Nifedipine for local use in conservative treatment of anal fissures : Preliminary results of a multicenter study

This study was performed according to a prospective, randomized, double-blind, multicenter design. The aim was to test the efficacy of local application of nifedipine gel" in healing acute anal fissure by relaxing the internal anal sphincter. Two hundred eighty-three patients who gave informed...

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Veröffentlicht in:Diseases of the colon & rectum 1999-08, Vol.42 (8), p.1011-1015
Hauptverfasser: ANTROPOLI, C, PERROTTI, P, RUBINO, M, MARTINO, A, DE STEFANO, G, MIGLIORE, G, ANTROPOLI, M, PIAZZA, P
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container_end_page 1015
container_issue 8
container_start_page 1011
container_title Diseases of the colon & rectum
container_volume 42
creator ANTROPOLI, C
PERROTTI, P
RUBINO, M
MARTINO, A
DE STEFANO, G
MIGLIORE, G
ANTROPOLI, M
PIAZZA, P
description This study was performed according to a prospective, randomized, double-blind, multicenter design. The aim was to test the efficacy of local application of nifedipine gel" in healing acute anal fissure by relaxing the internal anal sphincter. Two hundred eighty-three patients who gave informed consent were recruited; they received a clinical examination. A questionnaire to evaluate the symptoms and the pain was administered, and a proctoscopy and anorectal manometry were performed. Patients treated with nifedipine (n = 141) used topical 0.2 percent nifedipine gel every 12 hours for three weeks. The control group, consisting of 142 patients, received topical 1 percent lidocaine and 1 percent hydrocortisone acetate gel during therapy. Manometry was performed before and on Days 14 and 21. Anal pressures were measured by recording resting and squeeze pressures. Results obtained were as follows: total remission from acute anal fissure was achieved after 21 days of therapy in 95 percent of the nifedipine-treated patients (P < 0.01), as opposed to 50 percent of the controls (P < 0.01), and previously elevated maximum resting anal pressures decreased from a mean value +/- standard deviation of 72.5 +/- 10.07 mmHg to 50.5 +/- 10.03 mmHg in the nifedipine group. This represents a mean reduction of 30 percent (P < 0.01). We also observed a significant decrease in squeeze pressures in nifedipine-treated patients (from a mean +/- standard deviation of 130.5 +/- 19.25 mmHg to 108.5 +/- 18.55 mmHg, a mean reduction of 16.8 percent; P < 0.01). No changes in anal pressures were observed in the control group. We did not observe any systemic side effect or significant anorectal bleeding in patients treated with nifedipine. Our study clearly demonstrates that the therapeutic use of nifedipine, which at present is used only in cardiovascular pathologies, should be extended with local use to the conservative treatment of anal fissures.
doi_str_mv 10.1007/BF02236693
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The aim was to test the efficacy of local application of nifedipine gel" in healing acute anal fissure by relaxing the internal anal sphincter. Two hundred eighty-three patients who gave informed consent were recruited; they received a clinical examination. A questionnaire to evaluate the symptoms and the pain was administered, and a proctoscopy and anorectal manometry were performed. Patients treated with nifedipine (n = 141) used topical 0.2 percent nifedipine gel every 12 hours for three weeks. The control group, consisting of 142 patients, received topical 1 percent lidocaine and 1 percent hydrocortisone acetate gel during therapy. Manometry was performed before and on Days 14 and 21. Anal pressures were measured by recording resting and squeeze pressures. Results obtained were as follows: total remission from acute anal fissure was achieved after 21 days of therapy in 95 percent of the nifedipine-treated patients (P &lt; 0.01), as opposed to 50 percent of the controls (P &lt; 0.01), and previously elevated maximum resting anal pressures decreased from a mean value +/- standard deviation of 72.5 +/- 10.07 mmHg to 50.5 +/- 10.03 mmHg in the nifedipine group. This represents a mean reduction of 30 percent (P &lt; 0.01). We also observed a significant decrease in squeeze pressures in nifedipine-treated patients (from a mean +/- standard deviation of 130.5 +/- 19.25 mmHg to 108.5 +/- 18.55 mmHg, a mean reduction of 16.8 percent; P &lt; 0.01). No changes in anal pressures were observed in the control group. We did not observe any systemic side effect or significant anorectal bleeding in patients treated with nifedipine. Our study clearly demonstrates that the therapeutic use of nifedipine, which at present is used only in cardiovascular pathologies, should be extended with local use to the conservative treatment of anal fissures.</description><identifier>ISSN: 0012-3706</identifier><identifier>EISSN: 1530-0358</identifier><identifier>DOI: 10.1007/BF02236693</identifier><identifier>PMID: 10458123</identifier><identifier>CODEN: DICRAG</identifier><language>eng</language><publisher>Secaucus, NJ: Springer</publisher><subject>Administration, Topical ; Adult ; Biological and medical sciences ; Digestive system ; Double-Blind Method ; Female ; Fissure in Ano - drug therapy ; Fissure in Ano - pathology ; Humans ; Male ; Medical sciences ; Middle Aged ; Nifedipine - administration &amp; dosage ; Nifedipine - therapeutic use ; Pharmacology. 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The aim was to test the efficacy of local application of nifedipine gel" in healing acute anal fissure by relaxing the internal anal sphincter. Two hundred eighty-three patients who gave informed consent were recruited; they received a clinical examination. A questionnaire to evaluate the symptoms and the pain was administered, and a proctoscopy and anorectal manometry were performed. Patients treated with nifedipine (n = 141) used topical 0.2 percent nifedipine gel every 12 hours for three weeks. The control group, consisting of 142 patients, received topical 1 percent lidocaine and 1 percent hydrocortisone acetate gel during therapy. Manometry was performed before and on Days 14 and 21. Anal pressures were measured by recording resting and squeeze pressures. Results obtained were as follows: total remission from acute anal fissure was achieved after 21 days of therapy in 95 percent of the nifedipine-treated patients (P &lt; 0.01), as opposed to 50 percent of the controls (P &lt; 0.01), and previously elevated maximum resting anal pressures decreased from a mean value +/- standard deviation of 72.5 +/- 10.07 mmHg to 50.5 +/- 10.03 mmHg in the nifedipine group. This represents a mean reduction of 30 percent (P &lt; 0.01). We also observed a significant decrease in squeeze pressures in nifedipine-treated patients (from a mean +/- standard deviation of 130.5 +/- 19.25 mmHg to 108.5 +/- 18.55 mmHg, a mean reduction of 16.8 percent; P &lt; 0.01). No changes in anal pressures were observed in the control group. We did not observe any systemic side effect or significant anorectal bleeding in patients treated with nifedipine. Our study clearly demonstrates that the therapeutic use of nifedipine, which at present is used only in cardiovascular pathologies, should be extended with local use to the conservative treatment of anal fissures.</abstract><cop>Secaucus, NJ</cop><pub>Springer</pub><pmid>10458123</pmid><doi>10.1007/BF02236693</doi><tpages>5</tpages></addata></record>
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ispartof Diseases of the colon & rectum, 1999-08, Vol.42 (8), p.1011-1015
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subjects Administration, Topical
Adult
Biological and medical sciences
Digestive system
Double-Blind Method
Female
Fissure in Ano - drug therapy
Fissure in Ano - pathology
Humans
Male
Medical sciences
Middle Aged
Nifedipine - administration & dosage
Nifedipine - therapeutic use
Pharmacology. Drug treatments
Prospective Studies
Treatment Outcome
Vasodilator Agents - administration & dosage
Vasodilator Agents - therapeutic use
title Nifedipine for local use in conservative treatment of anal fissures : Preliminary results of a multicenter study
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