Combination Therapy With Curcumin Plus Tamsulosin and Finasteride in the Treatment of Men With Benign Prostatic Hyperplasia

A Single Center, Randomized Control Study

Jing Qiao; Yu Gan; Yuchen Gong; Qingtian Song; Bo Zhang; Bingsheng Li; Feng Ru; Yang Li; Yao He

Disclosures

Transl Androl Urol. 2021;10(8):3432-3439. 

In This Article

Methods

Patients

A total of 143 untreated adult outpatients with a previous history of BPH or new cases, who visited the Department of Urology, Xiangya Hospital, Central South University (Changsha, Hunan) between December 2018 and January 2020 were identified, and 122 patients were included in the prospective, randomized, single center, two-parallel, 6-month clinical study with a case-to-control ratio of 1:1. The inclusion criteria were as follows: (I) age between 50 and 70 years; (II) total prostate-specific antigen (TPSA) <4 ng/mL; (III) IPSS ≥8; (IV) PV ≥30 mL; (V) maximum urine flow rate (Qmax) <5 mL/s and urine output ≥100 mL. Besides, subjects who had taken alpha-blockers, 5-alpha reductase inhibitors, proprietary Chinese medicine, or botanically derived drugs to treat BPH within the last 4 weeks could also be included in the study after 4 weeks of drug withdrawal under the supervision of the researchers. The exclusion criteria were as follows: (I) allergic to curcumin; (II) LUTS and ED medication history; (III) history of prostate surgery, prostate cancer, urethral stricture, urinary tract infection, urinary bladder stones, bladder cancer, or neurogenic bladder dysfunction; (IV) history of serious heart disease, renal dysfunction, hepatic dysfunction, diabetes, sexually transmitted diseases, malignant tumor, peptic ulcer, hemorrhagic disease, or mental illness. All patients signed the consent form before study entry. The study was approved by the Institutional Review Board of the Xiangya Hospital of Central South University with ethics clearance number 201703544. All procedures performed in this study involving human participants were in accordance with the Declaration of Helsinki (as revised in 2013).

Patients were allocated randomly to either the BSM or curcumin + BSM groups using computer randomization. In the BSM group, tamsulosin 0.2 mg, finasteride 5 mg, and 3 placebo tablets were administered once every night (n=61) for 6 months, while tamsulosin 0.2 mg, finasteride 5 mg, and 3 Naturewise® tablets (curcumin 2,250 mg) were administered once every night (n=61) in the curcumin + BSM group. Curcumin tablets and placebo tablets were indistinguishable in appearance. Among the enrolled 122 patients, 116 patients completed the study (Figure S1).

 Figure S1.

CONSORT diagram of flow of participants through the study. CONSORT, Consolidated Standards of Reporting Trials; BSM, best standard management.

Assessment Parameters

The following data were collected from all patients: age, BMI values, WC, PPFT, prostate-specific antigen (PSA) value, PV, Qmax, IPSS, and QoL, and the 5-item version of the International Index of Erectile Function (IIEF-5) scores, which are the primary outcome. PPFT was defined as the shortest vertical distance from the midsagittal symphysis pubis to the prostate. Magnetic resonance imaging (MRI) of patients was obtained using the 3.0T MAGNETIC resonance scanner (Intera Archieva, Philips Medical System, Amsterdam, The Netherlands) in our hospital, including axial T1-weighted images, multi-plane T2-weighted images, axial diffusion-weighted images, and dynamic contrast-enhanced prostate images. Analysis of these images was performed by two radiologists with experience in prostate radiology using an image archiving and communication system who were blinded to participants' group allocation. The radiologists agreed on the results. We compared basic data of the two patient groups, including the clinical indicators of the two groups before and after the treatment and the changes of the clinical indicators of the two groups after the treatment.

Statistical Analysis

Data were analyzed using SPSS version 20.0 statistical software (SPSS Inc., Chicago, IL, USA). Continuous variables were described as mean ± standard deviation (SD), and categorical variables were expressed as frequencies and percentages. Records were statistically analyzed using the Student's t-test. In addition, intergroup differences and intragroup differences in clinical indicators were analyzed by the Student's t-test and chi-square test. All statistical assessments were two-sided and considered significant at P<0.05.

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