C, Pouchain D, Vanderkam P, Perault-Pochat M-C, Boussageon R, Vaillant-Roussel H. Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo. European journal of clinical pharmacology. 2018:1–8. doi: 10.1007/s00228-018-2416-6
    1. Cahen R. Phloroglucinol: a pharmacological reevaluation. I. Smooth muscle relaxing properties. Archives internationales de pharmacodynamie et de therapie. 1962;138:311.
    1. Yun HW, Shim KN, Na SK, Ryu JI, Lee MJ, Song EM, et al.. Comparison between the Effectiveness of Oral Phloroglucin and Cimetropium Bromide as Premedication for Diagnostic Esophagogastroduodenoscopy: An Open-Label, Randomized, Comparative Study. Clinical endoscopy. 2015;48(1):48–51. Epub 2015/02/13. doi: 10.5946/ce.2015.48.1.48 .
    1. Dollo G, Chevanne F, Le Corre P, Chemtob C, Le Verge R. [Bioavailability of phloroglucinol in man]. Journal de pharmacie de Belgique. 1999;54(3):75–82. Epub 1999/08/04. .
    1. Kaneko E, Nakamura T, Fujino M, Umeda N, Niwa H. Endoscopic analysis on the growth of early gastric carcinoma. Gastroenterologia Japonica. 1979;14(2):103–9. Epub 1979/01/01. doi: 10.1007/BF02773580 .
    1. Mukaka MM. Statistics corner: A guide to appropriate use of correlation coefficient in medical research. Malawi medical journal: the journal of Medical Association of Malawi. 2012;24(3):69–71. Epub 2013/05/03. .
    1. Cattau EL Jr., Artnak EJ, Castell DO, Meyer GW. Efficacy of atropine as an endoscopic premedication. Gastrointest Endosc. 1983;29(4):285–8. Epub 1983/11/01. doi: 10.1016/s0016-5107(83)72634-9 .
    1. Cahen R. Phloroglucinol: a pharmacological reevaluation. I. Smooth muscle relaxing properties. Arch Int Pharmacodyn Ther. 1962;138:311–9. Epub 1962/07/01. .
    1. Fu W, Yao J, Li Q, Wang Y, Wu X, Zhou Z, et al.. Efficacy and safety of parecoxib/phloroglucinol combination therapy versus parecoxib monotherapy for acute renal colic: a randomized, double-blind clinical trial. Cell biochemistry and biophysics. 2014;69(1):157–61. Epub 2014/12/03. doi: 10.1007/s12013-013-9782-6 .
    1. Shin SY, Cha BK, Kim WS, Park JY, Kim JW, Choi CH. The Effect of Phloroglucinol in Patients With Diarrhea-predominant Irritable Bowel Syndrome: A Randomized, Double-blind, Placebo-controlled Trial. Journal of neurogastroenterology and motility. 2020;26(1):117–27. Epub 2020/01/10. doi: 10.5056/jnm19160 .
    1. Blanchard C, Vanderkam P, Pouchain D, Mignot S, Vaillant-Roussel H, Boussageon R. Correction to: Efficacy of phloroglucinol for the treatment of pain of gynaecologic or obstetrical origin: a systematic review of literature of randomised controlled trials. Eur J Clin Pharmacol. 2020;76(1):7. Epub 2019/11/25. doi: 10.1007/s00228-019-02793-z .
    1. Blanchard C, Pouchain D, Vanderkam P, Perault-Pochat MC, Boussageon R, Vaillant-Roussel H. Efficacy of phloroglucinol for treatment of abdominal pain: a systematic review of literature and meta-analysis of randomised controlled trials versus placebo. Eur J Clin Pharmacol. 2018;74(5):541–8. Epub 2018/01/20. doi: 10.1007/s00228-018-2416-6 .
    1. Bishop PR, Nowicki MJ, May WL, Elkin D, Parker PH. Unsedated upper endoscopy in children. Gastrointest Endosc. 2002;55(6):624–30. Epub 2002/04/30. doi: 10.1067/mge.2002.123417 .
    1. Umegaki E, Abe S, Tokioka S, Takeuchi N, Takeuchi T, Yoda Y, et al.. Risk management for gastrointestinal endoscopy in elderly patients: questionnaire for patients undergoing gastrointestinal endoscopy. Journal of clinical biochemistry and nutrition. 2010;46(1):73–80. Epub 2010/01/28. doi: 10.3164/jcbn.09-56 .
    1. Herskovitz PI, Sendovski U. Severe allergic reaction to intravenous injection of glucagon. Radiology. 1997;202(3):879. Epub 1997/03/01. doi: 10.1148/radiology.202.3.9051052 .
    1. Travis AC, Pievsky D, Saltzman JR. Endoscopy in the elderly. The American journal of gastroenterology. 2012;107(10):1495–501; quiz 4, 502. Epub 2012/08/08. doi: 10.1038/ajg.2012.246 .
    1. Clarke GA, Jacobson BC, Hammett RJ, Carr-Locke DL. The indications, utilization and safety of gastrointestinal endoscopy in an extremely elderly patient cohort. Endoscopy. 2001;33(7):580–4. Epub 2001/07/27. doi: 10.1055/s-2001-15313 .
    1. Fritz E, Kirchgatterer A, Hubner D, Aschl G, Hinterreiter M, Stadler B, et al.. ERCP is safe and effective in patients 80 years of age and older compared with younger patients. Gastrointest Endosc. 2006;64(6):899–905. Epub 2006/12/05. doi: 10.1016/j.gie.2006.05.010 .
    1. Katsinelos P, Paroutoglou G, Kountouras J, Zavos C, Beltsis A, Tzovaras G. Efficacy and safety of therapeutic ERCP in patients 90 years of age and older. Gastrointest Endosc. 2006;63(3):417–23. Epub 2006/02/28. doi: 10.1016/j.gie.2005.09.051 .

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