A multi-center, randomized, open label, two-arm study to evaluate safety & efficacy of nutraceutical tablet as adjuvant when compared with standard of care in patients with benign prostatic hyperplasia

Background

Benign Prostrate Hyperplasia (BPH) is a progressive disease of ageing men that may be associated with enlargement of the prostate and lower urinary tract symptoms (LUTS). Herbal/Nutraceutical formulations in addition to standard of care (SOC) could alleviate the symptoms, and thus improve the quality of life of patients.

Objectives

To evaluate safety & efficacy of nutraceutical tablet as an adjuvant with SOC.

Materials and Methods

This was a prospective, randomized two-arm study aimed to assess the safety and efficacy of Herbal/Nutraceutical Formulation (IP) + SOC versus only SOC, in BPH patients. The primary efficacy endpoint was the change in international prostate symptom score (IPSS) within and between two arms. The safety was evaluated in terms of adverse events and change in prostate specific antigen (PSA) levels.

Results

140 eligible patients (70 / arm) were evaluated for efficacy and safety endpoints. The baseline characteristics of patients in two arms differed nonsignificantly. The change in IPSS-storage, voiding and QoL scores, from day 1 to 90 were statistically significant in both the arms (p < 0.0001). However, by day 90, the change in these scores in SOC+IP arm were significantly higher than that of SOC arm. Further, the change in International Index of Erectile Function (IIEF) scores was significant in SOC+IP arm (p < 0.05), while non-significant in SOC arm. The adverse events non-significantly differed between two arms.

Conclusion

The herbal/nutraceutical formulation combined with SOC are safe and effective for the treatment of BPH. The combination therapy was effective in reducing urine-related symptoms and improving the QoL of BPH patients.