Clinical evaluation of patients with benign prostatic hyperplasia, treated with the natural product Calprost®: a randomized, controlled study

• Главные авторы: Magnelis Machado-Leiva (Автор), Daise Jiménez-Rodríguez (Автор), Tatiana Festary-Casanovas (Автор), Deydree C. Silveira-Pacheco (Автор), Emilio S. Barroso-de la Cruz (Автор), Mariela Suárez-Reyes (Автор), Genma Salas-Cruz (Автор), Haydee Wong-Arocha (Автор), Roberto Fernández-Viera (Автор), Ángela D. Tuero-Iglesias (Автор), René Delgado-Hernández (Автор), Idrian García-García (Автор), Calprost Study Group (Автор)
• Формат: ‌
• Опубликовано: GarVal Editorial Ltda., 2016-10-01T00:00:00Z.
• Предметы: article
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Итог

Context: Benign Prostatic Hyperplasia (BPH) is a common disease that course with Lower Urinary Tract Symptoms (LUTS), mainly in over 50 years-old men. Commonly indicated drugs such as alpha adrenergic-blockers are life-treatment with some adverse reactions. Center for Drug Research and Development produce a microencapsulated lipophilic extract of pumpkin seed oil (Calprost®) with anti-androgenic, anti-inflammatory, antioxidant, antiproliferative and diuretic properties. Aims: To evaluate the effect and safety of Calprost® in patients with BPH and LUTS. Methods: A multicenter, randomized, controlled, open exploratory clinical trial was conducted. Two experimental groups, study group (Calprost®, 140 mg daily) (n=81), and control group (terazosin, 2 mg daily) (n=50) were conformed. All the patients were treated during three months. Efficacy was evaluated through International Prostate Symptoms Score (IPSS), residual bladder volume and prostate volume. Results: Most of the included patients (74.0%) were white skin color and their mean age was 66 yrs. Fifteen patients, nine of them from terazosin group, withdraw the trial voluntarily. A significant reduction in the overall IPSS scale was obtained for both groups. Nevertheless, some obstructive (intermittency, straining) and irritative (frequency, urgency) urinary symptoms decreased more markedly in the Calprost® group being milder. Median residual and prostatic volumes decreased significantly (p=0.048 and p=0.002, respectively) only into the Calprost® group. Most of the adverse events were recorded in the terazosin group (79.4%), where postural hypotension prevailed. Conclusions: The natural product Calprost® was probed as a successful treatment of patients with BPH/LUTS, being also well-tolerated.

Примечание

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