4 Pharmacovigilance in Ayurveda: Drug Interactions Drugs are active substances that are prescribed in an effort to protect, promote, and prioritize health. Drugs are meant to alleviate symptoms, correct laboratory/imaging abnormalities, resolve disease states, and prevent potential complications. Sometimes, however, adverse effects may occur with the use of a particular drug. Such adverse drug events may or may not be directly due to the drug being used. If causality is proven, the adverse drug event is labeled as an adverse drug reaction (ADR). The increasing use of drugs, in various permutations and combinations, is associated with a greater risk of ADRs. The epidemic of metabolic syndrome and associated diseases requires long-term or indefinite treatment, and thus adds to the risk of ADRs. Traditionally, ADR reporting or pharmacovigilance, has been a neglected aspect of clinical care. The WHO defines pharmacovigilance as “the science and activities relating to the detection, evaluation, understanding, and prevention of adverse effects or any other drug-related problem.” Ayurveda has always understood the importance of pharmacovigilance and ADR. The Table enumerates various types of ADRs listed in Ayurveda. Ayurveda also describes drug– herb interactions and drug– exercise interactions. This is important for modern medical care, in which dieticians, lifestyle coaches, and doctors sometimes work with little or no communication between each other. Well-meaning therapeutic interventions Table. Pharmacovigilance in Ayurveda Modern Term Ayurvedic Term Example Drug interaction Viruddha-dravya-prayoga Hypoglycemia with antibiotics such as levofloxacin and gatifloxacin or antimalarials such as quinine in persons on OADs Overdose of drugs Ati-matra-dravya-prayoga Overdose of insulin in persons with diabetes Administration of unwholesome drugs Ahitatamadravyas Use of appetite-reducing and weight-reducing drugs in type 1 diabetes Administration of drugs across the spectrum of diseases Avastanusara-dravya prayoga Dosage according to eGFR Therapeutic procedural complications Panchakarma-vyapad, Shalya upoya Use of appetite- and weight-reducing procedures in persons with type 1 diabetes and pancreatic diabetes OADs, oral antidiabetic drugs; eGFR, estimated glomerular filtration rate. (eg, dietary restriction or intensive exercise) may lead to ADRs if not accompanied by appropriate and adequate changes in drug regimens and doses. Ayurveda speaks of the need to avoid incompatibility (viruddha-ahara) and ensure appropriate dietary restrictions (pathya-sevana). These must be understood by all medical practitioners. In the forthcoming issues of Alloveda, we will further explore and expand upon, the concept of pharmacovigilance in Ayurveda. We will work together to ensure a healthier and safer world for our fellow citizens. Source: Ajanal M, et al. J Young Pharm. 2013;5(4):116–120. The science of integrating well-documented clinical experiences and experiential observations into research ideas through transdisciplinary exploratory studies is known as reverse pharmacology. These clinical observations of reverse pharmacology are used to develop effective drug candidates from the leads through preclinical and clinical research. Reverse pharmacology utilizes traditional medicine and the knowledge of traditional healers to discover drugs. This is also known as “from bedside to bench side,” and it reverses the pipeline from clinics to laboratories, which happens in reverse in general. The traditional strategy for drug discovery is: Molecule → Rat or Mice → Man The reverse pharmacology approach is: Man → Rat or Mice → Molecule One of the best-known drug discoveries using reverse pharmacology is reserpine, an alkaloid isolated from Rauwolfia serpentina, also known as Indian snakeroot. In 1931, Indian scientists Sen and Bose successfully demonstrated the antihypertensive and sedative properties of reserpine. However, they noted several unusual side effects such as gynecomastia, depression, and extrapyramidal syndrome. Later, in 1949, Rustom Jal Vakil published a trial of R serpentina on patients with essential hypertension. According to his study, R serpentina reduced systolic and diastolic blood pressure. Although it took years to deduce the mechanisms of these side effects, these clinical efforts led to the discovery of new antidepressant, antiParkinson’s, and prolactin-reducing drugs. At present, reserpine is available in the market as an antihypertensive alkaloid. This was probably the first time the principles of reverse pharmacology were systematically used for focused, fast-track drug discovery based on Ayurveda. Reverse pharmacology is more time- and costefficient and has a higher success rate than the conventional method of drug development, which is more expensive and time intensive. Additionally, reverse pharmacology has led to the development of a few promising lead molecules, such as curcumin (from Turmeric/Haridra) for inflammation; psoralen (from Babchi/Bakuchi) for psoriasis; and papain (from Papaya/Erandakarkati) for increasing platelet count. Hence, it can be concluded that reverse pharmacology will continue to be useful in the future for discovering novel uses for old prescription drugs. Source: Patwardhan B, et al. Drug discovery and ayurveda. In: Patwardhan B, et al, eds. Integrative Approaches for Health. Academic Press; 2015:229–258. Reverse Pharmacology: Traditional Medicine–Inspired Drug Discovery Strategy Dr Sanjay Kalra and Dr Supriya Bhalerao Dr Jeetendra Singh Metabolic Syndrome: Facts and Figures z Metabolic syndrome is a cluster of risk factors, which includes waist circumference (> 40'' in men and 35'' in women), raised triglycerides (≥ 150 mg/dL), low high-density lipoprotein cholesterol (< 40 mg/dL in men or < 50 mg/dL in women), impaired fasting glucose (≥ l00 mg/dL), and high blood pressure (≥ 130/85 mmHg).1 According to the latest National Family Health Survey 2019–2020 (NFHS-5), 21% of women and 24% of men aged ≥ 15 years are hypertensive, and 39% of the women and 49% of the men in this age group are prehypertensive. More men (14%) than women (12%) have high random blood glucose levels (> 140 mg/dL). The percentage of overweight or obese women has increased from 21% to 24% and from 19% to 23% among men.2 z The global prevalence of metabolic syndrome ranges from 7.1% to 41.6%. According to the ATP III criteria, the estimated prevalence is 35% in USA, ~ 25% in Latin America, 20.7% to 37.2% in the Gulf countries, and 26.1% in South Asia.3 The prevalence is also rising among children (2.8%) and adolescents (4.8%).4 z According to a meta-analysis published in 2020, the overall prevalence of metabolic syndrome in India was 30%. The prevalence was higher among older adults aged 50 to 59 years comparedwith adolescents aged 18 to 29 years (52% vs 13%, respectively), in people living in urban areas compared with rural areas (32% vs 22%, respectively), and in women compared with men (35% vs 26%, respectively).5 z Up to 80% of individuals with diabetes have metabolic syndrome. The life expectancy is reduced by a decade among these patients.6 z The risk of developing type 2 diabetes 5 to 10 years later increases 5-fold in people with metabolic syndrome, while the risk of cardiovascular disease increases 2- to 3-fold.6 z Individuals with sedentary lifestyle are nearly 7 times more likely to have metabolic syndrome; the chances are 5.5 times higher with the use of palm oil. Individuals who eat meat (≥ 2 times per week) are 5.9 times more likely to have metabolic syndrome compared with those who do not eat meat or eat once in a week.6 z The prevalence of metabolic syndrome among adult patients with psoriasis has been reported to be 32%.7 A cross-sectional study from Singapore mentions the prevalence of metabolic syndrome to be 45.1% in patients with psoriasis.8 z In patients with acute pancreatitis, the incidence rate of metabolic syndrome has been calculated to be ~ 31%.9 References 1. Swarup S, et al. Metabolic Syndrome [Updated October 24, 2022]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022. 2. National Family Health Survey (NFHS-5), 2019–21. India Report. http://rchiips.org/nfhs/NFHS-5Reports/NFHS-5_INDIA_REPORT.pdf. Accessed January 12, 2023. 3. Meher T, Sahoo H. Clin Epidemiol Glob Health. 2020;8:1047–1052. 4. Noubiap JJ, et al. Lancet Child Adolesc Health. 2022;6(3):158–170. 5. Krishnamoorthy Y, et al. PLoS One. 2020;15(10):e0240971. 6. Gemeda D, et al. J Diabetes Res. 2022;2022:8162342. 7. Liu L, et al. J Eur Acad Dermatol Venereol. 2022;36(11):1969–1979. 8. Chan WMM, et al. Singapore Med J. 2020;61(4):194–199. 9. Shen Z, et al. BMC Gastroenterol. 2021;21(1):17.
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