Topical Nifedipine(®) for conservative treatment of acute haemorrhoidal thrombosis.

Objective The aim of this prospective, randomized trial was to test the efficacy of the local application of Nifedipine gel® in healing acute thrombosed haemorrhoids by relaxing the internal anal sphincter. Patients and methods Ninety patients who gave written informed consent were recruited; they received a clinical examination, anoscopy and a questionnaire to evaluate symptoms, pain and concurrent use of analgesics. Patients treated with Nifedipine (n=46) received topical 0.3% Nifedipine and 1.5% lidocaine gel every 12 h for 2 weeks. The control group, consisting of 44 patients, received topical 1.5% lidocaine and 1% hydrocortisone acetate gel during therapy. Results The results were as follows: relief of pain in 84.7% in Nifedipine group as opposed to 50% of controls after 7 days of therapy (P < 0.01); oral analgesics were used by 8.6% of patients in the Nifedipine group as opposed to 54.5% of the control group (P < 0.01); resolution of thrombosed haemorrhoids occurred after 14 days of therapy in 91.3% of the Nifedipine-treated patients, as opposed to 45.4% of the controls (P < 0.01). No systemic side effects or significant anorectal bleeding were observed in patients treated with Nifedipine. Conclusion Our study clearly demonstrates that the use of Nifedipine, which at present is for treatment of cardiovascular disorders, should be extended to the conservative treatment of acute thrombosed haemorrhoids, using a topical application.