ERRATUM: A Single-Blind, Randomized, Controlled Trial Assessing the Efficacy and Safety Parameters of Traditional Thai Medicine, Aphayathikun, in Prediabetic Men with Lower Urinary Tract Symptoms http://www.doi.org/10.26538/tjnpr/v7i11.12
Main Article Content
Abstract
Lower urinary tract symptoms (LUTS) are not only more common in the elderly, but various pathophysiological pathways suggest a link between hyperglycemia and LUTS. Due to the long-standing traditional use of medicinal plants in Thailand, the present work aims to establish the safety and efficacy of Aphayathikun (AP), a recorded Thai Traditional medicinal drug for LUTS. The standardized decoction of AP has been established, and phenolic and flavonoid content, antioxidant activity, and in vivo toxicity were assessed using previously published methods. A randomized, open-label, controlled study was conducted on 34 prediabetic men with mild to moderate uncomplicated LUTS. As a supplementary treatment for standard self-management, 30 mL of AP decoction was administered thrice daily before meals for 14 consecutive days. Baseline and endpoint (the 4th week) improvements in IPSS scores, blood glucose control, serum lipid profiles, and liver function testing of the subjects were determined. There was an improvement in the total IPSS score and a significant decrease in the IPSS voiding and storage subscores among the subjects in the AP group. Additionally, the quality-of-life index, as measured by the IPSS, and the number of nocturia episodes per night decreased significantly from baseline to the 4th week in the AP group. This traditional polyherbal preparation, AP decoction, appears to be a safe and effective therapy option for the alternative treatment of mild-to-moderate LUTS in prediabetic patients.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
References
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas 9th Edittion. Diabetes Res Clin Pract. 2019; 157:107843.
Hostalek U. Global epidemiology of prediabetes - present and future perspectives. Clin Diabetes Endocrinol. 2019; 5:5.
Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, Cavan D, Shaw JE, Makaroff LE. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017; 128:40-50.
Priya G. Management of prediabetes. J Pak Med Assoc. 2018; 68(4):669-671.
Zheng Y, Ley SH, Hu FB. Global aetiology and epidemiology of type 2 diabetes mellitus and its complications. Nat Rev Endocrinol. 2018; 14(2):88-98.
Tam CA, Helfand BT, Erickson BA. The relationship between diabetes, diabetes severity, diabetes biomarkers, and the presence of lower urinary tract symptoms: findings from the National Health and Nutrition Examination Survey. Urology. 2017; 105:141-148.
Park S, Ryu JM, Lee M. Quality of life in older adults with benign prostatic hyperplasia. Healthc. 2020; 8(2):158.
Kopp W. Diet-induced hyperinsulinemia as a key factor in the etiology of both benign prostatic hyperplasia and essential hypertension? Nutr Metab Insights. 2018; 11:1-11.
Calmasini FB, McCarthy CG, Wenceslau CF, Priviero FBM, Antunes E, Webb RC. Toll-like receptor 9 regulates metabolic profile and contributes to obesity-induced benign prostatic hyperplasia in mice. Pharmacol Rep. 2020; 72(1):179-187.
Ngai HY, Yuen KKS, Ng CM, Cheng CH, Chu SKP. Metabolic syndrome and benign prostatic hyperplasia: An update. Asian J. Urol. 2017; 4(3):164-173.
Lim KB. Epidemiology of clinical benign prostatic hyperplasia. Asian J. Urol. 2017; 4(3):148-151.
Sarkar PL, Lee W, Williams ED, Lubik AA, Stylianou N, Shokoohmand A, Lehman ML, Hollier BG, Gunter JH, Nelson CC. Insulin enhances migration and invasion in prostate cancer cells by up-regulation of FOXC2. Front. Endocrinol. 2019; 10:481-481.
Andersson KE. Oxidative stress and lower urinary tract symptoms: cause or consequence? BJU Int. 2019; 123(5):749-750.
Andersson KE. Oxidative stress and its possible relation to lower urinary tract functional pathology. BJU Int. 2018; 121(4):527-533.
Nomiya M, Andersson KE, Yamaguchi O. Chronic bladder ischemia and oxidative stress: new pharmacotherapeutic targets for lower urinary tract symptoms. Int J Urol. 2015; 22(1):40-46.
Dreikorn K. The role of phytotherapy in treating lower urinary tract symptoms and benign prostatic hyperplasia. World J Urol. 2002; 19(6):426-435.
Lowe FC, Fagelman E. Phytotherapy in the treatment of benign prostatic hyperplasia: an update. Urology. 1999; 53(4):671-678.
Fornara P, Madersbacher S, Vahlensieck W, Bracher F, Romics I, Kil P. Phytotherapy adds to the therapeutic armamentarium for the treatment of mild-to-moderate lower urinary tract symptoms in men. Urol. Int. 2020; 104(5-6):333-342.
Vela-Navarrete R, Alcaraz A, Rodríguez-Antolín A, Miñana López B, Fernández-Gómez JM, Angulo JC, Castro Díaz D, Romero-Otero J, Brenes FJ, Carballido J, Molero García JM, Fernández-Pro Ledesma A, Cózar Olmos JM, Manasanch Dalmau J, Subirana Cachinero I, Herdman M, Ficarra V. Efficacy and safety of a hexanic extract of Serenoa repens (Permixon(®) ) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies. BJU Int. 2018; 122(6):1049-1065.
Bae WJ, Park HJ, Koo HC, Kim DR, Ha US, Kim KS, Kim SJ, Cho HJ, Hong SH, Lee JY, Hwang SY, Kim SW. The effect of Seoritae extract in men with mild to moderate lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Evid. Based Complementary Altern. Med. 2016; 2016:1-7.
Vahlensieck W, Theurer C, Pfitzer E, Patz B, Banik N, Engelmann U. Effects of pumpkin seed 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(3):286-295.
Wetchakul P, Goon JA, Adekoya AE, Olatunji OJ, Ruangchuay S, Jaisamut P, Issuriya A, Kunworarath N, Limsuwan S, Chusri S. Traditional tonifying polyherbal infusion, Jatu-Phala-Tiga, exerts antioxidant activities and extends lifespan of Caenorhabditis elegans. BMC Complement Altern Med. 2019; 19(1):209.
Limsuwan S, Jarukitsakul S, Issuriya A, Chusri S, Joycharat N, Jaisamut P, Saising J, Jetwanna KW, Voravuthikunchai SP. Thai herbal formulation 'Ya-Pit-Samut-Noi': Its antibacterial activities, effects on bacterial virulence factors and in vivo acute toxicity. J Ethnopharmacol. 2020; 259:1-13.
Thunthivehthchakul V. Manchusaravichian. In: Tumra Paetsart Sonkhrau Chabub Luang. (3rd ed.). Bangkok: The WatPho Thai Traditional Medical School; 1957. p 62-69.
Nalamolu KR, Nammi S. Antidiabetic and renoprotective effects of the chloroform extract of Terminalia chebula Retz. seeds in streptozotocin-induced diabetic rats. BMC Complement Altern Med. 2006; 6:17.
Srinivasan P, Vijayakumar S, Kothandaraman S, Palani M. Anti-diabetic activity of quercetin extracted from Phyllanthus emblica L. fruit: In silico and in vivo approaches. J. Pharm. Anal. 2018; 8(2):109-118.
Karan SK, Pal D, Mishra SK. Anti-hyperglycaemic effect of Vetiveria zizanioides (L.) nash root extract in alloxan induced diabetic rats. Asian J Chem. 2013; 25(3):1555-1557.
Singh P, Khosa RL, Mishra G, Jha KK. Antidiabetic activity of ethanolic extract of Cyperus rotundus rhizomes in streptozotocin-induced diabetic mice. J. Pharm. Bioallied Sci. 2015; 7(4):289-292.
OECD. Test No. 425: Acute Oral Toxicity: Up-and-Down Procedure, OECD Guidelines for the Testing of Chemicals, Section 4, OECD
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007; 39(2):175-191.
Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009; 41(4):1149-1160.
Tuomilehto J, Lindström J, Eriksson JG, Valle TT, Hämäläinen H, Ilanne-Parikka P, Keinänen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001; 344(18):1343-1350.
Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019; 202(3):558-563.
Hamvas A, Corradi G, Hegedüs M, Frang D. Experience with the Peponen capsule in the management of benign prostatic hyperplasia. Int Urol Nephrol. 1991; 23(1):51-55.
Murata K, Noguchi K, Kondo M, Onishi M, Watanabe N, Okamura K, Matsuda H. Inhibitory activities of Puerariae Flos against testosterone 5α-reductase and its hair growth promotion activities. J. Nat. Med. 2012; 66(1):158-165.
Kumar T, Chaiyasut C, Rungseevijitprapa W, Suttajit M. Screening of steroid
α-reductase inhibitory activity and total phenolic content of Thai plants. J. Med. Plant Res. 2011; 5(7):1265-1271.
Ghosh A, Pakhira BP, Tripathy A, Ghosh D. Male contraceptive efficacy of poly herbal formulation, contracept-TM, composed of aqueous extracts of Terminalia chebula fruit and Musa balbisiana seed in rat. Pharm. Biol. 2017; 55(1):2035-2042.
Leibbrand M, Siefer S, Schön C, Perrinjaquet-Moccetti T, Kompek A, Csernich A, Bucar F, Kreuter MH. 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. J. Med. Food. 2019; 22(6):551-559.
Fruhwirth GO, Hermetter A. Seeds and oil of the Styrian oil pumpkin: components and biological activities. Eur. J. Lipid Sci. Technol. 2007; 109:1128-1140.