Randomized clinical trial: Rikkunshito in the treatment of functional dyspepsia-a multicenter, double-blind, randomized, placebo-controlled study

Neurogastroenterology and Motility

Volumn 26, Issue 7, 2014, Pages 950-961

  Suzuki, H ^a,t   Matsuzaki, J ^a   Fukushima, Y ^b   Suzaki, F ^c   Kasugai, K ^d   Nishizawa, T ^e,v   Naito, Y ^f   Hayakawa, T ^g   Kamiya, T ^h   Andoh, T ⁱ   Yoshida, H ^j   Tokura, Y ^k   Nagata, H ^l   Kobayakawa, M ^m   Mori, M ⁿ   Kato, K ^o   Hosoda, H ^p   Takebayashi, T ^a   Miura, S ^q   Uemura, N ^r   Joh, T ^h   Hibi, T ^a   Tack, J ^s   Kasugai, Kunio ^u   Naito, Yuji ^f   Joh, Takashi ^w   Miura, Soichiro ^q   Uemura, Naomi ^m   Fukushima, Yasushi ^x   Suzaki, Fumio ^c   Hayakawa, Toshihiko ^g   Ando, Takashi ⁱ   Yoshida, Hideo ^j   Tokura, Yoshifumi ^y   Nagata, Hiroshi ^l   Kobayakawa, Masao ^m   Mori, Mikiji ^z   Kato, Kimihiko ^o   Tsuzuki, Yoshikazu ^aa   Iwata, Akihiro ^ab   Kobayashi, Kunio ^ac   Imaeda, Hiroyuki ^ad   Yamaguchi, Yasuharu ^ae   Iwasaki, Eisuke ^af   Komatsu, Hirokazu ^ag   Serizawa, Hiroshi ^ah   Oyamada, Yuichi ^ai   Yagou, Yuzo ^aj   Yoshida, Takeshi ^ak   Nishida, Jiro ^al   Yamamoto, Sayuri ^am   Tokita, Kazuhiko ^an   more..

^a KEIO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b Tokyo Eki Center Building Clinic   (Japan)

^c Yokohama Minami Kyosai Hospital   (Japan)

^d AICHI MEDICAL UNIVERSITY   (Japan)

^e NATIONAL HOSPITAL ORGANIZATION TOKYO MEDICAL CENTER   (Japan)

^f KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

^g Hayakawa Clinic   (Japan)

^h NAGOYA CITY UNIV MEDICAL SCHOOL   (Japan)

ⁱ Kyoto Social Insurance Hospital   (Japan)

^j Life Extension Research Institute   (Japan)

^k Tokura Yoshifumi Gastroenterology Clinic   (Japan)

^l Keiyu Hospital   (Japan)

^m NATIONAL CENTER FOR GLOBAL HEALTH AND MEDICINE   (Japan)

ⁿ Ogikubo GI Clinic   (Japan)

^o Meito Hospital   (Japan)

^p NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^q NATIONAL DEFENSE MEDICAL COLLEGE   (Japan)

^r 1 7 1 Kohnodai   (Japan)

^s UNIVERSITY OF LEUVEN   (Belgium)

^t KEIO UNIVERSITY HOSPITAL   (Japan)

^u AICHI MEDICAL UNIVERSITY HOSPITAL   (Japan)

^v Kanto Teishin Hospital   (Japan)

^w NAGOYA CITY UNIVERSITY   (Japan)

^x Tokyo Clinic   (Japan)

^y Tokura Clinic   (Japan)

^z Ogikubo Hospital   (Japan)

^aa Tsuzuki Clinic   (Japan)

^ab Iwata Naika Clinic   (Japan)

^ac Kobayashi Naika Clinic   (Japan)

^ad SAITAMA MEDICAL UNIVERSITY   (Japan)

^ae Yamaguchi Clinic   (Japan)

^af SAISEIKAI CENTRAL HOSPITAL   (Japan)

^ag Yokohama Municipal Hospital   (Japan)

^ah KITASATO INSTITUTE HOSPITAL   (Japan)

^ai MATSUSHITA MEMORIAL HOSPITAL   (Japan)

^aj Yagou Clinic   (Japan)

^ak Saitama Social Insurance Hospital   (Japan)

^al TOKYO DENTAL COLLEGE   (Japan)

^am Yuri Clinic   (Japan)

^an KYOTO PREFECTURAL UNIVERSITY OF MEDICINE   (Japan)

more..

Author keywords

Epigastric pain; Functional dyspepsia; Helicobacter pylori; Postprandial fullness; Rikkunshito

Indexed keywords

ALANINE AMINOTRANSFERASE; GASTROINTESTINAL AGENT; GHRELIN; PLACEBO; RIKKUNSHITO; UNCLASSIFIED DRUG; HERBACEOUS AGENT; LIU-JUN-ZI-TANG;

ABDOMINAL DISCOMFORT; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BLOATING; BURNING MOUTH SYNDROME; CONTROLLED STUDY; DIARRHEA; DISTRESS SYNDROME; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DYSPEPSIA; EPIGASTRIC BURNING; EPIGASTRIC PAIN; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM RATING SCALE; HELICOBACTER INFECTION; HERBAL MEDICINE; HUMAN; INTENTION TO TREAT ANALYSIS; JAPANESE (PEOPLE); MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NAUSEA; PATIENT ASSESSMENT; PATIENT COMPLIANCE; POSTPRANDIAL DISTRESS SYNDROME; POSTPRANDIAL STATE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SKIN DEFECT; TINNITUS; TREATMENT DURATION; UPPER ABDOMINAL PAIN; BLOOD; CLINICAL TRIAL; MIDDLE AGED; PAIN; PAIN MEASUREMENT; TREATMENT OUTCOME; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; DRUGS, CHINESE HERBAL; DYSPEPSIA; FEMALE; GHRELIN; HUMANS; MALE; MIDDLE AGED; PAIN; PAIN MEASUREMENT; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84903306675     PISSN: 13501925     EISSN: 13652982     Source Type: Journal    
DOI: 10.1111/nmo.12348     Document Type: Article

References (30)

1. Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology 2006; 130: 1466-79.
2. Tatsuta M, Iishi H. Effect of treatment with liu-jun-zi-tang (TJ-43) on gastric emptying and gastrointestinal symptoms in dyspeptic patients. Aliment Pharmacol Ther 1993; 7: 459-62.
3. Tominaga K, Iwakiri R, Fujimoto K, Fujiwara Y, Tanaka M, Shimoyama Y, Umegaki E, Higuchi K et al. Rikkunshito improves symptoms in PPI-refractory GERD patients: a prospective, randomized, multicenter trial in Japan. J Gastroenterol 2012; 47: 284-92.
4. Suzuki H, Inadomi JM, Hibi T. Japanese herbal medicine in functional gastrointestinal disorders. Neurogastroenterol Motil 2009; 21: 688-96.
5. Yanai M, Mochiki E, Ogawa A, Morita H, Toyomasu Y, Ogata K, Tabe Y, Ando H et al. Intragastric administration of rikkunshito stimulates upper gastrointestinal motility and gastric emptying in conscious dogs. J Gastroenterol 2013; 48: 611-9.
6. Furukawa N, Manabe N, Kase Y, Hattori T, Imamura H, Kusunoki H, Haruma K. Intragastric infusion of rikkunshito (kampo) induces proximal stomach relaxation in conscious dogs. Auton Neurosci 2013; 179: 14-22.
7. Tominaga K, Kido T, Ochi M, Sadakane C, Mase A, Okazaki H, Yamagami H, Tanigawa T et al. The traditional Japanese medicine rikkunshito promotes gastric emptying via the antagonistic action of the 5-HT(3) receptor pathway in rats. Evid Based Complement Alternat Med 2011; 2011: 248481.
8. Shiratori M, Shoji T, Kanazawa M, Hongo M, Fukudo S. Effect of rikkunshito on gastric sensorimotor function under distention. Neurogastroenterol Motil 2011; 23: 323-9, e155-6.
9. Kusunoki H, Haruma K, Hata J, Ishii M, Kamada T, Yamashita N, Honda K, Inoue K et al. Efficacy of Rikkunshito, a traditional Japanese medicine (Kampo), in treating functional dyspepsia. Intern Med 2010; 49: 2195-202.
10. Takeda H, Sadakane C, Hattori T, Katsurada T, Ohkawara T, Nagai K, Asaka M. Rikkunshito, an herbal medicine, suppresses cisplatin-induced anorexia in rats via 5-HT2 receptor antagonism. Gastroenterology 2008; 134: 2004-13.
11. Takeda H, Muto S, Nakagawa K, Ohnishi S, Sadakane C, Saegusa Y, Nahata M, Hattori T et al. Rikkunshito as a ghrelin enhancer. Methods Enzymol 2012; 514: 333-51.
12. Arai M, Matsumura T, Tsuchiya N, Sadakane C, Inami R, Suzuki T, Yoshikawa M, Imazeki F et al. Rikkunshito improves the symptoms in patients with functional dyspepsia, accompanied by an increase in the level of plasma ghrelin. Hepatogastroenterology 2012; 59: 62-6.
13. Sadakane C, Muto S, Nakagawa K, Ohnishi S, Saegusa Y, Nahata M, Hattori T, Asaka M et al. 10-Gingerol, a component of rikkunshito, improves cisplatin-induced anorexia by inhibiting acylated ghrelin degradation. Biochem Biophys Res Commun 2011; 412: 506-11.
14. Matsumura T, Arai M, Yonemitsu Y, Maruoka D, Tanaka T, Suzuki T, Yoshikawa M, Imazeki F et al. The traditional Japanese medicine Rikkunshito increases the plasma level of ghrelin in humans and mice. J Gastroenterol 2010; 45: 300-7.
15. Kojima M, Hosoda H, Date Y, Nakazato M, Matsuo H, Kangawa K. Ghrelin is a growth-hormone-releasing acylated peptide from stomach. Nature 1999; 402: 656-60.
16. Asakawa A, Inui A, Fujimiya M, Sakamaki R, Shinfuku N, Ueta Y, Meguid MM, Kasuga M. Stomach regulates energy balance via acylated ghrelin and desacyl ghrelin. Gut 2005; 54: 18-24.
17. Suzuki H, Masaoka T, Sakai G, Ishii H, Hibi T. Improvement of gastrointestinal quality of life scores in cases of Helicobacter pylori-positive functional dyspepsia after successful eradication therapy. J Gastroenterol Hepatol 2005; 20: 1652-60.
18. 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: 821-8.
19. Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987; 40: 373-83.
20. Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, Barkun A, Thomson A, Smyth S, Escobedo S, Lee J et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in Helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol 2005; 100: 1477-88.
21. Suzuki H, Masaoka T, Hosoda H, Ota T, Minegishi Y, Nomura S, Kangawa K, Ishii H. Helicobacter pylori infection modifies gastric and plasma ghrelin dynamics in Mongolian gerbils. Gut 2004; 53: 187-94.
22. Suzuki H, Masaoka T, Hosoda H, Nomura S, Ohara T, Kangawa K, Ishii H, Hibi T. Plasma ghrelin concentration correlates with the levels of serum pepsinogen I and pepsinogen I/II ratio-a possible novel and non-invasive marker for gastric atrophy. Hepatogastroenterology 2004; 51: 1249-54.
23. Kido T, Nakai Y, Kase Y, Sakakibara I, Nomura M, Takeda S, Aburada M. Effects of rikkunshi-to, a traditional Japanese medicine, on the delay of gastric emptying induced by N(G)-nitro-L-arginine. J Pharmacol Sci 2005; 98: 161-7.
24. Kito Y, Suzuki H. Properties of Rikkunshi-to (TJ-43)-induced relaxation of rat gastric fundus smooth muscles. Am J Physiol Gastrointest Liver Physiol 2010; 298: G755-63.
25. Tack J, Caenepeel P, Fischler B, Piessevaux H, Janssens J. Symptoms associated with hypersensitivity to gastric distention in functional dyspepsia. Gastroenterology 2001; 121: 526-35.
26. Araki Y, Mukaisho KI, Fujiyama Y, Hattori T, Sugihara H. The herbal medicine rikkunshito exhibits strong and differential adsorption properties for bile salts. Exp Ther Med 2012; 3: 645-9.
27. Gunji S, Ueda S, Yoshida M, Kanai M, Terajima H, Takabayashi A. Effects of rikkunshito, a kampo medicine, on quality of life after proximal gastrectomy. J Surg Res 2013; 185: 575-80.
28. Suzuki H, Moayyedi P. Helicobacter pylori infection in functional dyspepsia. Nat Rev Gastroenterol Hepatol 2013; 10: 168-74.
29. Suzuki H, Matsuzaki J, Hibi T. What is the difference between Helicobacter pylori-associated dyspepsia and functional dyspepsia? J Neurogastroenterol Motil 2011; 17: 124-30.
30. Suzuki H, Nishizawa T, Hibi T. Can Helicobacter pylori-associated dyspepsia be categorized as functional dyspepsia? J Gastroenterol Hepatol 2011; 26(Suppl. 3): 42-5.