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A phase II randomised double-blind placebo-controlled clinical trial investigating the efficacy and safety of ProstateEZE Max: a herbal medicine preparation for the management of symptoms of benign prostatic hypertrophy.

  • 2013-02-23
  • Complementary therapies in medicine 21(3)
    • Samantha Coulson
    • Amanda Rao
    • Shoshannah L Beck
    • Elizabeth Steels
    • Helen Gramotnev
    • Luis Vitetta

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 32
Population
57 otherwise healthy males aged 40-80 years that presented with medically diagnosed BPH
Methods
Phase II randomized double-blind placebo controlled clinical trial, 3 months of 1 capsule per day of either the herbal preparation (n = 32) or a matched placebo capsule (n = 25)
Blinding
Double-blind
Duration
3 months
Funding
Unclear

Objective

The aim of the clinical trial was to evaluate the efficacy and safety of ProstateEZE Max, an orally dosed herbal preparation containing Cucurbita pepo, Epilobium parviflorum, lycopene, Pygeum africanum and Serenoa repens in the management of symptoms of medically diagnosed benign prostate hypertrophy (BPH).

Design

This was a short-term phase II randomized double-blind placebo controlled clinical trial.

Setting

The trial was conducted on 57 otherwise healthy males aged 40-80 years that presented with medically diagnosed BPH.

Intervention

The trial participants were assigned to receive 3 months of treatment (1 capsule per day) with either the herbal preparation (n = 32) or a matched placebo capsule (n = 25).

Outcome measures

The primary outcome measure was the international prostate specific score (IPSS) measured at baseline, 1, 2 and 3 months. The secondary outcomes were the specific questions of the IPSS and day-time and night-time urinary frequency.

Results

There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p < 0.05). The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p < 0.03). The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p < 0.004).

Conclusion

The herbal preparation (ProstateEZE Max) was shown to be well tolerated and have a significant positive effect on physical symptoms of BPH when taken over 3 months, a clinically significant outcome in otherwise healthy men.

Research Insights

  • Blood Orange→Reduced IPSS Total Score

    There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate
  • Blood Orange→Reduced Night-time Urinary Frequency

    The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p < 0.004).

    Effect
    Beneficial
    Effect size
    Moderate
  • Blood Orange→Reduced Urinary Frequency

    The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p < 0.03).

    Effect
    Beneficial
    Effect size
    Small
  • Pygeum Bark→Reduced IPSS Total Score

    There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate
  • Pygeum Bark→Reduced Night-time Urinary Frequency

    The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p < 0.004).

    Effect
    Beneficial
    Effect size
    Moderate
  • Pygeum Bark→Reduced Urinary Frequency

    The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p < 0.03).

    Effect
    Beneficial
    Effect size
    Small
  • Saw Palmetto→Reduced IPSS Total Score

    There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate
  • Saw Palmetto→Reduced Night-time Urinary Frequency

    The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p < 0.004).

    Effect
    Beneficial
    Effect size
    Moderate
  • Saw Palmetto→Reduced Urinary Frequency

    The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p < 0.03).

    Effect
    Beneficial
    Effect size
    Small
  • Small-Flower Willow→Reduced IPSS Total Score

    There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate
  • Small-Flower Willow→Reduced Night-time Urinary Frequency

    The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p < 0.004).

    Effect
    Beneficial
    Effect size
    Moderate
  • Small-Flower Willow→Reduced Urinary Frequency

    The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p < 0.03).

    Effect
    Beneficial
    Effect size
    Small
  • Zucchini→Reduced IPSS Total Score

    There was a significant reduction in IPSS total median score in the active group of 36% as compared to 8% for the placebo group, during the 3-months intervention (p < 0.05).

    Effect
    Beneficial
    Effect size
    Moderate
  • Zucchini→Reduced Night-time Urinary Frequency

    The night-time urinary frequency was also significantly reduced in the active group (2.9-1.8, 39.3% compared to placebo (2.8-2.6 times, 7%) (p < 0.004).

    Effect
    Beneficial
    Effect size
    Moderate
  • Zucchini→Reduced Urinary Frequency

    The day-time urinary frequency in the active group also showed a significant reduction over the 3-months intervention (7.0-5.9 times per day, a reduction of 15.6% compared to no significant reduction change for the placebo group (6.2-6.3 times per day) (p < 0.03).

    Effect
    Beneficial
    Effect size
    Small

Adverse Events Reported

  • Zucchini→Overall tolerability

    The herbal preparation (ProstateEZE Max) was shown to be well tolerated

    Finding
    Reported
  • Blood Orange→Overall tolerability

    The herbal preparation (ProstateEZE Max) was shown to be well tolerated

    Finding
    Reported
  • Small-Flower Willow→Overall tolerability

    The herbal preparation (ProstateEZE Max) was shown to be well tolerated

    Finding
    Reported
  • Pygeum Bark→Overall tolerability

    The herbal preparation (ProstateEZE Max) was shown to be well tolerated

    Finding
    Reported
  • Saw Palmetto→Overall tolerability

    The herbal preparation (ProstateEZE Max) was shown to be well tolerated

    Finding
    Reported
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