Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Diseases of the Colon & Rectum
Published in: Diseases of the Colon & Rectum 7/2008

01-07-2008 | Original Contribution

Safety and Efficacy of New Glyceryl Trinitrate Suppository Formula: First Double Blind Placebo-Controlled Clinical Trial

Authors: M. H. Emami, M.D., S. Sayedyahossein, M.D., A. Aslani, Ph.D.

Published in: Diseases of the Colon & Rectum | Issue 7/2008

Login to get access

Purpose

This study was designed to assess the safety and efficacy of 0.2 percent glyceryl trinitrate suppository form in the healing of chronic anal fissure.

Methods

Thirty-four patients with symptomatic chronic anal fissures were assigned to 0.2 percent glyceryl trinitrate suppository (n = 21) or placebo (n = 13) in a double blind design. Patient's symptom scores were registered at first visit. A validated daily chart was given to assess their symptoms on a daily basis. Both groups received psyllium from the beginning of the study. They were assessed at two-week intervals for six weeks. Then, they started a washout period of one month and after that were crossed over for another six weeks. Chi-squared, t-tests, and analysis of variance were used for statistical analysis.

Results

Complete healing at six weeks was achieved in 12 of 21 patients (57 percent) in the glyceryl trinitrate group and 5 of 13 patients (38 percent) in the placebo (P < 0.05).The overall healing rates at the end of study were 15 of 21 (71 percent) vs. 11 of 13 (84 percent) in the glyceryl trinitrate and placebo groups, respectively (P > 0.05).

Conclusions

Application of 0.2 percent glyceryl trinitrate suppository form represents a new, promising, and effective treatment for chronic anal fissure.
Literature
1.
Khan H, Shukr I, Munir SH, et al. Effect of topical glyceryl trinitrate on the management of acute anal fissure. Rawal Med J J Pakistan Med Assoc 2006;31:1–4.
2.
Pescatori M, Interisano A. Annual report of the Italian coloproctology units. Tech Coloproctol 1995;3:29–30.
3.
4.
Sailer M, Bussen D, Debus ES, Fuchs KH, Thiede A. Quality of life in patients with benign anorectal disorders. Br J Surg 1998;85:1716–9.PubMedCrossRef
5.
McCallion K, Gardiner KR. Progress in the understanding and treatment of chronic anal fissure. Postgrad Med J 2001;77:753–8.PubMedCrossRef
6.
Minguez M, Tomas-Ridocci M, Garcia A, et al. Pressure of the anal canal in patients with haemorrhoids or with anal fissure. Effect of the topical application of an anaesthetic gel. Rev Esp Enferm Dig 1992;81:103–7.PubMed
7.
Notaras MJ. Lateral subcutaneous sphincterotomy for anal fissure—a new technique. Proc R Soc Med 1969;62:713.PubMed
8.
Khubchandani IT, Reed JF. Sequelae of internal sphincterotomy for chronic fissure in ano. Br J Surg 1989;76:431–4.PubMedCrossRef
9.
Christie A, Guest JF. Modelling the economic impact of managing a chronic anal fissure with a proprietary formulation of nitroglycerin (Rectogesic) compared to lateral internal sphincterotomy in the United Kingdom. Int J Colorectal Dis 2002;17:259–67.PubMedCrossRef
10.
Svendsen CB, Matzen P. Treatment of chronic anal fissure with topically applied nitroglycerin ointment. A systematic review of evidence-based results. Ugeskr Laeger 2002;164:3845–9.PubMed
11.
Scholefield JH, Bock JU, Marla B, et al. A dose finding study with 0.1%, 0.2%, and 0.4% glyceryl trinitrate ointment in patients with chronic anal fissures. Gut 2003;52:264–9.PubMedCrossRef
12.
Liberting G, Knight JS, Farouk R. Randomised trial of topical 0.2% glyceryl trinitrate and lateral internal sphincterotomy for the treatment of patients with chronic anal fissure: long-term follow-up. Eur J Surg 2002;168:418–21.CrossRef
13.
Jonas M, Lund JN, Scholefield JH. Topical 0.2% glyceryl trinitrate ointment for anal fissures: long-term efficacy in routine clinical practice. Colorectal Dis 2002;4:317–20.PubMedCrossRef
14.
Tankova L, Yoncheva K, Muhtarov M, Kadyan H, Draganov V. Topical mononitrate treatment in patients with anal fissure. Aliment Pharmacol Ther 2002;16:101–3.PubMedCrossRef
15.
Sonmez K, Demirogullari B, Ekingen G, et al. Randomized, placebo-controlled treatment of anal fissure by lidocaine, EMLA, and GTN in children. J Pediatr Surg 2002;37:1313–6.PubMedCrossRef
16.
Simpson J, Lund JN, Thompson RJ, Kapila L, Scholefield JH. The use of glyceryl trinitrate (GTN) in the treatment of chronic anal fissure in children. Med Sci Monit 2003;9:PI123–6.PubMed
17.
Ward DI, Miller BJ, Schache DJ, et al. Cut or paste? The use of glyceryl trinitrate paste in the treatment of acute and chronic anal fissure. ANZ J Surg 2000;70:19–21.CrossRef
18.
Skinner SA, Polglase AL, Le CT, Winnett JD. Treatment of anal fissure with glyceryl trinitrate in patients referred for surgical management. ANZ J Surg 2001;71:218–20.PubMedCrossRef
19.
Ehrenpreis ED, Rubin DT, Ginsburg PM, Meyers JS. Treatment of anal fissures with topical nitroglycerin. Expert Opin Pharmacother 2001;2:41–5.PubMedCrossRef
20.
Rattan S, Sarkar A, Chakder S. Nitric oxide pathway in rectoanal inhibitory reflex of opossum internal anal sphincter. Gastroenterology 1992;103:43–50.PubMed
21.
O’Kelly T, Brading A, Mortensen N. Nerve mediated relaxation of the human internal anal sphincter: the role of nitric oxide. Gut 1993;34:689–93.PubMedCrossRef
22.
Stebbing JF. Nitric oxide synthase neurones and neuromuscular behaviour of the anorectum. Ann R Coll Surg Engl 1998;80:137–45.PubMed
23.
Loder PB, Kamm MA, Nicholls RJ, et al. “Reversible chemical sphincterotomy” by local application of glyceryl trinitrate. Br J Surg 1994;81:1386–9.PubMedCrossRef
24.
Guillemot F, Leroi H, Lone YC, et al. Action of in situ nitroglycerin on upper anal canal pressure of patients with terminal constipation. A pilot study. Dis Colon Rectum 1993;36:372–6.PubMedCrossRef
25.
Carapeti EA, Kamm MA, McDonald PJ, et al. Randomised controlled trial shows that glyceryl trinitrate heals anal fissures, higher doses are not more effective, and there is a high recurrence rate. Gut 1999;44:727–30.PubMedCrossRef
26.
Dorfman G, Levitt M, Platell C. Treatment of chronic anal fissure with topical glyceryl trinitrate. Dis Colon Rectum 1999;42:1007–10.PubMedCrossRef
27.
Cundall JD, Gunn J, Easterbrook JR, Tilsed JV, Duthie GS. The dose response of the internal anal sphincter to topical application of glyceryl trinitrate ointment. Colorectal Dis 2001;3:259–62.PubMedCrossRef
28.
Graziano A, Svidler Lopez L, Lencinas S, et al. Long-term results of topical nitroglycerin in the treatment of chronic anal fissures are disappointing. Tech Coloproctol 2001;5:143–7.PubMedCrossRef
29.
Jonas M, Lobo DN, Gudgeon AM. Lateral internal sphincterotomy is not redundant in the era of glyceryl trinitrate therapy for chronic anal fissure. J R Soc Med 1999;92:186–8.PubMed
30.
Aslani A, Tavakoli N, Emami MH, Asadi F. Preparation and evaluation of physicochemical properties of glyceryl trinitrate suppository in the treatment of anal fissure. In: The 4th International Postgraduate Research Symposium on Pharmaceutics, Istanbul, Turkey, September 20 to 22, 2004.
31.
O’Kelly T, Brading A, Mortensen N. Nerve mediated relaxation of the human internal anal sphincter: the role of nitric oxide. Gut 1993;34:689–93.PubMedCrossRef
32.
Rattan S, Chakder S. Role of nitric oxide as a mediator of internal anal sphincter relaxation. Am J Physiol 1992;262:G107–12.PubMed
33.
Lund JN, Scholefield JH. Glyceryl trinitrate is an effective treatment for anal fissure. Dis Colon Rectum 1997;40:468–70.PubMedCrossRef
Metadata
Title
Safety and Efficacy of New Glyceryl Trinitrate Suppository Formula: First Double Blind Placebo-Controlled Clinical Trial
Authors
M. H. Emami, M.D.
S. Sayedyahossein, M.D.
A. Aslani, Ph.D.
Publication date
01-07-2008
Publisher
Springer-Verlag
Published in
Diseases of the Colon & Rectum / Issue 7/2008
Print ISSN: 0012-3706
Electronic ISSN: 1530-0358
DOI
https://doi.org/10.1007/s10350-008-9226-3

Other articles of this Issue 7/2008

Diseases of the Colon & Rectum 7/2008 Go to the issue

Original Contribution

Hybrid Capture II Detection of Oncogenic Human Papillomavirus: A Useful Tool When Evaluating Men Who Have Sex with Men with Atypical Squamous Cells of Undetermined Significance on Anal Cytology

Letter to the Editor

Stapled Hemorrhoidopexy: Histopathologic Concerns

Original Contribution

Hysterectomy Does Not Cause Constipation

Letter to the Editor

The Author Replies

Letter to the Editor

Subcutaneous Fissurotomy Included a Disguised and Unappreciated Anal Spincter Dilatation

Original Contribution

Persistent Symptoms After Elective Sigmoid Resection for Diverticulitis