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

H. Randolph Bailey, David E. Beck, Richard P. Billingham, Sander R. Binderow, Lester Gottesman, Tracy L. Hull, Sergio W. Larach, David A. Margolin, Jeffrey W. Milsom, Fabio M. Potenti, Janice F. Rafferty, Dennis S. Riff, Lawrence R. Sands, Anthony Senagore, Michael J. Stamos, Laurence F. Yee, Tonia M. Young-Fadok, Robert D. Gibbons

Research output: Contribution to journalArticle

57 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1192-1199
Number of pages8
JournalDiseases of the Colon and Rectum
Volume45
Issue number9
DOIs
StatePublished - Sep 2002
Externally publishedYes

Fingerprint

Fissure in Ano
Nitroglycerin
Ointments
Pain
Therapeutics
Headache
Placebos
Defecation
Pain Measurement
Visual Analog Scale
Double-Blind Method
Physical Examination
Equipment and Supplies

Keywords

  • Anal fissures
  • Anal pain
  • Nitroglycerin

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Bailey, H. R., Beck, D. E., Billingham, R. P., Binderow, S. R., Gottesman, L., Hull, T. L., ... Gibbons, R. D. (2002). A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures. Diseases of the Colon and Rectum, 45(9), 1192-1199. https://doi.org/10.1007/s10350-004-6392-9

A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures. / Bailey, H. Randolph; Beck, David E.; Billingham, Richard P.; Binderow, Sander R.; Gottesman, Lester; Hull, Tracy L.; Larach, Sergio W.; Margolin, David A.; Milsom, Jeffrey W.; Potenti, Fabio M.; Rafferty, Janice F.; Riff, Dennis S.; Sands, Lawrence R.; Senagore, Anthony; Stamos, Michael J.; Yee, Laurence F.; Young-Fadok, Tonia M.; Gibbons, Robert D.

In: Diseases of the Colon and Rectum, Vol. 45, No. 9, 09.2002, p. 1192-1199.

Research output: Contribution to journalArticle

Bailey, HR, Beck, DE, Billingham, RP, Binderow, SR, Gottesman, L, Hull, TL, Larach, SW, Margolin, DA, Milsom, JW, Potenti, FM, Rafferty, JF, Riff, DS, Sands, LR, Senagore, A, Stamos, MJ, Yee, LF, Young-Fadok, TM & Gibbons, RD 2002, 'A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures', Diseases of the Colon and Rectum, vol. 45, no. 9, pp. 1192-1199. https://doi.org/10.1007/s10350-004-6392-9
Bailey, H. Randolph ; Beck, David E. ; Billingham, Richard P. ; Binderow, Sander R. ; Gottesman, Lester ; Hull, Tracy L. ; Larach, Sergio W. ; Margolin, David A. ; Milsom, Jeffrey W. ; Potenti, Fabio M. ; Rafferty, Janice F. ; Riff, Dennis S. ; Sands, Lawrence R. ; Senagore, Anthony ; Stamos, Michael J. ; Yee, Laurence F. ; Young-Fadok, Tonia M. ; Gibbons, Robert D. / A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures. In: Diseases of the Colon and Rectum. 2002 ; Vol. 45, No. 9. pp. 1192-1199.
@article{299ae4ebbb8b42468fae50234a9083c2,
title = "A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures",
abstract = "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.",
keywords = "Anal fissures, Anal pain, Nitroglycerin",
author = "Bailey, {H. Randolph} and Beck, {David E.} and Billingham, {Richard P.} and Binderow, {Sander R.} and Lester Gottesman and Hull, {Tracy L.} and Larach, {Sergio W.} and Margolin, {David A.} and Milsom, {Jeffrey W.} and Potenti, {Fabio M.} and Rafferty, {Janice F.} and Riff, {Dennis S.} and Sands, {Lawrence R.} and Anthony Senagore and Stamos, {Michael J.} and Yee, {Laurence F.} and Young-Fadok, {Tonia M.} and Gibbons, {Robert D.}",
year = "2002",
month = "9",
doi = "10.1007/s10350-004-6392-9",
language = "English (US)",
volume = "45",
pages = "1192--1199",
journal = "Diseases of the Colon and Rectum",
issn = "0012-3706",
publisher = "Lippincott Williams and Wilkins",
number = "9",

}

TY - JOUR

T1 - A study to determine the nitroglycerin ointment dose and dosing interval that best promote the healing of chronic anal fissures

AU - Bailey, H. Randolph

AU - Beck, David E.

AU - Billingham, Richard P.

AU - Binderow, Sander R.

AU - Gottesman, Lester

AU - Hull, Tracy L.

AU - Larach, Sergio W.

AU - Margolin, David A.

AU - Milsom, Jeffrey W.

AU - Potenti, Fabio M.

AU - Rafferty, Janice F.

AU - Riff, Dennis S.

AU - Sands, Lawrence R.

AU - Senagore, Anthony

AU - Stamos, Michael J.

AU - Yee, Laurence F.

AU - Young-Fadok, Tonia M.

AU - Gibbons, Robert D.

PY - 2002/9

Y1 - 2002/9

N2 - 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.

AB - 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.

KW - Anal fissures

KW - Anal pain

KW - Nitroglycerin

UR - http://www.scopus.com/inward/record.url?scp=18544385660&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=18544385660&partnerID=8YFLogxK

U2 - 10.1007/s10350-004-6392-9

DO - 10.1007/s10350-004-6392-9

M3 - Article

VL - 45

SP - 1192

EP - 1199

JO - Diseases of the Colon and Rectum

JF - Diseases of the Colon and Rectum

SN - 0012-3706

IS - 9

ER -