Medicamentos Herbales y Suplementos Dietéticos: Evidencia, Seguridad y Desafíos Regulatorios en la actualidad
DOI:
https://doi.org/10.70099/BJ/2026.03.01.6Palabras clave:
suplementos dietéticos, medicina herbal, regulación, farmacovigilancia, seguridad, evidencia científica, armonización regulatoriaResumen
El uso de medicamentos herbales y suplementos dietéticos ha crecido de forma sostenida en las últimas dos décadas y hoy plantea preguntas muy concretas para la salud pública: qué productos realmente aportan beneficios, qué riesgos se están pasando por alto y cómo se están regulando. En esta revisión analizamos críticamente la literatura reciente y los marcos regulatorios vigentes, con énfasis en la evidencia de eficacia, los perfiles de seguridad descritos y la diversidad de enfoques regulatorios a nivel internacional. En conjunto, los datos sugieren que algunos productos —como Ginkgo biloba, Hypericum perforatum y determinadas formulaciones o cepas probióticas— cuentan con respaldo clínico moderado, pero que gran parte de la oferta comercial se apoya en evidencia limitada o poco consistente. En paralelo, persisten preocupaciones relevantes de seguridad, en especial la hepatotoxicidad, las interacciones con fármacos y la adulteración con principios activos sintéticos. Además, las diferencias regulatorias entre regiones (modelos con exigencias previas a la comercialización frente a enfoques centrados en la vigilancia poscomercialización) condicionan tanto la calidad de la evidencia disponible como la capacidad para detectar y gestionar riesgos. En consecuencia, se refuerza la necesidad de mejorar la farmacovigilancia, promover estudios clínicos más sólidos y avanzar hacia criterios regulatorios más coherentes que protejan al consumidor.
Citas
1. World Health Organization. WHO global report on traditional and complementary medicine 2019. Geneva: World Health Organization; 2019.
2. Thakkar S, Anklam E, Xu A, Ulberth F, Li J, Li B, et al. Regulatory landscape of dietary supplements and herbal medicines from a global perspective. Regul Toxicol Pharmacol. 2020;114:104647. doi:10.1016/j.yrtph.2020.104647.
3. Jagim AR, Harty PS, Kerksick CM. Common types of dietary supplements and adulteration: a review. Front Sports Act Living. 2023;5:1239121. doi:10.3389/fspor.2023.1239121.
4. Ekor M. The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol. 2014;4:177. doi:10.3389/fphar.2013.00177.
5. Domínguez Díaz LD, Fernández-Ruiz V, Cámara M. The frontier between nutrition and pharma: the international regulatory framework of functional foods, food supplements and nutraceuticals. Crit Rev Food Sci Nutr. 2020;60(9):1592-1603. doi:10.1080/10408398.2019.1592107.
6. Stickel F, Shouval D. Hepatotoxicity of herbal and dietary supplements: an update. Arch Toxicol. 2015;89(6):851-865. doi:10.1007/s00204-015-1471-3.
7. Komala M, Ong S, Qadri M, Elshafie L, Pollock C, Saad S. Investigating the regulatory process, safety, efficacy and product transparency for nutraceuticals in the USA, Europe and Australia. Foods. 2023;12(2):427. doi:10.3390/foods12020427.
8. Ng JY, Kim M, Suri A. Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review. J Pharm Policy Pract. 2022;15:55. doi:10.1186/s40545-022-00447-7.
9. Santini A, Cammarata S, Capone G, Ianaro A, Tenore G, Pani L, Novellino E. Nutraceuticals: opening the debate for a regulatory framework. Br J Clin Pharmacol. 2018;84:659-672. doi:10.1111/bcp.13496.
10. United States Congress. Dietary Supplement Health and Education Act of 1994 (DSHEA). Public Law 103-417. 1994.
11. Dwyer J, Coates PM, Smith M. Dietary Supplements: Regulatory Challenges and Research Resources. Nutrients. 2018;10(1):41. doi:10.3390/nu10010041.
12. Starr MJ. Too little, too late: ineffective regulation of dietary supplements in the United States. Am J Public Health. 2015;105(3):478-485. doi:10.2105/AJPH.2014.302348.
13. Coates PM, Bailey RL, Blumberg J, et al. The evolution of science and regulation of dietary supplements: past, present, and future. J Nutr. 2024;154(8):2335-2345. doi:10.1016/j.tjnut.2024.06.017.
14. European Parliament and Council. Directive 2004/24/EC of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC. Off J Eur Union. 2004.
15. European Parliament and Council. Directive 2002/46/EC of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Off J Eur Communities. 2002.
16. European Parliament and Council. Regulation (EC) No 1924/2006 of 20 December 2006 on nutrition and health claims made on foods. Off J Eur Union. 2006.
17. Bilia AR, Costa M. Medicinal plants and their preparations in the European market: Why has the harmonization failed? Phytomedicine. 2020;81:153421. doi:10.1016/j.phymed.2020.153421.
18. Government of Canada. Natural Health Products Regulations (SOR/2003-196). 2003.
19. Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA). Normativa técnica sanitaria para productos naturales procesados de uso medicinal. Quito: ARCSA; 2020.
20. Ng QX, Venkatanarayanan N, Ho CY. Clinical use of Hypericum perforatum (St John's wort) in depression: a meta-analysis. J Affect Disord. 2017;210:211-221.
21. Bailey RL. Current regulatory guidelines and resources to support research of dietary supplements in the United States. Crit Rev Food Sci Nutr. 2020;60(2):298-309. doi:10.1080/10408398.2018.1524364.
22. Vinson B, Holtmann G, et al. Efficacy and safety of STW 5-II for functional dyspepsia treatment: a patient data-based meta-analysis. Digestion. 2024;105(3):166-176. doi:10.1159/000535672.
23. Alammar N, Wang L, Saberi B, Nanavati J, Holtmann G, Shinohara RT, et al. The impact of peppermint oil on the irritable bowel syndrome: a meta-analysis of the pooled clinical data. BMC Complement Altern Med. 2019;19:21. doi:10.1186/s12906-018-2409-0.
24. Choi H, et al. Efficacy of melatonin for sleep: a meta-analysis of randomized controlled trials. Sleep Med Rev. 2022;63:101657. doi:10.1016/j.smrv.2022.101657.
25. Erland LAE, Saxena PK. Melatonin natural health products and supplements: presence of serotonin and significant variability of melatonin content. J Clin Sleep Med. 2017;13(2):275-281. doi:10.5664/jcsm.6462.
26. Shinjyo N, Waddell G. Valerian root in treating sleep problems and associated disorders—A systematic review and meta-analysis. J Evid Based Integr Med. 2020;25:2515690X20967323. doi:10.1177/2515690X20967323.
27. Nicolussi S, Drewe J, Butterweck V, Meyer Zu Schwabedissen HE. Pharmacokinetics and drug interactions of St. John's wort: a review. Drugs. 2020;80(13):1425-1446. doi:10.1007/s40265-020-01371-7.
28. Dai Q, et al. Effect of curcumin on osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Phytother Res. 2021;35(9):5174-5185.
29. Feng X, et al. Efficacy and safety of curcumin and Curcuma longa extract in osteoarthritis: a systematic review and meta-analysis. BMC Complement Med Ther. 2022;22:289. doi:10.1186/s12906-022-03740-9.
30. Navarro VJ, Khan I, Björnsson E, Seeff LB, Serrano J, Hoofnagle JH. Liver injury from herbal and dietary supplements. Hepatology. 2017;65(2):347-349. doi:10.1002/hep.28813.
31. Szajewska H, Kołodziej M. Systematic review with meta-analysis: Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea. Aliment Pharmacol Ther. 2015;42(7):793-801. doi:10.1111/apt.13344.
32. Goodman C, Keating G, Georgousopoulou E, Hespe C, Levett KM. Probiotics for the prevention of antibiotic-associated diarrhoea: a systematic review and meta-analysis. BMJ Open. 2021;11(8):e043054. doi:10.1136/bmjopen-2020-043054.
33. Abdel-Tawab M. Do We Need Plant Food Supplements? A critical examination of quality, safety, efficacy, and necessity for a new regulatory framework. Planta Med. 2017;84(5):372-393. doi:10.1055/s-0043-123764.
34. Crighton E, Coghlan ML, Farrington R, et al. A methodological framework for identifying contaminants and adulterants in botanical products using DNA sequencing and toxicological screening. J Pharm Biomed Anal. 2019;174:112834.
35. Veatch-Blohm M, Chicas I, Margolis K, Vanderminden R, Gochie M, Lila K. Screening for consistency and contamination within and between bottles of 29 herbal supplements. PLoS ONE. 2021;16(8):e0260463. doi:10.1371/journal.pone.0260463.
36. Djaoudene O, Romano A, Bradai Y, Zebiri F, Ouchene A, Yousfi Y, et al. A global overview of dietary supplements: regulation, market trends, usage during the COVID-19 pandemic, and health effects. Nutrients. 2023;15(15):3320. doi:10.3390/nu15153320.
37. Lin S, Tujios S. Hidden dangers: herbal and dietary supplement-induced hepatotoxicity. Livers. 2023;3(4):576-592. doi:10.3390/livers3040041.
38. Hudson A, Lopez E, Almalki A, Roe A, Calderón A. A review of the toxicity of compounds found in herbal dietary supplements. Planta Med. 2018;84(8):523-540. doi:10.1055/a-0605-3786.
39. Forgerini M, Schiavo G, Neto O, et al. Herbal medicines for weight loss and lipid profile improvement: a scoping review of therapeutic effects and safety. Phytother Res. 2025;39:4870-4912. doi:10.1002/ptr.70072.
40. Mishra S, Stierman B, Gahche JJ, Potischman N. Dietary supplement use among adults: United States, 2017–2018. NCHS Data Brief. 2021;(399):1-8.
41. Vojvodić S, Kobiljski D, Čonić B, Torović L. Landscape of herbal food supplements: where do we stand with health claims? Nutrients. 2025;17(9):1571. doi:10.3390/nu17091571.
42. Chopra A, Lordan R, Horbańczuk O, Atanasov A, et al. The current use and evolving landscape of nutraceuticals. Pharmacol Res. 2021;171:106001. doi:10.1016/j.phrs.2021.106001.
43. Dini I. The commercial importance to develop validated analytical methods to define phytochemical levels in herbal medicinal products. Phytother Res. 2022;36:1-15. doi:10.1002/ptr.7485.
44. Rocha T, Amaral JS, Oliveira MBPP. Adulteration of dietary supplements by the illegal addition of synthetic drugs: a review. Compr Rev Food Sci Food Saf. 2022;21(4):3182-3219.
45. Izzo AA. The clinical efficacy of herbal dietary supplements: A collection of recent systematic reviews and meta-analyses. Phytother Res. 2018;32(8):1423-1424. doi:10.1002/ptr.6128.
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Derechos de autor 2026 Diego Valarezo-Sevilla, Vanessa Sarzosa-Terán (Author)
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