Review for 10.1186/1471-230X-6-2 (2006)

Reviewer's report 
 Comparison Between Oral Omeprazole and Intra-venous Cimetidine in Reducing some Title: 
Complications of Duodenal Peptic Ulcers 
 1  3 April 2005 Version: Date: 
 Fook Hong H Ng Reviewer: 
Reviewer's report: 
Major Compulsory Revisions 
Abstract 
1. What is the meaning of sex-age matched groups? If this is the case, this study is not a 
randomized study. 
Method and Material Section 
1. First sentence – “In this randomized clinical trial designed study, 80 patients with upper 
gastrointestinal bleeding (hemathemesis or melena) referring to emergency departments of Imam 
and Sina hospitals in Tabriz, Iran were selected.” There must be an error in the number of patient and this number must be > 80. 
2. Ranitidine is safer than cimetidine. What is the reason for choosing cimetidine? 
3. Which companies produce cimetidine and omeprazole? 
4. What is the duration of the use NG-tube? I believe that it was more than 3 days. What is the 
reason for prolonged insertion of NG-tube which is quite uncomfortable? 
5. Generally, omeprazole is admistrated once daily? What is the specific reason for a twice daily 
dosing? 
6. Please define the inclusion and exclusion criteria clearly. 
7. Alcohol and adrenaline injection of high risk ulcer – please provide details in concentration. How do you choose between alcohol or adrenaline? At present, adrenaline injection and thermal 
coagulation is the gold standard in hemostasis. Please provide the reason for not using thermal 
coagulation. 
8. Randomization - What is the method for randomization? Computer generated random number, blinded envelope etc. Is this study single-blinded, double-blinded or unblinded? Please describe the 
details in the method of blinding. 
9. Ethical issue – Is this study approved by the local Ethic Committee? Is written informed consent obtained? 10. What is the duration of follow-up? 
11. Definition of re-bleeding : Rebleeding was defined as observation of red blood in stomach, 
hemoglobin fall more than 2 gr/dl during 24 hours, continuous melena for more than 7 days, and instability of vital signs (rise in pulse rate more than 110 per minute, positive tilt sign, and systolic blood pressure fall less than 90 mmHg in supine position). Is “and” correct? How do you know red 
blood in stomach? 
Results 
1. Risk factor for rebleeding – What is the definition of high risk of rebleeding? Please define this in 
the method. Table 2. what is the difference between active bleeding and oozing? Flat pigmentation 
is not a high risk factor for re-bleeding. 2. Please provide details of duodenal ulcer. Size of ulcer, location of ulcer, details in hemostasis – i.e. number of alcohol and adrenaline injection, volume of injection, success rate of hemostasis. 
Were patients with unsuccessful endosocpic hemostasis excluded? 
3. Were there any other confounding factors for re-bleeding? Warfarin, corticosteroid, 
thrombocytopenia, coagulopathy 
4. “On the other hand the need for blood transfusion for stabilizing vital signs in the first hours of 
admission was higher and also duration of active bleeding was longer in Omeprazole group comparing to Cimetidine group.” – Please give the exact number of unit of blood transfusion in the first hour, number of patients with hypovolaemic shock. Do you mean the initial bleeding was more 
severe in the Omeprazole group than the Cimetidine group? According to Table1 , Cimetidine group 
received significantly more blood transfusion than the Omeprazole group. Is there any discrepancy? 
5. A re-bleeding of 50% in the Cimetidine group is exceedingly high. In most series, the rebleeding rates are less than 25% in patients without receiving proton pump infusion. Please explain 
6. Please state clearly the number of patients with rebleeding and the rebleeding rate in the Results. 
7. Is there any side effect of treatment? Confusion etc 
8. What are the causes of mortality? 
Discussion 
1. “High dose oral omeprazole controls gastrointestinal bleeding by reducing gastric parietal cell mass in Asians in comparison to Caucasians.” Please clarify the meaning of this statement. 
2. The style of presentation in the discussion must be re-written. Some information in the discussion 
should be placed in the result. 
Minor Essential Revisions 
Abstract: 
1. Exact figure should be stated in the statement “the need for blood transfusion much lower in 
Omeprazole group (p< 0.003) and also rebleeding rate was significantly lower than Cimetidine group 
(p< 0.001).” Information on insignificant result can be shorten. 
2. “Although there was not any significant difference in duration of hospitalization between 2 groups 
but statistically non-significant shorter periods of hospitalization in Omeprazole group (p= 0.074) can 
also be very important for its lower costs.” This statement can be deleted. 
 Unable to decide on acceptance or rejection until the authors have responded to the What next?: 
major compulsory revisions 
 An article of limited interest Level of interest: 
 Needs some language corrections before being published Quality of written English: 
 No Statistical review: 
Declaration of competing interests: 
I declare that I have no competing interests