OBJECTIVES: To evaluate the efficacy of topical application of viable bacille Calmette-Guérin (BCG) as a primary line of treatment in patients with condylomata acuminata. METHODS: We recruited 50 patients from the Department of Andrology and Sexually Transmitted Diseases, Cairo University Hospital complaining of genital warts. Patients were divided into two groups. Group 1 consisted of 25 patients who received BCG as a weekly topical treatment for 6 consecutive weeks. If still resistant, another intensive three-times-a-week course for 3 consecutive weeks was given. Group 2 consisted of 25 patients who received 0.9% saline solution as a placebo solution with the same procedure and follow-up as for group 1. All patients were followed up for 6 consecutive months. During the treatment course, the local response, wart state and size, and any side effects were reported. RESULTS: A complete response with the disappearance of all condylomata acuminata was achieved in 20 (80%) of the 25 patients after a maximum of six BCG applications. Three patients (12%) needed another, more extensive, course, resulting in complete clearance 3 weeks later. Only 2 patients (8%) did not achieve a full response even after application of the intensified BCG course. No response was detected in the placebo group, with no improvement during follow-up. No recurrence developed in any responder. Minimal side effects, such as transient erythema and fever, were recorded during the study. CONCLUSIONS:Topical BCG in the treatment of genital warts attained a high success rate in our study compared with the placebo solution, with insignificant side effects and no recurrence.
RCT Entities:
OBJECTIVES: To evaluate the efficacy of topical application of viable bacille Calmette-Guérin (BCG) as a primary line of treatment in patients with condylomata acuminata. METHODS: We recruited 50 patients from the Department of Andrology and Sexually Transmitted Diseases, Cairo University Hospital complaining of genital warts. Patients were divided into two groups. Group 1 consisted of 25 patients who received BCG as a weekly topical treatment for 6 consecutive weeks. If still resistant, another intensive three-times-a-week course for 3 consecutive weeks was given. Group 2 consisted of 25 patients who received 0.9% saline solution as a placebo solution with the same procedure and follow-up as for group 1. All patients were followed up for 6 consecutive months. During the treatment course, the local response, wart state and size, and any side effects were reported. RESULTS: A complete response with the disappearance of all condylomata acuminata was achieved in 20 (80%) of the 25 patients after a maximum of six BCG applications. Three patients (12%) needed another, more extensive, course, resulting in complete clearance 3 weeks later. Only 2 patients (8%) did not achieve a full response even after application of the intensified BCG course. No response was detected in the placebo group, with no improvement during follow-up. No recurrence developed in any responder. Minimal side effects, such as transient erythema and fever, were recorded during the study. CONCLUSIONS: Topical BCG in the treatment of genital warts attained a high success rate in our study compared with the placebo solution, with insignificant side effects and no recurrence.