PURPOSE: This study was performed according to a prospective, randomized, o
pen design. The aim was to test the efficacy of local application of nifedi
pine ointment in healing acute thrombosed external hemorrhoids. METHODS: Ni
nety-eight patients who gave their informed consent were recruited; they re
ceived clinical examination and anoscopy. A questionnaire to evaluate sympt
oms, pain, and concurrent use of analgesics was administered. Patients trea
ted with nifedipine (n = 50) used topical 0.3 percent nifedipine and 1.5 pe
rcent lidocaine ointment every 12 hours for two weeks. The control group, c
onsisting of 48 patients, received topical 1.5 percent lidocaine ointment d
uring therapy. RESULTS: Results obtained were as follows: complete relief o
f pain in 43 patients (86 percent) of the nifedipine-treated group as oppos
ed 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 nif
edipine-treated group as opposed to 26 patients (54.1 percent) of the contr
ol group after 7 days of therapy (P < 0.01); and resolution of acute thromb
osed external hemorrhoids was achieved after 14 days of therapy in 46 patie
nts (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 sys
temic side effect in patients treated with nifedipine. CONCLUSIONS: Our stu
dy clearly demonstrates that the use of topical nifedipine, which at presen
t is for treatment of cardiovascular disorders, is a reliable new option in
the conservative treatment of thrombosed external hemorrhoids.