2024, Número 1
<< Anterior Siguiente >>
Med Int Mex 2024; 40 (1)
Eficacia y seguridad de una fitofórmula coadyuvante en el tratamiento de pacientes con diabetes mellitus tipo 2
García ENA, Morales TH, Sacchi CR, Morales SN, Ortega GJI, Primelles GJA, Valencia GMM, Ayala CE, Ochoa MC
Idioma: Español
Referencias bibliográficas: 77
Paginas: 19-35
Archivo PDF: 282.31 Kb.
RESUMEN
Objetivo: Evaluar la eficacia y seguridad de la fitofórmula Elevaté® Body Balance
que incluye varios productos naturales (shilajit, chaga, moringa, berberina y bayetilla)
como coadyuvante en el tratamiento de pacientes con diabetes mellitus tipo 2.
Materiales y Métodos: Estudio retrospectivo de casos y controles, analítico,
comparativo, que incluyó pacientes con diabetes mellitus 2, realizado de enero a
diciembre de 2016. El grupo experimental recibió 1.5 g al día de la fitofórmula y el
grupo control recibió placebo (50 mg al día de vitamina C) durante 90 días. Se hicieron
determinaciones sociodemográficas, clínicas, somatométricas y bioquímicas. Además,
un subanálisis a segmentos de la población sin tratamiento alopático, así como a la
población que consumió la fitofórmula 180 días.
Resultados: Se incluyeron 368 sujetos: 269 en el grupo experimental y 99 en el
grupo control. Se observaron disminución en las concentraciones de la HbA1c en la
población total, junto con aumento de la población dentro de la categoría de “buen
control”, que se correlacionaron con la reducción de parámetros somatométricos y
bioquímicos asociados con riesgo cardiometabólico en los pacientes que recibieron la
fitofórmula durante 3 meses. La evaluación de las reacciones adversas reportadas por
los pacientes sugiere que el consumo de la fitofórmula es seguro como coadyuvante
en el tratamiento de pacientes con diabetes mellitus 2.
Conclusiones: Los resultados muestran un potencial uso eficaz y seguro de shilajit,
chaga, moringa, berberina y bayetilla en una fitofórmula como coadyuvante en el
control glucémico de los pacientes con diabetes mellitus tipo 2.
REFERENCIAS (EN ESTE ARTÍCULO)
Roden M, Shulman GI. The integrative biology of type 2diabetes. Nature 2019; 576 (7785): 51-60. https://doi.org/10.1038/s41586-019-1797-8.
Classification and Diagnosis of Diabetes: Standards ofMedical Care in Diabetes—2022. Diabetes Care 2022;45 (Supplement 1): S17-38. https://doi.org/10.2337/dc22-S002.
Sun H, Saeedi P, Karuranga S, Pinkepank M, Ogurtsova K,Duncan BB, et al. IDF Diabetes Atlas: Global, regional andcountry-level diabetes prevalence estimates for 2021 andprojections for 2045. Diabetes Res Clin Pract 2022; 183:109119. https://doi.org/10.1016/j.diabres.2021.109119.
Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S,Unwin N, et al. Global and regional diabetes prevalenceestimates for 2019 and projections for 2030 and 2045:Results from the International Diabetes Federation DiabetesAtlas, 9th edition. Diabetes Res Clin Pract 2019; 157:107843. doi: 10.1016/j.diabres.2019.107843.
Secretaría de Salud S de P y P de la SDG de Epidemiología.https://www.gob.mx/cms/uploads/attachment/file/562699/InformeCierre2019_DMT2_hospitalaria.PDF.2019. Informe Epidemiológico de Cierre 2019: Sistemade Vigilancia Epidemiológica Hospitalaria de DIABETESMELLITUS TIPO 2. Ciudad de México, México; 2019.
Gomes MB, Rathmann W, Charbonnel B, Khunti K, KosiborodM, Nicolucci A, et al. Treatment of type 2 diabetesmellitus worldwide: Baseline patient characteristics in theglobal DISCOVER study. Diabetes Res Clin Pract 2019; 151:20-32. doi: 10.1016/j.diabres.2019.03.024.
ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM,Bruemmer D, et al. Pharmacologic approaches to glycemictreatment: Standards of care in diabetes—2023. DiabetesCare 2023; 46 (Supplement_1): S140-57. https://doi.org/10.2337/dc23-S009.
Evert AB, Dennison M, Gardner CD, Garvey WT, Lau KHK,MacLeod J, et al. Nutrition therapy for adults with diabetesor prediabetes: A consensus report. Diabetes Care 2019;42 (5): 731-54. doi: 10.2337/dci19-0014.
Jay Kogan A. Overcoming obstacles to effective care oftype 2 diabetes. Am J Manag Care 2009; 15 (9): 255-62.
Nwadiugwu MC, Bastola DR, Haas C, Russell D. Identifyingglycemic variability in diabetes patient cohorts and evaluatingdisease outcomes. J Clin Med 2021; 10 (7): 1477. doi:10.3390/jcm10071477.
Kieu A, King J, Govender RD, Östlundh L. The benefits ofutilizing continuous glucose monitoring of diabetes mellitusin primary care: a systematic review. J Diabetes Sci Technol2023; 17 (3): 762-74. doi: 10.1177/19322968211070855.
González Block MÁ, Díaz Portillo SP, Morales HR, RodríguezSaldaña J, Gutiérrez Calderón E. Diabetes care innovationin the Mexican Institute for Social Insurance: Scaling up thepreventive chronic disease care model to address criticalcoverage constraints. Prim Care Diabetes 2021; 15 (2):314-22. doi: 10.1016/j.pcd.2020.10.012.
Pang GM, Li FX, Yan Y, Zhang Y, Kong LL, Zhu P, et al. Herbalmedicine in the treatment of patients with type 2 diabetesmellitus. Chin Med J (Engl) 2019; 132 (1): 78-85. doi:10.1097/CM9.0000000000000006.
Onaolapo AY, Onaolapo OJ. Nutraceuticals and diet-basedphytochemicals in type 2 diabetes mellitus: From wholefood to components with defined roles and mechanisms.Curr Diabetes Rev 2019; 16 (1): 12-25. doi: 10.2174/1573399814666181031103930.
Sridharan K, Mohan R, Ramaratnam S, PanneerselvamD. Ayurvedic treatments for diabetes mellitus. CochraneDatabase of Syst Rev 2011; 2015. doi: 10.1002/14651858.CD008288.pub2.
Suvarna R, Shenoy RP, Hadapad BS, Nayak AV. Effectivenessof polyherbal formulations for the treatment of type 2Diabetes mellitus - A systematic review and meta-analysis.J Ayurveda Integr Med 2021; 12 (1): 213-22. doi: 10.1016/j.jaim.2020.11.002.
Feinberg T, Wieland LS, Miller LE, Munir K, Pollin TI,Shuldiner AR, et al. Polyherbal dietary supplementationfor prediabetic adults: study protocol for a randomizedcontrolled trial. Trials 2019; 20 (1): 24. doi: 10.1186/s13063-018-3032-6.
Stohs SJ. Safety and efficacy of shilajit (mumie, moomiyo).Phytotherapy Res 2014; 28 (4): 475-9. doi: 10.1002/ptr.5018.
Hou Q, He WJ, Wu YS, Hao HJ, et al. Berberine: A traditionalnatural product with novel biological activities. Altern TherHealth Med. 2020 Jul; 26:20–7.
Noor G, Ahmad MdA, Ahsan F, Mahmood T, Arif M,Khushtar M. A phytochemical and ethnopharmacologicalrecapitulation on hamelia patens. Drug Res 2020; 70 (05):188-98. doi: 10.1055/a-1131-7856.
Dhakad AK, Ikram M, Sharma S, Khan S, Pandey VV, SinghA. Biological, nutritional, and therapeutic significance ofMoringa oleifera Lam. Phytother Res 2019; 33 (11): 2870-903. doi: 10.1002/ptr.6475.
Szychowski KA, Skóra B, Pomianek T, Gmiński J. Inonotusobliquus – from folk medicine to clinical use. J TraditComplement Med 2021; 11 (4): 293-302. https://doi.org/10.1016/j.jtcme.2020.08.003.
Ying YM, Zhang LY, Zhang X, Bai HB, Liang DE, Ma LF, etal. Terpenoids with alpha-glucosidase inhibitory activity from the submerged culture of Inonotus obliquus.Phytochemistry 2014; 108: 171-6. doi: 10.1016/j.phytochem.2014.09.022.
Shin Y, Tamai Y, Terazawa M. Chemical constituents of Inonotusobliquus II: a new triterpene, 21,24-cyclopentalanosta-3β,21,25-triol-8-ene from sclerotium. J Wood Sci 2001; 47(4): 313-6. https://doi.org/10.1007/BF00766719.
Wold CW, Gerwick WH, Wangensteen H, InngjerdingenKT. Bioactive triterpenoids and water-soluble melaninfrom Inonotus obliquus (Chaga) with immunomodulatoryactivity. J Funct Foods 2020; 71: 104025. https://doi.org/10.1016/j.jff.2020.104025.
Ma L, Chen H, Dong P, Lu X. Anti-inflammatory and anticanceractivities of extracts and compounds from themushroom Inonotus obliquus. Food Chem 2013; 139 (1-4):503-8. doi: 10.1016/j.foodchem.2013.01.030.
Zhukovich EN SMSLPT. Tetracyclic triterpenes from InonotusObliquus (Pers.) Pil. (Chaga) growing in Russia. PharmChem J 2010. https://doi.org/10.1007/s11094-010-0500-z.
Kim JH, Park SK, Cho CW, Le BV, Kim YH, Bao H, et al.Quality control and evaluation of Inonotus obliquus usingHPLC method with novel marker compounds. J Anal SciTechnol. 2020; 11 (1): 52. https://doi.org/10.1186/s40543-020-00249-z.
Ding R, Zhao M, Fan J, Hu X, Wang M, Zhong S, et al. Mechanismsof generation and exudation of Tibetan medicineShilajit (Zhaxun). Chin Med 2020; 15 (1): 65. https://doi.org/10.1186/s13020-020-00343-9.
Al-Salman F, Redha AA, Al-Zaimor Z. Inorganic analysisand antioxidant activity of shilajit. Int J Sci Res Chem Sci2020; 7 (3): 5-10.
Carrasco-Gallardo C, Guzmán L, Maccioni RB. Shilajit:A Natural phytocomplex with potential procognitiveactivity. Int J Alzheimers Dis 2012; 2012: 1-4. doi:10.1155/2012/674142.
Agarwal SP, Khanna R, Karmarkar R, Anwer MdK, Khar RK.Shilajit: a review. Phytother Res 2007; 21 (5): 401-5. doi:10.1002/ptr.2100.
Wilson E, Rajamanickam GV, Dubey GP, Klose P, Musial F,Saha FJ, et al. Review on shilajit used in traditional Indianmedicine. J Ethnopharmacol. 2011; 136 (1): 1-9. doi:10.1016/j.jep.2011.04.033.
Rego T. O efeito da berberina na sensibilidade à insulinanum modelo animal de diabetes tipo 2. [Coimbra]: Universidadede Coimbra; 2021.
Li Z, Geng YN, Jiang JD, Kong WJ. Antioxidant and antiinflammatoryactivities of berberine in the treatment ofdiabetes mellitus. Evid Based Complement Alternat Med2014; 2014: 1-12. doi: 10.1155/2014/289264.
Zhang H, Wei J, Xue R, Wu JD, Zhao W, Wang ZZ, et al.Berberine lowers blood glucose in type 2 diabetes mellituspatients through increasing insulin receptor expression.Metabolism 2010; 59 (2): 285-92. doi: 10.1016/j.metabol.2009.07.029.
Och A, Och M, Nowak R, Podgórska D, Podgórski R. Berberine,a herbal metabolite in the metabolic syndrome: The riskfactors, course, and consequences of the disease. Molecules2022; 27 (4): 1351. doi: 10.3390/molecules27041351.
Han J, Lin H, Huang W. Modulating gut microbiota as ananti-diabetic mechanism of berberine. Med Sci Monit 2011;17 (7): RA164-7. doi: 10.12659/msm.881842.
Anwar F, Latif S, Ashraf M, Gilani AH. Moringa oleifera: afood plant with multiple medicinal uses. Phytother Res2007; 21 (1): 17-25. doi: 10.1002/ptr.2023.
Jaiswal D, Rai PK, Mehta S, Chatterji S, Shukla S, Rai DK, et al.Role of Moringa oleifera in regulation of diabetes-inducedoxidative stress. Asian Pac J Trop Med 2013; 6 (6): 426-32.doi: 10.1016/S1995-7645(13)60068-1.
Manohar VS, Jayasree T, Kiran K, Rupa M, et al. Evaluationof hypoglycemic and antihyperglycemic effect of freshlyprepared aqueous extract of Moringa oleifera leaves innormal and diabetic rabbits. J Chem Pharm 2012; 4: 249-53.
Woldekidan S, Mulu A, Ergetie W, Teka F, Meressa A, TadeleA, et al. Evaluation of antihyperglycemic effect of extract ofMoringa stenopetala (Baker f.) aqueous leaves on alloxaninduceddiabetic rats. Diabetes Metab Syndr Obes 2021;14: 185-92. doi: 10.2147/DMSO.S266794.
Alonso-Castro AJ, Balleza-Ramos S, Hernández-Morales A,Zapata-Morales JR, González-Chávez MM, Carranza-ÁlvarezC. Toxicity and antinociceptive effects of Hamelia patens.Rev Bras Farmacognosia 2015; 25 (2): 170-6. https://doi.org/10.1016/j.bjp.2015.03.007.
Rugerio-Escalona C, Ordaz-Pichardo C, Becerra-MartinezE, Cruz-López M del C, López-y-López VE, Mendieta-Moctezuma A, et al. “Diabetes and metabolism disordersmedicinal plants: A glance at the past and a look to thefuture 2018”: Antihyperglycemic activity of Hamelia patensJacq. Extracts. Evid Based Complement Alt Med 2018;2018: 1-9. doi: 10.1155/2018/7926452.
Reyes-Chilpa R, Rivera J, Oropeza M, Mendoza P, AmekrazB, Jankowski C, et al. Methanol extracts of hamelia patenscontaining oxindole alkaloids relax KCl-induced contractionin rat myometrium. Biol Pharm Bull 2004; 27 (10): 1617-20.doi: 10.1248/bpb.27.1617.
Surana AR, Wagh RD. GC-MS profiling and antidepressantlikeeffect of the extracts of Hamelia patens in animalmodel. Bangladesh J Pharmacol 2017; 12 (4): 410. Doi:10.3329/bjp.v12i4.32622.
Paz JEW, Contreras CR, Munguía AR, Aguilar CN, InungarayMLC. Phenolic content and antibacterial activity of extractsof Hamelia patens obtained by different extractionmethods. Braz J Microbiol 2018; 49 (3): 656-61. https://doi.org/10.1016/j.bjm.2017.03.018.
Flores-Sanchez IJ, Ramos-Valdivia AC. A review frompatents inspired by two plant genera: Uncaria and Hamelia.Phytochem Rev 2017; 16 (4): 693-723. https://doi.org/10.1007/s11101-017-9498-0.
Ragheb SR, El Wakeel LM, Nasr MS, Sabri NA. Impact ofrutin and vitamin C combination on oxidative stress andglycemic control in patients with type 2 diabetes. ClinNutr ESPEN 2020; 35: 128-35. https://doi.org/10.1016/j.clnesp.2019.10.015.
Bishop N, Schorah CJ, Wales JK. The effect of vitamin Csupplementation on diabetic hyperlipidemia: a doubleblind, crossover study. Diabet Med 1985; 2 (2): 121-4. doi:10.1111/j.1464-5491.1985.tb00614.x.
Instituto Mexicano del Seguro Social CT de EC y C deUM de AE. http://www.imss.gob.mx/sites/all/statics/guiasclinicas/718GRR.pdf. 2018. Diagnóstico y TratamientoFarmacológico de la Diabetes Mellitus Tipo 2 en el PrimerNivel de Atención. Guía de Referencia Rápida: Guía dePráctica Clínica.
Diario Oficial de la Federación (DOF). http://dof.gob.mx/nota_detalle.php?codigo=5490830&fecha=19/07/2017.2017. NORMA Oficial Mexicana NOM-220-SSA1-2016,Instalación y operación de la farmacovigilancia.
Ross SA. Breaking down patient and physician barriers tooptimize glycemic control in type 2 diabetes. Am J Med2013; 126: S38-S48. doi: 10.1016/j.amjmed.2013.06.012.
Rushforth B, McCrorie C, Glidewell L, Midgley E, Foy R.Barriers to effective management of type 2 diabetes inprimary care: Qualitative systematic review. Br J Gen Pract2016; 66: e114-e127. doi: 10.3399/bjgp16X683509.
Balbaa M, El-Zeftawy M, Abdulmalek SA. Therapeuticscreening of herbal remedies for the management ofdiabetes. Molecules 2021; 26 (22): 6836. doi: 10.3390/molecules26226836.
Padhi S, Nayak AK, Behera A. Type II diabetes mellitus:a review on recent drug-based therapeutics. BiomedPharmacother 2020; 131: 110708. doi: 10.1016/j.biopha.2020.110708.
Wei Y, Ding QY, Yeung C, Huang YS, Zhang BX, Zhang LL,Miao RY, Di S, Zhao LH, Tong XL. Evidence and potentialmechanisms of traditional chinese medicine for the adjuvanttreatment of coronary heart disease in patients withdiabetes mellitus: A systematic review and meta-analysiswith trial sequential analysis. J Diabetes Res 2022; 2022:2545476. doi: 10.1155/2022/2545476.
Sartore G, Ragazzi E, Antonello G, Cosma C, Lapolla A. Effectof a new formulation of nutraceuticals as an add-on to metforminmonotherapy for patients with type 2 diabetes andsuboptimal glycemic control: A randomized controlled trial.Nutrients 2021; 13 (7): 2373. doi: 10.3390/nu13072373.
Rao AS, Hegde S, Pacioretty LM, DeBenedetto J, Babish JG.Nigella sativa and Trigonella foenum-graecum supplementedchapatis safely improve HbA1c, body weight, waist circumference,blood lipids, and fatty liver in overweight and diabeticsubjects: A twelve-week safety and efficacy study. J MedFood 2020; 23 (9): 905-919. doi: 10.1089/jmf.2020.0075.
Rotman-Pikielny P, Ness-Abramof R, Charach G, Roitman A,Zissin R, Levy Y. Efficacy and safety of the dietary supplementDBCare® in patients with type 2 diabetes mellitus andinadequate glycemic control. J Am Coll Nutr 2014; 33 (1):55-62. doi: 10.1080/07315724.2014.870008.
Pan J, Xu Y, Chen S, Tu Y, Mo Y, Gao F, Zhou J, Hu C, Jia W.The effectiveness of traditional Chinese medicine jinlidagranules on glycemic variability in newly diagnosed type2 diabetes: A double-blinded, randomized trial. J DiabetesRes 2021; 2021: 6303063. doi: 10.1155/2021/6303063.
Zhang Z, Liang X, Tong L, Lv Y, Yi H, Gong P, Tian X, Cui Q, LiuT, Zhang L. Effect of Inonotus obliquus (Fr.) Pilat extract onthe regulation of glycolipid metabolism via PI3K/Akt andAMPK/ACC pathways in mice. J Ethnopharmacol 2021; 273:113963. doi: 10.1016/j.jep.2021.113963.
Bhattacharya SK, Satyan KS, Chakrabarti A. Effect of Trasina,an Ayurvedic herbal formulation, on pancreatic islet superoxidedismutase activity in hyperglycaemic rats. Indian JExp Biol 1997; 35 (3): 297-9.
Zhang N, Liu X, Zhuang L, Liu X, Zhao H, Shan Y, Liu Z, Li F,Wang Y, Fang J. Berberine decreases insulin resistance in aPCOS rats by improving GLUT4: Dual regulation of the PI3K/AKT and MAPK pathways. Regul Toxicol Pharmacol 2020;110: 104544. doi: 10.1016/j.yrtph.2019.104544.
Girogino F, Laviola L, Leonardini A. Pathophysiology oftype 2 diabetes: Rationale for different oral antidiabetictreatment strategies. Diabetes Res Clin Prac 2005; 68:S22-9. doi: 10.1016/j.diabres.2005.03.012.
Birková A. Caffeic acid: a brief overview of its presence,metabolism, and bioactivity. Bioact Compd Health Dis2020; 3 (4): 74. DOI: 10.31989/bchd.v3i4.692.
Espíndola KMM, Ferreira RG, Narvaez LEM, Silva RosarioACR, da Silva AHM, Silva AGB, et al. Chemical and pharmacologicalaspects of caffeic acid and its activity in hepatocarcinoma.Front Oncol 2019; 9. https://doi.org/10.3389/fonc.2019.00541.
Hosseini A, Razavi BM, Banach M, Hosseinzadeh H. Quercetinand metabolic syndrome: A review. Phytother Res2021; 35 (10): 5352-64. doi: 10.1002/ptr.7144.
Shatylo V, Antoniuk-Shcheglova I, Naskalova S, BondarenkoO, Havalko A, Krasnienkov D, et al. Cardio-metabolicbenefits of quercetin in elderly patients with metabolicsyndrome. PharmaNutrition 2021; 15: 100250. https://doi.org/10.1016/j.phanu.2020.100250.
Ye X, Liu Y, Hu J, Gao Y, Ma Y, Wen D. Chlorogenic acidinducedgut microbiota improves metabolic endotoxemia.Front Endocrinol (Lausanne) 2021; 12. doi: 10.3389/fendo.2021.762691.
Santana-Gálvez J, Cisneros-Zevallos L, Jacobo-VelázquezD. Chlorogenic acid: recent advances on its dual role asa food additive and a nutraceutical against metabolicsyndrome. Molecules 2017; 22 (3): 358. doi: 10.3390/molecules22030358.
Hodges JK, Zhu J, Yu Z, Vodovotz Y, Brock G, Sasaki GY,et al. Intestinal-level anti-inflammatory bioactivities ofcatechin-rich green tea: Rationale, design, and methods ofa double-blind, randomized, placebo-controlled crossovertrial in metabolic syndrome and healthy adults. ContempClin Trials Commun 2020; 17: 100495. doi: 10.1016/j.conctc.2019.100495.
Muvhulawa N, Dludla P V., Ziqubu K, Mthembu SXH,Mthiyane F, Nkambule BB, et al. Rutin ameliorates inflammationand improves metabolic function: A comprehensiveanalysis of scientific literature. Pharmacol Res 2022; 178:106163. doi: 10.1016/j.phrs.2022.106163.
Cai C, Cheng W, Shi T, Liao Y, Zhou M, Liao Z. Rutin alleviatescolon lesions and regulates gut microbiota in diabeticmice. Sci Rep 2023; 13 (1): 4897. https://doi.org/10.1038/s41598-023-31647-z.
Yin J, Xing H, Ye J. Efficacy of berberine in patients withtype 2 diabetes mellitus. Metabolism 2008; 57 (5): 712-7.doi: 10.1016/j.metabol.2008.01.013.
Harrison SA, Gunn N, Neff GW, Kohli A, Liu L, Flyer A,Goldkind L, Di Bisceglie AM. A phase 2, proof of concept,randomised controlled trial of berberine ursodeoxycholatein patients with presumed non-alcoholic steatohepatitisand type 2 diabetes. Nat Commun 2021; 12 (1): 5503. doi:10.1038/s41467-021-25701-5.
Zhang Y, Li X, Zou D, Liu W, Yang J, Zhu N, Huo L, Wang M,Hong J, Wu P, Ren G, Ning G. Treatment of type 2 diabetesand dyslipidemia with the natural plant alkaloid berberine.J Clin Endocrinol Metab 2008; 93 (7): 2559-65. doi:10.1210/jc.2007-2404.