Paolo Pietro Suraci, Luca Erra, Giovanni Di Gregorio, Giorgio Martino, Filippo Gianfrancesco, Eleonora Rosato, Giuseppe Candita, Paolo Benanti, Onofrio Antonio Rera, Alice Antonioni, Antonio Luigi Pastore, Manfredi Bruno Sequi, Fabio Maria Valenzi, Damiano Graziani, Riccardo Lombardo, Cosimo De Nunzio, Yazan Al Salhi, Andrea Fuschi, Antonio Carbone, Giorgio Bozzini
Journal: Medicina (Kaunas, Lithuania) 2025;61(7):
PMID: 40731854
: While α1-blockers like silodosin are the mainstay for treating lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), combination therapy with phytotherapeutics may provide enhanced symptom control. Xipag is a novel formulation containing Graminex G96 (pollen extract) and Teupol 25P (teupolioside), offering anti-inflammatory and antiandrogenic effects. This study aimed to evaluate the efficacy of Xipag versus hexanic extract of (HESr), both in combination with silodosin, in patients with LUTS/BPH. : We conducted a single-center, prospective, observational, comparative study involving male patients with moderate-to-severe LUTSs undergoing treatment with silodosin. Patients were allocated to receive either Xipag or HESr in addition to silodosin, with follow-up every 3 months for 12 months. Primary outcomes included changes in symptom scores such as IPSS, QoL, and functional improvements such as peak urinary flow rate (Qmax). Multivariable regression analyses were used to assess predictors of the response. : Patients receiving Xipag showed significantly greater improvements in Qmax at all follow-up points ( < 0.05), with earlier and more sustained benefits compared to the HESr group. QoL index scores and PSA levels were also significantly better in the Xipag group starting from month six onward. IPSS scores improved in both groups but were significantly lower in the Xipag group only at 12 months ( = 0.04). No differences in erectile function (IIEF-5) or adverse events were observed. : Xipag in combination with silodosin provides superior improvement in urinary flow, symptom-related QoL, and PSA reduction compared to HESr plus silodosin, with a favorable safety profile. These findings support the use of multi-target nutraceuticals like Xipag as a valuable adjunct in the management of LUTS/BPH. Larger randomized trials are warranted to confirm these results and explore underlying mechanisms.
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