Clinical Evaluation of Efficacy and Safety of a Herbal Formulation in Benign Prostatic Hyperplasia: A Single Blind, Randomized, Placebo-Controlled Study

Abstract

Benign prostatic hyperplasia (BPH) is a condition intimately related to ageing. Currently available treatment options for the management of BPH have various limitations and associated adverse effects. A polyherbal formulation is claimed to be beneficial in patients with benign prostatic hyperplasia. This single blind, placebo-controlled study evaluated the clinical efficacy and safety of polyherbal formulation in BPH. Material and Methods: A total of 60 patients who were diagnosed as BPH and who were willing to give informed consent were included in the study. At the randomization visit, a detailed medical history was obtained and the patients underwent a thorough systemic examination and digital rectal examination. Routine blood analysis, urinalysis and serum levels of prostate specific antigen were carried out. Abdominal pelvic ultrasonography was done at entry and after completing the study. The severity of the urinary parameters was evaluated using American Urological Association symptom score. All the patients were randomized using random table into either polyherbal group (n = 30) or placebo (n = 30). Each patient received either polyherbal formulation or placebo in a dose of 2 capsules twice a day with meals for two months. All adverse events reported by the patients or observed by investigators were recorded. Statistical analysis was done according to the intention-to-treat principles. Analysis was performed between the groups using Fisher's exact test or unpaired "t" test (Independent t-test). Results: Fifty-six patients completed the study. There was a significant improvement in the mean AUA symptom score, PVR urine volume urinary hesitancy, intermittent flow, straining during urination, sense of incomplete micturition and frequency of night-time urination, in the polyherbal formulation group. Four patients from the placebo group withdrew from the study due to lack of benefit to the treatment. Conclusion: The beneficial clinical efficacy of polyherbal formulation observed in this study in the management of BPH could be due to the synergistic actions of its potent herbs. This polyherbal formulation was well tolerated and safe.

Khar-e-khasak (Tribulus terrestris): An Unani medicine in the management of benign prostatic hyperplasia: A narrative review

“…For two months, each patient took either a polyherbal formulation or a placebo in a dose of two capsules twice a day with meals. The mean AUA symptom score significantly improved; at the beginning of treatment, the AUA scores for the Polyherbal formulation and placebo groups were 14.60±3.20 and 13.80±4.60, respectively, and at the end of therapy, they were 9.2±2.60 and 12.90±3.80, respectively (p value 0.0001) [23] . 32 patients from Mootraghata who met the criteria for BPH were randomly assigned to one of three treatment groups, and a study on the use of Gokshuradi Vati and Dhanyaka Gokshura Ghrita Matra Basti in the management of BPH was done.…”

“…Prostate weight (Gms) in the placebo group and Polyherbal formulation was 34.60±8.70 and 32.60±8.30 at the beginning of treatment which becomes 32.60±9.40 and 34.50±6.60, respectively, at the end of treatment. Post-void residual (PVR) volume (ml) in the Polyherbal formulation and placebo group at the beginning of treatment was 85.30±20.20 and 86.20±18.20 and at the end of therapy it was 52.10±23.10 and 89.70±28.30, respectively (p-value 0.0001) [23] . Prostate gland's size had significantly decreased [24] .…”

Effects of an Oil-Free Hydroethanolic Pumpkin Seed Extract on Symptom Frequency and Severity in Men with Benign Prostatic Hyperplasia: A Pilot Study in Humans

“…In a study of Jeyaraman and Patki 24 investigating a polyherbal formulation in BPH patients over a period of 2 months, postvoid residual volume was also measured and a significant reduction was reported from 85.3 to 52.1 mL. The difference was highly significant in comparison to placebo.…”

Clinical evaluation of polyherbal formulation (Uricare Tablet) in benign prostatic hyperplasia: randomized, placebo controlled, single blinded clinical study

“…10 The Uricare tablet shows moderate activity in the treatment of the Prostate enlargement by showing the reduction in the I-PSS score and improving the quality of Life. Experimental study has assumed that the ingredients of Uricare tablet possesses both α-adreno receptor antagonist and 5α-reductase enzyme inhibitory activities.…”