Reviewer's report
Title:Effects of acotiamide on esophageal motor function and gastroesophageal
reflux in healthy volunteers
Version:2Date:31 May 2015
Reviewer: Kei Matsueda
Reviewer's report:
I have reviewed the manuscript entitled “ Effect of acotiamide on esophageal
motor function and gastroesophageal reflux in healthy volunteers “ and my
comments are as follows:
Authors adopted cross over protocol in this study, however HRM and MII-pH are
the stressful tests and may influence outcome of the second study.
They also did not use placebo, but GI motility could be altered via brain-gut axis.
Therefore, it is better to select parallel-group studies with placebo to eliminate the
above mentioned problems and to define the drug efficacy.
Nevertheless, this study was worth to publish because this is the first study
showing acotiamide does not enhance esophageal motor functions or prevent
GERD events in humans, and the following data may support the author’s
conclusions.
Several studies have shown that acotiamide does not enhance gastric emptying
in healthy volunteers but enhance in FD patients (1,2). In animal studies, the
similar results were reported (3).
1) Adam B et al. Z-338 improves meal-induced symptoms in functional
dyspepsia: double
blind, randomized, placebo controlled crossover study. Gastroenterology 2009;
136:A 535
2) Zai H et al. Effect of acotiamide on gastric emptying in healthy adult humans.
3) Seto K et al. Acotiamide hydrochloride (Z-338), a novel prokinetic agent,
restores delayed gastric emptying and feeding inhibition induced by restrain
stress in rats. Neurogastroenterol Motil 2008;20:1052-9
GER, gastroesophageal reflux was not listed in List of Abbreviations.
~~~~~~~~~~~~~~~~~~~~~~~~~~
Kei Matsueda, MD, PhD
Director: Sakura Life Clinic
1-14-7-2F Kinshi Sumida Tokyo 130-0013
Japan
Tel: 81-3-3625-5547 Fax: 81-3-5819-2258
e-mail: matsueda@slclinic.com
~~~~~~~~~~~~~~~~~~~~~~~~~~~
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I have been a speaker and honoraria recipient for Zeria Pharmaceutical Co. Ltd
and Astellas Pharma Inc.
Reviewer's report
Title:Effects of acotiamide on esophageal motor function and gastroesophageal
reflux in healthy volunteers
Version:2Date:31 May 2015
Reviewer: Kei Matsueda
Reviewer's report:
I have reviewed the manuscript entitled “ Effect of acotiamide on esophageal
motor function and gastroesophageal reflux in healthy volunteers “ and my
comments are as follows:
Authors adopted cross over protocol in this study, however HRM and MII-pH are
the stressful tests and may influence outcome of the second study.
They also did not use placebo, but GI motility could be altered via brain-gut axis.
Therefore, it is better to select parallel-group studies with placebo to eliminate the
above mentioned problems and to define the drug efficacy.
Nevertheless, this study was worth to publish because this is the first study
showing acotiamide does not enhance esophageal motor functions or prevent
GERD events in humans, and the following data may support the author’s
conclusions.
Several studies have shown that acotiamide does not enhance gastric emptying
in healthy volunteers but enhance in FD patients (1,2). In animal studies, the
similar results were reported (3).
1) Adam B et al. Z-338 improves meal-induced symptoms in functional
dyspepsia: double
blind, randomized, placebo controlled crossover study. Gastroenterology 2009;
136:A 535
2) Zai H et al. Effect of acotiamide on gastric emptying in healthy adult humans.
3) Seto K et al. Acotiamide hydrochloride (Z-338), a novel prokinetic agent,
restores delayed gastric emptying and feeding inhibition induced by restrain
stress in rats. Neurogastroenterol Motil 2008;20:1052-9
GER, gastroesophageal reflux was not listed in List of Abbreviations.
~~~~~~~~~~~~~~~~~~~~~~~~~~
Kei Matsueda, MD, PhD
Director: Sakura Life Clinic
1-14-7-2F Kinshi Sumida Tokyo 130-0013
Japan
Tel: 81-3-3625-5547 Fax: 81-3-5819-2258
e-mail: matsueda@slclinic.com
~~~~~~~~~~~~~~~~~~~~~~~~~~~
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I have been a speaker and honoraria recipient for Zeria Pharmaceutical Co. Ltd
and Astellas Pharma Inc.
Please review this paper.
user
Reviewer's report
Title:Effects of acotiamide on esophageal motor function and gastroesophageal
reflux in healthy volunteers
Version:2Date:31 May 2015
Reviewer: Kei Matsueda
Reviewer's report:
I have reviewed the manuscript entitled “ Effect of acotiamide on esophageal
motor function and gastroesophageal reflux in healthy volunteers “ and my
comments are as follows:
Authors adopted cross over protocol in this study, however HRM and MII-pH are
the stressful tests and may influence outcome of the second study.
They also did not use placebo, but GI motility could be altered via brain-gut axis.
Therefore, it is better to select parallel-group studies with placebo to eliminate the
above mentioned problems and to define the drug efficacy.
Nevertheless, this study was worth to publish because this is the first study
showing acotiamide does not enhance esophageal motor functions or prevent
GERD events in humans, and the following data may support the author’s
conclusions.
Several studies have shown that acotiamide does not enhance gastric emptying
in healthy volunteers but enhance in FD patients (1,2). In animal studies, the
similar results were reported (3).
1) Adam B et al. Z-338 improves meal-induced symptoms in functional
dyspepsia: double
blind, randomized, placebo controlled crossover study. Gastroenterology 2009;
136:A 535
2) Zai H et al. Effect of acotiamide on gastric emptying in healthy adult humans.
3) Seto K et al. Acotiamide hydrochloride (Z-338), a novel prokinetic agent,
restores delayed gastric emptying and feeding inhibition induced by restrain
stress in rats. Neurogastroenterol Motil 2008;20:1052-9
GER, gastroesophageal reflux was not listed in List of Abbreviations.
~~~~~~~~~~~~~~~~~~~~~~~~~~
Kei Matsueda, MD, PhD
Director: Sakura Life Clinic
1-14-7-2F Kinshi Sumida Tokyo 130-0013
Japan
Tel: 81-3-3625-5547 Fax: 81-3-5819-2258
e-mail: matsueda@slclinic.com
~~~~~~~~~~~~~~~~~~~~~~~~~~~
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a statistician.
Declaration of competing interests:
I have been a speaker and honoraria recipient for Zeria Pharmaceutical Co. Ltd
and Astellas Pharma Inc.
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