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Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2%

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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Purpose

To compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures.

Methods

This was a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal fissure were randomised to treatment with diltiazem or Levorag® Emulgel twice daily for 8 weeks. Primary endpoint was complete healing of the anal fissure after 12 weeks. Secondary endpoints included incidence of adverse events and efficacy on pain relief.

Results

In total, 55 patients were included. Inclusion was terminated prematurely due to a slow inclusion rate. Complete fissure healing at 12 weeks follow-up was overall achieved in 31 of 55 (56%) patients, 18 of 29 (62%) in the diltiazem group compared with 13 of 26 (50%) in the Levorag® Emulgel group (P = 0.424). Pain relief was significantly better at day seven in patients treated with diltiazem (P = 0.040) compared with Levorag® Emulgel, whereas there were no differences in early (3 days) or late (12 weeks) pain relief. Three patients (10.3%) developed severe perianal exanthema during diltiazem treatment, whereas no side effects were observed in the Levorag® Emulgel group.

Conclusion

The study demonstrated statistical non-inferiority of Levorag® Emulgel compared with diltiazem in the treatment of chronic anal fissure. Diltiazem resulted in a more prompt pain relief and also in a substantial number of local allergic reactions. Levorag® Emulgel may therefore be an alternative in these patients.

Trial registration

Clinicaltrials.gov no. NCT02158013

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Data availability

Only the authors had full and uninhibited access to the data and the final publication right.

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Acknowledgements

Research nurse Tina Lee Brøndum assisted in the generation of the EasyTrial database and management of logistical aspects of this trial. Dr. Susanne Strauss assisted in the inclusion and control of patients.

Funding

The execution of this study was supported financially by Sacomed ApS, Denmark, including the costs for the gels and the randomisation. No financial support was received from the manufacturers of the experimental or control compounds, and none of the investigators had any financial association with Sacomed ApS.

Author information

Authors and Affiliations

  1. Digestive Disease Center K, Bispebjerg Hospital, University of Copenhagen, Bispebjerg Bakke 23, 2400, Copenhagen NV, Denmark

    Andreas Nordholm-Carstensen, Helene Perregaard, Kikke Bartholin Hagen & Peter-Martin Krarup

  2. Department of Surgery, Zealand University Hospital, Køge, Denmark

    Kirsten Lykke Wahlstrøm

  3. Department of Surgery, Aarhus University Hospital, Aarhus, Denmark

    Helene Tarri Hougaard

Authors
  1. Andreas Nordholm-Carstensen
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  2. Helene Perregaard
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  3. Kirsten Lykke Wahlstrøm
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  4. Kikke Bartholin Hagen
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  5. Helene Tarri Hougaard
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  6. Peter-Martin Krarup
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Corresponding author

Correspondence to Andreas Nordholm-Carstensen.

Ethics declarations

All patients gave informed written consent before inclusion. The study was registered and approved by the local Ethical Committee and the Data Registration Authorities (BHH-2014-031, I-Suite No. 02946).

Conflict of interest

The authors declare that they have no conflict of interest.

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Nordholm-Carstensen, A., Perregaard, H., Wahlstrøm, K.L. et al. Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2%. Int J Colorectal Dis 35, 615–621 (2020). https://doi.org/10.1007/s00384-020-03515-z

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  • DOI: https://doi.org/10.1007/s00384-020-03515-z

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