CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Conservative treatment of acute thrombosed external hemorrhoids with topical nifedipine.

PURPOSE: This study was performed according to a prospective, randomized, open design. The aim was to test the efficacy of local application of nifedipine ointment in healing acute thrombosed external hemorrhoids.

METHODS: Ninety-eight patients who gave their informed consent were recruited; they received clinical examination and anoscopy. A questionnaire to evaluate symptoms, pain, and concurrent use of analgesics was administered. Patients treated with nifedipine (n = 50) used topical 0.3 percent nifedipine and 1.5 percent lidocaine ointment every 12 hours for two weeks. The control group, consisting of 48 patients, received topical 1.5 percent lidocaine ointment during therapy.

RESULTS: Results obtained were as follows: complete relief of pain in 43 patients (86 percent) of the nifedipine-treated group as opposed to 24 patients (50 percent) of the control group after 7 days of therapy (P < 0.01); oral analgesics were used by 4 patients (8 percent) in the nifedipine-treated group as opposed to 26 patients (54.1 percent) of the control group after 7 days of therapy (P < 0.01); and resolution of acute thrombosed external hemorrhoids was achieved after 14 days of therapy in 46 patients (92 percent) of the nifedipine-treated group, as opposed to 22 patients (45.8 percent) of the control group (P < 0.01). We did not observe any systemic side effect in patients treated with nifedipine.

CONCLUSIONS: Our study clearly demonstrates that the use of topical nifedipine, which at present is for treatment of cardiovascular disorders, is a reliable new option in the conservative treatment of thrombosed external hemorrhoids.

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