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Topical Minoxidil Versus Topical Diltiazem for Chemical Sphincterotomy of Chronic Anal Fissure: A Prospective, Randomized, Double-Blind, Clinical Trial

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Abstract

Background

Anal fissure is a common anorectal problem causing severe pain and discomfort to the patients. Chemical sphincterotomy has emerged as a noninvasive alternative to the surgical methods of fissure treatment. The objective of this study was evaluation of the efficacy and the adverse effects of topically applied minoxidil in chemical sphincterotomy of chronic anal fissure in comparison with topical diltiazem.

Methods

A total of 88 patients with chronic anal fissure aged between 15 and 65 years were included in this double-blind, randomized clinical trial and were randomly assigned to either 0.5% minoxidil cream or 2% diltiazem cream twice daily for 2 weeks. The pain intensity, bleeding, wound healing, itching, headache, dizziness, significant drop in blood pressure, allergy and fissure relapse were assessed on a monthly basis for 2 months.

Results

Both diltiazem and minoxidil reduced the pain, bleeding and improved fissure healing with no significant difference. There were no between-groups differences in the frequencies of adverse effects, except for itching which was slightly higher with minoxidil during the first month. Allergy occurred in two patients in the minoxidil group, which was not severe and did not lead to discontinuation of the trial.

Conclusion

Topically administered minoxidil is of equal efficacy as diltiazem in the treatment of chronic anal fissure with low frequency of adverse effects. Thus, it can be considered as an agent for chemical sphincterotomy of anal fissure, but the itching at the beginning of the treatment can affect the adherence of the patient to treatment.

Trial registration number IRCT2015041414483N6 (the full trial protocol could be accessed online at www.irct.ir).

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Acknowledgements

This study was funded by a grant from the vice chancellor for research at Mazandaran University of Medical Sciences and carried out as the project of Dr. Mehdi Khalvati to receive the degree of Specialist in Surgery. The authors acknowledge the writing assistance from Dr. Roja Hadianamrei.

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Authors and Affiliations

  1. Department of Surgery, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran

    Mina Alvandipour & Mehdi Khalvati

  2. Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, 18th Km Farahabad Boulevard, Sari, Mazandaran Province, 48175861, Iran

    Shahram Ala & Neda Koulaeinejad

  3. Department of Health, Biostatistics and Medical Research, Mazandaran University of Medical Sciences, Sari, Mazandaran Province, Iran

    Jamshid Yazdanicharati

Authors
  1. Mina Alvandipour
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  2. Shahram Ala
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  3. Mehdi Khalvati
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  4. Jamshid Yazdanicharati
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  5. Neda Koulaeinejad
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Corresponding author

Correspondence to Shahram Ala.

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Alvandipour, M., Ala, S., Khalvati, M. et al. Topical Minoxidil Versus Topical Diltiazem for Chemical Sphincterotomy of Chronic Anal Fissure: A Prospective, Randomized, Double-Blind, Clinical Trial. World J Surg 42, 2252–2258 (2018). https://doi.org/10.1007/s00268-017-4449-x

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  • DOI: https://doi.org/10.1007/s00268-017-4449-x

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