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Benign prostatic hyperplasia treatment with the natural product Calprost


Article published in Journal of Pharmacy & Pharmacognosy Research 4(5): 187-198, 2016. (PDF)

Original Article | Artículo Original

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

[Evaluación clínica de pacientes con hiperplasia prostática benigna, tratados con el producto natural Calprost®: estudio aleatorizado, controlado]

Magnelis Machado-Leiva1, Daise Jiménez-Rodríguez2, Tatiana Festary-Casanovas2, Deydree  C. Silveira-Pacheco3, Emilio S. Barroso-de la Cruz4, Mariela Suárez-Reyes1, Genma Salas-Cruz1, Haydee Wong-Arocha3, Roberto Fernández-Viera4, Ángela D. Tuero-Iglesias5, René Delgado-Hernández2, Idrian García-García2*, for the Calprost Study Group

1Urology and Natural and Traditional Medicine Services, Clinical-Surgical Hospital “Dr. Luis Díaz Soto”, Havana, Cuba
2Clinical Trials Group, Research Direction, Center for Drug Research and Development, Ave. 26 and Puentes Grandes, No. 1605, Nuevo Vedado,Havana, Cuba
3Urology Service, Clinical-Surgical Hospital “Joaquín Albarrán”, Havana, Cuba
4Urology Service, Clinical-Surgical Hospital “Iván Portuondo”, San Antonio de los Baños, Artemisa, Cuba
5Center for Genetic Engineering and Biotechnology, Havana, Cuba.

*E-mail: idrian.garcia@cidem.cu

Abstract

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.

Keywords: Benign prostatic hyperplasia; Calprost®; IPSS; lower urinary tract symptoms, pumpkin seed oil, terazosin.

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Información

Esta entrada fue publicada el 21 de septiembre de 2016 por en Benign Prostatic Hyperplasia, Clinical Pharmacology, Clinical Trial, Phytotherapy.

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