Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure

Summary

No study to date has compared topical DTZ to MEBO ointment in the treatment of anal fissure. Therefore, the present study aims to compare the efficacy and safety of DTZ to MEBO in the treatment of acute anal fissure. The investigators propose to conduct a comparative randomized clinical study. In this study, the investigators will compare patients with acute anal fissure receiving MEBO ointment vs Topical DTZ ointment vs a combination of MEBO and DTZ ointment. Hypothesis: MEBO in combination with DTZ is more effective than DTZ or MEBO alone in the treatment of acute anal fissure.

Timeline

Start

2019-12-01

Primary completion

2026-01-01

Completion

2026-01-30

Publications

• Background Hadianamrei R. Topical diltiazem in management of chronic anal fissure: a review of the literature. Clinical Investigation. 2014;4(10):923-34.
• Background Sailer M, Bussen D, Debus ES, Fuchs KH, Thiede A. Quality of life in patients with benign anorectal disorders. Br J Surg. 1998 Dec;85(12):1716-9. doi: 10.1046/j.1365-2168.1998.00958.x.
• Background Ram E, Alper D, Stein GY, Bramnik Z, Dreznik Z. Internal anal sphincter function following lateral internal sphincterotomy for anal fissure: a long-term manometric study. Ann Surg. 2005 Aug;242(2):208-11. doi: 10.1097/01.sla.0000171036.39886.fa.
• Background Herzig DO, Lu KC. Anal fissure. Surg Clin North Am. 2010 Feb;90(1):33-44, Table of Contents. doi: 10.1016/j.suc.2009.09.002.
• Background Li W, Ma Y, Yang Q, Pan Y, Meng Q. Moist exposed burn ointment for treating pressure ulcers: A multicenter randomized controlled trial. Medicine (Baltimore). 2017 Jul;96(29):e7582. doi: 10.1097/MD.0000000000007582.
• Background Hirsch T, Ashkar W, Schumacher O, Steinstraesser L, Ingianni G, Cedidi CC. Moist Exposed Burn Ointment (MEBO) in partial thickness burns - a randomized, comparative open mono-center study on the efficacy of dermaheal (MEBO) ointment on thermal 2nd degree burns compared to conventional therapy. Eur J Med Res. 2008 Nov 24;13(11):505-10.
• Background Ang ES, Lee ST, Gan CS, See P, Chan YH, Ng LH, Machin D. The role of alternative therapy in the management of partial thickness burns of the face--experience with the use of moist exposed burn ointment (MEBO) compared with silver sulphadiazine. Ann Acad Med Singap. 2000 Jan;29(1):7-10.
• Background National Institute for Health and Care Excellence. Chronic anal fissure: 2% topical diltiazem hydrochloride. Evidence Summary. Manchester: 2013.
• Background Schochet E, Khubchandani I. Pathophysiology of Chronic Anal Fissure: Current Understanding and Clinical Applications. Societa Italiana di Chirurgia ColoRettale. 2007;15:130-5.
• Background Bansal AR, Yadav PK, Godara R, Pal N, Tripura R, Jaikaran. Comparative evaluation of 0.2% glyceryl trinitrate vs. 2% diltiazem ointment in treatment of chronic anal fissure treatment - a randomized trial. Hellenic Journal of Surgery. 2016;88(1):25-30.
• Background Steele SR, Madoff RD. Systematic review: the treatment of anal fissure. Aliment Pharmacol Ther. 2006 Jul 15;24(2):247-57. doi: 10.1111/j.1365-2036.2006.02990.x.
• Background Antropoli C, Perrotti P, Rubino M, Martino A, De Stefano G, Migliore G, Antropoli M, Piazza P. Nifedipine for local use in conservative treatment of anal fissures: preliminary results of a multicenter study. Dis Colon Rectum. 1999 Aug;42(8):1011-5. doi: 10.1007/BF02236693.
• Background Collins EE, Lund JN. A review of chronic anal fissure management. Tech Coloproctol. 2007 Sep;11(3):209-23. doi: 10.1007/s10151-007-0355-9. Epub 2007 Aug 3.
• Background Amir H, Tibi Y, Groutz A, Amit A, Azem F. Unpredicted gender preference of obstetricians and gynecologists by Muslim Israeli-Arab women. Patient Educ Couns. 2012 Feb;86(2):259-63. doi: 10.1016/j.pec.2011.05.016. Epub 2011 Jun 16.
• Background Medhi B, Rao RS, Prakash A, Prakash O, Kaman L, Pandhi P. Recent advances in the pharmacotherapy of chronic anal fissure: an update. Asian J Surg. 2008 Jul;31(3):154-63. doi: 10.1016/S1015-9584(08)60078-0.
• Background Medhi B, Prakash A, Upadhyay S, Xess D, Yadav TD, Kaman L. Comparison of observational and controlled clinical trials of diltiazem in the treatment of chronic anal fissure. Indian J Surg. 2011 Dec;73(6):427-31. doi: 10.1007/s12262-011-0340-4. Epub 2011 Oct 18.
• Background Tsunoda A, Kashiwagura Y, Hirose K, Sasaki T, Kano N. Quality of life in patients with chronic anal fissure after topical treatment with diltiazem. World J Gastrointest Surg. 2012 Nov 27;4(11):251-5. doi: 10.4240/wjgs.v4.i11.251.
• Background Stewart DB Sr, Gaertner W, Glasgow S, Migaly J, Feingold D, Steele SR. Clinical Practice Guideline for the Management of Anal Fissures. Dis Colon Rectum. 2017 Jan;60(1):7-14. doi: 10.1097/DCR.0000000000000735. No abstract available.
• Background Katsinelos P, Kountouras J, Paroutoglou G, Beltsis A, Chatzimavroudis G, Zavos C, Katsinelos T, Papaziogas B. Aggressive treatment of acute anal fissure with 0.5% nifedipine ointment prevents its evolution to chronicity. World J Gastroenterol. 2006 Oct 14;12(38):6203-6. doi: 10.3748/wjg.v12.i38.6203.
• Background Guo-Lin H, Zhong-shen L. Experience with MEBO in Treating 42 Cases of Anal Fissure. The Chinese Journal of Burns Wounds and Surface Ulcers. 2001(2).
• Background Zhong-gui C, Jun Z, Ze-zi A. Analysis of the efficacy of MEBO in treating 51 cases of anal fissure. The Chinese Journal of Burns Wounds & Surface Ulcers 2004(3).
• Background Patankar R, Mishra A. A prospective non-comparative study to assess the effectiveness and safety of combination laxative therapy containing milk of magnesia, liquid paraffin and sodium picosulphate (Cremaffin-Plus®) in the management of constipation in patients with anal fissure/hemorrhoids/obstructive defecation syndrome. International Surgery Journal. 2017;4(12).
• Background Srikrishna S, Robinson D, Cardozo L. Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J. 2010 May;21(5):523-8. doi: 10.1007/s00192-009-1069-5. Epub 2009 Dec 15.
• El Charif MH, Doughan S, Kredly R, Kassas S, Azab R, Sbaity E. MEBO versus topical Diltiazem versus a combination of both ointments in the treatment of acute anal fissure: a randomized clinical trial protocol. BMC Complement Med Ther. 2021 Feb 24;21(1):75. doi: 10.1186/s12906-021-03227-z.

Drugs

Indications

No indication recorded.