Topical Nifedipine vs. Topical Glyceryl Trinitrate  for Treatment of Chronic Anal Fissure

Tiberiu Ezri M.D., Sergio Susmallian M.D.. Diseases of the Colon & Rectum June 2003, Volume 46, Issue 6, pp 805-808

Abstract

PURPOSE: Nifedipine (administered orally or applied topically) has been effective for nonsurgical treatment of anal fissure. We compared the efficacy of nifedipine vs. glyceryl trinitrate for chemical sphincterotomy of anal fissure. METHODS: In a prospective, double-blind trial, 52 patients suffering from chronic anal fissure were randomly and equally allocated to receive either glyceryl trinitrate or nifedipine, both applied topically to the perianal region. The end point of the study was healing within a predetermined period (6 months). Variables assessed included demographic data (age, gender), symptoms associated with the fissure, duration of treatment, percentage of healing, untoward effects of treatment, pain scores, duration of follow-up, recurrence, and need for complementary means of treatment. Descriptive data are presented as mean ± standard deviation and quantal data as percentage. Inference analysis was performed using the Student’s t-test for the descriptive data and the chi-squared or Fisher’s exact test for nominal variables. RESULTS: No significant differences were recorded with regard to age, gender, symptoms associated with the fissure, or duration of treatment. Healing rate was higher (P < 0.04) with nifedipine (89 percent) as compared with glyceryl trinitrate (58 percent). Treatment side effects (headache, flushing) were more frequent (P < 0.01) with glyceryl trinitrate (40 percent) as compared with nifedipine (5 percent). Pain scores were significantly lower (P < 0.03) on completion of treatment in both groups (3.2 in glyceryl trinitrate and 3.4 in nifedipine vs. 6.2 and 6.1, respectively), but did not differ between the two groups. Recurrence occurred in 31 percent of patients treated with glyceryl trinitrate and 42 percent of those treated with nifedipine after a mean period of 18 ± 3 weeks and 12 ± 4 weeks, respectively. CONCLUSION: Topical application of nifedipine for management of chronic anal fissure was more effective and had fewer side effects than topical glyceryl trinitrate. Recurrence was frequent with both drugs.

Topical Nifedipine With Lidocaine Ointment vs. Active Control for Treatment of Chronic Anal Fissure

Pasquale Perrotti M.D., Antonio Bove M.D., Carmine Antropoli M.D., Domenico Molino M.D., Massimo Antropoli M.D., Antonio Balzano M.D., Guglielmo De Stefano M.D., Francesco Attena M.D.. Diseases of the Colon & Rectum November 2002, Volume 45, Issue 11, pp 1468-1475

Abstract

PURPOSE: Chronic anal fissure may be treated by chemical or surgical sphincterotomy. The aim of this study was to test the efficacy of local application of nifedipine and lidocaine ointment in healing chronic anal fissure. METHODS: The study was performed according to a prospective, randomized, double-blind design. One hundred ten patients who gave informed consent were recruited. They received a clinical examination, a questionnaire to evaluate symptoms and pain, anorectal manometry, and anoscopy. Healing of anal fissure at Day 42 of therapy was defined as the primary efficacy variable of the study. Patients treated with nifedipine (n = 55) used topical 0.3 percent nifedipine and 1.5 percent lidocaine ointment every 12 hours for 6 weeks. The control group (n = 55) received topical 1.5 percent lidocaine and 1 percent hydrocortisone acetate ointment during therapy. Anal pressures were measured by recording resting and maximal voluntary contraction pressures at baseline and at Day 21. Long-term outcomes were determined after a median follow-up of 18 months. RESULTS: Healing of chronic anal fissure was achieved after 6 weeks of therapy in 94.5 percent of the nifedipine-treated patients (P < 0.001) as opposed to 16.4 percent of the controls. Mean anal resting pressure decreased from a mean value ± standard deviation of 47.2 ± 14.6 to 42 ± 12.4 mmHg in the nifedipine group. This represents a mean reduction of 11 percent (P = 0.002). Changes of maximal voluntary contraction in nifedipine-treated patients were not significant. No changes in mean anal resting pressure and maximal voluntary contraction were observed in the control group. We did not observe any systemic side effect in patients treated with nifedipine. After the blinding was removed, recurrence of the fissure was observed in 3 of 52 patients in the nifedipine group within 1 year of treatment, and 2 of these patients healed with an additional course of topical nifedipine and lidocaine ointment. CONCLUSIONS: Our study clearly demonstrates that the therapeutic use of topical nifedipine and lidocaine ointment should be extended to the conservative treatment of chronic anal fissure.

Refer to Algorithm for Chronic Neuropathy for its use in neuropathic pain.

Back to Physicians Page

Back to Ingredients Page