Review for 10.1186/1471-230X-7-36 (2007)

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  23 May 2007 Version: Date: 
 Ly-Mee Yu Reviewer: 
Reviewer's report: 
General 
This pilot study compared the clinical and immunohistochemical parameters in inflammatory bowel disease 
(IBD) patients randomised to oral lactulose as adjuvant therapy or standard therapy. Both the randomisation 
and analysis of this study were stratified by type of disease (i.e. Crohn’s disease (CD) or ulcerative colitis 
(UC)). However, I’m concerned if the analysis and reporting of data had been adequately carried out. 
------------------------------------------------------------------------------- Major Compulsory Revisions (that the author must respond to before a decision on publication can be reached) 
Methods section 
1. Why did the authors exclude 2 participants who had no biopsy taken on the first colonoscopy while biopsies were available on only 20 of the 31 participants included in the study (i.e. 9 didn’t have biopsies by 
included in the study)? Perhaps the authors should clarify this. Also what was the result why the 9 
participants did not have biopsies? 
2. There are results appeared in the methods section that should be placed in the results section (e.g. baseline CAI and CDAI scores, and results from analysis of covariance). 
3. The authors have mentioned the use of analysis of covariance or some other ‘multivariate tests’ to 
investigate influence of other parameters on outcomes. However, I don’t think this small pilot study has sufficient power to carry out such analysis and would advise the authors to omit these from the paper. 4. Wilcoxon rank sum test is a nonparametric test for unpaired 
Results section 
1. There should be a Table to describe the demographic and clinical characteristics of participants at randomisation. 2. The reference to the statistical significance of the changes from baseline in the individual groups should 
be deleted. Instead, the authors should report the results (P-values, estimated treatment effect and 
confidence intervals) of comparison of the two randomised groups. The whole point of a randomised trial is to yield unbiased comparisons of the groups, which must be the focus of the paper. 3. There is quite a variation in the outcomes collected at baseline between the two groups. The authors 
should consider a more appropriate method to adjust of this baseline difference. 
4. Since this is an online journal that has no limits on word count, the authors are encouraged to report all the results in the text. Especially, those stated ‘data not shown’. All outcomes that were mentioned in the methods section should be reported in the results section. 
Abstract 
1. Results in the abstract should focus on the findings of the primary outcome rather than any arbitrary 
significant outcome. In this case, quality of life is neither a clinical or histological outcome. 2. Conclusion should not based on findings from within group comparisons. 
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Minor Essential Revisions (such as missing labels on figures, or the wrong use of a term, which the author can be trusted to correct) 
1. What are ESR and CRP in the paper stand for? 
------------------------------------------------------------------------------- Discretionary Revisions (which the author can choose to ignore) 
 Unable to decide on acceptance or rejection until the authors have responded to the major What next?: 
compulsory revisions 
 An article whose findings are important to those with closely related research interests Level of interest: 
 Acceptable Quality of written English: 
 Yes, and I have assessed the statistics in my report. Statistical review: 
Declaration of competing interests: 
I declare that I have no competing interests