BPH treatment with the natural product Calprost®

J Pharm Pharmacogn Res 4(5): 187-198, 2016.

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.

Resumen

Contexto: La Hiperplasia Prostática Benigna (HPB) es una enfermedad común en hombres mayores de 50 años de edad, que cursa con Síntomas del Tracto Urinario Bajo (STUB). Los tratamientos de por vida con medicamentos bloqueadores alfa-adrenérgicos producen algunas reacciones adversas. El Centro de Investigación y Desarrollo de Medicamentos produce un extracto lipofílico microencapsulado de aceite de semillas de calabaza (Calprost®) con propiedades anti-androgénicas, anti-inflamatorias, antioxidantes, antirproliferativas y diuréticas.

Objetivos: Evaluar el efecto  y seguridad del Calprost® en pacientes con BPH/STUB.

Métodos: Se realizó un  estudio exploratorio, multicéntrico, aleatorizado, controlado y abierto. Se conformaron dos grupos experimentales, estudio (Calprost®, 140 mg diarios) (n=81), y control (terazosina, 2 mg diarios) (n=50). Todos los pacientes fueron tratados durante tres meses. La eficacia se evaluó mediante la sintomatología urinaria (escala IPSS), volumen vesical residual y volumen prostático.

Resultados: La mayoría de los pacientes (74.0%) fueron blancos, con edad promedio de 66 años. Quince pacientes, nueve de ellos del grupo terazosina, abandonaron el estudio voluntariamente. Hubo disminución significativa de la escala global de síntomas en ambos grupos, aunque algunos de ellos se redujeron notablemente solo en el grupo Calprost®, llegando a ser más ligeros. La mediana tanto del volumen residual (p=0.048) como del prostático (p=0.002) disminuyó de manera significativa solo en el grupo tratado con Calprost®. El porcentaje de eventos adversos presentados fue mayor con la terazosina (79.4%), prevaleciendo la hipotensión postural.

Conclusiones: El producto natural Calprost® fue efectivo en el tratamiento de la HPB/STUB, siendo además bien tolerado.

Palabras Clave: Aceite de semilla de calabaza; Calprost®; hiperplasia prostática benigna; IPSS; síntomas del tracto urinario bajo; terazosina.

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Citation Format: Machado-Leiva M, Jiménez-Rodríguez D, Festary-Casanovas T, Silveira-Pacheco DC, Barroso-de la Cruz ES, Suárez-Reyes M, Salas-Cruz G, Wong-Arocha H, Fernández-Viera R, Tuero-Iglesias AD, Delgado-Hernández R, García-García Idrian, for the Calprost Study Group (2016) Clinical evaluation of patients with benign prostatic hyperplasia, treated with the natural product Calprost®: a randomized, controlled study.J Pharm Pharmacogn Res 4(5): 187-198.

© 2016 Journal of Pharmacy & Pharmacognosy Research (JPPRes)