Application of viable bacille Calmette-Guerin topically as a potential therapeutic modality in condylomata acuminata: A placebo-controlled study

Department of Andrology and Sexually Transmitted Diseases, Cairo University Hospital, Cairo, Egypt.
Urology (Impact Factor: 2.19). 03/2005; 65(2):247-50. DOI: 10.1016/j.urology.2004.09.025
Source: PubMed


To evaluate the efficacy of topical application of viable bacille Calmette-Guérin (BCG) as a primary line of treatment in patients with condylomata acuminata.
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.
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.
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.

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    • "BCG instillation into the bladder is also used against bladder cancer [2] [3], and its non-specific immunological effects may also be beneficial for other diseases. For instance, two small clinical trials recently showed that local application of BCG is effective against common [4] and genital [5] warts. In addition, for many years epidemiological data have suggested that BCG has protective effects against non-mycobacterial infections and some allergic diseases such as asthma [6]. "
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    ABSTRACT: The Bacille Calmette-Guerin (BCG) vaccine is the only vaccine proved to be effective against tuberculosis and it remains the most commonly used vaccine worldwide. In addition to its effects on mycobacterial diseases, an increasing body of epidemiological evidence accumulated since its introduction in 1921 shows that BCG also exerts beneficial non-specific effects ranging from protection against non-mycobacterial diseases, decreased incidence of allergic diseases, and treatment of certain malignancies. The biological substrate of these effects is mediated partly by heterologous effects on adaptive immunity, but also on the potentiation of innate immune responses through epigenetic mechanisms, a process termed 'trained immunity'. The process of trained immunity may also play a role in the beneficial effects of BCG against tuberculosis and Mycobacterium tuberculosis infection, and this could have important consequences for our quest for improving vaccination strategies.
    Seminars in Immunology 10/2014; 26(6). DOI:10.1016/j.smim.2014.09.006 · 5.17 Impact Factor
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    • "Previous clinical studies have demonstrated that topical BCG is highly effective in the treatment of Condylomata acuminata (6,7), including flat condyloma of the cervix (8). While Condylomata acuminata is associated with low-risk human papillomavirus (HPV) infection, no study has examined the efficacy of BCG immunotherapy in high-risk HPV-related diseases such as cervical cancer. "
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    ABSTRACT: Bacillus Calmette-Guerin (BCG) immunotherapy is established as an effective adjuvant intravesical treatment for non-muscle invasive bladder cancer. BCG is also effective in the treatment of Condylomata acuminata caused by low-risk human papilloma virus (HPV). The aim of this study was to determine the efficacy of BCG for the treatment of cervical cancer or HPV high-risk infections. BCG-activated killer (BAK) cells were incubated with a high-risk HPV18-infected cervical cancer cell line, HeLa. The cell cycle distribution and apoptotic index of the HeLa cells were analyzed by flow cytometry. The alterations of HPV-E7, retinoblastoma (RB) and E2F1 levels were detected at the transcriptional and translational levels. The BAK cell cytotoxicity to HeLa cells was 24.08, 14.74 and 6.8% and the natural killer (NK) cell cytotoxicity was 17.62, 10.78 and 5.8% at the E/T ratios of 40:1, 20:1 and 10:1, respectively. The BAK cells significantly induced the apoptosis of HeLa cells to result in an apoptosis level of 24.2% compared with 13.45% by the NK cell treatment at the ratio of 20:1. BAK cells inhibit the proliferation of HeLa cells by G(1)/S cell cycle arrest and this may be associated with the RB/E2F1 pathway. However, G(1)/S arrest and the alteration of RB protein (pRB) and E2F1 levels in the HeLa cells did not show significant differences between the BAK cell- and NK cell-treated groups. HPV-E7 appeared not to be associated with the alteration in cell cycle progression. This study showed that immunotherapy may be a potential treatment for cervical cancer and that BCG immunotherapy may be an alternative and effective method, but further experiments and clinical trials are required to verify this effect.
    Experimental and therapeutic medicine 02/2013; 5(2):561-566. DOI:10.3892/etm.2012.855 · 1.27 Impact Factor
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    ABSTRACT: 29 Türk Jinekolojik Onkoloji Dergisi 2009-2, Sayfa 29-34 Kondiloma aküminata di¤er ad›yla genital si¤iller, geliflmifl ülkel-erde en s›k görülen cinsel yolla bulaflan hastal›klardan biri olup prevalans› giderek artmaktad›r. Genital si¤illerin etkeni human papil-lomavirus (HPV)'dür ve viral aktivite enfekte kiflinin immün duru-muna göre de¤iflkenlik göstermektedir. Olgular›n %20 kadar›nda spontan regresyon gözlenebilmektedir. Tedavi modaliteleri topikal sitotoksik (bi/triklorasetik asit, podofilin, podofilotoksin, 5-flor-ourasil, yeflil çay ekstresi catechinler), immünoterapötik (imiquimod, interferon, Candida/kabakulak antijeni, BCG, oral inosiplex) ve ablatif/destrüktif cerrahi (kriyoterapi, lazer, elektrokoterizasyon, cer-rahi eksizyon) yöntemler olarak s›n›fland›r›labilir. Birçok tedavi yön-temi oldu¤undan hangi yöntemin kullan›laca¤›na karar verirken lezy-onun büyüklü¤ü, say›s›, lokalizasyonu, yayg›nl›¤› ve efllik eden durumlar (immünsupresyon, gebelik gibi) kadar hekimin ve hastan›n tercihi de belirleyici olmaktad›r. Oldukça genifl olan tedavi yöntemleri spektrumu içinde gerçekte hiçbir yöntem di¤erlerine üstün de¤ildir, ve tüm tedavi modaliteleri için de¤iflik oranlarda nüks bildirilmifltir, oran %30-70 olarak verilmektedir. Genital HPV enfeksiyonlar›n›n henüz radikal bir tedavisinin olmamas› ve serviks kanseri ile olan iliflkisi nedeniyle önleyici stratejiler önem kazanmaktad›r. Bunlardan birisi olan yeni afl› tedavileri ile enfeksiyonun engellenerek hastal›¤›n insidans›n›n›n azalaca¤› düflünülmektedir. Anahtar Kelimeler: Kondiloma aküminata, genital si¤iller, human papillomavirus (HPV), tedavi Condylomata acuminata, genital warts, are a common sexually transmitted disease in developed countries and its prevalance is increasing with time. Human papillomavirus (HPV) is the cause of genital warts and the viral activity depends on the immune status of the infected individual. Spontaneous regression of warts is seen in up to 20% of the cases. Various treatment modalities have been described which can be separated into topical cytotoxic (bi/trichloroacetic acid, podophyllin, podophyllotoxin, 5-fluorouracil, green tea catechins), immunomodulatory (imiquimod, interferon, Candida or mumps anti-gen, Bacillus Calmette-Guerin (BCG), oral inosiplex) and ablative/destructive surgery (cryotherapy, laser, electrocauterization, surgical excision). Multiple treatment approaches exist for the man-agement of genital warts, therefore treatment method decisions are based upon the number, size, extent and location of warts, co-existing medical conditions (e.g. immunodeficiency, pregnancy), and patient and physician preferences as well. Among such a large spectrum of treatment alternatives, no one therapeutic modality is superior to oth-ers and various recurrence rates have been reported for all of the methods, ranging between 30-70%. As there is currently no cure for HPV infection and a causal role for HPV infections in cervical cancer has been documented, preventive measures are increasingly impor-tant. New vaccine therapy for prevention of infection promise to reduce the incidence of disease.
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