Reviewer's report 
 Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory Title: 
bowel disease: a prospective, randomised and controlled pilot study. 
 2  27 December 2006 Version: Date: 
 Ahmed Madisch Reviewer: 
Reviewer's report: 
General 
The present pilot study is well conducted and an important hypothesis is generated, but, however, the final conclusion of the paper, that the present study showed an efficacy of lactulose for treatment of UC is too strong a statement and cannot be concluded from this paper. Thus, the conclusion has to be softened. 
Major Compulsory Revisions (that the author must respond to before a decision on publication can be 
reached) 
Moreover, some amendments and clarifications are needed as follows: 
• How many of the patients were referred to hospital due to symptoms, please specify. 
• How many patients received newly anti-inflammatory drugs or were the dose changed? This is very 
important, because more UC patients of the lactulose group received prednisolon > 5 mg and 5 ASA compared to the controls. Possibly, this is reason for the significant difference between the two groups and 
it is not effect of lactulose. This was underlined by the fact, that the distribution of the anti-inflammatory 
drugs of CD groups were similar and in these patients no effect of lactulose was observed. This possible bias should be discuss further in the paper. 
• A possible placebo effect should also be mentioned and discussed. 
• Do the authors have an idea, why the CDAI improved in the CD patients without receiving lactulose ? 
• ?-antitrypsin and pH (for compliance) were measured, but not mentioned in the result section. 
• The method part should be shortened, especially the histological and immunohistochemical evaluation. 
The results were inconsistent and interpretation was very difficult, because many of the observed effects 
were due to the anti-inflammatory drugs. 
 Accept after minor essential revisions What next?: 
 An article of importance in its field Level of interest: 
 Acceptable Quality of written English: 
 No, the manuscript does not need to be seen by a statistician. Statistical review: 
Reviewer's report 
 Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory Title: 
bowel disease: a prospective, randomised and controlled pilot study. 
 2  27 December 2006 Version: Date: 
 Ahmed Madisch Reviewer: 
Reviewer's report: 
General 
The present pilot study is well conducted and an important hypothesis is generated, but, however, the final conclusion of the paper, that the present study showed an efficacy of lactulose for treatment of UC is too strong a statement and cannot be concluded from this paper. Thus, the conclusion has to be softened. 
Major Compulsory Revisions (that the author must respond to before a decision on publication can be 
reached) 
Moreover, some amendments and clarifications are needed as follows: 
• How many of the patients were referred to hospital due to symptoms, please specify. 
• How many patients received newly anti-inflammatory drugs or were the dose changed? This is very 
important, because more UC patients of the lactulose group received prednisolon > 5 mg and 5 ASA compared to the controls. Possibly, this is reason for the significant difference between the two groups and 
it is not effect of lactulose. This was underlined by the fact, that the distribution of the anti-inflammatory 
drugs of CD groups were similar and in these patients no effect of lactulose was observed. This possible bias should be discuss further in the paper. 
• A possible placebo effect should also be mentioned and discussed. 
• Do the authors have an idea, why the CDAI improved in the CD patients without receiving lactulose ? 
• ?-antitrypsin and pH (for compliance) were measured, but not mentioned in the result section. 
• The method part should be shortened, especially the histological and immunohistochemical evaluation. 
The results were inconsistent and interpretation was very difficult, because many of the observed effects 
were due to the anti-inflammatory drugs. 
 Accept after minor essential revisions What next?: 
 An article of importance in its field Level of interest: 
 Acceptable Quality of written English: 
 No, the manuscript does not need to be seen by a statistician. Statistical review: 
Please review this paper.
user
Reviewer's report 
 Effect of oral lactulose on clinical and immunohistochemical parameters in patients with inflammatory Title: 
bowel disease: a prospective, randomised and controlled pilot study. 
 2  27 December 2006 Version: Date: 
 Ahmed Madisch Reviewer: 
Reviewer's report: 
General 
The present pilot study is well conducted and an important hypothesis is generated, but, however, the final conclusion of the paper, that the present study showed an efficacy of lactulose for treatment of UC is too strong a statement and cannot be concluded from this paper. Thus, the conclusion has to be softened. 
Major Compulsory Revisions (that the author must respond to before a decision on publication can be 
reached) 
Moreover, some amendments and clarifications are needed as follows: 
• How many of the patients were referred to hospital due to symptoms, please specify. 
• How many patients received newly anti-inflammatory drugs or were the dose changed? This is very 
important, because more UC patients of the lactulose group received prednisolon > 5 mg and 5 ASA compared to the controls. Possibly, this is reason for the significant difference between the two groups and 
it is not effect of lactulose. This was underlined by the fact, that the distribution of the anti-inflammatory 
drugs of CD groups were similar and in these patients no effect of lactulose was observed. This possible bias should be discuss further in the paper. 
• A possible placebo effect should also be mentioned and discussed. 
• Do the authors have an idea, why the CDAI improved in the CD patients without receiving lactulose ? 
• ?-antitrypsin and pH (for compliance) were measured, but not mentioned in the result section. 
• The method part should be shortened, especially the histological and immunohistochemical evaluation. 
The results were inconsistent and interpretation was very difficult, because many of the observed effects 
were due to the anti-inflammatory drugs. 
 Accept after minor essential revisions What next?: 
 An article of importance in its field Level of interest: 
 Acceptable Quality of written English: 
 No, the manuscript does not need to be seen by a statistician. Statistical review: 
assistant