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Saudi Journal of Kidney Diseases and Transplantation
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Table of Contents   
LETTER TO THE EDITOR  
Year : 2014  |  Volume : 25  |  Issue : 4  |  Page : 886-887
Remarks about the study of the effect of Helicobacter Pylori on vitamin B 12 blood levels in chronic renal failure patients: A single blind control trial


Students' Research Committee, Baqiyatallah University of Medical Sciences, Tehran, IR, Iran

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Date of Web Publication24-Jun-2014
 

How to cite this article:
Rezaee-Zavareh MS, Beinabaj MR. Remarks about the study of the effect of Helicobacter Pylori on vitamin B 12 blood levels in chronic renal failure patients: A single blind control trial. Saudi J Kidney Dis Transpl 2014;25:886-7

How to cite this URL:
Rezaee-Zavareh MS, Beinabaj MR. Remarks about the study of the effect of Helicobacter Pylori on vitamin B 12 blood levels in chronic renal failure patients: A single blind control trial. Saudi J Kidney Dis Transpl [serial online] 2014 [cited 2019 Dec 11];25:886-7. Available from: http://www.sjkdt.org/text.asp?2014/25/4/886/135201
To the Editor,

We read with great interest the paper written by Dr. Khedmat and colleagues titled "The effect of Helicobacter pylori on vitamin B 12 blood levels in chronic renal failure patients: A single blind control trial" [1] recently published in your esteemed journal.

Some previous studies have investigated the correlation between Helicobacter pylori infec­tion (HPI) and vitamin B 12 serum level in both chronic renal failure patients and in the general population. [2],[3]

In Khedmat et al's study, the investigators evaluated 82 patients with chronic kidney di­sease (CKD) about HPI and reported that 50 patients had HPI and 32 patients were without HPI. Then, they measured the vitamin B 12 serum level of these patients before and after treatment for HPI and finally concluded that there was a correlation between vitamin B 12 deficiency and HPI status in CKD patients. However, there are some challenging points about their work that we would like to point out.

In the title of this article, it was mentioned that the study was a single-blind control trial. We know that some factors like intervention, randomization and existence of a control group is necessary for a clinical trial, but in this study there was no explanation about these factors. Usually, when the patients do not know that they are receiving a placebo, the model is called single blindness. Khedmat et al used only one type of treatment and, also, they did not explain the usage of any placebo treatment in the method part of their paper as all the patients with HPI received the treatment. Therefore, it seems that there are some ques­tions about randomization and intervention. Additionally, in our opinion, the authors could consider another control group (patients with HPI and without CKD) in their study. In this way, they could skillfully determine factors (CKD, HPI or both) that are responsible for reducing the vitamin B 12 serum levels.

In conclusion, again, we appreciate Khedmat et al for conducting such an important applied project.

Authors Reply

To the Editor,

Thank you very much for giving us the opportunity to reply to this letter on our study. The authors of the letter state that "we know that some factors like intervention, randomi­zation and existence of a control group is necessary for a clinical trial." Although rando­mization and placebo control groups could make a study more powerful, it is not always necessary or even possible. In our study, the ethics committee actually protested the idea of not using therapeutic drugs for any of the patients as controls.

About the other question "authors could com­pare vitamin B 12 serum level between CKD patients with and without HPI." The investi-gators' decision in this study was to use the patients as their own controls and to check le­vels before and after treatment and the impact of HP eradication on the vitamin levels, which produces no selection bias in the analyses. And, finally, on the blinding method in our study, the single blindness here means that they were not aware of the urease test result during the study period. I wish this reply makes enough clarifications of our study.

Dr. Hossein Khedmat,

Department of Internal Medicine,

Baqiyatallah University of Medical Sciences,

Tehran, Iran

E-mail: Khedmat.h@gmail.com

References

  1. Khedmat H, Amini M, Karbasi A, Azizi R. The effect of Helicobacter pylori on vitamin B 12 blood levels in chronic renal failure patients: A single blind control trial. Saudi J Kidney Dis Transpl 2013;24:759-63.


 
   References Top

1.Khedmat H, Amini M, Karbasi A, Azizi R. The effect of Helicobacter pylori on vitamin B 12 blood levels in chronic renal failure pa­tients: A single blind control trial. Saudi J Kidney Dis Transpl 2013;24:759-63.  Back to cited text no. 1
[PUBMED]  Medknow Journal  
2.Dierkes J, Ebert M, Malfertheiner P, Luley C. Helicobacter pylori infection, vitamin B12 and homocysteine. A review. Dig Dis 2003;21: 237-44.  Back to cited text no. 2
    
3.Trimarchi H, Forrester M, Schropp J, Pereyra H, Freixas EA. Low initial vitamin B12 levels in Helicobacter pylori--positive patients on chronic hemodialysis. Nephron Clin Pract 2004;96:c28-32.  Back to cited text no. 3
    

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Correspondence Address:
Mohammad Saeid Rezaee-Zavareh
Students' Research Committee, Baqiyatallah University of Medical Sciences, Tehran, IR
Iran
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DOI: 10.4103/1319-2442.135201

PMID: 24969209

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