Clinical Effects of Oral Supplementation of Gamma-Cyclodextrin Curcumin Complex in Male Patients with Moderate-To-Severe Benign Prostatic Hyperplasia-Related Lower Urinary Tract Symptoms
Fabio Crocerossa, Francesco Cantiello, Lorenzo Bagalá, Francesco Sicoli, Umberto Carbonara, Celeste Manfredi, Ugo Giovanni Falagario, Alessandro Veccia, Savio Domenico Pandolfo, Luigi Napolitano, Matteo Ferro, Michele Di Dio, Nicola Mondaini, Rocco Damiano
Abstract
<b><i>Introduction:</i></b> Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms (LUTSs) in males. Curcumin exhibits anti-inflammatory and anti-tumor properties which may be effective for BPH. This multi-arm observational study evaluated the real-world efficacy of QURMIN<sup>®</sup> (Gamma-cyclodextrin-curcumin Complex-CAVACURMIN<sup>®</sup>) as single or combination therapy for BPH. <b><i>Methods:</i></b> Men with moderate-severe LUTS/BPH, receiving a 6-month supplementation with QURMIN<sup>®</sup> alone or in combination with BPH-specific medication were propensity score matched with patients not taking curcumin and then divided into subgroups based on concomitant baseline treatment. Cohorts were compared in the 6-month variation of IPSS, quality of life (IPSS-QoL), Benign Prostatic Hyperplasia Impact Index (BII) and uroflowmetry parameters. Curcumin tolerability was evaluated in terms of discontinuations and adverse effects. <b><i>Results:</i></b> The 1:1 propensity score matching resulted in a treatment-naïve (<i>n</i> = 152), an alpha-blocker only (AB) (<i>n</i> = 138) and AB + 5-alpha reductase inhibitors (5-ARIs) (<i>n</i> = 78) subgroup. After 6 months, drug-naïve patients taking curcumin reported significant improvement in IPSS-storage (−3.9, <i>p</i> &lt; 0.001), IPSS-voiding (−2.0, <i>p</i> = 0.011), IPSS-total (−5.9, <i>p</i> &lt; 0.001), IPSS-QoL (−3.9, <i>p</i> &lt; 0.001), BII (−2.0, <i>p</i> &lt; 0.001), <i>Q</i><sub>max</sub> (+3.1 mL/s, <i>p</i> &lt; 0.001), <i>Q</i><sub>mean</sub> (+1.9 mL/s, <i>p</i> = 0.005), post-void residual volume (−7.7 mL, <i>p</i> &lt; 0.001), and PSA (−0.3 ng/mL, <i>p</i> = 0.003), compared to controls. Patients taking ABs and curcumin showed improvement in IPSS-storage (−2.7, <i>p</i> &lt; 0.001), IPSS-voiding (−1.3, <i>p</i> = 0.033), IPSS-total (−3.5, <i>p</i> &lt; 0.001), IPSS-QoL (−1.1, <i>p</i> = 0.004), BII (−1.7, <i>p</i> = 0.006), <i>Q</i><sub>max</sub> (+1.0 mL/s, <i>p</i> = 0.006), and PSA (−0.2 ng/mL, <i>p</i> = 0.01). Patients taking curcumin and AB + 5-ARI showed improvement in IPSS-storage (−1.3, <i>p</i> = 0.007), IPSS-total (−1.6, <i>p</i> = 0.034), IPSS-QoL (−1.1, <i>p</i> &lt; 0.001), and BII (−2.0, <i>p</i> &lt; 0.001). No adverse reactions were reported for curcumin supplementation. <b><i>Conclusion:</i></b> QURMIN<sup>®</sup> (CAVACURMIN<sup>®</sup>) led to significant improvements in symptom burden, uroflow parameters, and QoL, without significant additional side effects, thus proving to be a potential new treatment for BPH, either as a single therapy or in addition to standard treatment.