Skip to main content
SpringerLink
Log in

Topical Nifedipine With Lidocaine Ointment vs. Active Control for Treatment of Chronic Anal Fissure

Results of a Prospective, Randomized, Double-Blind Study

  • Published:
Diseases of the Colon & Rectum

Abstract

PURPOSE: Chronic anal fissure may be treated by chemical or surgical sphincterotomy. The aim of this study was to test the efficacy of local application of nifedipine and lidocaine ointment in healing chronic anal fissure. METHODS: The study was performed according to a prospective, randomized, double-blind design. One hundred ten patients who gave informed consent were recruited. They received a clinical examination, a questionnaire to evaluate symptoms and pain, anorectal manometry, and anoscopy. Healing of anal fissure at Day 42 of therapy was defined as the primary efficacy variable of the study. Patients treated with nifedipine (n = 55) used topical 0.3 percent nifedipine and 1.5 percent lidocaine ointment every 12 hours for 6 weeks. The control group (n = 55) received topical 1.5 percent lidocaine and 1 percent hydrocortisone acetate ointment during therapy. Anal pressures were measured by recording resting and maximal voluntary contraction pressures at baseline and at Day 21. Long-term outcomes were determined after a median follow-up of 18 months. RESULTS: Healing of chronic anal fissure was achieved after 6 weeks of therapy in 94.5 percent of the nifedipine-treated patients (P < 0.001) as opposed to 16.4 percent of the controls. Mean anal resting pressure decreased from a mean value ± standard deviation of 47.2 ± 14.6 to 42 ± 12.4 mmHg in the nifedipine group. This represents a mean reduction of 11 percent (P = 0.002). Changes of maximal voluntary contraction in nifedipine-treated patients were not significant. No changes in mean anal resting pressure and maximal voluntary contraction were observed in the control group. We did not observe any systemic side effect in patients treated with nifedipine. After the blinding was removed, recurrence of the fissure was observed in 3 of 52 patients in the nifedipine group within 1 year of treatment, and 2 of these patients healed with an additional course of topical nifedipine and lidocaine ointment. CONCLUSIONS: Our study clearly demonstrates that the therapeutic use of topical nifedipine and lidocaine ointment should be extended to the conservative treatment of chronic anal fissure.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. JN Lund JH Scholefield (1996) ArticleTitleAetiology and treatment of anal fissure Br J Surg 83 1335–1344 Occurrence Handle1:STN:280:ByiD1Mboslw%3D Occurrence Handle8944447

    CAS  PubMed  Google Scholar 

  2. R Farouk GS Duthie AB MacGregor DC Bartolo (1994) ArticleTitleSustained internal sphincter hypertonia in patients with chronic anal fissure Dis Colon Rectum 37 424–429 Occurrence Handle1:STN:280:ByuB3sjgsl0%3D Occurrence Handle8181401

    CAS  PubMed  Google Scholar 

  3. WR Schouten JW Briel JJ Auwerda EJ De Graaf (1996) ArticleTitleIschaemic nature of anal fissure Br J Surg 83 63–65 Occurrence Handle1:STN:280:BymB28vgsFQ%3D Occurrence Handle8653368

    CAS  PubMed  Google Scholar 

  4. C Oh CM Divino RM Steinhagen (1995) ArticleTitleAnal fissure Dis Colon Rectum 38 378–382

    Google Scholar 

  5. SL Jensen F Lund OV Nielsen G Tange (1984) ArticleTitleLateral subcutaneous sphincterotomy versus anal dilatation in the treatment of fissure in ano Br Med J 289 528–530

    Google Scholar 

  6. DC Nyam JH Pemberton (1999) ArticleTitleLong-term results of lateral internal sphincterotomy for chronic anal fissure with particular reference to incidence of fecal incontinence Dis Colon Rectum 42 1306–1310 Occurrence Handle1:STN:280:DyaK1Mvls1SgtQ%3D%3D Occurrence Handle10528769

    CAS  PubMed  Google Scholar 

  7. WH Jost (1997) ArticleTitleOne hundred cases of anal fissure treated with botulin toxin Dis Colon Rectum 40 1029–1032 Occurrence Handle1:STN:280:ByiH3sfhsFE%3D Occurrence Handle9293930

    CAS  PubMed  Google Scholar 

  8. G Maria E Cassetta D Gui G Brisinda AR Bentivoglio A Albanese (1998) ArticleTitleA comparison of botulinum toxin and saline for the treatment of chronic anal fissure N Engl J Med 338 217–220 Occurrence Handle10.1056/NEJM199801223380402 Occurrence Handle1:CAS:528:DyaK1cXosVeqsQ%3D%3D Occurrence Handle9435326

    Article  CAS  PubMed  Google Scholar 

  9. WR Schouten JW Briel MO Boerma JJ Auwerda EB Wilms BH Graatsma (1996) ArticleTitlePathophysiological aspects and clinical outcome of intra-anal application of isosorbide dinitrate in patients with chronic anal fissure Gut 39 465–469 Occurrence Handle1:STN:280:ByiC3cnptVM%3D Occurrence Handle8949655

    CAS  PubMed  Google Scholar 

  10. JN Lund JH Scholefield (1997) ArticleTitleA randomized, prospective, double-blind, placebo-controlled trial of glyceryl trinitrate ointment in treatment of anal fissure Lancet 349 11–14 Occurrence Handle10.1016/S0140-6736(96)06090-4 Occurrence Handle1:CAS:528:DyaK2sXltVaqug%3D%3D Occurrence Handle8988115

    Article  CAS  PubMed  Google Scholar 

  11. ML Kennedy S Sowter H Nguyen DZ Lubowski (1999) ArticleTitleGlyceryl trinitrate ointment for the treatment of chronic anal fissure Dis Colon Rectum 42 1000–1006 Occurrence Handle1:STN:280:DyaK1MzosFejsQ%3D%3D Occurrence Handle10458121

    CAS  PubMed  Google Scholar 

  12. EA Carapeti MA Kamm RK Phillips (2000) ArticleTitleTopical diltiazem and betanachol decrease anal sphincter pressure and heal anal fissures without side effects Dis Colon Rectum 43 1359–1362

    Google Scholar 

  13. C Antropoli P Perrotti M Rubino (1999) ArticleTitleNifedipine for local use in conservative treatment of anal fissures Dis Colon Rectum 42 1011–1015 Occurrence Handle1:STN:280:DyaK1MzosFejtw%3D%3D Occurrence Handle10458123

    CAS  PubMed  Google Scholar 

  14. TA Cook MM Smilgin Humphreys NJ Mortensen (1999) ArticleTitleOral nifedipine reduces resting anal pressure and heals chronic anal fissures Br J Surg 86 1269–1273 Occurrence Handle10.1046/j.1365-2168.1999.01292.x Occurrence Handle1:STN:280:DC%2BD3c%2FgvF2lsA%3D%3D Occurrence Handle10540130

    Article  CAS  PubMed  Google Scholar 

  15. DF Altomare M Rinaldi G Milito (2000) ArticleTitleGlyceryl trinitrate for chronic anal fissure—healing or headache? Results of a multicenter, randomized, placebo-controlled, double-blind trial Dis Colon Rectum 43 174–181 Occurrence Handle1:STN:280:DC%2BD3c7lvF2lsQ%3D%3D Occurrence Handle10696890

    CAS  PubMed  Google Scholar 

  16. EA Carapeti MA Kamm PJ McDonald SJ Chadwick D Melville RK Phillips (1999) ArticleTitleRandomized controlled trial shows that glyceryl trinitrate heals anal fissures, higher doses are not more effective, and there is a high recurrence rate Gut 44 727–730 Occurrence Handle1:CAS:528:DyaK1MXjtF2kt74%3D Occurrence Handle10205213

    CAS  PubMed  Google Scholar 

  17. EA Carapeti MA Kamm BK Evans RK Phillips (1999) ArticleTitleTopical diltiazem and bethanechol decrease anal sphincter pressure without side effects Gut 45 719–722

    Google Scholar 

  18. JS Knight M Birks R Farouk (2001) ArticleTitleTopical diltiazem ointment in the treatment of chronic anal fissure Br J Surg 88 553–556 Occurrence Handle10.1046/j.1365-2168.2001.01736.x Occurrence Handle1:STN:280:DC%2BD3M3htVShsQ%3D%3D Occurrence Handle11298624

    Article  CAS  PubMed  Google Scholar 

  19. P Perrotti C Antropoli G Noschese (2000) ArticleTitleTopical nifedipine for conservative treatment of acute haemorrhoidal thrombosis Colorectal Dis 2 18–21 Occurrence Handle10.1046/j.1463-1318.2000.00130.x

    Article  Google Scholar 

  20. P Perrotti C Antropoli D Molino G De Stefano M Antropoli (2001) ArticleTitleConservative treatment of acute thrombosed external hemorrhoids with topical nifedipine Dis Colon Rectum 44 405–409 Occurrence Handle1:STN:280:DC%2BD3M7pvFyrug%3D%3D Occurrence Handle11289288

    CAS  PubMed  Google Scholar 

  21. P McDonald AM Driscoll RJ Nicholls (1983) ArticleTitleThe anal dilator in the conservative management of acute anal fissures Br J Surg 70 25–26 Occurrence Handle1:STN:280:BiyC38fhvVE%3D Occurrence Handle6337670

    CAS  PubMed  Google Scholar 

  22. SI Jensen (1986) ArticleTitleTreatment of first episodes of acute anal fissure Br Med J 292 1167–1169

    Google Scholar 

  23. IT Khubchandani JF Reed (1989) ArticleTitleSequelae of internal sphincterotomy for chronic anal fissure in ano Br J Surg 76 431–434 Occurrence Handle1:STN:280:BiaB1cjmsFA%3D Occurrence Handle2736353

    CAS  PubMed  Google Scholar 

  24. G Brisinda G Maria AR Bentivoglio E Cassetta D Gui A Albanese (1999) ArticleTitleA comparison of injections of botulinum toxin and topical nitroglycerin ointment for the treatment of chronic anal fissure N Engl J Med 341 65–69 Occurrence Handle10.1056/NEJM199907083410201 Occurrence Handle1:CAS:528:DyaK1MXks1GlsLc%3D Occurrence Handle10395629

    Article  CAS  PubMed  Google Scholar 

  25. WH Jost S Schanne H Militz K Schimrigk (1995) ArticleTitlePerianal thrombosis following injection therapy into the external anal sphincter using botulin toxin [letter] Dis Colon Rectum 38 781–69 Occurrence Handle1:STN:280:ByqA3s7gvFI%3D Occurrence Handle7607047

    CAS  PubMed  Google Scholar 

  26. CS Richard R Gregoire EA Plewes (2000) ArticleTitleInternal sphincterotomy is superior to topical nitroglycerin in the treatment of chronic anal fissure Dis Colon Rectum 43 1048–1058 Occurrence Handle1:STN:280:DC%2BD3cvitVSgsg%3D%3D Occurrence Handle10950002

    CAS  PubMed  Google Scholar 

  27. SJ Watson MA Kamm RJ Nicholls RK Phillips (1996) ArticleTitleTopical glyceryl trinitrate in the treatment of chronic anal fissure Br J Surg 83 771–775 Occurrence Handle1:STN:280:BymA3svot10%3D Occurrence Handle8696736

    CAS  PubMed  Google Scholar 

  28. NH Hyman PA Cataldo (1999) ArticleTitleNitroglycerin ointment for anal fissures Dis Colon Rectum 42 383–385 Occurrence Handle1:STN:280:DyaK1M3jvVaktQ%3D%3D Occurrence Handle10223761

    CAS  PubMed  Google Scholar 

  29. PB Loder MA Kamm RJ Nicholls RK Phillips (1994) ArticleTitleReversible chemical sphincterotomy by local application of glyceryl trinitrate Br J Surg 81 1386–1389 Occurrence Handle1:STN:280:ByqD2c7it1Y%3D Occurrence Handle7953427

    CAS  PubMed  Google Scholar 

  30. SR Gorfine (1995) ArticleTitleTreatment of benign anal disease with topical nitroglycerin Dis Colon Rectum 38 453–457 Occurrence Handle1:STN:280:ByqB2Mvps1E%3D Occurrence Handle7736873

    CAS  PubMed  Google Scholar 

  31. H Bacher HJ Mischinger G Werkgartner (1997) ArticleTitleLocal nitroglycerin for treatment of anal fissures Dis Colon Rectum 40 840–845 Occurrence Handle1:STN:280:ByiA28vptFE%3D Occurrence Handle9221864

    CAS  PubMed  Google Scholar 

  32. DJ Triggle (1990) ArticleTitleCalcium, calcium channels, and calcium channel antagonists Can J Physiol Pharmacol 68 1474–1481

    Google Scholar 

  33. P Jonard B Essamri (1987) ArticleTitleDiltiazem and internal anal sphincter [letter] Lancet 1 754–1481 Occurrence Handle10.1016/S0140-6736(87)90402-8

    Article  Google Scholar 

  34. E Chrysos E Xynos G Tzovaras OJ Zoras J Tsiaoussis SJ Vassilakis (1996) ArticleTitleEffect of nifedipine on rectoanal motility Dis Colon Rectum 39 212–216

    Google Scholar 

  35. TA Cook AF Brading NJ Mortensen (1999) ArticleTitleDifferences in contractile properties of anorectal smooth muscle and the effects of calcium channel blockade Br J Surg 86 70–75 Occurrence Handle10.1046/j.1365-2168.1999.00998.x

    Article  Google Scholar 

  36. TA Cook AF Brading NJ Mortensen (1999) ArticleTitleEffects of nifedipine on anorectal smooth muscle in vitro Dis Colon Rectum 42 782–787

    Google Scholar 

  37. M Jonas KR Neal JF Abercrombie JH Scholefield (2001) ArticleTitleA randomized trial of oral vs. topical diltiazem for chronic anal fissures Dis Colon Rectum 44 1074–1078 Occurrence Handle1:STN:280:DC%2BD3MvptFOjsA%3D%3D Occurrence Handle11535842

    CAS  PubMed  Google Scholar 

  38. LH Opie (1996) ArticleTitleCalcium channel antagonists in the treatment of coronary artery disease Prog Cardiovasc Dis 38 273–290

    Google Scholar 

  39. AM Katz WD Hager FC Messineo AJ Pappano (1984) ArticleTitleCellular actions and pharmacology of the calcium-channel blockers drugs Am J Med 77 2–10

    Google Scholar 

  40. NJ Carty B Moran CD Johnson (1994) ArticleTitleAnorectal physiology measurements are of no value in clinical practice. True or false? Ann R Coll Surg Engl 76 276–280

    Google Scholar 

  41. N Katoh S Hirano S Kishimoto H Yasuno (1997) ArticleTitleCalcium channel blockers suppress the contact hypersensitivity reaction (CHR) by inhibiting antigen transport and presentation by epidermal Langerhans cells in mice Clin Exp Immunol 108 302–308 Occurrence Handle10.1046/j.1365-2249.1997.d01-1024.x

    Article  Google Scholar 

  42. JD Fleischmann HN Huntley WB Shingleton DB Wentworth (1991) ArticleTitleClinical and immunological response to nifedipine for the treatment of interstitial cystitis J Urol 146 1235–1239

    Google Scholar 

  43. AC Brown JM Sumfest JV Rozwadowski (1989) ArticleTitleHistopathology of the internal anal sphincter in chronic anal fissure Dis Colon Rectum 32 680–683

    Google Scholar 

  44. H Oshiro I Kobayashi D Kim H Takenaka RW Hobson WN Duran (1995) ArticleTitleL-type calcium channel blockers modulate the microvascular hyperpermeability induced by platelet-activating factor in vivo J Vasc Surg 22 732–739

    Google Scholar 

  45. AJ Landau RT Eberhardt WH Frishman (1994) ArticleTitleIntranasal delivery of cardiovascular agents Am Heart J 127 1594–1599 Occurrence Handle10.1016/0002-8703(94)90391-3

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Divisione VII, Chirurgia Gastroenterologica and Gastroenterology Unit, A. Cardarelli Hospital, and Istituto di Igiene e Medicina Preventiva, 2nd University of Naples, School of Medicine, Naples, Italy

    Pasquale Perrotti M.D., Antonio Bove M.D., Carmine Antropoli M.D., Domenico Molino M.D., Massimo Antropoli M.D., Antonio Balzano M.D., Guglielmo De Stefano M.D. & Francesco Attena M.D.

Authors
  1. Pasquale Perrotti M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Antonio Bove M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Carmine Antropoli M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Domenico Molino M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Massimo Antropoli M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Antonio Balzano M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Guglielmo De Stefano M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Francesco Attena M.D.
    View author publications

    You can also search for this author in PubMed Google Scholar

About this article

Cite this article

Perrotti, P., Bove, A., Antropoli, C. et al. Topical Nifedipine With Lidocaine Ointment vs. Active Control for Treatment of Chronic Anal Fissure. Dis Colon Rectum 45, 1468–1475 (2002). https://doi.org/10.1007/s10350-004-6452-1

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10350-004-6452-1

Keywords

Search

Navigation