Clinical Evaluation of Efficacy and Safety of a Herbal Formulation in Benign Prostatic Hyperplasia: A Single Blind, Randomized, Placebo-Controlled Study — Oak Academic Publishing
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Clinical Evaluation of Efficacy and Safety of a Herbal Formulation in Benign Prostatic Hyperplasia: A Single Blind, Randomized, Placebo-Controlled Study
Department of Urology, Madras Medical College, Chennai, India
,
The Himalaya Drug Company, Bangalore, India
1 Department of Urology, Madras Medical College, Chennai, India
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.
KeywordsPhytotherapyAyurvedaClinical Evaluation
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