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


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.

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R. Jeyaraman and P. S. Patki, "Clinical Evaluation of Efficacy and Safety of a Herbal Formulation in Benign Prostatic Hyperplasia: A Single Blind, Randomized, Placebo-Controlled Study," Open Journal of Urology, Vol. 2 No. 3A, 2012, pp. 157-163. doi: 10.4236/oju.2012.223030.

Conflicts of Interest

The authors declare no conflicts of interest.


[1] H. M. Arrighi, E. J. Metter, H. A. Guess and J. L. Fozzard, “Natural History of Benign Prostatic Hyperplasia and Risk of Prostatectomy: The Baltimore Longitudinal Study of Aging,” Urology, Vol. 38, No. 1, 1991, pp. 4-8.
[2] S. J. Berry, D. S. Coffey, P. C. Walsh and L. L. Ewing, “The Development of Human Benign Prostatic Hyperplasia with Age,” Journal of Urology, Vol. 132, 1984, PP. 474-479.
[3] J. E. Oesterling, “Benign Prostatic Hyperplasia—Medical and Minimally Invasive Treatment Options,” NEJM, Vol. 332, 1995, pp. 99-110.
[4] J. D. McConnell, “The Pathophysiology of Benign Prostatic Hyperplasia,” Journal of Anthology, Vol. 12, 1991, pp. 356-363.
[5] M. H. Minsley and S. Wrenn, “Long-Term Care of the Tracheostomy Patient from an Outpatient Perspective,” ORL-Head and Neck Nursing, Vol. 14, No. 4, 1996, pp. 18-22.
[6] N. K. Roberts, “The Selective Approach to Successful Stomal Management at Home,” ORL—Head and Neck Nursing, Vol. 13, No. 4, 1995, pp. 12-16.
[7] T. J. Beckman and L. A. Mynderse, “Evaluation and Medical Management of Benign Prostatic Hyperplasia,” Mayo Clinic Proceedings, Vol. 80, No. 10, 2005, pp. 1356-1362.
[8] M. T. Rosenberg, D. R. Staskin, S. A. Kaplan, S. A. MacDiarmid, D. K. Newman and D. A. Ohl, “A Practical Guide to the Evaluation and Treatment of Male Lower Urinary Tract Symptoms in the Primary Care Setting,” International Journal of Clinical Practice, Vol. 61, 2007, pp. 1535-1546.
[9] AUA Practice Guidelines Committee, “AUA Guideline on Management of Benign Prostatic Hyperplasia: Diagnosis and Treatment Recommendations,” Chapter 1, 2003, pp. 1-11.
[10] C. G. Roehrborn, “The Potential of Serum Prostate-Specific Antigen as a Predictor of Clinical Response in Patients with Lower Urinary Tract Symptoms and Benign Prostatic Hyperplasia,” British Journal of Urology International, Vol. 93, 2004, pp. 21-26.
[11] J. A. Schalken, “Molecular and Cellular Prostate Biology: Origin of Prostate-Specific Antigen Expression and Implications for Benign Prostatic Hyperplasia,” British Journal of Urology International, Vol. 93, 2004, pp. 5-9.
[12] M. J. Barry and C. G. Roehrborn, “Benign Prostatic Hyperplasia,” British Medical Journal, Vol. 323, 2001, pp. 1042-1046.
[13] C. R. Chapple, “Pharmacological Therapy of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms: An Overview for the Practising Clinician,” British Journal of Urology International, Vol. 94, 2004, pp. 738-744.
[14] C. L. Eaton, “Aetiology and Pathogenesis of Benign Prostatic Hyperplasia,” Current Opinion in Urology, Vol. 13, 2003, pp. 7-10.
[15] T. J. Beckman and L. A. Mynderse, “Evaluation and Medical Management of Benign Prostatic Hyperplasia,” Mayo Clinic Proceedings, Vol. 80, No. 10, 2005, pp. 1356-1362.
[16] A. Tubaro and C. D. Nunzio, “The Current Role of Open Surgery in BPH,” EAU-EBU Update Series, Vol. 4, 2006, pp. 191-201.
[17] G. Maria, G. Brisinda, I. M. Civello, A. R. Bentivoglio, G. Sganga and A. Albanese, “Relief by Botulinum Toxin of Voiding Dysfunction Due to Benign Prostatic Hyperplasia: Results of a Randomized, Placebo-Controlled Study Giorgio,” Urology, Vol. 62, No. 2, 2003, pp. 259-265.
[18] G. L. Lu-Yao, M. J. Barry, C. H. Chang, et al., “For the Prostate Patient Outcomes Research Team (PORT): Transurethral Resection of the Prostate among Medicare Beneficiaries in the United States: Time Trends and Outcomes,” Urology, Vol. 44, 1994, pp. 692-698.
[19] Operational Guidance, “Information Needed to Support Clinical Trials of Herbal Products,” World Health Organization on Behalf of the Special Programme for Research and Training in Tropical Diseases, 2005, TDR/GEN/Guidance/05.1.
[20] E. Whitley and J. Ball, “Statistics Review 4: Sample Size Calculations,” Critical Care, Vol. 6, 2002, pp. 335-341.
[21] J. D. McConnell, M. J. Barry and R. C. Bruskewitz, “Benign Prostatic Hyperplasia: Diagnosis and Treatment (Clinical Practice Guideline No. 8),” In: M. D. Rockville, Ed., Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services, 1994.
[22] J. D. McConnell, “Androgen Ablation and Blockade in the Treatment of Benign Prostatic Hyperplasia,” Urologic Clinics of North America, Vol. 17, 1990, pp. 661-670.
[23] E. Stoner, “The Clinical Development of a 5 Alpha-Reductase Inhibitor, Finasteride,” The Journal of Steroid Biochemistry and Molecular Biology, Vol. 37, 1990, pp. 375-378.
[24] G. Bartsch, R. S. Rittmaster and H. Klocker, “Dihydro-testosterone and the Concept of 5Alpha-Reductase Inhibition in Human Benign Prostatic Hyperplasia,” World Journal of Urology, Vol. 19, 2002, pp. 413-425.
[25] R. N. Biswas and S. O. Temburnikar, “Safed Musali (Chlorophytum Species)—A Wonder Drug in the Tropical Zone,” XIth World Foresty Conference, Canada, 2003.
[26] R. N. Yadava and J. Jharbade, “New Antibacterial Triterpenoid Saponin from Lactuca scariola,” Fitoterapia, Vol. 79, No. 4, 2008, pp. 245-249.
[27] R. P. Samy, “Antimicrobial Activity of Some Medicinal Plants from India,” Fitoterapia, Vol. 76, No. 7-8, 2005, pp. 697-699.
[28] S. N. Yoganarasimhan, “Mucuna pruriens. Medicinal Plants of India. Tamil Nadu,” Bangalore, Vol. 2, 2000, p. 366.
[29] V. N. Pandey, “Pharmacological investigations of Certain Medicinal Plants & Compound Formulations Used in Ayurveda & Siddha,” 1st Edition, CCRAS, Department of ISM & H. Govt. of India, New Delhi, 1996, pp. 69-72.
[30] G. K. A. Adepoju and O. O. Oduben, “Effect of Mucuna pruriens on Some Hematological and Biochemical Parameters,” Journal of Medicinal Plants Research, Vol. 3, No. 2, 2009, pp. 73-76.
[31] C. P. Khare, “Parmelia perlata. Encyclopedia of Indian Medicinal Plants,” Springer, Berlin, 2004, pp. 352-353.
[32] M. A. Momoh and M. U. Adikwu, “Evaluation of the Effect of Colloidal Silver on the Antibacterial Activity of Ethanolic Extract of Lichen Parmelia perlata,” African Journal of Pharmacy Pharmacology, Vol. 2, No. 6, 2008, pp. 106-109.
[33] L. V. Asolkar, K. K. Kakkar and O. J. Chakre, “Argyreia speciosa. Second Supplement to Glossary of Indian Medicinal Plants with Active Principles,” CSIR, Govt. of India, New Delhi, 1992, p. 87.
[34] A. B. Gokhale, A. S. Damre, K. R. Kulkami and M. N. Saraf, “Preliminary Evaluation of Anti-Inflammatory and Anti-Arthritic Activity of S. lappa, A. speciosa and A. aspera,” Phytomedicine, Vol. 9, No. 5, 2002, 433-437.
[35] C. H. Hong, S. K. Hur, O. J. Oh, S. S. Kim, K. A. Nam and S. K. Lee, “Evaluation of Natural Products on Inhibition of Inducible Cyclooxygenase (COX-2) and Nitric Oxide Synthase (iNOS) in Cultured Mouse Macrophage Cells,” Journal of Ethnopharmacology, Vol. 83, No. 1-2, 2002, pp. 153-159.
[36] R. N. Chopra, I. C. Chopra, K. L. Handa and L. D. Kapur, “Tribulus terrestris. Chopra’s Indigenous Drugs of India,” U N Dhur & Sons Private Limited, Kolkata, 1958, p. 430.
[37] G. L. Hammond, O. Lukkarinen, P. Vihko, M. Kontturi and R. Vihko, “The Hormonal Status of Patients with Benign Prostatis Hypertrophy: FSH, LH, TSH and Prolactin Responses to Releasing Hormones,” Clinical Endocrinology, Vol. 10, No. 6, 1979, pp. 545-552.
[38] M. L Kuhut, et al., “Ingestion of a Dietary Supplement Containing Dehydroepiandrosterone (DHEA) and Androstenedione Has Minimal Effect on Immune Function in Middle-Aged Men,” Journal of the American College of Nutrition, Vol. 22, No. 5, 2003, pp. 363-371.
[39] C. P. Khare, “Leptadenia reticulata. Indian Medicinal Plants: Illustrated Dictionary,” Springer, Berlin, 2007, p. 371.
[40] S. N. Yoganarasimhan, “Leptadenia reticulata. Medicinal Plants,” Vol. 2, Tamil Nadu, Bangalore, 2000, p. 322.
[41] F. M Parabia, et al., “Effect of Plant Growth Regulators on in Vitro Morphogenesis of Leptadenia reticulata (Retz.) W and A. from Nodal Explants,” Current Sciences, Vol. 92, No. 9, 2007, pp. 1290-1293.
[42] L. S. Marks, et al., “Effects of a Saw Palmetto Herbal Blend in Men with Symptomatic Benign Prostatic Hyperplasia,” Journal of Urology, Vol. 163, 2000, pp. 1451-1456.
[43] J. A. Vale, et al., “An Analysis of the Costs of Alternative Treatments for Benign Prostatic Hypertrophy,” Journal of the Royal Society of Medicine, Vol. 88, No. 11, 1995, pp. 644-648.

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