Published in Frontiers in Gastroenterology\u2014an open-access research in digestive health, liver disease, infections, cancer and gastrointestinal care\u2014the study found that about 40 percent of the patients developed acute-on-chronic liver failure (ACLF)\u2014a condition where a patient with underlying chronic liver disease suddenly develops severe liver failure.<\/p>\n
According to the study, among those who developed ACLF, around 39 percent died. Overall mortality among all patients studied was about 22 percent.<\/p>\n
\u201cWe have published the largest analytical study of Ayurveda, Homeopathy, Siddha, Unani and Folk-Traditional Medicinal products that have harmed patients, presenting with liver damage, to our department,\u201d wrote lead author Dr Cyriac Abby Philips, a Kerala-based specialist in Hepatology and Liver Transplant Medicine, who is popular on social media with the name \u2018LiverDoc\u2019.<\/p>\n
Researchers say this is the most exhaustive analytical study that correlated clinical outcomes in such patients. \u201cOur study\u2019s data collection ended in 2023, but we continue to see patients coming in with liver damage linked to alternative medicine use,\u201d Arif Hussain, Kerala-based clinical research associate and the study\u2019s lead researcher who works with Dr Philips, told ThePrint.<\/p>\n
Also Read:<\/strong> 65,000 misleading ads flagged, 3,000 adverse drug reactions recorded since 2018, says Ayush secretary<\/a><\/p>\n \u00a0<\/p>\n How researchers found Ayush link<\/strong><\/p>\n Explaining how the study concluded that liver damage was linked to Ayush medicines, Hussain explained that the study relied on diagnosis of exclusion and temporal association, meaning the liver injury was directly linked to the initiation and subsequent period of consumption of alternative medicines.<\/p>\n Researchers mandatorily ruled out other common causes of liver damage, such as viral hepatitis, alcohol use or other prescription drugs. After this, expert adjudication of the cases was undertaken to decide whether the alternative medicines were likely involved.<\/p>\n Hussain said the researchers did not use the now obsolete formal scoring system called RUCAM (Roussel Uclaf Causality Assessment Method), a standardised clinical scoring system used to determine the likelihood that a specific drug caused liver injury.<\/p>\n This is because, he said, RUCAM works best when a patient has taken only one medicine. In this study, many patients concurrently used several alternative medicine products at the same time, which makes such scoring tools unreliable. \u201cThe study\u2019s primary focus was on analysing what was inside the products that potentially harmed the patients,\u201d he said.<\/p>\n \u201cWe focused on what was inside the 386 alternative medicine products\u2014heavy metals, hidden drugs, other undisclosed content\u2014and then linked those findings to patient outcomes,\u201d he explained. Hussain said this approach is similar to the practical method used by major international research groups that study drug-induced liver injury (DILI).<\/p>\n One such group is the Drug-Induced Liver Injury Network (DILIN) in the United States. Another is the Latin American Drug-Induced Liver Injury Network (LATINDILI), which studies liver injury cases across countries in Latin America. These networks investigate cases where medicines, supplements, or herbal products may have harmed the liver.<\/p>\n What Ayurveda experts say<\/strong><\/p>\n Ayurveda experts ThePrint spoke to said the study\u2019s conclusions should be interpreted cautiously. \u201cThe adverse outcomes reported are more plausibly attributable to adulterated, spurious, or misbranded products, which can occur across any healthcare system when manufacturing standards and regulatory oversight are inadequate,\u201d said Professor Anupam Shrivastava, Head, Department of Rasa Shastra & Bhaishajya Kalpana and former medical superintendent, National Institute of Ayurveda (NIA), Jaipur.<\/p>\n \u201cSuch issues primarily reflect deficiencies in quality control and product authentication, rather than inherent toxicity of well-formulated medicines,\u201d Shrivastava, who is also the chairman of IPR (Intellectual Property Rights) Cell, added.<\/p>\n In an elaborate written response to ThePrint, Shrivastava said, \u201cThe study does not specify dosage forms such as tablets, churna, vati, or arishta and their quantity. Instead, it uses broad categories, like herbal products, traditional medicines, complementary and alternative medicine (CAM) products, and unlabelled preparations. Because the specific product identities are not revealed, the findings cannot be independently addressed, verified or reproduced.\u201d<\/p>\n Unlabelled products, heavy metals & hidden drugs<\/strong><\/p>\n One of the most striking findings of the study, according to the researchers associated with the study, is unlabelled medicines\u2014products sold without ingredient lists, batch numbers or manufacturer details.<\/p>\n Patients who died had consumed almost twice as many unlabelled products as those who survived. Mortality rose from about 14 percent among patients who took none of these products, to roughly 43 percent among those who consumed three or more.<\/p>\n According to Hussain, the results highlight the importance of traceability. \u201cNo medicines should be sold without labels or mislabelling today. But when it comes to alternative medicines, it is still happening,\u201d said Hussain who is also a former homoeopathy practitioner.<\/p>\n \u201cThis is not limited to one system\u2014it happens with Ayurveda, Homoeopathy, Siddha, Unani and others. We found that patients who consumed unlabelled products had higher mortality,\u201d he added.<\/p>\n Laboratory testing revealed that many products contained toxic heavy metals above international safety limits. Mercury levels exceeded World Health Organisation limits in 34 percent of products, cadmium in 25 percent, arsenic in 21 percent, and lead in 14 percent. Siddha products demonstrated the highest prevalence of lead (56.2 percent) and arsenic (62.5 percent) exceedances compared to Ayurveda.<\/p>\n Cadmium exposure showed the strongest association with severe outcomes. Cadmium is a chemical that exerts toxic effects on the kidneys as well as the skeletal and respiratory systems, and is classified as a human carcinogen. About 76 percent of patients exposed to cadmium above safety limits developed ACLF, compared with around 23 percent among those not exposed, the study found.<\/p>\n \u201cUsually we focus on arsenic, lead or mercury, but cadmium was an unexpected finding,\u201d Hussain said. Researchers also detected hidden pharmaceutical drugs in about 27.7 percent of the products. These included corticosteroids, antibiotics, sedatives and painkillers such as nimesulide, a drug restricted in several countries due to liver safety concerns.<\/p>\n In December 2025, the central government banned nimesulide formulations above 100 mg, citing potential health risks.<\/p>\n