Review for 10.1186/s12876-022-02181-5 (2022)

Reviewer’s report
Title: 
A Novel Duodenal-Release Formulation of Caraway Oil and L-Menthol is
a Safe, Effective and Well Tolerated Therapy for Functional Dyspepsia
Version: 
0 
Date: 
15 Jan 2022
Reviewer's report:
This is a post-marketing evaluation of the efficacy and safety profile of a new
combination of cumin oil and L-menthol for the treatment of functional
dyspepsia.
It is a very interesting product due to the high prevalence of this chronic disorder
which negatively affects the quality of life and the economic burden for the
health system.
In patients with FD, complementary or alternative (herbal) treatments are widely
used to improve symptoms and quality of life.
However, I have some critical issues:
* the authors do not consider any distinction between epigastric pain syndrome
(EPS) and postprandial distress syndrome (PDS) and although this combination
of herbal medicines appears to have a substantial effect in both subgroups this
needs to be confirmed. In my opinion a subgroup analysis is useful.
* The difference between major and moderate improvement is unclear in Figure
1 and Table 1. Please it should be clarified;
* it is not clear whether the study involves a single center or several centers,
several pharmacies in the area or not
* it is not clear how long the product was taken also because some bought it,
others used medical samples.
* the age and gender of the participants were not recorded
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Is the study design appropriate to answer the research question (including the use
of appropriate controls), and are the conclusions supported by the evidence
presented?
Yes
Are the methods sufficiently described to allow the study to be repeated?
No
Is the use of statistics and treatment of uncertainties appropriate?
Yes
Is the presentation of the work clear?
Yes
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes