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.

RCT Entities:   Population Interventions Outcomes