Protective Effect of Asacol in Combination with Pantoprazole in Ulcerative Colitis Patients Who Defecate Asacol Tablets Intactly: A Clinical Trial Study

Abstract

Purpose

Mesalazine formulations are the drug of choice in the treatment of ulcerative colitis (UC). They are released at alkaline pH in order to deliver 5-aminosalicylic acid to the colon. The colonic pH is significantly lower in UC patients than in normal patients. This study was conducted for the first time to evaluate the clinical efficacy of co-administration of pantoprazole and Asacol in the treatment of ulcerative colitis patients who excrete intact Asacol tablets in the feces.

Patients and Methods

Thirty patients with mild-to-moderate active ulcerative colitis who reported passing intact Asacol tablets in stools received oral Asacol plus pantoprazole for 2 weeks. The demographic characteristics of the patients and the body mass index were collected through interviews. For each patient, the stool frequency, visible blood, and presence of intact Asacol tablets in the stool were compared before and pantoprazole treatment.

Results

There was a significant difference in the stool frequency (number of daily stools) before and after pantoprazole treatment (mean ± sd, 6.06 ± 1.04 vs 1.5± 0.5; P<0.001). In addition, pantoprazole administration statistically reduced visible blood in the stool (100%; P<0.001). Co-administration of pantoprazole and Asacol was effective in all age groups and both sexes. None of the patients reported the presence of intact Asacol tablets in their stools.

Conclusions

Co-administration of pantoprazole and Asacol would be useful for symptom management UC patients that excrete intact Asacol tablets in their feces through increasing the gastric pH and releasing the maximum concentration of the drug in the proximal gastrointestinal tract.

Keywords:

• Asacol
• pantoprazole
• treatment
• ulcerative colitis
• pH

Ethics Approval and Consent to Participate

All the participants written informed consent prior to the study and this study was conducted in accordance with the Declaration of Helsinki. The protocol was approved by the Kermanshah University of Medical Sciences Ethics Committee (IRCT2017012227761N3).

Data Sharing Statement

The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request and were received permission for use by the Kermanshah University of Medical Sciences Ethics Committee.

Acknowledgments

The authors want to thank their colleagues in Imam Reza Therapeutic Educational hospital of Kermanshah, Iran for their contribution to the patient’s diagnosis. We also extend our thanks to clinical research development center of Imam Reza Hospital affiliated to Kermanshah University of Medical Sciences for their kind support. This study received financial support  from Kermanshah University of Medical Sciences, Iran (Grant Number. 95611).

Disclosure

The authors declared no conflicts of interest in this work.