Efficacy of a polyherbal formulation in the management of benign prostatic hyperplasia: a randomized, controlled trial

Authors

  • Shabir Ahmad Bhat Department of Moalajat, Regional Research Institute of Unani Medicine, Naseembagh, University of Kashmir, Srinagar, Jammu and Kashmir, India
  • Shameem Ahmad Rather Department of Moalajat, Regional Research Institute of Unani Medicine, Naseembagh, University of Kashmir, Srinagar, Jammu and Kashmir, India
  • Naquibul Islam Department of Moalajat, Regional Research Institute of Unani Medicine, Naseembagh, University of Kashmir, Srinagar, Jammu and Kashmir, India

DOI:

https://doi.org/10.18203/2349-3933.ijam20213242

Keywords:

Benign prostatic hyperplasia, LUTS, Habb-i-muqil, Quality of life

Abstract

Background: Benign prostatic hyperplasia (BPH) affects a significant number of men beyond the age of 40 years with its incidence reaching up to 90% in 80’s. Despite multiple treatment innovations, BPH still remains a nightmare for ageing men, mostly due to its distressing lower urinary tract symptoms (LUTS) and sexual dysfunction. The severity of LUTS is graded by international prostate symptom score or American urological association symptom index (AUA-SI) along with impact on quality of life (QOL). The objective of this study was to evaluate the efficacy of an Unani polyherbal formulation, Habb-i-muqil, in improving the AUA-SI and QOL in patients with BPH.

Methods:In an open, standard controlled study, 76 men, diagnosed with clinical BPH, aged between 40 and 80 years were randomly allocated for treatment for duration of 90 days with Habb-i-muqil (test drug) or Tamsulosin (standard control) after ethical approval. AUA-SI and QOL were assessed at baseline (0 day) and days 15, 30, 45, 60, 75 and 90.

Results: Analysis of 60 men showed that after 90 days of treatment the percentage changes in the AUA-SI from baseline were 59.4 and 49.4% by Habb-i-muqil and tamsulosin, respectively. The test drug produced statistically significant improvement (p<0.001) in overall AUA-SI and QOL compared with standard control.

Conclusions:The Unani polyherbal formulation, Habb-i-muqil, was effective in improving AUA-SI and QOL in men with BPH in comparison to tamsulosin. Both the treatments were generally well tolerated. 

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References

Skinder D, Zacharia I, Studin J, Covino J. Benign prostatic hyperplasia: A clinical review. JAAPA. 2016;29(8):19-23.

Roehrborn CG, McConnell JD. In: Walsh P, Retik A, Vaughan E, Wein A, eds. Etiology, pathophysiology, epidemiology and natural history of benign prostatic hyperplasia. Campbell’s Urology. 8th ed. Philadelphia: Saunders; 2002. 1297-1336.

Kishorebabu A, Sree SN, Chandralekha SP. A review of benign prostatic hyperplasia. World J Current Med Pharm Res. 2019;1(5):192-7.

Roehrborn CG. Male lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). Med Clin North Am. 2011;95(1):87-100.

Nunzio C, Presicce F, Tubaro A. Inflammatory mediators in the development and progression of benign prostatic hyperplasia. Nat Rev Urol. 2016;13(10):613-26.

Kruslin B, Tomas D, Dzombeta T, Milkovic PM, Ulamec M. Inflammation in Prostatic Hyperplasia and Carcinoma-Basic Scientific Approach. Front. Oncol. 2017;7:77.

Vignera S, Condorelli RA, Russo GI, Morgia G, Calogero AE. Endocrine control of benign prostatic hyperplasia. Andrology. 2016;4(3):404-11.

Parsons JK, Sarma AV, McVary K, Wei JT. Obesity and benign prostatic hyperplasia: clinical connections, emerging etiological paradigms and future directions. J Urol. 2013;189(1):102-6.

Bhat SA, Rather SA, Islam N. An overview of benign prostatic hyperplasia and its appreciation in Greco-Arab (Unani) system of medicine. Asian J Urol. 2021.

CCRUM. Kabiruddin M. Kitāb Al-Akhlāt. New Delhi: CCRUM; 2009: 79,85.

Dornbier R, Pahouja G, Branch J, McVary KT. The New American Urological Association Benign Prostatic Hyperplasia Clinical Guidelines: 2019 Update. Curr Urol Rep. 2020;21(9):32.

Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TRW, Mamoulakis C, et al. Management of Non-neurogenic Male LUTS: EAU Guidelines. European Association of Urology. 2020.

Dong Z, Wang Z, Yang K, Liu Y, Gao W, Chen W. Tamsulosin versus terazosin for benign prostatic hyperplasia: a systematic review. Syst Biol Reprod Med. 2009;55(4):129-36.

Kabir-ud-din M. Makhzanul Mufradāt. 3rd ed. New Delhi: Idara Kitāb-ul-Shifa; 2014: 50,95,96,225,261,355,356,388,389,415,416.

Antaki D. Tazkira ulul Albab wa Jami‘ul Ajabul Ajāb Part III. New Delhi: CCRUM; 2010: 48-49.

CCRUM. National Formulary of Unani Medicine Part I. New Delhi: CCRUM; 1993: 69.

Sarup P, Bala S, Kamboj S. Pharmacology and Phytochemistry of oleo-gum resin of commiphora wightii (Guggulu). Scientific. 2015;5:1-14.

Bhat SA, Rather SA. Medicinal benefits and scientific justification of commiphora mukul (muqil): a review. J Drug Delivery Therap. 2021;11(1):170-2.

Jain G, Das P. Guggulsterone: mechanism of action and prospects of chemoprevention in prostate cancer. Int J Pharm Sci Res. 2020;11(4):1527-36.

Bhat AA, Prabhu KS, Kuttikrishnan S, Krishnankutty R, Ramzi M. Potential therapeutic targets of guggulsterone in cancer. Nutr Metab. 2017;14:23.

Foster HE, Barry MJ, Gandhi MC, Kaplan SA, Kohler TS, Lerner LB, et al. Benign Prostatic Hyperplasia: Surgical Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms. American Urological Association, 2019. Available at: https://www.auanet.org/guidelines/benign-prostatic-hyperplasia-(bph)-guideline . Accessed on 15 July 2021.

Gnyawali D, Sharma U. Correlation of prostate volume with ‘International Prostate Symptom Score’ and ‘Benign Prostatic Hyperplasia-Impact Index’ in benign prostatic hyperplasia. J Societ Surg Nepal. 2014;17(1):6-9.

Tarique M, Ali T. A comparative study of efficacy and safety of a Unani formulation with the currently available drugs (Tamsulosin and Finasteride) in the management of lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia. Int J Sci Res. 2020;9(1):66-7.

Vahlensieck W, Theurer C, Pfitzer E, Patz B, Banik N, Engelmann U. Effects of Pumpkin Seeds in men with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia in the One-Year Randomized, Placebo-Controlled GRANU Study. Urol Int. 2015;94:286-95.

Khan ZH, Akhtar MZ, Akhtar MW, Parveen S. Clinical study on haemorrhoids and therapeutic evaluation of habb-e-rasaut and habb-e-muqil in its management. Hamdard Medicus. 2013;56(1):31-9.

Ansari A, Saleem S. Clinical efficacy of certain Unani treatment in the management of Waja-ur-Rukba (Knee-Osteoarthitis): a comparative observational study. J Biological Scientif Opinion. 2019;7(1):4-6.

Khare CP. Indian medicinal plants, An Illustrated Dictionary. New York, NY: Springer Science; 2007: 32,33,79,101,238,239,253,663,654.

Madersbacher S, Sampson N, Culig Z. Pathophysiology of benign prostatic hyperplasia and benign prostatic enlargement: a mini-review. Gerontology. 2019;65:458-64.

Loeb S, Kettermann A, Carter HB, Ferrucci L, Metter EJ, Walsh PC. Prostate volume changes over time: Results from the Baltimore Longitudinal Study of Aging. J Urol. 2009;182:1458-62.

Bosch JL, Tilling K, Bohnen AM, Bangma CH, Donovan JL. Establishing normal reference ranges for prostate volume change with age in the population-based Krimpen-study: Prediction of future prostate volume in individual men. Prostate. 2007;67:1816-24.

Roehrborn CG, Wilson TH, Black LK. Quantifying the contribution of symptom improvement to satisfaction of men with moderate to severe benign prostatic hyperplasia: 4-year data from the combat trial. J Urol. 2012;187:1732-8.

Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Corkery E, et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol. 1995;154(5):1770-4.

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Published

2021-08-21

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Original Research Articles