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Herbal Drugs: Efficacy, Toxicity, and Safety Issues

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Abstract

Herbal drugs are being in use for the management of human health and for prevention as well as to cure human diseases since ancient civilization. In recent days, the use of herbal drugs has been increased significantly in various forms such as herbal formulations, dietary supplements, and nutraceuticals in the global market. This growing demand undoubtedly proves the therapeutic claims of herbal drugs as biomedicines and/or functional foods. However, the safe use of herbal products/herbal medicines is still challenging due to the toxicity and regulatory issues. This review discusses toxicity-related and safety issues of herbal medicinal products, factors responsible for, and suitable remedial measures. Some challenges associated with monitoring the safety of herbal drugs are also discussed to ensure their effectiveness for adequate protection of public health and the relevant regulatory issues.

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Abbreviations

CAM:

Complementary and alternative medicines

CVS:

Cardiovascular system

DSHEA:

Dietary Supplement Health and Education Act of 1994

FDA:

Food and Drug Administration

GC-MS:

Gas chromatography-mass spectrometry

GMP:

Good manufacturing practices

HMPs:

Herbal medicinal products

LC-MS:

Liquid chromatography-mass spectrometry

TM:

Traditional medicine

WHO:

World Health Organization

References

  • Abubakar AR, Chedi BAZ, Mohammed KG, Haque M (2015) Drug interaction and its implication in clinical practice and personalized medicine. Natl J Physiol Pharm Pharmacol 5:343–349

    Article  CAS  Google Scholar 

  • Akerele O (1993) Summary of WHO guidelines for the assessment of herbal medicines. HerbalGram 28:13–19

    Google Scholar 

  • Ang-Lee MK, Moss J, Yuan CS (2001) Herbal medicines and perioperative care. J Am Med Assoc 286:208–216

    Article  CAS  Google Scholar 

  • Bandaranayake WM (2006) Quality control, screening, toxicity, and regulation of herbal drugs modern Phytomedicine. In: Ahmad I, Aqil F, Owais M (eds) Turning medicinal plants into drugs. Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim, pp 25–57

    Chapter  Google Scholar 

  • Bauer R, Tittel G (1996) Quality assessment of herbal preparations as a precondition of pharmacological and clinical studies. Phytomedicine 2:193–198

    Article  CAS  PubMed  Google Scholar 

  • Bijauliya R, Alok S, Chanchal DK, Kumar M (2017) A comprehensive review on standardization of herbal drugs. Int J Pharm Sci Res 8:3663–3677

    CAS  Google Scholar 

  • Bland SE (1998) Drug-food interactions. J Pharm Soc Wisconsin 14:S28–S35

    Google Scholar 

  • Boullata JI, Nace AM (2000) Safety issues with herbal medicine. Pharmacotherapy 20:257–269

    Article  CAS  PubMed  Google Scholar 

  • Bushra R, Aslam N, Khan AY (2011) Food-drug interactions. Oman Med J 26:77–83

    Article  PubMed  PubMed Central  Google Scholar 

  • Calixto JB (2000) Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Braz J Med Biol Res 33:179–189

    Article  CAS  PubMed  Google Scholar 

  • Cordell GA, Colvard MD (2012) Natural products and traditional medicine: turning on a paradigm. J Nat Prod 75:514–525

    Article  CAS  PubMed  Google Scholar 

  • Coxeter PD, McLachlan AJ, Duke CC, Roufogalis BD (2004) Herb-drug interactions: an evidence based approach. Curr Med Chem 11:1513–1525

    Article  CAS  PubMed  Google Scholar 

  • Cragg GM, Newman DJ, Snader KM (1997) Natural products in drug discovery and development. J Nat Prod 60:52–60

    Article  CAS  PubMed  Google Scholar 

  • D’Arcy PF (1993) Adverse reactions and interactions with herbal medicines. Part 2—drug interactions. Adverse Drug React Toxicol Rev 12:147–162

    PubMed  Google Scholar 

  • De Smet PAGM (1995) Health risks of herbal remedies. Drug Saf 13:81–93

    Article  PubMed  Google Scholar 

  • De Smet PAGM (1997) The role of plant derived drugs and herbal medicines in healthcare. Drugs 54:801–840

    Article  PubMed  Google Scholar 

  • Drew A, Myers SP (1997) Safety issues in herbal medicine: implications for the health professions. Med J Aust 166:538–541

    Article  CAS  PubMed  Google Scholar 

  • Ekor M (2014) The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol 4:1–10

    Article  CAS  Google Scholar 

  • Ernst E (2005) The efficacy of herbal medicine—an overview. Fundam Clin Pharmacol 19:405–409

    Article  CAS  PubMed  Google Scholar 

  • Ernst E (2011) Herbal medicinal products: an overview of systematic reviews and meta-analyses. Perfusion 14:398–404

    Google Scholar 

  • Fabricant DS, Farnsworth NR (2001) The value of plants used in traditional medicine for drug discovery. Environ Health Perspect 109:69–75

    CAS  PubMed  PubMed Central  Google Scholar 

  • Farnsworth NR, Akerele O, Bingel AS, Soejarto DD, Guo Z (1985) Medicinal plants in therapy. Bull World Health Organ 63:965–981

    CAS  PubMed  PubMed Central  Google Scholar 

  • Fetrow CW, Avila JR (2004) Professional’s handbook of complementary and alternative medicines. Lippincott Williams & Wilkins, Philadelphia

    Google Scholar 

  • Fugh-Berman A, Ernst E (2001) Herb-drug interactions: review and assessment of report reliability. Br J Clin Pharmacol 52:587–595

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  • Ganesan A (2008) The impact of natural products upon modern drug discovery. Curr Opin Chem Biol 12:306–317

    Article  CAS  PubMed  Google Scholar 

  • George P (2011) Concerns regarding the safety and toxicity of medicinal plants—an overview. J Appl Pharm Sci 1:40–44

    Google Scholar 

  • Herr SM, Ernst E, Young VSL (2002) Herb-drug interaction handbook. Church Street Books, New York

    Google Scholar 

  • Izzo AA, Ernst E (2011) Interactions between herbal medicines and prescribed drugs: a systematic review. 15:2163–2175

    Google Scholar 

  • Jamshidi-Kia F, Lorigooini Z, Amini-Khoei H (2018) Medicinal plants: past history and future perspective. J Herbmed Pharmacol 7:1–7

    Article  Google Scholar 

  • Kong JM, Goh NK, Chia LS, Chia TF (2003) Recent advances in traditional plant drugs and orchids. Acta Pharm Sin 24:7–21

    CAS  Google Scholar 

  • Mukherjee PK, Harwansh RK, Bahadur S, Banerjee S, Kar A (2006) Evidence based validation of Indian traditional medicine—way forward. World J Tradit Chin Med 2:48–61

    Article  Google Scholar 

  • Mukherjee PK, Harwansh RK, Bahadur S (2013) Standardization and chemoprofiling of herbal medicine through marker analysis. Pharm Rev 58:161–163

    Google Scholar 

  • Nasri H, Shirzad H (2012) Toxicity and safety of medicinal plants. J Herbmed Pharmacol 2:21–22

    Google Scholar 

  • Nikam P, Kareparamban J, Jadhav A, Kadam V (2012) Future trends in standardization of herbal drugs. J Appl Pharm Sci 2:38–44

    Google Scholar 

  • Otles S, Senturk A (2014) Food and drug interactions: a general review. Acta Sci Pol Technol Aliment 13:89–102

    Article  CAS  PubMed  Google Scholar 

  • Pal SK, Shukla Y (2003) Herbal medicine: current status and the future. Asian J Cancer Prev 4:281–288

    Google Scholar 

  • Parle M, Bansal N (2006) Herbal medicines: are they safe? Nat Prod Rad 5:6–14

    Google Scholar 

  • Patra KC, Pareta SK, Harwansh RK, Kumar KJ (2012) Traditional approaches towards standardization of herbal medicines—a review. J Pharm Sci Technol 2:372–379

    Google Scholar 

  • Roberts JE, Tyler VE (1997) Tyler’s herbs of choice. The therapeutic use of phytomedicinals. The Haworth Press, New York

    Google Scholar 

  • Rodrigues E, Barnes J (2013) Pharmacovigilance of herbal medicines: the potential contributions of ethnobotanical and ethnopharmacological studies. Drug Saf 36:1–12

    Article  PubMed  Google Scholar 

  • Saxena A, Tripathi KP, Roy S, Khan F, Sharma A (2008) Pharmacovigilance: effects of herbal components on human drugs interactions involving cytochrome P450. Bioinformation 3:198–204

    Article  PubMed  PubMed Central  Google Scholar 

  • Schulz V, Hänsel R, Tyler VE (2001) Rational phytotherapy. A physician’s guide to herbal medicine. Springer, Berlin

    Book  Google Scholar 

  • Shetti S, Kumar CD, Srivastava NK (2011) Pharmacovigilance of herbal medicines: current state and future directions. Pharmacogn Mag 7:69–73

    Article  PubMed  PubMed Central  Google Scholar 

  • Shukla SS, Saraf S, Saraf S (2009) Approaches towards standardization and quality assessment of herbals. J Res Edu Indian Med 15:25–32

    Google Scholar 

  • Shulammithi R, Sharanya M, Tejaswini R, Kiranmai M (2016) Standardization and quality evaluation of herbal drugs. IOSR J Pharm Biol Sci 11:89–100

    Google Scholar 

  • Staines SS (2011) Herbal medicines: adverse effects and drug-herb interactions. J Malta Coll Pharm Pract 11:38–42

    Google Scholar 

  • Tasneem TSS (2012) Drug-herb interactions. Int J Pharmaceut Chem Biol Sci 3:75–78

    Google Scholar 

  • Thomas AS, Varughese P, Shirwaikar A, Shirwaikar A (2012) Herb-drug interactions: a review. Hygeia J D Med 4:33–40

    Google Scholar 

  • Warude D, Patwardhan B (2005) Botanicals: quality and regulatory issues. J Sci Ind Res 64:83–92

    Google Scholar 

  • WHO (2004) WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. World Health Organization, Geneva

    Google Scholar 

  • WHO (2005a) WHO global atlas of traditional, complementary and alternative medicine. In: Ong CK, Bodek G, Grundy CB, Kin S (eds) . World Health Organization, Geneva

    Google Scholar 

  • WHO (2005b) National Policy on traditional medicine and regulation of herbal medicines—report of a WHO global survey. World Health Organization, Geneva

    Google Scholar 

  • Wu SK, Ghantous H, Birnkrant DB (2008) Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States. Food Chem Toxicol 46:2606–2610

    Article  CAS  PubMed  Google Scholar 

  • Yuan H, Ma Q, Ye L, Piao G (2016) The traditional medicine and modern medicine from natural products. Molecules 21:1–18

    Article  Google Scholar 

  • Zhang J, Onakpoya IJ, Posadzki P, Eddouks M (2015) The safety of herbal medicine: from prejudice to evidence. Evid Based Complement Alternat Med 2015:316706

    PubMed  PubMed Central  Google Scholar 

  • Zhi-Xu H, Thach C, Zhou SF (2014) Clinical herb-drug interactions as a safety concern in pharmacotherapy. J Pharmacol Drug Metab 1:1–3

    Google Scholar 

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Correspondence to Dipak Chetia .

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Rudrapal, M., Chetia, D. (2021). Herbal Drugs: Efficacy, Toxicity, and Safety Issues. In: Mandal, S.C., Chakraborty, R., Sen, S. (eds) Evidence Based Validation of Traditional Medicines. Springer, Singapore. https://doi.org/10.1007/978-981-15-8127-4_26

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