A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures

Bailey, H. R., Beck, D. E., Billingham, R. P., Binderow, S. R., Gottesman, L., Hull, T. L., Larach, S. W., Margolin, D. A., Milsom, J. W., Potenti, F. M., Rafferty, J. F., Riff, D. S., Sands, L. R., Senagore, A., Stamos, M. J., Yee, L. F., Young-Fadok, T. M., Gibbons, R. D. and Fissure Study Grp (2002). A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures. In: Annual Meeting of the American Society of Colon and Rectal Surgeons, Boston Massachusetts, (1192-1199). 24-29 June 2000. doi:10.1007/s10350-004-6392-9


Author Bailey, H. R.
Beck, D. E.
Billingham, R. P.
Binderow, S. R.
Gottesman, L.
Hull, T. L.
Larach, S. W.
Margolin, D. A.
Milsom, J. W.
Potenti, F. M.
Rafferty, J. F.
Riff, D. S.
Sands, L. R.
Senagore, A.
Stamos, M. J.
Yee, L. F.
Young-Fadok, T. M.
Gibbons, R. D.
Fissure Study Grp
Title of paper A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures
Conference name Annual Meeting of the American Society of Colon and Rectal Surgeons
Conference location Boston Massachusetts
Conference dates 24-29 June 2000
Journal name Diseases of the Colon & Rectum   Check publisher's open access policy
Place of Publication New York, NY, United States
Publisher Lippincott Williams & Wilkins
Publication Year 2002
Sub-type Fully published paper
DOI 10.1007/s10350-004-6392-9
ISSN 0012-3706
1530-0358
Volume 45
Issue 9
Start page 1192
End page 1199
Total pages 8
Language eng
Formatted Abstract/Summary
PURPOSE: The aim of this study was to determine the optimal dose and dosing interval of nitroglycerin ointment to heal chronic anal fissures.

METHOD
: A randomized, double-blind study of intra-anally applied nitroglycerin ointment (Anogesic™) was conducted in 17 centers in 304 patients with chronic anal fissures. The patients were randomly assigned to one of eight treatment regimens (0.0, 0.1, 0.2, 0.4 percent nitroglycerin ointment applied twice or three times per day), for up to eight weeks. A dose-measuring device standardized the delivery of 374 mg ointment. Healing of fissures (complete reepithelialization) was assessed by physical examination using an observer unaware of treatment allocation. The subjects assessed pain intensity daily by completing a diary containing a visual analog scale for average pain intensity for the day, the worst pain intensity for the day, and pain intensity at the last defecation.

RESULTS
: There were no significant differences in fissure healing among any of the treatment groups; all groups, including placebo had a healing rate of approximately 50 percent. This rate of placebo response was inexplicably higher than previously reported in the literature. Treatment with 0.4 percent (1.5 mg) nitroglycerin ointment was associated with a significant (P < 0.0002) decrease in average pain intensity compared with vehicle as assessed by patients with a visual analog scale. The decreases were observed by Day 4 of treatment. At 8 weeks the magnitude of the difference between 0.4 percent nitroglycerin and control was a 21 percent reduction in average pain. Treatment was well tolerated, with only 3.29 percent of patients discontinuing treatment because of headache. Headaches were the primary adverse event and were dose related.

CONCLUSION
: Nitroglycerin ointment did not alter healing but significantly and rapidly reduced the pain associated with chronic anal fissures.
Keyword anal fissures
nitroglycerin
anal pain
Glyceryl-Trinitrate Ointment
Placebo-Controlled Trial
Lateral Internal Sphincterotomy
Topical Nitroglycerin
Double-Blind
Nitric-Oxide
In-Ano
Pressure
Hemorrhoids
Management
Q-Index Code E1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Conference Paper
Collection: School of Medicine Publications
 
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