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: 
26 Nov 2021
Reviewer's report:
This is a real-life post marketing survey on a herbal dosage form to manage
functional dyspepsia; The study was possibly supported by the producing
pharmaceutical company .
1- Description of the included sample : it is not clear if the patients were
diagnosed as FD by a standard definition and by a reliable person i.e. a physician
or not. More description is needed . 
2- Differentiating self-users versus prescription-users also first-time users from
regular users are needed in methods and analysis. 
3- It is to be noted in discussion that regular frequent users are mostly consisted
of those who had previous good experiences !
4- Description of recommended dose and usage : The text does not cover details
about timing of use , number of 
drugs that are permitted and even if the
medication was an on-demand or maintenance one. Due to lack of description, it
is impossible to evaluate the drug efficacy in different types of user based on the
total used dose or their self-practice . 
5- 
The PRO that was 
administered 
in the survey 
was 
a simple questionnaire that
contains just two main items about FD : pain 
and fullness 
with a 3-point Likert
scale ; description about its validity is required .
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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?
No
Is the presentation of the work clear?
No
Are the images in this manuscript (including electrophoretic gels and blots) free
from apparent manipulation?
Yes