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image of Mebendazole as an Adjunct Therapy with Mesalamine to Increase Efficacy and Maintenance Therapy for Ulcerative Colitis Patients: A Pilot Study

Abstract

Background

Ulcerative colitis (UC) is an inflammatory disorder of the large intestine characterized by inflammation in the mucosal tissue of the colon and rectal area. In the present pilot study, we assessed the efficacy of combining mebendazole with mesalamine in moderate UC patients.

Methods

In the present exploratory pilot trial, designed to assess both the safety and preliminary efficacy of mebendazole, a total number of 10 moderate UC patients with Mayo scores ranging from 6 to 9 were enrolled. The participants were divided into two groups at random and were treated with 3 gr mesalamine per day plus 300 mg/day mebendazole or matching placebo for 3 months. The efficacy of treatment was assessed in 8 and 12-week timelines with Mayo score. Moreover, the safety of the given dose of mebendazole in UC patients was also assessed by laboratory tests.

Results

The addition of mebendazole to the mesalamine in the treatment regimen of patients suffering from UC caused a greater decrease in the Mayo score of the patients compared to the mesalamine monotherapy at 8 and 12-week timelines. Despite this trend, statistical significance was not reached, likely due to the limited sample size. Moreover, all the patients in the mebendazole group experienced clinical remission at the 12-week timeline, but 4 of 5 patients in the placebo group experienced a clinical remission state, indicating that mebendazole caused a 20% increase in the clinical remission rate. As indicated by the results of the laboratory tests, the given dose of mebendazole showed no toxicity in the patients.

Conclusion

The addition of mebendazole to mesalamine for UC treatment appears to be a safe and potentially beneficial approach to enhance mesalamine’s efficacy and reduce clinical symptoms. However, given the small sample size and the short study duration, further large-scale, long-term trials are necessary to validate these preliminary findings.

Clinical Trial Registration Number

IRCT20220115053713N2.

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2025-07-07
2025-08-14

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/content/journals/cpd/10.2174/0113816128372513250616182826
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Mebendazole as an Adjunct Therapy with Mesalamine to Increase Efficacy and Maintenance Therapy for Ulcerative Colitis Patients: A Pilot Study
Bentham Science Publishers ; https://doi.org/10.2174/0113816128372513250616182826
/content/journals/cpd/10.2174/0113816128372513250616182826
/content/journals/cpd/10.2174/0113816128372513250616182826
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  • Article Type:     Research Article
Keywords: IBD ; inflammation ; drug repurposing ; mebendazole ; mesalamine ; Ulcerative colitis

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