Clinical effects of oral supplementation of gamma-ciclodextrin curcumin complex in male patients with moderate-to-severe BPH-related Lower Urinary Tract Symptoms

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.