A dose finding study with 0.1%, 0.2%, and 0.4% glyceryl trinitrate ointment in patients with chronic anal fissures

Scholefield, J.H.; Bock, J.U.; Marla, B.; Richter, H.J.; Athanasiadis, S.; Pröls, M.; Herold, A.
February 2003
Gut;Feb2003, Vol. 52 Issue 2, p264
Academic Journal
Background: Anal fissure is a common painful condition affecting the anal canal. The majority of acute fissures heal spontaneously. However, some of these acute fissures do not resolve but become chronic. Chronic anal fissures were traditionally treated by anal dilation or by lateral sphincterotomy. However, both of these surgical treatments may cause a degree of incontinence in up to 30% of patients. Several recent trials have shown that nitric oxide donors such as glyceryl trinitrate (GTN) can reduce sphincter pressure and heal up to 70% of chronic fissures. Aim: This study addressed the dose-response to three different concentrations of GTN ointment compared with placebo in a double blind randomised controlled trial. Method: A double blind, multicentre, randomised controlled trial was set up to compare placebo ointment against three active treatment arms (0.1%, 0.2%, and 0.4% GTN ointment applied at a dose of 220 mg h,vice daily) in chronic anal fissures. The primary end point was complete healing of the fissure. Results: Two hundred patients were recruited over an eight month period from 18 centres. After eight weeks of treatment the healing rate in the placebo group was 37.5% compared with 46.9% for 0.1%, 40.4% for 0.2%, and 54.1% for 0.4% GTN. None was significantly better than the placebo response. A secondary analysis excluded fissures without secondary criteria for chronicity. Healing rates were then found to be 24% in the placebo group compared with 50% in the 0.1% GTN group, 36% in the 0.2% group, and 57% in the 0.4% GTN group. These values were statistically significantly different for the placebo group compared with 0.1% GTN, 0.4% GTN, and for the GTN treated group as a whole. Conclusions: The results of this study have demonstrated the significant benefit of topical GTN when applied to patients suffering from chronic anal fissures but acute fissures showed a tendency to resolve spontaneously. The high proportion of fissures which healed in the...


Related Articles

  • Glyceryl trinitrate for fissures: patch or paste? Lund, Jonathan N. // International Journal of Colorectal Disease;Jul2000, Vol. 15 Issue 4, p246 

    Compares the effectiveness of topical glyceryl trinitrate (GTN) and GTN patch in healing chronic anal fissures. Healing rate of nitric oxide; Dosage of GTN that were applied on the patients; Responses of the patients to both treatments.

  • Idiopathic hypertensive anal canal: a place of internal sphincterotomy. Farid, Mohamed; Nakeeb, Ayman El; Youssef, Mohamed; Omar, Waleed; Fouda, Elyamani; Youssef, Tamer; Thabet, Waleed; Elmoneum, Hisham Abd; Khafagy, Wael; El Nakeeb, Ayman // Journal of Gastrointestinal Surgery;Sep2009, Vol. 13 Issue 9, p1607 

    Background: Hypertensive anal canal is frequently known to be associated with the presence of anal fissure. Based on clinical experience, we hypothesized that idiopathic anal sphincter hypertonia was a condition equivalent to anal fissure, and therefore, it could be treated the same...

  • A randomized trial of glyceryl trinitrate ointment and nitroglycerin patch in healing of anal fissures. Zuberi, Bader Faiyaz; Rajput, Muhammad Ramzan; Abro, Hafeezullah; Shaikh, Sikandar Ali // International Journal of Colorectal Disease;Jul2000, Vol. 15 Issue 4, p243 

    Mean maximum anal resting pressure is directly related to the activity of the smooth muscles of the internal and external sphincters and has been found to be increased in the patients of anal fissure. It has been shown that blood flow at the posterior midline of anoderm is inversely related to...

  • Glyceryl trinitrate ointment (0.25%) and anal cryothermal dilators in the treatment of chronic anal fissures. Visconte, Michele Schiano di; Munegato, Gabriele; Schiano di Visconte, Michele // Journal of Gastrointestinal Surgery;Jul2009, Vol. 13 Issue 7, p1283 

    Introduction: Chronic anal fissure is a common benign disorder; for this condition, lateral internal sphincterotomy is the "gold standard" of treatment. Alternative medical treatments have not proven to be as effective as left lateral internal sphincterotomy.Aim: This...

  • Treatment of chronic anal fissure with topical nitroglycerin ointment 0.4%: a prospective clinical study. Perez-Legaz, J.; Arroyo, A.; Ruiz-Tovar, J.; Lopez-Delgado, A.; Frangi, A.; Moya, P.; Santos, J.; Candela, F.; Calpena, R. // Techniques in Coloproctology;Dec2011, Vol. 15 Issue 4, p475 

    A letter to the editor is presented regarding the use of the commercial nitroglycerin (NTG) ointment Rectogesic® or glyceryl trinitrate 0.4% in treating chronic anal fissure.

  • Prospective clinical trial comparing sphincterotomy, nitroglycerin ointment and xylocaine/lactulose combination for the treatment of anal fissure. Karamanlis, E.; Michalopoulos, A.; Papadopoulos, V.; Mekras, A.; Panagiotou, D.; Ioannidis, A.; Basdanis, G.; Fahantidis, E. // Techniques in Coloproctology;Sep2010, Vol. 14, p21 

    Background: The aim of this study is to compare the ability of three treatments in patients with anal fissure, sphincterotomy, nitroglycerin ointment and combination of gel xylocaine and lactulose. Methods: Ninety adults divided in three groups of 30 patients each group, received one of the...

  • New drugs and dosage forms.  // American Journal of Health-System Pharmacy;8/1/2011, Vol. 68 Issue 15, p1372 

    The article offers information on the dosage forms and indications for the drugs Azficel-T suspension (marketed as Laviv by Fibrocell Science), Nitroglycerin ointment (marketed as Rectiv by Pro- Strakan Group), and Oxycodone hydrochloride tablets (marketed as Oxecta by Pfizer).

  • Lateral internal sphincterotomy is not redundant in the era of glyceryl trinitrate therapy for chronic anal fissure. Jonas, M.; Lobo, D. N.; Gudgeon, A. M. // Journal of the Royal Society of Medicine;Apr1999, Vol. 92 Issue 4, p186 

    Lateral internal sphincterotomy has been the standard treatment for chronic anal fissure, but fissure healing rates of up to 80% with topical glyceryl trinitrate (GTN) treatment have suggested that this operation may become redundant. We evaluated the results of topical treatment of chronic anal...

  • 0.4% Nitroglycerin Ointment: In the Treatment of Chronic Anal Fissure Pain. Fenton, Caroline; Wellington, Keri; Easthope, Stephanie E // Drugs;2006, Vol. 66 Issue 3, p343 

    â–´ 0.4% Nitroglycerin ointment is an intra-anal formulation of nitroglycerin (glyceryl trinitrate) indicated for the treatment of chronic anal fissure pain.â–´ Nitroglycerin is a nitric oxide (NO) donor, which reduces the increased anal canal pressure caused by a hypertonic internal...

  • 0.4% Nitroglycerin Ointment in the Treatment of Chronic Anal Fissure Pain: A Viewpoint by Jonathan N. Lund. Lund, Jonathan N. // Drugs;2006, Vol. 66 Issue 3, p350 

    â–´ Letrozole is a highly selective, nonsteroidal, third-generation aromatase inhibitor approved for first-line and extended adjuvant therapy in postmenopausal women with hormone-responsive, early-stage breast cancer. Binding of letrozole to the haeme component of the cytochrome P450...


Read the Article


Sign out of this library

Other Topics