Evaluation of the Effect of the oral Formulation Prepared from the Extract of Pomegranate Peel for the Treatment of Benign Prostate Hyperplasia: A Triple-Blind Randomized Clinical Trial

Background: Benign prostatic hyperplasia (BPH) is a common condition affecting older men, primarily driven by hormonal imbalances and inflammation. This study aimed to investigate the effects of pomegranate peel extract, rich in anti-inflammatory and antioxidant polyphenolic compounds like anthocyanins and tannins, on BPH symptoms compared to a placebo. Methods: Forty patients aged 50-80 with BPH from Ghaem Hospital in Mashhad were randomly assigned to either the treatment or control group. The treatment group (20 patients) received 250 mg of pomegranate peel extract capsules three times daily alongside tamsulosin 0.4 mg nightly for four months. In the control group (20 patients) lactose capsules was prescribed as a placebo with the same dosing. The severity of lower urinary symptoms was assessed using the International Prostate Symptom Score (IPSS), along with prostate size via ultrasound at baseline and after 2 and 4 months and prostate-specific antigen (PSA) serum levels just at the beginning and end of study. Results: Baseline prostate sizes, PSA serum level and IPSS scores were comparable between two groups (P>0.05). At the 4-month follow-up, the pomegranate peel extract group demonstrated significantly lower symptom scores compared to the placebo group (P=0.004), although no meaningful difference was observed after 2 months (P=0.067). Moreover, the prostate size did not change meaningfully after 2 and 4 months in comparison with the placebo group (P=0.226 & 0.355) and also PSA serum level was not significantly lower in pomegranate group after 4 months of therapy (P=206). Conclusion: As indicated by the IPSS, a daily regimen of 250 mg of pomegranate peel extract for four months effectively alleviated BPH symptoms. This suggests its potential as a treatment option for BPH, warranting further human studies to explore its efficacy.