Abstract and Introduction
Background: To perform a prospective, randomized, single center study to investigate the efficacy of combined use of curcumin, an anti-inflammatory agent, with the best standard management (BSM, tamsulosin and finasteride) in benign prostatic hyperplasia (BPH) patients.
Methods: One hundred and twenty-two consecutive patients were randomized to receive tamsulosin 0.2 mg, finasteride 5 mg, and curcumin 2,250 mg once a day (curcumin + BSM group, n=61) versus tamsulosin 0.2 mg, finasteride 5 mg, and placebo (BSM group, n=61) for 6 months. The safety of treatments and their efficacy on improving waist circumference (WC), periprostatic fat thickness (PPFT), lower urinary tract symptoms (LUTS), and sexual function were assessed at baseline and month 6.
Results: One hundred and sixteen patients completed the whole procedure (116/122, 95.1%). There were significant improvements in prostate volume (PV), maximum flow rate (Qmax), the International Prostate Symptom Score (IPSS), IPSS-voiding subscore (IPSS-V), IPSS-storage subscore (IPSS-S), and quality of life (QoL) from baseline after treatment in both groups. Additionally, both WC and PPFT decreased significantly after treatments than those at baseline in the curcumin + BSM group. Also, WC and PPFT in the curcumin + BSM group were significantly lower than those in the BSM group. In addition, IPSS-S, QoL score, and the 5-item version of the International Index of Erectile Function (IIEF-5) in the curcumin + BSM group improved significantly compared with those in the BSM group.
Conclusions: We conclude that curcumin combined with tamsulosin and finasteride has more beneficial effects in reducing PPFT, protecting erectile function, improving urinary retention symptoms, and QoL scores in BPH patients compared to tamsulosin and finasteride alone.
Trial Registration: Chinese Clinical Trial Registry ChiCTR2100043800.
Benign prostatic hyperplasia (BPH) is a common disorder that occurs mainly in older men. Recent studies have shown that prostatic inflammation contributes to the pathogenesis and disease progression of BPH, which is also correlated with the severity of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED).[1,2] The most common medical treatments for BPH are alpha-blockers (e.g., tamsulosin) and 5-alpha reductase inhibitors (e.g., finasteride), both of which lack direct anti-inflammatory effects and have a possible side impact on sexual and erectile functions.[3,4] As a result, combination therapy with anti-inflammatory drugs seems to be a more effective strategy for BPH treatment. However, non-steroidal anti-inflammatory drugs (NSAIDS) commonly used in clinical practice have many side effects such as gastrointestinal inflammation, upper gastrointestinal ulcers and perforation. Moreover, NSAIDS has shown adverse reactions to the central nervous, circulatory, and respiratory systems, limiting their clinical applications. Therefore, there is a need to explore a novel anti-inflammatory agent with high efficacy and lower toxicity, which may elevate compliance, alleviate the LUTS, and improve BPH patients' quality of life (QoL).
In recent years, phytotherapeutic agents have attracted considerable attention because of their comprehensive anti-inflammatory and anti-oxidative stress properties, and, more importantly, they have the advantages of being safe and non-toxic.[7,8] Curcumin is a natural plant polyphenol extracted from the root of plants of Zingiberaceae and Araceae. Much evidence is available to show that curcumin possesses anti-inflammatory, antioxidant, anti-cancer, anti-fibrosis, lipid-modifying, and antiarthritic effects without obvious adverse effects. Curcumin has also shown a potential function of suppressing the progression of BPH. It has been reported that the incidence of BPH in India, especially in southern India, was significantly lower than that in western countries, with reduced LUTS symptoms and a lower incidence of acute urinary retention. Residents in these areas have a high curcumin intake due to their preference for curry. Moreover, data from a prospective controlled clinical trial revealed that the supplementation of curcumin with finasteride leads to significant improvements in the International Prostate Symptom Score (IPSS) and QoL scores and controls urinary infections in BPH patients. Cosentino et al. also found that curcumin could significantly reduce the inflammatory symptoms in BPH patients who underwent transurethral resection of the prostate (TURP), with fewer side effects than NSAIDS.
Periprostatic fat (PPF), which surrounds the prostate, can produce several hormones and cytokines involving autocrine, paracrine, and endocrine signals, including vascular endothelial growth factor, interleukin-1 beta, interleukin-6, leptin, and adiponectin. Our previous study found that periprostatic fat thickness (PPFT) was significantly correlated with prostate volume (PV), LUTS symptoms, and ED degree in BPH patients. PPFT can better identify high-risk BPH patients with disease progression. Some clinical studies have also suggested a positive impact of curcumin supplementation on body weight, body mass index (BMI), and waist circumference (WC).[15,16] However, to the best of our knowledge, there has been no research targeting the effect of curcumin on PPF in BHP patients. To the best of our knowledge, this is the first study evaluating the effects of curcumin combined with best standard management (BSM) on BMI, body weight, and PPF in BPH patients.
Therefore, this study evaluates the efficacy of combined use of curcumin and the standard treatment strategy (tamsulosin and finasteride) to improve WC, visceral fat (PPF), LUTS, and sexual function in BPH patients. Moreover, this prospective study also aims to assess the efficacy and safety of curcumin. We present the following article in accordance with the CONSORT reporting checklist (available at https://dx.doi.org/10.21037/tau-21-567).
Transl Androl Urol. 2021;10(8):3432-3439. © 2021 AME Publishing Company