Clinical effects of oral supplementation of gamma-ciclodextrin curcumin complex in male patients with moderate-to-severe BPH-related Lower Urinary Tract Symptoms
Authors: Crocerossa Fabio , Bagalá Lorenzo , Sicoli Francesco , Carbonara Umberto , Manfredi Celeste , Falagario Ugo , Veccia Alessandro , Pandolfo Savio D , Napolitano Luigi , Ferro Matteo , Dio Michele Di , Cantiello Francesco , Mondaini Nicola , Damiano Rocco 
Published: February 2023

Abstract
Background
Benign prostatic hyperplasia (BPH) is the most common cause of lower urinary tract symptoms (LUTS) in males. Curcumin, the main curcuminoid, exhibits antioxidant, anti-inflammatory and anti-tumor properties that may make it an effective treatment for BPH. This multi-arm observational study evaluated the real-world efficacy of QURMIN® (Gamma-cyclodextrin curcumin Complex - CAVACURMIN®) as single or combination therapy for BPH.
Methods
Men with moderate-severe LUTS/BPH receiving a 6-month supplementation with QURMIN® alone or in combination with BPH-specific medication were propensity score matched with a control cohort of patients not taking curcumin and then divided into subgroups based on concomitant baseline treatment. Cohorts were compared by assessing differences in 6-month variation in International Prostate Symptom Score (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. Differences were assessed using the Student's t test or the Mann-Whitney U test.
Results
The 1:1 propensity score matching resulted in three subgroups, each containing an equal number of participants from study and control cohort: a treatment-naïve subgroup (n = 152), patients taking alpha-blockers (AB)(n = 138) and a subgroup taking AB + 5-alpha reductase inhibitors (5-ARI) (n = 78). After 6 months, drug-naïve patients taking curcumin reported significant improvement in IPSS storage (-3.9,p < 0.001), IPSS voiding (-2.0,p = 0.011), IPSS total (-5.9,p < 0.001), IPSS-QoL (-3.9,p < 0.001), BII (-2.0,p < 0.001), Qmax (+ 3.1 ml/s,p < 0.001), Qmean (+ 1.9 ml/s,p = 0.005), PVR (-7.7 ml,p < 0.001), and PSA (-0.3 ng/ml,p = 0.003), compared to controls. Among patients taking AB, those under curcumin showed significantly greater change in IPSS storage (-2.7,p < 0.001), IPSS voiding (-1.3,p = 0.033), IPSS total (-3.5,p < 0.001), IPSS-QoL (-1.1,p = 0.004), BII (-1.7,p = 0.006), Qmax (+ 1.0 ml/s,p = 0.006) and PSA (-0.2 ng/ml,p = 0.01). Patients assuming curcumin in addition to AB + 5-ARI showed significantly greater change in IPSS storage (-1.3,p = 0.007), IPSS total (-1.6,p = 0.034), IPSS-QoL (-1.1,p < 0.001) and BII (-2.0,p < 0.001). No adverse reactions were reported for repeated administration of curcumin supplementation.
Conclusions
QURMIN® (CAVACURMIN®) 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.
Trial registration:
This study was approved by the local Ethical Committee (n. 269/2022) - retrospectively registered.