JerMa88/BMC_Gastroenterology_Peer_Reviews huggingface dataset:
Review for 10.1186/1471-230X-11-90 (2011)

Reviewer's report
Title:Role of inducible nitric oxide synthase pathway on methotrexate-induced
intestinal mucositis in rodents
Version: 2Date:21 July 2011
Reviewer: Guntram Grassl
Reviewer's report:
The revised version of the manuscript “Role of inducible nitric oxide synthase
pathway on methotrexate-induced intestinal mucositis in rodents” has
significantly improved. I believe it is now suitable for publication.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-89 (2011)

Reviewer's report
Title:The prone 12 o'clock position reduces ileal intubation time during
colonoscopy compared to the left lateral 6 o'clock (standard) position
Version: 1Date:17 May 2011
Reviewer: Derek Jewell
Reviewer's report:
This is a straightforward report of a well-designed clinical trial relating to ileal
intubation during colonoscopy. The study was well powered, the question to be
answered was clinically relevant and the study was well executed. Although it
has been common practice over many years to move patients into different
positions during difficult colonoscopic procedures, this is the first time that a
formal study comparing 2 positions for ileal intubation has been attempted. It is a
very neat study.
There are 2 minor errors: medazolam should be midazolam, oxymetry should be
oximetry
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-89 (2011)

Reviewer's report
Title:The prone 12 o'clock position reduces ileal intubation time during
colonoscopy compared to the left lateral 6 o'clock (standard) position
Version: 1Date:6 June 2011
Reviewer: Anna Buchner
Reviewer's report:
The study by Dr De Silva and colleagues aims to compare the prone 12 o’clock
position with the standard left lateral 12 o’clock position for ileal intubation. It
consists of the pilot study of 10 patients in which using the fluoroscopy exam the
prone 12 o’clock position was determined to be the best for the ileocecal valve
location and then the second part in which 150 patients were randomized to
either ileal intubation in prone 12 o’clock position or left lateral 12 o’clock
position. It concludes that the prone 12 o’clock position represents a more
efficient (faster) approach for the ileocecal valve intubation.
The study raises a practical point of technique for ileal intubations. Overall it is an
interesting and practical concept though its clinical significance need to be further
clarified. Other studies, not quoted here report pathologic abnormalities in the
terminal ileum as low as 0.3% of all study patients (Kennedy G et al Surg
Endoscopy 2008).
The study is well written. It requires some major clarifications:
1. Was the time of ileal intubation related in anyway to the experience of the
endoscopists, the nursing staff and the whole team? Other studies did report the
significance of these confounding variables for ileal intubation.
2. How was the change of position executed- did it apply to the whole procedure
or to only time of the ileocecal valve intubation?
3. Did other confounding variables such as adequate bowel preparation, age of
the patients, gender etc. have had an impact on the finding of the prone 12
o’clock position being more efficient?
4. Was there was a learning curve for successful ileal intubation observed in both
groups?
5. Did the pilot part of the study consist of completely different patients or
whether these patients included any of 150 patients?
Minor essential revisions:
The discussion needs to also enlist all potential limitations including the argument
of the prior studies that ileoscopy can show abnormal findings for only 1% of the
patients ( Kennedy F Surg Endoscopy 2008) as well as lack of confounding
variables analyzed in the study (endoscopists, nurse, bowel prep etc) which
could also play an important role.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
declare that I have no competing interests'
Review for 10.1186/1471-230X-11-87 (2011)

Reviewer's report
Title:An Australian Audit of Vaccination Status in Children and Adolescents with
Inflammatory Bowel Disease
Version: 1Date:18 March 2011
Reviewer: Fernando Fernández Bañares
Reviewer's report:
The paper by Crawford NW et al entitled “An Australian Audit of vaccination in
children….” deals about a topic that has been previously addressed in other
published papers. In addition, the conclusions are essentially coincidental with
previous published results. Essentially, they conclude that there is a poor
compliance for specific vaccination program recommended for IBD patients.
Thus, this study does not provide additional relevant information.
Major comments
1. The bibliography is not updated.
For example, the most important recently published papers concerning the
relevance of hepatitis B virus infection in IBD are not included.
2. Methods and Results.
The study was conducted between July and November 2007. Since 2007, the
awareness concerning the importance to implement vaccination programs in IBD
patients has increased. And this fact was partly due to the publication and wide
diffusion of review articles and guidelines for the prevention of opportunistic
infections in IBD. (Viget N. Gut 2008; Toruner M Gastroenterology 2008; Rahier
JF et al European evidence-based Consensus on the prevention, diagnosis and
management of opportunistic infections in inflammatory bowel disease. J Crohn’s
Colitis 2009; 3:47–91).
Thus, the interest of data collected in 2007 is very limited. Instead, it would be
interesting to assess if the actual knowledge about the importance of
opportunistic infection prevention has increased the implementation of the
recommended vaccination programs at present.
3. Discussion
In the discussion the authors really addressed the major methodological
limitations. That is the retrospective nature of the review, and only half of
participants being contactable. In addition the study also do not provide
information regarding if patients have a good immunological response to
vaccines since only 18% of the patients have VPD serology sample.
Minor comments
Some spelling mistakes such as patents (last paragraph of discussion) instead of
patients
Level of interest: An article of limited interest
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I have no financial nor non-financial competing interests about this paper.
Review for 10.1186/1471-230X-11-87 (2011)

Reviewer's report
Title:An Australian Audit of Vaccination Status in Children and Adolescents with
Inflammatory Bowel Disease
Version: 1Date:20 April 2011
Reviewer: shaji S sebastian
Reviewer's report:
1. resuls section needs reviewing particulary in relation to presntation of CIs
2. Recent papers by Jahier et all (GUT and APT) relevant in discussion and
references
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Review for 10.1186/1471-230X-11-87 (2011)

Reviewer's report
Title:An Australian Audit of Vaccination Status in Children and Adolescents with
Inflammatory Bowel Disease
Version: 2Date:17 June 2011
Reviewer: Petar Mamula
Reviewer's report:
The authors have answered all the questions. Only one issue remains before I
would accept the manuscript for publication. The rates of immunization are
reported at 5% for pneumococcal and 10% for flu vaccine using 101 patients as a
denominator. Since not all 101 patients had complete records obtained the
authors should either use the number of patients with complete records as a
denominator or describe in the discussion section that reported rate may not
reflect the actual immunization rate due to incomplete records.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Review for 10.1186/1471-230X-11-88 (2011)

Reviewer's report
Title:Gastrointestinal complaints and certified long-term sickness absence in the
HUSK study.
Version: 1Date:23 February 2011
Reviewer: Paul Enck
Reviewer's report:
I have a few minor essential revisions that need the attention of the authors:
a) I do not understand the sentence (p 8) "These 14 days serve as a "wash-out"
period ...", and I specifically do not understand how a 14-day period would
prevent reverse causation, but a longer period would not.
b) The term "somatisation disorder" which has a specific meaning that may not
be familiar to most agstroenterologists occurs on page 14 for the first time,
although some of the features of it are discussed also in the introduction.
c) The sentence (on page 15) referring to animal work and inflammation is a bit
"off label" - there are many more human studies that link stress to UC or CD.
d) In the Conclusion section, the sentence starting "The results ..." has an
incorrect wording: it appears to me tha authros would like to say that "... to
explain work related outcomes of of functional GI complaints" rather than "...work
related functional outcomes ..."
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-88 (2011)

Reviewer's report
Title:Do gastrointestinal complaints increase the risk for subsequent medically
certified long-term sickness absence? The HUSK study.
Version: 2Date:31 May 2011
Reviewer: Paul Enck
Reviewer's report:
I feel the authors have adequately replied to all concerns and have revised their
ms accordingly - unfortunately, the changes made are not visible in the ms
provided
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.
Review for 10.1186/1471-230X-11-86 (2011)

Reviewer's report
Title:Appointment waiting times and education level influence the quality of
bowel preparation in adult patients undergoing colonoscopy
Version: 2Date:12 June 2011
Reviewer: Ole Høie
Reviewer's report:
I have read the comments and revisions made by the authors. I have no
additional comments. The manuscript may be publoished without further
revisions.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Review for 10.1186/1471-230X-11-86 (2011)

Reviewer's report
Title:Appointment waiting times and education level influence the quality of
bowel preparation in adult patients undergoing colonoscopy
Version: 2Date:20 June 2011
Reviewer: Benjamin Lebwohl
Reviewer's report:
The revisions are noted and are acceptable.
Two minor essential revisions:
I am uncertain why the authors reference the Ottawa Bowel Preparation and
Boston Bowel Preparation scales after describing the scale that they used. The
scale used in this study more closely resembles the Aronchick scale (Aronchick
CA, Lipshutz WH, Wright H, et al. Validation of an instrument to assess colon
cleansing [abstract].AmJ Gastroenterol 1999;94:2667.) The point of the Ottawa
and Boston scales was to reduce the subjectivitiy inherent in the Aronchick scale.
It would be more fitting to reference Aronchick at that point (Methods section,
under the heading Bowel Preparation and Grading) while acknowledging (as the
authors appropriately do) as a limitation in the Discussion section that neither the
Ottawa nor the Boston scale was used.
The authors state that “the association of increased patient discomfort with poor
bowel preparation during and 1-hour post-colonoscopy was independent of the
indication for the procedure and the total colonoscopy time.” However, the data is
not shown. In their response to the reviewers, the authors mention that “a linear
regression was performed.” If the outcome was moderate-to-severe discomfort, I
assume that the authors had actually performed logistic (not linear) regression. In
any case, the authors should either state the odds ratio with 95% confidence
limits, or simply state “data not shown.”
When the authors comment on this finding in the Discussion, they write
“Furthermore, poor bowel preparation additionally resulted in more patient
discomfort, presumably from the longer duration of procedure and excessive air
insufflations, as sedation doses were similar in patients with and without poor
preparation.” It is inconsistent to state that this occurs “presumably from the
longer duration of procedure” if this finding was significant independent of total
colonoscopy time.
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 declare that I have no competing interests.
Review for 10.1186/1471-230X-11-85 (2011)

Reviewer's report
Title:Short-term and Medium-term Clinical Outcomes of Laparoscopic-assisted
and Open Surgery for Colorectal Cancer: A Single Center Retrospective
Case-control Study
Version: 3Date:14 February 2011
Reviewer: Seigo Kitano
Reviewer's report:
In this manuscript, authors show the advantages of laparoscopy-assisted surgery
for colorectal cancer by case-control study with large series. The following
revisions should be considered.
1.The clinical findings of operations for colon cancer are different from that for
rectal cancer. Authors should analyze the outcome of operation for each cancer.
2.How extent of lymph nodes dissection is performed?
3.Fig.1 shows the over-all survival. Authors should show and discuss the
disease-free survival.
4.Fig 2 (page 14, line10) is missing.
Level of interest: An article of outstanding merit and interest in its field
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Review for 10.1186/1471-230X-11-85 (2011)

Reviewer's report
Title:Short-term and Medium-term Clinical Outcomes of Laparoscopic-assisted
and Open Surgery for Colorectal Cancer: A Single Center Retrospective
Case-control Study
Version: 5Date:19 May 2011
Reviewer: Seigo Kitano
Reviewer's report:
Comments to authors:
The authors revised correctly this manuscript according to the suggestions of the
reviewers. The manuscript is clearly improved.
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.
Review for 10.1186/1471-230X-11-85 (2011)

Reviewer's report
Title:Short-term and Medium-term Clinical Outcomes of Laparoscopic-assisted
and Open Surgery for Colorectal Cancer: A Single Center Retrospective
Case-control Study
Version: 5Date:22 May 2011
Reviewer: jonas nygren
Reviewer's report:
The paper has improved. It will need another round of English proof reading. In
my opinion discussion is too lengthy. Pre study power calculation should be
mentioned in Statistics.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
Review for 10.1186/1471-230X-11-84 (2011)

Reviewer's report
Title:Intrahepatic blood flow assessment by Doppler ultrasonography:
relationship among hepatic vein, portal vein, hepatic artery and portal pressure
intraoperatively measured in patients with portal hypertension
Version: 2Date:21 January 2011
Reviewer: soon koo Baik
Reviewer's report:
The main conclusion of the study is that hepatic vein (HV) waveform changes in
patients with portal hypertension can indicate severity of portal pressure: There
are some limitations as following;
1.Accuracy and Reproducibility
: Accurate measurement with being reproducible is the most crucial in the study
of Doppler ultrasonography. Authors did not state the intra-and inter-observer
variability. Authors should show up the coefficient of variation(calculated by
dividing the standard deviation by mean and multiplying by 100) in terms of
reproducibility. For instance, to evaluate the intraindividual reproducibility, one
must measure the day-to-day variability for at least 5 consecutive days in about
10 subjects. Acceptable coefficient of variation would be approximately 10% in
HV and 5% in PVV according to previous study.
2.Why were HV waveforms measured not in right hepatic vein but in middle
hepatic vein?
: Most of previous studies for hepatic vein abnormalities showed that HV
waveform were measured at right HV because of advantage in terms of accuracy
and reproducibility, rather than middle HV. Authors should clarify this point
Level of interest: An article of importance in its field
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-84 (2011)

Reviewer's report
Title:Assessment of intrahepatic blood flow by Doppler ultrasonography:
relationship between the hepatic vein, portal vein, hepatic artery and portal
pressure measured intraoperatively in patients with portal hypertension
Version: 3Date:11 March 2011
Reviewer: soon koo Baik
Reviewer's report:
I have no more comments, except authors describe the value of coefficient of
variation for PVV in results part.
Review for 10.1186/1471-230X-11-84 (2011)

Reviewer's report
Title:Assessment of intrahepatic blood flow by Doppler ultrasonography:
relationship between the hepatic vein, portal vein, hepatic artery and portal
pressure measured intraoperatively in patients with portal hypertension
Version: 3Date:15 March 2011
Reviewer: Annalisa Berzigotti
Reviewer's report:
The authors answered only partially to most criticisms; consequently
unfortunately the content of the article did not improve significantly.
Level of interest: An article of insufficient interest to warrant publication in a
scientific/medical journal
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Review for 10.1186/1471-230X-11-84 (2011)

Reviewer's report
Title:Assessment of intrahepatic blood flow by Doppler ultrasonography:
relationship between the hepatic vein, portal vein, hepatic artery and portal
pressure measured intraoperatively in patients with portal hypertension
Version: 3Date:17 March 2011
Reviewer: Seyed-Mohammad Fereshtehnejad
Reviewer's report:
Dear editor of BMC Gastroenterology journal;
I reviewed the revised version of the manuscript titled: "Assessment of
intrahepatic blood flow by Doppler ultrasonography: relationship between the
hepatic vein, portal vein, hepatic artery and portal pressure measured
intraoperatively in patients with portal". The manuscript is well revised; however,
some minor points remained including:
1. As it was previously mentioned, it is better to give some data about sample
size calculation in the "Methods" section of the article.
2. Although the authors answered that the two groups of study were matched
regarding some baseline characteristics, nothing is mentioned about the details
of matching process in the text of the revised manuscript.
3. No data on baseline characteristics of the control group are presented neither
in the text of the results nor in the Table 1.
Finally, I think it is necessary to consider these comments in this manuscript.
SM Fereshtehnejad MD. MPH.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Review for 10.1186/1471-230X-11-84 (2011)

Reviewer's report
Title:Assessment of intrahepatic blood flow by Doppler ultrasonography:
relationship between the hepatic vein, portal vein, hepatic artery and portal
pressure measured intraoperatively in patients with portal hypertension
Version: 4Date:12 April 2011
Reviewer: Annalisa Berzigotti
Reviewer's report:
- Major Compulsory Revisions
The addition of the requested data has improved the quality of the paper.
However, after observing the clinical characteristics of the patients (Table 1) I
have a major concern on the inclusion criteria: if most patients had no major
complications of portal hypertension (most had no or small varices and no or light
ascites), which was the indication for shunting surgery? This should be detailed
and added to the text.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Review for 10.1186/1471-230X-11-84 (2011)

Reviewer's report
Title:Assessment of intrahepatic blood flow by Doppler ultrasonography:
relationship between the hepatic vein, portal vein, hepatic artery and portal
pressure measured intraoperatively in patients with portal hypertension
Version: 5Date:13 May 2011
Reviewer: Annalisa Berzigotti
Reviewer's report:
The authors partially answered to the criticisms previously raised.
Minor Essential Revisions
The only accepted indication for shunt surgery in portal hypertension is
secondary prophylaxis (history of recurrent variceal bleeding) in Child A patients
(De Franchis et al. Baveno V consensus conference, J Hepatology 2010); in
patients with ascites transjugular intrahepatic porto-systemic shunt has to be
preferred due to a lower mortality related to the procedure. Prophylactic surgery
in patients who have not bled yet is contraindicated due to its high risk
(Consensus conference of Baveno III and IV).
Since some of the patients included in the present paper were treated with
derivative surgery as a primary prophylaxis (3 patients underwent shunt surgery
for hyperdynamic syndrome alone and 4 due to "CT showing cirrhosis with large
tubercules), I think the authors should include in the text:
1) the number/percentage of patients with an history of variceal bleeding
2) the detailed indications of derivative surgery in their Hospital
3) the indication of derivative surgery in all the patients included in the present
study
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Review for 10.1186/1471-230X-11-83 (2011)

Reviewer's report
Title:The Prevalence, Incidence and Natural History of Primary Sclerosing
Cholangitis in an Ethnically Diverse Population
Version: 1Date:10 June 2011
Reviewer: Jens J.W. J Tischendorf
Reviewer's report:
The authors wrote a manuscript about PSC patients from diverse ethnical
backgrounds. This topic is very promising since there is only a small knowledge
of the natural course of the disease dependent on race. However, in 53.8% of all
169 patients in this study, the ethnicity is described as “unknown/other”. Among
the remaining small number of PSC patients with known ethnicity, the important
clinical question of risk assessment or determination of prognostic factors for the
natural course of this disease dependent on race cannot be answered. This
drawback should be addressed in the discussion, as the specialty of diverse
ethnicity in this study is highlighted even in the title by the authors. In summary,
this is a well written manuscript, though it is lacking a significant amount of new
information for the reader.
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Review for 10.1186/1471-230X-11-83 (2011)

Reviewer's report
Title:The Prevalence, Incidence and Natural History of Primary Sclerosing
Cholangitis in an Ethnically Diverse Population
Version: 1Date:14 June 2011
Reviewer: Timothy Card
Reviewer's report:
This is a nicely written report of what seems to me a well conducted study in a
dataset appropriate to the questions it seeks to answer. I have no major
concerns regarding it.
Discretionary Revisions
Though I appreciate that the authors have sought to place their work in most
regards in the mainstream in this subject, I think they have underplayed the
differences somewhat. This is as they point out the second recent population
based study of a large unselected population to find that PSC is rarer than stated
by some enthusiasts. It would appear to me that another departure of both these
studies is that they have found lower rates of IBD in PSC than often stated.
Precisely how this should be interpreted is open to debate, as it would imply
either that the more selected populations are atypical in having so much IBD, or
that in the generality of cases IBD is under diagnosed. I would have welcomed
more discussion around this point.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-82 (2011)

Reviewer's report
Title:Allergic proctocolitis refractory to maternal oligoantigenic diet in exclusively
breast-fed infants: a clinical observation.
Version: 2Date:1 March 2011
Reviewer: Jay Lieberman
Reviewer's report:
Major Compulsory Revisions -
I see no major compulsory revisions. This study is limited in scope and truthfully,
does not add very much to the field. In many ways, it simply confirms some of the
data already established in the field, such as that published by Dr. Lake in 2000.
It does add data on patch testing, and shows that patch testing was positive to
various proteins, but does not use this information in any way. Since all patients
that were patch tested were then placed on amino acid formula, how is one to
know the relevance of the patch test. If the patch test had never been done,
nothing would have changed clinically (i.e., all patients could have been put on
amino acid formula and improved without patch testing). Also, were any controls
(such as IgE-mediated food allergic children) patch tested to breast milk?
Perhaps controls would have positive testing to breast milk for example, as well.
Minor Essential Revisions --
1. Background - the data on the percentage requiring formula is not quite correct.
Lake showed that 12% of the children in his study required specialized formula.
7% responded to extensively hydrolyzed formula, while 5% required amino acid
formula. That is the larges case series that I am aware of.
2. Case Presentation - Authors state "mothers were on cow's milk and soy and/or
egg-free diets". It would be nice to know exactly how many were on which diet.
Were 7 on milk free? Were all 14 on milk free?
3. Case Presentation - In the description of the biopsies, it states "60 eosinophils
per 10 high power field in the lamina propria in almost one biopsy specimen in six
infants" is very confusing. What does this mean?
4. Discussion - In the second paragraph, it states "The prognosis is good with
gradual and complete resolution after 72-96 hours of maternal allergen
avoidance". I am assuming the authors mean that previous studies have shown
that, but their data argues that this is not the case in their patient population.
5. Conclusion - It states that biopsy is required to confirm a diagnosis. I think
many clinicians would argue this point. many clinicians will simply transition an
infant with hemotchezia only to an empiric trial of amino acid formula, and if the
bleeding resolves, no pursue any invasive testing.
Discretionary Revisions
It may benefit the paper to concentrate more on the patch testing if possible, as
this is really the novel part of the study.
Level of interest: An article of limited interest
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Review for 10.1186/1471-230X-11-82 (2011)

Reviewer's report
Title:Allergic proctocolitis refractory to maternal oligoantigenic diet in exclusively
breast-fed infants: a clinical observation.
Version: 3Date:1 June 2011
Reviewer: Ralf G Heine
Reviewer's report:
The overall quality of the paper is improved after the extensive revision by the
authors. The addition of Table 1 has made the clinical detail provided much
clearer. However, some limitations remain, mainly relating to the assessment of
the diagnostic accuracy and clinical usefulness of atopy patch testing in this
cohort of patients. At the start of the discussion the authors state:
“APT positivity for foods and breast milk, in our case series of exclusively
breast-fed infants with APC, confirms the hypothesis that food proteins can be
transferred through lactation and are potentially able to induce an allergic
reaction in infants.”
And conclude by saying:
“We suggest patch testing for foods could become an important diagnostic tool to
identify a polisensitization, with the potential objective to correctly address the
maternal diet. Patch testing for breast milk seems to be able to demonstrate the
passage of food proteins deriving from the maternal diet in exclusively breast-fed
infants.”
However, this is an over-interpretation of the available APT results from this
study as results were not confirmed by food challenge. Instead, all infants were
placed on an elemental diet. It therefore remains unclear what proportion of
infants had false-positive or false-negative results. For example, only half of
infants had a positive patch test to cow’s milk but the authors assumed that
allergic proctocolitis was mainly due to cow’s milk proteins transferred through
breast milk. This would suggest a false-negative rate of about 50% and illustrates
that the APT most likely has a low sensitivity which would significantly limit its
usefulness as a diagnostic tool.
The authors can safely deduct from their study that allergic proctocolitis in infants
is a non-IgE-mediated condition. In addition, all infants who failed to respond to a
maternal elimination diet improved on amino acid-based formula (AAF). This is
useful clinical information. However, it does not necessarily imply an allergic
mechanism as food challenges were not performed.
In summary, the role of the APT as a diagnostic tool in this study remains
speculative and is not backed up by the data provided. These limitations should
be made clearer in the discussion.
Review for 10.1186/1471-230X-11-81 (2011)

Reviewer's report
Title:To compare the effect of two Zhizhu pills in the treat- ment of functional
dyspepsia of spleen-deficiency and qi-stagnation syndromea randomized ,
double- blinded multicenter and group sequential study design
Version: 1Date:6 August 2010
Reviewer: Muhammad Nabeel Ghayur
Reviewer's report:
Wu et al have presented some very good data in terms of looking for a potential
therapy by use of traditional Chinese therapy and presenting it after assessing
the results obtained in a double blinded randomized controlled trial.
The paper deserves publication in the journal, but would be good to add the
following suggestions in the paper:
Minor revisions
1. It would be good to show if the plants (used as therapy for functional
dyspepsia) have been used traditionally in Chinese medicine for gastrointestinal
disorders. Please provide relevant references.
2. How and from where the test plant drug was obtained? Was it
formulated/prepared by the authors or purchased from some manufacturers?
Also state the method of its preparation and formulation if it was prepared by the
authors themselves. In this case also provide how and by whom the plant
material was identified and the relevant herbarium registration material.
3. It will be good to expand (in the discussion part) more on the pharmacological
reasoning/mechanism of action behind the chemicals possibly responsible for the
beneficial effect in dyspepsia.
4. Please expand more on the TCM equivalent term for f.dyspepsia, especially
where the authors refer to 'spleen-deficiency' and 'qi-stagnation syndrome'. It will
help the readers to get a grip of what the authors ate referring to here.
Level of interest: An article of outstanding merit and interest in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-81 (2011)

Reviewer's report
Title:To compare the effect of two Zhizhu pills in the treat- ment of functional
dyspepsia of spleen-deficiency and qi-stagnation syndromea randomized ,
double- blinded multicenter and group sequential study design
Version: 1Date:27 October 2010
Reviewer: Carl J Lombard
Reviewer's report:
Major
The purpose of this paper is not clear to me. I am not sure if this paper is about
reporting the results of the trial or whether it is an example of a comparative trial
with a particular type of stopping boundary.
If it is the first then I have problem with the reporting of the results of the trial
since no effect size of confidence interval is reported. The pre-post distribution of
the symptom score is not given by group.
If it is the second option one would expect a much more detailed expose of why
the whitehead design was used and not any of the other group sequential design
even those of whitehead in 2001 for example. This outline would be of benefit to
the reader. Showing the calculation of the effect size and confidence intervals
using the stopped trial will also be useful in 'this' type of paper.
At the moment this paper is neither of the cases outlined above.
What was the basis for assumming that the one product will have a superiority of
15%? Why was equivalence not considered?
From checking the details on the stopping boundaries given in the analysis
section I could deduce that the metric of comparison was the log odds ratio and
that theta 1 given in this section is the value of this statistics under H1. These
descriptive details are missing. In the Results section under TT the test statistic
referred to is a log- rank statistic which is incorrect
Table 1
The presentation of the descriptive statistics in this table is not good.
What are the statistics - mean, median, standard deviation? Why brackets in the
one group and +_ in the other? The main critique is that of presenting p-values
for the baseline comparisons. Why is this done - was the randomisation flawed?
Please drop the column of p-value in this table
Results table - no sure why no estimated effects within and between groups are
presented with the necessary confidence intervals taking the interim monitoring
into account?
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Review for 10.1186/1471-230X-11-81 (2011)

Reviewer's report
Title:To compare the efficacy of two kinds of Zhizhu pills in the treatment of
functional dyspepsia of spleen-deficiency and qi-stagnation syndromeA
randomized group sequential trial
Version: 3Date:7 March 2011
Reviewer: Muhammad Nabeel Ghayur
Reviewer's report:
The authors have justified and explained all the issues raised, thus the paper can
now be accepted in its present form.
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-81 (2011)

Reviewer's report
Title:To compare the efficacy of two kinds of Zhizhu pills in the treatment of
functional dyspepsia of spleen-deficiency and qi-stagnation syndromeA
randomized group sequential trial
Version: 3Date:22 March 2011
Reviewer: Carl J Lombard
Reviewer's report:
The authors have re-written the manuscript to make it clear that it is the results of
a comparative trial that is being reported. Comparative between two compounds.
Looking at the title of reference 18 made the design clear to me: answering the
question which of the compounds is the best? The word comparative might be
included in the title : a randomized group sequential comparative trial
The description of the stopping boundary and test statistics is fine. Once the
boundary is crossed in the study we can say that the one compund is
significantly better than the other with some p-value. The comments that was not
addressed is the answer to: how much better? The effect size or difference
between the compounds is 22%. You have to provide the estimate and its
appropriate confidence interval since this is the main result of the trial. The
problem you face is the correct calculation of the confidence interval since this is
not a SSD but a sequential design in which you had three looks and then
stopped the study.
You provide the symptom score at baseline were it is good enough for
information purposes but it is not provided for the post randomisation time point.
Your main outcome is based on this and the descriptive statistics of the post
score will be useful for other researchers planning other studies.
P-values should no be reported for baseline comparisons since the difference
observed is known to be due to chance only- the effect you achieved by
randomisation.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Review for 10.1186/1471-230X-11-81 (2011)

Reviewer's report
Title:To compare the efficacy of two kinds of Zhizhu pills in the treatment of
functional dyspepsia of spleen-deficiency and qi-stagnation syndromea
randomized group sequential comparative trial
Version: 4Date:10 June 2011
Reviewer: Carl J Lombard
Reviewer's report:
Minor essential revisions
1. The log(OR) is the scale of the TT testing being done. This is fine but the
estimate of the effect should be expressed on the odds ratio scale since this is
the standard scale for expressing the benefit or risk.
Hence taking the exponent for the estimate and CI one gets OR=2.91 with
95%CI: 1.40 to 6.06) for the benefit of IFCA relative to IFCS. This should be
presented in the abstract and body of the text in place of the log(OR).
2. The last paragraph of the statistical methods should be deleted since it is no
longer relevant
3. The headings of Figure I and II should be clear and self-sufficient
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
'I declare that I have no competing interests'
Review for 10.1186/1471-230X-11-80 (2011)

Reviewer's report
Title:Paracetamol in therapeutic dosages and acute liver injury: causality
assessment in a prospective case series.
Version: 1Date:13 December 2010
Reviewer: ken J simpson
Reviewer's report:
See attached file
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-80 (2011)

Reviewer's report
Title:Paracetamol in therapeutic dosages and acute liver injury: causality
assessment in a prospective case series.
Version: 1Date:4 January 2011
Reviewer: Philip Newsome
Reviewer's report:
The authors report a series of cases in which ALI results from likely therapeutic
paracetamol ingestion. It is not clear however what this adds to the literature that
already exists relating to paracetamol induced toxicity. In that respect the
message of the manuscript is not adding to what is already known. The authors
need to be clear what advance they are proposing in their manuscript.
The manner in which the cases are decided to be paracetamol induced is not
entirely clear.
What was the outcome of these patients, and to what extent was the dose
adjusted for weight?
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests.
Review for 10.1186/1471-230X-11-80 (2011)

Reviewer's report
Title:Paracetamol in therapeutic dosages and acute liver injury: causality
assessment in a prospective case series.
Version: 2Date:21 February 2011
Reviewer: ken J simpson
Reviewer's report:
The authors have responded to the points made in a satisfactory fashion
Level of interest: An article of limited interest
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
'I declare that I have no competing interests'
Review for 10.1186/1471-230X-11-79 (2011)

Reviewer's report
Title:A simple dummy liver assist device prolongs anhepatic survival in a
porcine model of total hepatectomy by slight hypothermia.
Version: 1Date:6 April 2011
Reviewer: Vanessa Stadlbauer
Reviewer's report:
This manuscript wanted to develop a dummy model for liver assist devices and
found that slight hypothermia is associated with longer survival of anhepatic pigs.
This study is of importance for future developments in this area.
However, I think that there is the possibility to further improve the manuscript.
Major revisions
Please describe the endotoxin measurement in more detail since the LAL assay
is difficult in serum/plasma samples. Do you have data on LBP or sCD14 levels
or on cytokines (TNFalpha, IL6, IL10, TNFR ...)? Such data would possibly clarify
the paradox of prolonged survival but elevated endotoxin levels.
It would also be interesting to see the individual endotoxin levels of the animals
at the last timepoint.
Minor revisions:
Table and figures: please check the spelling (albumin, hemoglobin, endotoxin)
Discretionary revisions
The introduction could be shortened
Level of interest: An article of importance in its field
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-79 (2011)

Reviewer's report
Title:A simple dummy liver assist device prolongs anhepatic survival in a
porcine model of total hepatectomy by slight hypothermia.
Version: 2Date:7 June 2011
Reviewer: Vanessa Stadlbauer
Reviewer's report:
My questions have been answered sufficiently
Level of interest: An article of importance in its field
Quality of written English: Acceptable
Statistical review: Yes, and I have assessed the statistics in my report.
Declaration of competing interests:
I declare that I have no competing interests
Review for 10.1186/1471-230X-11-79 (2011)

Reviewer's report
Title:A simple dummy liver assist device prolongs anhepatic survival in a
porcine model of total hepatectomy by slight hypothermia.
Version: 2Date:7 June 2011
Reviewer: NIKOLAOS ARKADOPOULOS
Reviewer's report:
The authors have successfully addressed all points raised in my review. The
manuscript is now suitable for publication.
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 declare that I have no competing interests.
Review for 10.1186/1471-230X-11-67 (2011)

Reviewer's report
Title:Endoscopic resection of duodenal bulb carcinoid tumor larger than 10mm
in diameter.
Version: 1Date:11 December 2010
Reviewer: Hironori Tsujimoto
Reviewer's report:
Major Compulsory Revisions
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Review for 10.1186/1471-230X-11-67 (2011)

Reviewer's report
Title:Endoscopic resection of duodenal bulb carcinoid tumor larger than 10mm
in diameter.
Version: 1Date:16 December 2010
Reviewer: YOSHINORI IGARASHI
Reviewer's report:
Major points
This case is not indication of endoscopic treatments.
Carinoid tumors over 10mm have the high risk of metastasis.
Many reports wrote the metastasis of carcinoid over 10mm.
It is not the indication of endoscopic treatments.
Morever the technique is not recommended.
Traditional EMR is somtime uclear of lateral margin.
Then EMR using EVL or ESD is usually perfomed.
Level of interest: An article of limited interest
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.
Review for 10.1186/1471-230X-11-67 (2011)

Reviewer's report
Title:Endoscopic resection of duodenal bulb carcinoid tumor larger than 10mm
in diameter.
Version: 1Date:23 March 2011
Reviewer: Stefan von Delius
Reviewer's report:
The authors report a series of 4 duodenal neuroendocrine tumors resected by
EMR. They conclude, that even tumors larger than 10 mm can be treated by
endoscopic resection after confirming that the tumor confined to the submucosal
layer in EUS examination and exclusion of lymph node involvement by
abdominal CT and US.
Overall, this is an interesting topic.
In general, the terminology should be “neuroendocrine tumors” and not
“carcinoids”.
Case presentation
To my opinion such a case presentation must include more details about the
patients, i.e. age, sex, clinical presentation (especially in the light of the presence
of a neuroendocrine tumor: diarrhea, ulcers,…?), comorbidities and the grading
of the tumor. Moreover, details about pathology should be given: Grading?
Immunohistochemistry?
Were the tumors endocrinologically active or inactive?
Please improve grammar and English expression, e.g. replace “swollen” by
“enlarged”, … .
To me the manuscript seems not suitable for publication in the current form.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Needs some language corrections before being
published
Statistical review: No, the manuscript does not need to be seen by a
statistician.