The efficacy and tolerability of pollen extract in combination with hyaluronic acid and vitamins in the management of patients affected by chronic prostatitis/chronic pelvic pain syndrome: a 26 weeks, randomized, controlled, single-blinded, phase III study

Cai, Tommaso; Gallelli, Luca; Cione, Erika; Verze, Paolo; Palmieri, Alessandro; Mirone, Vincenzo; Bonkat, Gernot; Wagenlehner, Florian M. E.; Johansen, Truls E. Bjerklund

doi:10.23736/s2724-6051.21.04141-2

Cited by 6 publications

(5 citation statements)

References 24 publications

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“…Consistent with our previous article, we used the Naranjo scale and the Drug Interaction Probability Scale to evaluate the development of ADRs or DDIs, respectively [ 19 , 20 , 21 , 22 ].…”

Section: Methodsmentioning

confidence: 99%

Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study

Gallelli¹,

Scuteri²,

Burdino³

et al. 2022

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Benign prostatic hyperplasia (BPH) is a common cause of male lower urinary tract symptoms (LUTS) that can reduce quality of life. Even if several drugs can be used in its treatment, the development of adverse drug reactions (ADRs) represents the most common cause of low adherence. In the present study, we evaluate both the efficacy and the safety of a new nutrient fixed combination of Pollen Extract plus Teupolioside, named Xipag®, in patients with LUTS. We conduct a pilot single center open label clinical study between 1 March 2020 and 30 June 2020 in patients with BPH referred to general practitioner’s ambulatories. Male patients > 45 years, sexually active, with clinical symptoms of LUTS and with a diagnosis of HPB were enrolled and received one tablet/day of Xipag® (T0), for three months (T1: end of treatment). The IPSS and IIEF-5 questionnaires were carried out at T0 and T1 and represent the first end point, whereas the primary safety end point was considered the absence of ADR or of drug–drug interactions related to Xipag® administration. During the study period, 25 subjects aged 43 to 76 years (mean 62.7 ± 9) were enrolled and completed the study. The clinical evaluation in T1 documented that Xipag® induced a statistically significant improvement (p < 0.01) in symptoms, as documented by the IPSS questionnaire (range 22.7–88.9; mean 55.2 ± 23.6), without the development of ADRs. In conclusion, this is the first real-world study that showed the efficacy and the safety of Xipag® in the BPH patients with LUTS.

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“…Consistent with our previous article, we used the Naranjo scale and the Drug Interaction Probability Scale to evaluate the development of ADRs or DDIs, respectively [ 19 , 20 , 21 , 22 ].…”

Section: Methodsmentioning

confidence: 99%

Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study

Gallelli¹,

Scuteri²,

Burdino³

et al. 2022

Life

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“…Urinary symptoms, pain and quality of life were evaluated using the IPSS, VAS and NIH-CPSI. Each outcome was reassessed by the same operator, as reported in previous studies by the authors ( 20 , 21 ).…”

Section: Methodsmentioning

confidence: 99%

“…General characteristics of the study participants were expressed with descriptive statistics (means, standard deviations or ranges). The calculation of the sample size needed for enrollment was based on the expected questionnaire results (improvement of quality of life) in line with published results from other studies ( 14 , 20 , 21 ). The required sample size was calculated under the following conditions: Difference between the groups, 35% of patients who reach a reduction in 15% of the NIH-CPSI total score; α error level, 0.05 two-sided; statistical power, 80%; and anticipated effect size, Cohen's d=0.5.…”

Section: Methodsmentioning

confidence: 99%

Extracorporeal shock wave therapy in association with bromelain and escin for the management of patients affected by chronic prostatitis/chronic pelvic pain syndrome

et al. 2022

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Extracorporeal shock wave therapy (ESWT) has been purposed for the management of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) with encouraging results. Phytotherapeutic compounds have been used in everyday clinical practice for patients with CP/CPSS due to their anti-inflammatory properties. The present study aimed to investigate the effects of ESWT in association with the use of bromelain and escin extracts in patients with CP/CPSS. For this purpose, 95 patients with a clinical diagnosis of CP/CPSS were enrolled in the study. The patients were randomly allocated to either the ESWT plus bromelain and escin group (group A; n=48) or the ESWT only group (group B; n=47). A total of five weekly ESWT treatment sessions were administered alone or in combination with bromelain and escin. Each session consisted of 3,000 focused shock waves. Doses of 160 and 500 mg/day bromelain and escin were administered respectively for 5 weeks. The changes in urinary symptoms, pain and quality of life were considered the main outcome measures and were assessed at baseline, and at 4, 12 and 24 weeks of follow-up. Urinary symptoms, pain and quality of life were evaluated using the international prostatic symptoms score (IPSS), visual analog scale (VAS) and the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI). After 4 weeks, the mean VAS score, mean IPSS and mean satisfaction rate score had significantly improved in patients receiving ESWT plus bromelain and escin. After 12 weeks, the mean IPSS and mean satisfaction rate score were stable in the ESWT plus bromelain and escin group, while the mean VAS score was significantly lower when compared with the baseline values in both groups. On the whole, the present study demonstrates that in patients affected by CP/CPPS, treatment with ESWT plus bromelain and escin leads to pain resolution, and both treatments improve the IPSS, VAS and NIH-CPSI results.

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“…Herbal extracts endowed with antioxidant/anti-inflammatory effects have been long considered as a reliable strategy to blunt the burden of oxidative stress and inflammation in prostate and ovary tissue [ 3 , 4 , 5 ]. Pollen extract represents an innovative approach for the management of the clinical symptoms related to prostatitis [ 6 ], being also able to relieve inflammation and hyperplasia of the prostate [ 7 ], with anticancer potential most likely associated with antioxidant and antimutagenic effects [ 8 ]. In this case, pollen appears to relieve pain in patients with benign prostatic hyperplasia, at least in the early stages.…”

Section: Introductionmentioning

confidence: 99%

Protective Effects of PollenAid Plus Soft Gel Capsules’ Hydroalcoholic Extract in Isolated Prostates and Ovaries Exposed to Lipopolysaccharide

et al. 2022

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Pollen extract represents an innovative approach for the management of the clinical symptoms related to prostatitis and pelvic inflammatory disease (PID). In this context, the aims of the present work were to analyze the phenolic composition of a hydroalcoholic extract of PollenAid Plus soft gel capsules, and to evaluate the extract’s cytotoxic effects, in human prostate cancer PC3 cells and human ovary cancer OVCAR-3 cells. Additionally, protective effects were investigated in isolated prostate and ovary specimens exposed to lipopolysaccharide (LPS). The phytochemical investigation identified catechin, chlorogenic acid, gentisic acid, and 3-hydroxytyrosol as the prominent phenolics. The extract did not exert a relevant cytotoxic effect on PC3 and OVCAR-3 cells. However, the extract showed a dose-dependent inhibition of pro-inflammatory IL-6 and TNF-α gene expression in prostate and ovary specimens, and the extract was effective in preventing the LPS-induced upregulation of CAT and SOD gene expression, which are deeply involved in tissue antioxidant defense systems. Finally, a docking approach suggested the capability of catechin and chlorogenic acid to interact with the TRPV1 receptor, playing a master role in prostate inflammation. Overall, the present findings demonstrated anti-inflammatory and antioxidant effects of this formulation; thus, suggesting its capability in the management of the clinical symptoms related to prostatitis and PID.

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The efficacy and tolerability of pollen extract in combination with hyaluronic acid and vitamins in the management of patients affected by chronic prostatitis/chronic pelvic pain syndrome: a 26 weeks, randomized, controlled, single-blinded, phase III study

Cited by 6 publications

References 24 publications

Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study

Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study

Extracorporeal shock wave therapy in association with bromelain and escin for the management of patients affected by chronic prostatitis/chronic pelvic pain syndrome

Protective Effects of PollenAid Plus Soft Gel Capsules’ Hydroalcoholic Extract in Isolated Prostates and Ovaries Exposed to Lipopolysaccharide

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