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The Use of a Combination of Vaccinium Macracarpon, Lycium barbarum L. and Probiotics (Bifiprost®) for the Prevention of Chronic Bacterial Prostatitis: A Double-Blind Randomized Study.

  • 2019
  • Urologia internationalis 103(4)
    • Francesco Chiancone
    • Maurizio Carrino
    • Clemente Meccariello
    • Luigi Pucci
    • Maurizio Fedelini
    • Paolo Fedelini

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 120
Population
120 patients with chronic bacterial prostatitis (NIH type II) with recurrent infections due to enterobacteriaceae
Methods
Randomized into 2 groups to receive Bifiprost® + Serenoa Repens 320 mg or Serenoa Repens 320 mg alone daily for 24 weeks after antibiotic treatment and culture negativization
Duration
24 weeks
  • Large Human Trial

Introduction

To evaluate the efficacy of Bifiprost® + Serenoa Repens 320 mg versus Serenoa Repens 320 mg alone for the prevention of chronic bacterial prostatitis (CBP) due to enterobacteriaceae.

Methods

Between September 2016 and September 2018, 120 patients with CBP at the National Institutes of Health (NIH type II) with recurrent infections due to enterobacteriaceae (Escherichia Coli and Enterococcus faecalis) were enrolled and randomized into 2 groups each to receive Bifiprost® + Serenoa Repens 320 mg (Group A) or Serenoa Repens 320 mg alone (Group B) daily for 24 weeks (after receiving a proper antibiotic treatment with subsequent culture negativization). The primary endpoint was the reduction in the episodes of prostatitis. The secondary endpoint evaluated was the score of the NIH-Chronic Prostatitis Symptom Index (NIH-CPSI). Evaluation was performed at baseline and at 12, 24, and 36 weeks.

Results

The patients of the Group A experienced a significantly larger reduction in the prostatitis episodes than the Group B at 24 and 36 weeks, but they did not experience a significantly larger reduction at 12 weeks. After 12 weeks of treatment, the mean NIH-CPSI score was reduced in both groups compared with baselines, but no significant differences were seen between the Group A and Group B. On the contrary, we observed a significant difference in the mean NIH-CPSI score between the 2 groups at 24 and 36 weeks.

Conclusion

The association of Bifiprost® and Serenoa Repens 320 mg improves the prevention of the episodes of CBP due to enterobacteriaceae and ameliorates prostatitis-related symptoms after 6 months of therapy. The long-term impact on the entero-urinary route was also seen 3 months after the end of the treatment.

Research Insights

  • Saw Palmetto→Reduced Chronic Prostatitis Symptom Index Score

    After 12 weeks of treatment, the mean NIH-CPSI score was reduced in both groups compared with baselines, but no significant differences were seen between the Group A and Group B. On the contrary, we observed a significant difference in the mean NIH-CPSI score between the 2 groups at 24 and 36 weeks.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    320 mg/day
  • Saw Palmetto→Reduced Prostatitis Episodes

    The patients of the Group A experienced a significantly larger reduction in the prostatitis episodes than the Group B at 24 and 36 weeks, but they did not experience a significantly larger reduction at 12 weeks.

    Effect
    Beneficial
    Effect size
    Small
    Dose
    320 mg/day
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