Abstract | PURPOSE: 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. METHODS: 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: 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. CONCLUSIONS:
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Authors | C Antropoli, P Perrotti, M Rubino, A Martino, G De Stefano, G Migliore, M Antropoli, P Piazza |
Journal | Diseases of the colon and rectum
(Dis Colon Rectum)
Vol. 42
Issue 8
Pg. 1011-5
(Aug 1999)
ISSN: 0012-3706 [Print] United States |
PMID | 10458123
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Vasodilator Agents
- Nifedipine
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Topics |
- Administration, Topical
- Adult
- Double-Blind Method
- Female
- Fissure in Ano
(drug therapy, pathology)
- Humans
- Male
- Middle Aged
- Nifedipine
(administration & dosage, therapeutic use)
- Prospective Studies
- Treatment Outcome
- Vasodilator Agents
(administration & dosage, therapeutic use)
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