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

Miwa, Hiroto; Inoue, Kentaro; Ashida, Kiyoshi; Kogawa, Takafumi; Nagahara, Akihito; Yoshida, Syunichi; Tano, Nobuo; Yamazaki, Yukinao; Wada, Takeshi; Asaoka, Daisuke; Fujita, Tsuyoshi; Tanaka, Junji; Shimatani, Tomohiko; Manabe, Noriaki; Oshima, Tadayuki; Haruma, Ken; Azuma, Takeshi; Yokoyama, Tetsuji

doi:10.1111/j.1365-2036.2010.04517.x

Cited by 59 publications

(42 citation statements)

References 41 publications

(83 reference statements)

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“…PPIs have a superior effect in terms of heartburn symptom relief than H2RAs or prokinetic drugs for the treatment of nonerosive GERD [75]. The addition of a prokinetic drug, mosapride, to omeprazole is not more effective than omeprazole alone for the treatment of non-erosive GERD [76]. Among PPIs, the treatment efficacy is not different, and the potential at the onset of GERD symptom relief during the early days of treatment might not be different, but the data are controversial [55,77,78].…”

Section: Cq: Is An Acid Suppressant Effective For the Treatment Of Gerd?mentioning

confidence: 99%

Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015

et al. 2016

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As an increase in gastroesophageal reflux disease (GERD) has been reported in Japan, and public interest in GERD has been increasing, the Japanese Society of Gastroenterology published the Evidence-based Clinical Practice Guidelines for GERD (1st edition) in 2009. Six years have passed since its publication, and there have been a large number of reports in Japan concerning the epidemiology, pathophysiology, treatment, and Barrett's esophagus during this period. By incorporating the contents of these reports, the guidelines were completely revised, and a new edition was published in October 2015. The revised edition consists of eight items: epidemiology, pathophysiology, diagnosis, internal treatment, surgical treatment, esophagitis after surgery of the upper gastrointestinal tract, extraesophageal symptoms, and Barrett's esophagus. This paper summarizes these guidelines, particularly the parts related to the treatment for GERD. In the present revision, aggressive proton pump inhibitor (PPI) maintenance therapy is recommended for severe erosive GERD, and on-demand therapy or continuous maintenance therapy is recommended for mild erosive GERD or PPI-responsive non-erosive GERD. Moreover, PPI-resistant GERD (insufficient symptomatic improvement and/or esophageal mucosal break persisting despite the administration of PPI at a standard dose for 8 weeks) is defined, and a standard-dose PPI twice a day, change in PPI, change in the PPI timing of dosing, addition of a prokinetic drug, addition of rikkunshito (traditional Japanese herbal medicine), and addition of histamine H2-receptor antagonist are recommended for its treatment. If no improvement is observed even after these treatments, pathophysiological evaluation with esophageal impedancepH monitoring or esophageal manometry at an expert facility for diseases of the esophagus is recommended.

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Section: Cq: Is An Acid Suppressant Effective For the Treatment Of Gerd?mentioning

confidence: 99%

Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015

et al. 2016

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“…10 According to previous studies, PPI + mosapride combination therapy significantly improves ERD symptoms compared to PPI alone, but there was no major difference in the endoscopic healing rate. 11 A recent meta-analysis concluded that the combination therapy partially helps to improve QOL, but that it has no effect on alleviating symptoms or endoscopic healing.…”

Section: Introductionmentioning

confidence: 99%

A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease

Lee

Kim

Cho

et al. 2017

J Neurogastroenterol Motil

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Background/AimsWe aim to evaluate the efficacy and safety of combination therapy in erosive reflux disease (ERD) patients by comparing endoscopic healing rates according to the Los Angeles classification for esomeprazole alone, and esomeprazole plus mosapride. MethodsA total of 116 ERD patients were randomized to receive esomeprazole 40 mg once daily plus mosapride 5 mg 3 times daily (E+M group), or esomeprazole plus placebo (E only group) for 8 weeks. Patients recorded gastroesophageal reflux disease (GERD) symptom questionnaire at weeks 4 and 8. The primary endpoint was the endoscopic healing rate of ERD after 8 weeks of treatment. ResultsEndoscopic healing rates according to the Los Angeles classification was 32 (66.7%) in the E+M group and 26 (60.5%) in the E only group, but there was no statistically significant difference between the groups. Only at 4 weeks, the total GERD symptom score changes relative to the baseline significantly improved in the E+M group than that of the E only group (-13.4 ± 14.7 vs -8.0 ± 12.3, P = 0.041), and upper abdominal pain and belching score changes showed significantly improved in the E+M group than that of the E only group (P = 0.018 and P = 0.013, respectively). ConclusionsThe combination of a proton pump inhibitor with mosapride shows a tendency for upper abdominal pain, belching, and total GERD symptoms scores to improve more rapidly. This suggests that combination therapy with esomeprazole and mosapride will be useful for rapid improvement of specific GERD symptoms, such as upper abdominal pain and belching in ERD patients.

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“…21,22 Adding prokinetic drugs to PPI in the treatment of GERD is recommended, due to enhancing esophageal motor function, although the efficacy is controversial. [23][24][25][26][27] PPI induced the delay of gastric emptying in solid food, but there was few literature about prevention of the treatment delayed gastric emptying, and evaluations on dyspeptic symptoms. 8,[28][29][30] Tegaserod (5-HT4 receptor agonist) was used to normalize the delayed gastric empting caused by PPIs in previous study, but tegaserod is out of market from its cardiovascular risk, so there is no proven safe drug which was studied for preventing the PPI induce delayed gastric emptying.…”

Section: Discussionmentioning

confidence: 99%

Effects of the Addition of Mosapride to Gastroesophageal Reflux Disease Patients on Proton Pump Inhibitor: A Prospective Randomized, Double-blind Study

Lim

Kim

Youn

et al. 2013

J Neurogastroenterol Motil

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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

Abstract: SUMMARY BackgroundProton pump inhibitors (PPIs) are less effective in non-erosive reflux disease (NERD) patients than in reflux oesophagitis patients. Whether the addition of prokinetics to PPIs improves NERD patients' symptoms remains unknown.

Cited by 59 publications

References 41 publications

Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015

Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015

A Double-blind, Randomized, Multicenter Clinical Trial Investigating the Efficacy and Safety of Esomeprazole Single Therapy Versus Mosapride and Esomeprazole Combined Therapy in Patients with Esophageal Reflux Disease

Effects of the Addition of Mosapride to Gastroesophageal Reflux Disease Patients on Proton Pump Inhibitor: A Prospective Randomized, Double-blind Study

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