Disappearance of Plaque Following Treatment with Antioxidants in Peyronie's Disease Patients-A Report of 3 Cases.

Peyronie's disease (PD) is a fibrotic disorder of the penile tunica albuginea. To date, only a few cases of recovery from PD following medical treatment have been reported in the literature. In this article, we describe three new cases of PD where patients achieved complete resorption of plaque following multimodal antioxidant treatment. In all three cases, treatment included the following antioxidants: bilberry, propolis, ginkgo biloba, silymarin, and vitamin E. Only in case nos. 1 and 2 did we also use the following antioxidant substances: L-carnitine, coenzyme Q10, and Boswellia. In all three cases, we also used a local therapy with diclofenac gel. Only in case no. 2 did we also use periodic perilesional injections with pentoxifylline. Although the sample of cases presented here was small, these patients incontrovertibly experienced complete plaque disappearance and recovery (in one case, only after a short course of treatment). Therefore, it is our conviction that urologists may find our experiences of considerable interest in their clinical practices.

Serenoa repens and its effects on male sexual function. A systematic review and meta-analysis of clinical trials.

BACKGROUND: Serenoa repens (SR) is a plant used to treat benign prostatic hyperplasia and prostatitis. We know that SR act as a 5α-reductase inhibitor, moreover, several studies have proved that SR has anti-inflammatory and antioxidant properties. There is some belief among patients that SR may negatively impact male sexual function. Such belief is circulating in non-medical social networks and is perhaps maintained by patients as a result of incorrect web surfing. However, it is also possible that SR may exert a "nocebo" effect thus negatively impacting on the general well-being of patients. OBJECTIVE: The aim of this study is to investigate whether SR is causing negative effects on male sexual function. METHODS: To ascertain the effect of SR on male sexual function, we conducted a systematic review and meta-analysis, by performing an electronic database search in accordance with the PRISMA guidelines. RESULTS: Out of 20 included papers, 8 papers reported comparisons of SR with placebo, and 7 studies reported comparisons of SR with tamsulosin. The standardized mean difference of changes from baseline scores of sexual function was not significantly different between SR and placebo (SMD: 0.43, 95% CI: 0.18 to 1.05; I^2 = 95%). Similarly, no significant mean differences in the Male Sexual Function-4 (MSF-4) test scores were found between SR and tamsulosin (SMD: -0.31, 95% CI: -0.82 to 0.19; I^2 = 90%). CONCLUSIONS: We found no statistically significant differences between negative effects on sexual function in patients treated with SR compared to patients who received placebo. The results of our meta-analysis are similar to those of other systematic reviews. Studies are warranted to ascertain whether any such effects might occur as a result of a nocebo effect.

Rationale of combination therapy with antioxidants in medical management of Peyronie's disease: results of clinical application.

Peyronie's disease (PD) is a connective tissue disorder involving the tunica albuginea of the corpora cavernosa of the penis. We have published several studies describing a "combined therapy" for PD patients, but the present study aims to clearly demonstrate how the association between various antioxidants in PD treatment can significantly increase the likelihood of therapeutic success. We used the following substances: silymarin, ginkgo biloba, vitamin E, bilberry, topical diclofenac sodium, and pentoxifylline (PTX). We analyzed the therapeutic impact and possible side effects of one or more antioxidants in patients with early-stage PD. To clearly prove that it is possible to achieve better results when combining more than one agent, we designed this study with five treatment groups, corresponding, respectively, to the administration of a single oral antioxidant; two oral antioxidants; three oral antioxidants; five oral antioxidants + local diclofenac; and five oral antioxidants + local diclofenac + PTX by perilesional injection. One hundred and twenty patients were assigned to five groups of treatment designed according to the abovementioned study aim. Outcomes after 6 months of treatment showed that combined antioxidant therapy is effective in treating PD. Statistical analysis showed significant differences between the treatment groups with regard to: improvement and disappearance of penile pain; percentage of reduction in the volume of penile plaque; reduction in penile curvature; recovery of erectile function in patients with erectile dysfunction; increase in the International Index of Erectile Function score; and reduction of psychosexual impact. Furthermore, we observed that the clinical efficacy of combined therapy is greater when topical use of diclofenac gel and perilesional injection of PTX are added to oral treatment with more than one antioxidant. Although several articles have already been published reporting the effectiveness of combined treatment in PD, this is the first study clearly proving how, as the number of substances used in treatment rises, a proportionally greater therapeutic effect is achieved.

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

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.

Long-term multimodal therapy (verapamil associated with propolis, blueberry, vitamin E and local diclofenac) on patients with Peyronie's disease (chronic inflammation of the tunica albuginea). Results of a controlled study.

OBJECTIVE: to demonstrate the possible effectiveness of a long-term multimodal medical therapy in patients with Peyronie's disease (PD) we carried out a controlled study on 82 patients diagnosed with PD, whereas in the scientific literature the conservative treatment of this disease is much discussed. METHODS: 82 patients (mean age=53.6±10.1 years-range 23-68) diagnosed with PD were selected for this study. Of these 41 patients (group A) were treated for 18 months as follows: Verapamil penile injections (12 total injections for six months and subsequently every month for twelve months: total 24 injections) + Iontophoresis with Verapamil/daily + blueberries 160mg/daily + propolis 600mg/daily + Vitamin E 600mg/daily + topical Diclofenac/daily. The other 41 patients spontaneously decided not to receive treatment for several motives and then were introduced as a control group B. All patients were controlled at 6- and 18-month follow up with the same diagnostic tests completed before the therapy (penile ultrasound, photograph documentation, pain scale etc.). RESULTS: In group A, after treatment of 6 and 18 months, the change in plaque volume consisted in volume reduction= - 47.6% and -73.6% respectively, while in group B, the change consisted of an increase in plaque volume= +55.7% and +118.7% respectively (p=0.000). In group A, after treatment of 6 and 18 months, improvement of curvature occurred in 76.3% and 81.5% of the cases respectively, while in group B it occurred in 2.7% and 8.1%, respectively (p<0.0001). CONCLUSION: Our results showed that a long-term multimodal medical therapy (Verapamil associated with Antioxidants and local Diclofenac) is statistically effective to treat PD patients, if we consider that lower therapeutic outcomes were achieved after 6 months treatment (medium-term treatment). Furthermore, this study confirms that the best treatment modality for PD is a combination therapy.

Peironimev-Plus® in the treatment of chronic inflammation of tunica albuginea (Peyronie's disease). results of a controlled study.

Peyronie's Disease (PD) is a connective tissue disorder involving the growth of fibrous plaques in penile corpora cavernosa (tunica albuginea). The conservative treatment is indicated in the development stage of PD for at least one year after diagnosis and in case of penile pain. This study was conducted to demonstrate the possible effectiveness of the new substances of Peironimev-plus®. Sixty four patients (age: 29-65 years, mean: 52.57 ± 9.06) diagnosed with PD were enrolled in a medical treatment. All patients underwent the following diagnostic tests: penile ultrasound, photographic documentation of penile curvature, IIEF questionnaire (erectile function score), pain evaluation with Visual Analogue pain Scale (VAS). The patients were divided into two treatment groups with different combinations of drugs: A = Peironimev-plus/oral/one tablet-daily + Verapamil injection (peri-lesional) 10 mg/every two weeks + Verapamil iontophoresis/5 mg/three times a week - for 6 months; B = Verapamil injection (peri-lesional) 10 mg/every two weeks + Verapamil iontophoresis/5 mg/three times a week - for 6 months. Intergroup analysis revealed statistically significant differences: in group A the effective plaque size reduction was -30.8% while in the group B the reduction was -18.0% (p=0.000). In group A the improvement of curvature occurred in 85.1% of the cases while in group B this occurred only in 53.5% (p=0.024), moreover the mean curvature decrease was respectively - 8.7° and - 4.6° (p=0.002). IIEF score was significantly improved in group A patients with erectile dysfunction (p=0.02). Our results suggest that Peironimev-plus is an effective drug in treating PD and it may help to prevent the progression of PD.