Nutritional interventions for the prevention and treatment of cancer therapy-induced oral mucositis: an umbrella review of systematic reviews and meta-analysis.

CONTEXT: To date, the efficacy of nutritional interventions on oral mucositis (OM) in patients with cancer, and the quality of this evidence have not been explored. OBJECTIVE: The goal of this umbrella review was to provide a comprehensive evaluation of nutritional interventions for patients with cancer with OM, as well as to assess the quality of this evidence. DATA SOURCES: Meta-analyses were searched for using PubMed, Scopus, and ISI Web of Science databases until December 2021, with no time restrictions. DATA EXTRACTION: Meta-analyses of randomized control trials that evaluated the effects of nutritional interventions on the incidence of OM in patients with cancer had inclusion criteria for this umbrella review. Data extraction, quality assessment of meta-analyses, and primary studies were done independently by 2 authors. The Grading of Recommendations Assessment, Development, and Evaluation technique was used to grade the certainty of evidence. DATA ANALYSIS: A total of 26 meta-analyses were included in this umbrella review. The results showed that honey, glutamine, and propolis can reduce the incidence of severe OM, based on moderate evidence quality. In addition, zinc supplementation significantly reduced the incidence of OM, regardless of symptom severity; however, low certainty of the evidence was observed. The effects of vitamin E, curcumin, and probiotics on OM were not statistically significant. CONCLUSION: This umbrella review shows that honey, glutamine, and propolis can significantly reduce the incidence of severe OM. These findings need to be confirmed with well-designed, longitudinal randomized controlled trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration no. CRD42022301010.

The activity of propolis against pathogenic fungi isolated from human infections

Abstract Propolis is a resinous hive product collected by bees from the buds or other parts of plants. It is known for having various biological properties, including antifungal activity. Among the substances present in propolis, flavonoids and phenolic acids and their esters are responsible for its antifungal properties. This means that propolis is ideal for use as an antifungal agent in alternative medicine to treat a number of both topical and systemic infections caused by Candida species and other yeast-like fungi, dermatophyte and nondermatophyte moulds, without the serious side effects typical of synthetic treatment. It is also active against strains of fungi that are resistant to polyenes and azoles, the classes of drugs most commonly used to treat fungal infections. In this article, we review current knowledge about the activity of propolis from different parts of the world and its components in vitro and in vivo against pathogenic fungi isolated from human infections. The article also indicates the possible mechanism of antifungal activity of propolis and its components.

The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial.

BACKGROUND: The 2019 coronavirus disease (COVID-19) pandemic continues to spread and affects large numbers of people with unprecedented impacts. Experimental evidence has already been obtained for use of the standardized extract of Brazilian green propolis (EPP-AF) against viral targets, and clinical rationality has been demonstrated for testing this extract as an adjunct to treatment in patients affected by COVID-19. The BeeCovid2 study aims to assess whether EPP-AF has an impact on the improvement of patients hospitalized with COVID-19 by reducing the length of hospital stay. METHODS: BeeCovid2 is a randomized, double-blinded, placebo-controlled clinical study being conducted in Brazil to provide further evidence on the effectiveness of standardized green propolis extract as an adjunctive treatment for adults hospitalized with COVID-19. Hospitalized patients over 18 years of age with a confirmed diagnosis of COVID-19 and up to 14 days of symptoms were included. Patients under mechanical ventilation at randomization, pregnant women, cancer patients, transplanted or using immunosuppression, HIV patients, patients who used propolis in the last 30 days, bacterial or fungal infection at randomization, impossibility of using medication orally or enterally, and advanced chronic diseases (e.g., advanced heart failure, severe liver disease, and end-stage chronic kidney disease). Enrolled patients are randomized at a 1:1 ratio to receive placebo or standardized propolis extract (900 mg/day) for 10 days. The study treatments are administered in a double-blinded manner, and patients are followed for 28 days. The primary outcome is the difference in length of hospital stay in days between groups. Secondary outcomes include the need for mechanical ventilation, the rate of secondary infection, rate of acute kidney injury, the need for renal replacement therapy, the requirement for vasoactive drugs, the use of an intra-aortic balloon pump (IABP), and the use of extracorporeal membrane oxygenation (ECMO). DISCUSSION: This trial is very useful and will provide more data on the effectiveness of using the standardized Brazilian green propolis extract as an adjunctive treatment in association with standard care in adults hospitalized with moderate to severe acute COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov NCT04800224 . Registered on March 16, 2021.

Behavioral, Biochemical and Histopathological effects of Standardised Pomegranate extract with Vinpocetine, Propolis or Cocoa in a rat model of Parkinson's disease.

INTRODUCTION: Parkinsonism is a neurodegenerative disorder. Pomegranate (POM) has been previously shown to have a dopaminergic neuroprotective effect against parkinsonism. OBJECTIVE: The aim of the current study is to investigate the possible effect of POM in combination with each of vinpocetine, propolis, or cocoa in the treatment of parkinsonism disease even without being given as adjuvant to L-dopa . METHODS: Rats were divided into seven groups, one normal and six RT model groups. One of the RT groups (2.5 mg/kg/48 h/10 doses sc), for 20 days served as non-treated parkinsonism model, whereas the others were treated with either L-dopa (10 mg/kg, p.o./day) or with POM (150 mg/kg, p.o./day) together with each of the following; vinpocetine (VIN) (20 mg/kg, p.o./day), propolis (300 mg/kg, p.o./day), cocoa (24 mg/kg, p.o./day). Motor and cognitive performances were examined using four tests (catalepsy, swimming, Y-maze, open field). Striatal dopamine, norepinephrine, serotonin, GABA, glutamate, acetylcholinesterase, GSK-3ß, BDNF levels were assessed as well as MDA, SOD, TAC, IL-1ß, TNF-α, iNOs, and caspase-3. Also, histopathological examinations of different brain regions were determined. RESULTS: Treatment with L-dopa alone or with all POM combination groups alleviated the deficits in locomotor activities, cognition, neurotransmitter levels, acetylcholinesterase activity, oxidative stress, and inflammatory markers as well as caspase-3 expression induced by RT. CONCLUSION: Combinations of POM with each of VIN, propolis, or cocoa have a promising disease-modifying antiparkinsonian therapy even without being given as an adjuvant to L-dopa.

Stingless bee propolis, metformin, and their combination alleviate diabetic cardiomyopathy

Abstract Background and aim: Stingless bee propolis, a resinous compound processed by mandibular secretion of stingless bees, is used for maintenance of hygiene and stability of beehives. Research on stingless bee propolis shows therapeutic properties attributed to polyphenols exhibiting antioxidative, antihyperglycemic and antiischemic effect. However, the cardioprotective effect of stingless bee propolis on diabetic cardiomyopathy is unknown. Methods: Adult male Sprague Dawley rats were randomised to five groups: normal group, diabetic group, diabetic given metformin (DM+M), diabetic given propolis (DM+P) and diabetic given combination therapy (DM+M+P) and treated for four weeks. Body weight, fasting blood glucose, food and water intake were taken weekly. At the end of experiment, biomarkers of oxidative damage were measured in serum and heart tissue. Antioxidants in heart tissue were quantified. Part of left ventricle of heart was processed for histological staining including Haematoxylin and Eosin (H&E) stain for myocyte size and Masson's Trichrome (MT) stain for heart fibrosis and perivascular fibrosis. Results: Propolis alleviated features of diabetic cardiomyopathy such as myocyte hypertrophy, heart fibrosis and perivascular fibrosis associated with improvement in antioxidative status. Conclusion: This study reports beneficial effect of propolis and combination with metformin in alleviating histopathological feature of diabetic cardiomyopathy by modulating antioxidants, making propolis an emerging complementary therapy.

Efficacy of Brazilian green propolis (EPP-AF®) as an adjunct treatment for hospitalized COVID-19 patients: A randomized, controlled clinical trial.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promotes challenging immune and inflammatory phenomena. Though various therapeutic possibilities have been tested against coronavirus disease 2019 (COVID-19), the most adequate treatment has not yet been established. Propolis is a natural product with considerable evidence of immunoregulatory and anti-inflammatory activities, and experimental data point to potential against viral targets. We hypothesized that propolis can reduce the negative effects of COVID-19. METHODS: In a randomized, controlled, open-label, single-center trial, hospitalized adult COVID-19 patients were treated with a standardized green propolis extract (EPP-AF®ï¸) as an adjunct therapy. Patients were allocated to receive standard care plus an oral dose of 400 mg or 800 mg/day of green propolis for seven days, or standard care alone. Standard care included all necessary interventions, as determined by the attending physician. The primary end point was the time to clinical improvement, defined as the length of hospital stay or oxygen therapy dependency duration. Secondary outcomes included acute kidney injury and need for intensive care or vasoactive drugs. Patients were followed for 28 days after admission. RESULTS: We enrolled 124 patients; 40 were assigned to EPP-AF®ï¸ 400 mg/day, 42 to EPP-AF®ï¸ 800 mg/day, and 42 to the control group. The length of hospital stay post-intervention was shorter in both propolis groups than in the control group; lower dose, median 7 days versus 12 days (95% confidence interval [CI] -6.23 to -0.07; p = 0.049) and higher dose, median 6 days versus 12 days (95% CI -7.00 to -1.09; p = 0.009). Propolis did not significantly affect the need for oxygen supplementation. In the high dose propolis group, there was a lower rate of acute kidney injury than in the controls (4.8 vs 23.8%), (odds ratio [OR] 0.18; 95% CI 0.03-0.84; p = 0.048). No patient had propolis treatment discontinued due to adverse events. CONCLUSIONS: Addition of propolis to the standard care procedures resulted in clinical benefits for the hospitalized COVID-19 patients, especially evidenced by a reduction in the length of hospital stay. Consequently, we conclude that propolis can reduce the impact of COVID-19.

Expanding Patch Testing Beyond the Baseline Series: Usefulness of Customized Antimicrobials, Vehicles, and Cosmetics Series.

BACKGROUND: Testing cosmetics and their ingredients is essential to avoid missing relevant allergens and to monitor fluctuating incidence of hypersensitivity. OBJECTIVE: The aim of this study was to review the usefulness of patch testing with a customized antimicrobials, vehicles, and cosmetics (AVC) series over 15 years at a single Canadian site. METHODS: Between January 1, 2005, and December 31, 2019, patients suspected of having cosmetics allergy were patch tested with a 40-allergen AVC series in addition to the North American Contact Dermatitis Group standard screening series. We reviewed the patch test results of 2868 patients. RESULTS: We consecutively patch tested with the baseline series 6103 patients, of which 2868 (47%) were also tested with the AVC series. Of 53 different allergens that were tested at some point, 26 remained in the series throughout the 15-year span. The most common positive allergens were thimerosal (4.52%), polyvidone-iodine (2.25%), propolis (2.06%), sodium metabisulfite (1.94%), dodecyl gallate (1.53%), carmine (1.10%), lauryl glucoside (1.01%), sandalwood oil (0.7%), and tert-butylhydroquinone (0.7%). CONCLUSIONS: Although the expansion of the North American Contact Dermatitis Group standard screening series has decreased the yield from the AVC series from 21.1% to 13.9%, it still remains a useful adjunct for patients suspected of having cosmetics or disinfectants allergy.

Evidence on the Health Benefits of Supplemental Propolis.

Propolis is a honey-related product with reported health benefits such as improved immunity, lowered blood pressure, treated allergies and skin conditions. A literature review and narrative synthesis were conducted to investigate the evidence on the reported health benefits and future direction of propolis products. Using a predefined search strategy we searched Medline (OvidSP), Embase and Central for quantitative and qualitative studies (1990-2018). Citation, reference, hand searches and expert consultation were also undertaken. Studies of randomised control trials and observational data on humans with health-related outcomes were included. Collected data were entered into NVivo software (Version 12, QRS International) and analysed using a thematic framework and a narrative synthesis of emergent themes. A total of 63 publications were discussed. The majority were cell-based and animal studies, with a few key human trials conducted. There is significant promise for propolis as an effective antioxidant and anti-inflammatory agent with particular promise in cardiometabolic health.

Propolis as an Adjuvant in the Healing of Human Diabetic Foot Wounds Receiving Care in the Diagnostic and Treatment Centre from the Regional Hospital of Talca.

OBJECTIVE: Diabetic foot wounds are a relevant diabetes complication and a major health problem. It has been described that propolis has health benefits due to its anti-inflammatory, antioxidant, and support in the healing process. The current study assessed the effect of propolis as an adjuvant in the healing of human diabetic foot ulcers. This was evaluated in a randomized placebo-controlled study of subjects receiving care in the Diagnostic and Treatment Centre from the Regional Hospital of Talca, Chile. RESEARCH DESIGN AND METHODS: Randomized subjects received ambulatory healing treatment for diabetes foot wounds with propolis spray (3%), which was applied to cover the entire wound surface each time it was dressed from week 0 until cicatrization or 8 weeks as a maximum. Two serum samples were taken (day 0 and end of the study) for cytokine and oxidative stress analyses. Also, macro- and microscopy were analyzed in the process of wound healing. RESULTS: The study comprised 31 subjects with type 2 diabetes in treatment for diabetic foot wounds in the Diagnostic and Treatment Centre from the Regional Hospital of Talca. Propolis promotes a reduction of the wound's area by an average of 4 cm2, related to an increase in the connective tissue deposit compared to the control. Also, propolis increased the glutathione (GSH) and GSH/glutathione disulfide (GSSG) ratio (p < 0.02), depleted tumor necrosis factor- (TNF-) α, and increased interleukin- (IL-) 10 levels. Topical propolis did not modify the biochemical parameters in the serum of the studied subjects. CONCLUSIONS: The topical use of propolis turned out to be an interesting therapeutic strategy as an adjuvant in the care of diabetes foot wounds due to its ability to improve and promote healing based on its anti-inflammatory and antioxidant profile. This trial is registered with NCT03649243.

Biological Activities of Red Propolis: A Review.

BACKGROUND: The red propolis (RdProp) is a resin produced by Apis mellifera bees, which collect the reddish exudate on the surface of its botanic source, the species Dalbergia ecastophyllum, popularly known in Brazil as "rabo de bugio". Considered as the 13th type of Brazilian propolis, this resin has been gaining prominence due to its natural composition, rich in bioactive substances not found in other types of propolis. OBJECTIVE: This review aims to address the most important characteristics of RdProp, its botanical origin, the main constituents, its biological properties and the patents related to this natural product. METHOD: By means of the SciFinder, Google Patents, Patus® and Spacenet, scientific articles and patents involving the term "red propolis" were searched until August 2017. RESULTS: A number of biological properties, including antimicrobial, anti-inflammatory, antiparasitic, antitumor, antioxidant, metabolic and nutraceutical activities are attributed to RdProp, demonstrating the great potential of its use in the food, pharmaceutical and cosmetics industries. CONCLUSION: The available papers are associated to pharmacological potential of RdProp, but the molecular mechanisms or bioactive compounds responsible for each activity have not yet been fully elucidat ed. The RdProp patents currently found are directed to components for the pharmaceutical industry (EP2070543A1; WO2014186851A1; FR3006589A1; CN1775277A; CN105797149A; CN1879859A), cosmetic (JP6012138B2; JP2008247830A; JP6012138B2) and food (JP5478392B2; CN101380052A; WO2006038690A1).

Avaliação in-vitro da atividade antifúngica e da citotoxicidade da própolis de copaíba contra espécies do gênero Candida spp / In-vitro evaluation of the antifungal activity and cytotoxicity of copaiba propolis against Candida spp

OBJETIVOS: verificar a atividade antifúngica e a citotoxicidade da própolis de copaíba e de um protótipo de enxaguante bucal contra espécies do gênero Candida spp. METODOLOGIA: o perfil cromatográfico do extrato de própolis foi realizado por Cromatografia Líquida de Ultraeficiência em Fase Reversa (RP-UPLC). A atividade antifúngica do extrato de própolis de copaíba (EPC) e do seu protótipo de enxaguante bucal contra C. albicans, C. tropicalis e C. krusei foi avaliada por microdiluição em caldo e discodifusão em ágar. A citotoxicidade foi verificada pelo ensaio de MTT em fibroblastos 3T3 ¿ L1. RESULTADOS: Fenóis foram os principais compostos encontrados, sendo identificados dentre eles o ácido caféico (ácido fenólico) e canferol (flavonóide). Os valores de CIM foram 156 ug/ml, 312 ug/ml e 625 ug/ml para C. albicans, C. tropicalis e C. krusei respectivamente, indicando atividade antifúngica presente, mas moderada. Os valores das zonas de inibição verificaram inibição do crescimento das leveduras e sugeriram uma atividade fungistática do enxaguante bucal. Em relação aos testes de citotoxicidade, o EPC exerce, em baixas concentrações, um efeito dose dependente sobre a proliferação de fibroblastos 3T3-L1 e pode exercer um efeito regenerador de tecidos. CONCLUSÕES: a própolis investigada apresenta potencial antifúngico moderado contra Candida spp., podendo ser o enxaguante bucal uma opção terapêutica no combate da candidíase oral, já que o seu tratamento é baseado no controle e não na erradicação das leveduras. Estudos futuros sobre a caracterização dos seus compostos químicos, aperfeiçoamento do produto e ensaios clínicos deverão ser realizados

Objectives: verify the antifungal activity and cytotoxicity of copaiba propolis and its mouthwash prototype against Candida spp. Methodology: the chromatographic profile of the propolis extract was perpormed by Reverse Phase Ultra-efficiency Liquid Chromatography (RP-UPLC)....

Biological and therapeutic properties of bee pollen: a review.

Natural products, including bee products, are particularly appreciated by consumers and are used for therapeutic purposes as alternative drugs. However, it is not known whether treatments with bee products are safe and how to minimise the health risks of such products. Among others, bee pollen is a natural honeybee product promoted as a valuable source of nourishing substances and energy. The health-enhancing value of bee pollen is expected due to the wide range of secondary plant metabolites (tocopherol, niacin, thiamine, biotin and folic acid, polyphenols, carotenoid pigments, phytosterols), besides enzymes and co-enzymes, contained in bee pollen. The promising reports on the antioxidant, anti-inflammatory, anticariogenic antibacterial, antifungicidal, hepatoprotective, anti-atherosclerotic, immune enhancing potential require long-term and large cohort clinical studies. The main difficulty in the application of bee pollen in modern phytomedicine is related to the wide species-specific variation in its composition. Therefore, the variations may differently contribute to bee-pollen properties and biological activity and thus in therapeutic effects. In principle, we can unequivocally recommend bee pollen as a valuable dietary supplement. Although the bee-pollen components have potential bioactive and therapeutic properties, extensive research is required before bee pollen can be used in therapy. © 2016 Society of Chemical Industry.

Influência da própolis sobre os perfis leucocitário e proteico de camundongos e tempo de fechamento de feridas excisionais limpas e infectadas por Staphylococcus aureus / Influence of Propolis on leukocyte and protein profiles of mice and closing time of excisional wounds clean and infected by Staphylococcus aureus

RESUMO Este estudo teve como objetivo avaliar os efeitos da própolis sobre os perfis leucocitário e protéico de camundongos e sobre o tempo de fechamento de lesões de pele confeccionadas experimentalmente, limpas e infectadas com Staphylococcus aureus. No primeiro, foram utilizados 48 animais divididos em quatro grupos, sendo um tratado com solução hidroalcóolica pura e três tratados com própolis a 10%, nas dosagens de 20 mg, 40 mg e 80 mg por animal de 25 gramas de peso, em única aplicação intraperitoneal. Foram coletadas amostras de sangue no segundo, 10º, 18º e 26º dias após o tratamento para realização de leucograma, proteinograma e fracionamento eletroforético das proteínas. Na avaliação da atividade cicatrizante, também foram utilizados 48 camundongos divididos em seis grupos, nos quais realizou-se a confecção cirúrgica de feridas na dimensão de 1cm2, após anestesia dissociativa. Dois grupos serviram como controle para feridas limpas e infectadas. Dois grupos de feridas infectadas por S. aureuse dois grupos de feridas limpas foram tratados com própolis a 5% e 10%, sendo a escolha destas concentrações baseada em um estudo piloto realizado. Os resultados mostraram que o tratamento com própolis influencia o leucograma e o proteinograma, de forma dose-dependente, sendo que a maior dose utilizada desencadeou leucocitose com linfocitose e aumento de proteínas da fração gamaglobulínica, no 10º dia após o início do tratamento. Também mostraram que a concentração da solução influenciou o tempo de cicatrização das feridas infectadas, ocorrendo em menor tempo no grupo tratado com a solução a 5%.

ABSTRACT This study aimed to evaluate the propolis effects on both the leukocyte and protein profiles of mice and on the closing time of skin lesions made experimentally, clean and infected with Staphylococcus aureus. The first 48 animals were divided into four groups, one treated with pure alcohol solution and three treated with propolis 10% at dosages of 20 mg, 40 mg and 80 mg per 25 g of animal weight in an intraperitoneal single application . Blood samples in the second, and then 10º, 18º and 26º days after treatment were collected in order to perform WBC, proteins and electrophoretic fractionation of proteins. Regarding the healing activity, also 48 mice divided into six groups were used, in whom surgical wounds in the size of 1cm2 were purposely inflicted , after the dissociative anesthesia were applied . Two groups served as control ones, for clean and infected wounds. Two groups of S. aureus with infected wounds and two groups with clean sores were treated with 5% and 10 % propolis, being this concentration choice based on a pilot study previously performed. The results showed that treatment with propolis influences leukocyte and protein concentrations in a dose- dependent manner, with the highest dose triggering leukocytosis with lymphocytosis and increasing the protein fraction of gamaglobulínica, on the 10th day after the start of treatment. It also indicated that the concentration of the solution influence the time of healing of infected wounds, since the process on the group treated with 5% solution happened faster.

Heat immersion therapy-A new approach for contact dermatitis to propolis?

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Topical botanically derived products: use, skin reactions, and usefulness of patch tests. A multicentre Italian study.

BACKGROUND: The evidence on the safety of topical preparations containing botanical extracts is limited. OBJECTIVES: To assess (i) the use of botanically derived compounds in a large population, (ii) the incidence of cutaneous side-effects, and (iii) the diagnostic usefulness of patch testing. METHODS: A questionnaire was used in 2661 patients to assess both the prevalence and type of topical botanical preparations used, and the occurrence of adverse skin reactions. Patients declaring adverse reactions were patch tested with (i) the Italian (SIDAPA) baseline series, (ii) an additional botanical series, and (iii) the patients' own products. RESULTS: Of the patients, 1274 (48%) reported the use of topical botanical products; 139 patients (11%) commented on adverse cutaneous reactions; 75 (54%) showed positive reactions with the Italian baseline series. Among the 122 patients tested with the botanical series, 19 (16%) showed positive reactions, in many cases with concomitant relevant positivity to at least one allergen of the Italian series connected with cosmetics. The commonest botanically derived allergens were propolis, Compositae extracts, and Melaleuca alternifolia (tea tree) oil. CONCLUSIONS: Contact allergy is a possible adverse effect of natural products. Baseline series supplemented with the commonest botanical allergens may be adequate for detecting most of the cases of contact allergy to natural topical products.

Propolis-induced descending necrotizing mediastinitis and aspiration pneumonia.

Propolis is a resinous substance collected by bees as a sealant for their hives. It is also used in traditional medicine as an antioxidant and antiinflammatory agent to treat ulcers, superficial burns, and microbial diseases. In this report, a 40-year-old woman who took liquid propolis for relief of her common cold experienced severe sore throat, dysphagia, and easy choking followed by fever and chills. Descending necrotizing mediastinitis and concomitant aspiration pneumonia were evident on the image studies. We performed video-assisted thoracoscopic surgery to achieve immediate and adequate drainage, and the patient resumed normal deglutition 2 months later. Early diagnosis and prompt video-assisted thoracoscopic surgery intervention are paramount to manage this life-threatening situation.

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.