Efficacy and safety evaluation of pentoxifylline associated with other antioxidants in medical treatment of Peyronie's disease: a case-control study

Gianni Paulis,1,2 Davide Barletta,3 Paolo Turchi,4 Antonio Vitarelli,5 Giuseppe Dachille,6 Andrea Fabiani,7 Romano Gennaro8 1Regina Apostolorum Hospital, Andrology Center, Albano L, 2Castelfidardo Medical Team, Peyronie's Disease Care Center, Rome, 3Department of Urology, Andrology Center, San Matteo Hospital, Pavia, 4Azienda ASL 4 Prato – Andrology Service, Prato, 5Department of Urology, University of Bari, 6Department of Urology, S Giacomo Hospital, Monopoli, Bari, 7Department of Surgery, Section of Urology and Andrology, Macerata, 8Department of Urologic Oncology, Section of Avellino, Italian League Against Cancer, Avellino, Italy Abstract: Peyronie's disease (PD) is a chronic disorder involving the tunica albuginea surrounding the corpora cavernosa of the penis. A conservative treatment is indicated in the first stage of disease. The aim of this study was to assess the therapeutic impact and possible side effects of treatment with pentoxifylline (PTX) in combination with other antioxidants in 307 patients with early-stage PD. Patients were subdivided into three groups: A, B, and C. Both groups, A and B, comprising of 206 patients, underwent treatment, whereas Group C was the control group (n=101). Treatment lasted 6 months and included the following: Group A: PTX 400 mg twice a day + propolis 600 mg/d + blueberry 160 mg/d + vitamin E 600 mg/d + diclofenac 4% gel twice/a day + PTX 100 mg via perilesional penile injection/every other week (12 injections in all); Group B: the same treatment as Group A except for the penile PTX injections. After the 6-month treatment course, we obtained the following results: actual mean decrease in plaque volume -46.9% and -24.8% in Group A and B, respectively (P<0.0001); mean curvature reduction -10.1° and -4.8°, respectively (P<0.0001); resolution of pain in 67.6% and 67.2% of cases, respectively (P=0.961); recovery of normal penile rigidity in 56.09% and 23.5% of cases, respectively (P=0.005). After 6 months, progression of disease was observed in all patients belonging to Group C: plaque volume +123.3%; curvature +15.7°; no recovery of penile rigidity. The statistically significant results of our study show that multimodal treatment with PTX in association with other antioxidants and topical diclofenac is efficacious in treating early-stage PD. Furthermore, treatment proved to be more effective when PTX was administered both orally and by penile injection. No serious adverse effects occurred.Keywords: multimodal treatment, penile curvature, penile injections, antioxidant supplementatio