Acute Fulminant Hepatic Failure in 23-Year-Old Female Taking Homeopathic Remedy.

Homeopathic remedies made primarily from eggshells, and therefore calcium, can be marketed for treatment of back pain and vaginal discharge. We present a case of a 23-year-old otherwise healthy woman who presented with acute liver failure (ALF) ultimately requiring liver transplantation as a result of taking increased doses of a homeopathic product with the primary ingredient of eggshells. Although relatively uncommon compared with medications such as acetaminophen, herbal supplements have been reported to cause drug-induced liver injury (DILI), thought to be primarily due to contaminants. This is the first known report of DILI resulting from a homeopathic product with the primary ingredient of eggshells, and it demonstrates the importance of early ALF recognition and treatment, as well as the importance of practicing caution when using homeopathic supplements.

A series of homeopathic remedies-related severe drug-induced liver injury from South India.

INTRODUCTION: Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non-liver-related systemic side effects. We present the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center. METHODS: A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy. RESULTS: Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute on chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in 'supposed' ultra-dilute formulations. CONCLUSION: Homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not 'gentle placebos.'

Toxic hepatitis-associated aplastic anaemia after dual homeopathic remedies and Gymnema sylvestre use.

Hepatitis-associated aplastic anaemia (HAAA) is a rare condition characterised by onset of acute hepatitis which is followed by development of severe pancytopenia due to bone marrow failure within 6 months. This syndrome can be precipitated by acute viral infections, but the aetiology remains unknown in the majority. Drug-induced HAAA is extremely rare and has been reported with nutritional and dietary supplements in current literature. We report the first cases of ayurvedic herbal and homeopathic remedies-associated HAAA in two patients which proved fatal in both. Evaluation of patients with acute hepatitis and severe pancytopenia must include a detailed evaluation for complementary and alternative medicine use.

SuperTCM: A biocultural database combining biological pathways and historical linguistic data of Chinese Materia Medica for drug development.

AIM OF THE STUDY: Botanicals used in Traditional Chinese Medicine (TCM) are a rich source for drug discovery and provide models for multi-component drug development. To facilitate the studies of the actions of TCM drugs and expand their applications, a comprehensive database is urgently required. METHODS: One online resource connects all the relevant data from multiple scientific sources and languages. Drug information from published TCM databases and the official Chinese Pharmacopoeia as well as specialized meta-websites such as Kew's Medicinal Plant Names Service was integrated on a higher level. RESULTS: Our database, SuperTCM, covers the aspects of TCM derived from medicinal plants, encompassing pharmacological recipes up to chemical compounds. It provides the information for 6516 TCM drugs (or "herbs") with 5372 botanical species, 55,772 active ingredients against 543 targets in 254 KEGG pathways associated with 8634 diseases. SuperTCM is freely available at http://tcm.charite.de/supertcm.

Material Risks of Homeopathic Medicinal Products: Regulatory Frameworks, Results of Preclinical Toxicology, and Clinical Meta-Analyses and Their Implications.

Homeopathy is widely used and broadly accepted by health care professionals and the general public but less in academic circles. To assess possible material health risks of homeopathic medicinal products, it is necessary to identify, select, and synthesize the findings of recent reviews of controlled homeopathic clinical trials. Matching these findings with experimental data from toxicological studies helps to clarify what is known and not known about the material risks of homeopathic medicines. Rules for toxicological risk assessment and management need to be applied independently of individual attitudes towards specific therapeutic options. European regulatory bodies have developed special protocols and decision trees to assure the safety of nonindividualized homeopathic remedies. This narrative review leads to suggestions that could ease and improve toxicological decision making. No homeopathy-specific type or pattern of side effects could be extracted from the meta-analysis data. No differences in the frequency of adverse reactions between homeopathic treatment and placebo treatment could be seen, no matter whether adverse events were reported in a quantitative or a qualitative manner. Some patterns of side effects show that adverse reactions do not necessarily correlate with treatment but with the condition of the patient. Overall, the controlled clinical data available for the material risk assessment of homeopathic remedies support the statement that, if a risk exists, it must be so small that it has not yet been established. To make our risk findings useful for personal decisions regarding homeopathy, we provide a thought experiment based on four different health situations and ask the question: is homeopathy as a monotherapy or as an add-on treatment an option or should it be rejected?

Multicenter Clinical Trials Analyzing Efficacy and Safety of Topical Cortex Phellodendri Compound Fluid in Treatment of Diabetic Foot Ulcers.

BACKGROUND The aim of this study was to analyze the clinical application of cortex phellodendri compound fluid (CPCF) in the treatment of diabetic foot ulcers. MATERIAL AND METHODS From January 2012 to December 2015, a total of 720 cases of diabetic foot ulcers (DFU) were randomly assigned into an experimental group (n=540) that was treated by CPCF and a control group (n=180) that was treated by a Kangfuxin solution (KFS). After 4 weeks of treatment, their ulcer area, serum growth factor, clinical total effective rate, and incidence of adverse events were assessed. RESULTS There were 720 patients who completed the trial. The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05). There was no significant difference in the adverse events rates between the 2 groups. CONCLUSIONS CPCF external treatment of diabetic foot ulcer can promote ulcer healing and increase the concentration of growth factors, and it is safe and reliable.

[Effects of a homeopathic medication on clinical signs of canine atopic dermatitis]. / Wirkung eines homöopathischen Arzneimittels auf die klinische Symptomatik von Hunden mit atopischer Dermatitis.

OBJECTIVE: A commercially available medication containing homeopathic ingredients showed first signs of success in atopic dermatitis in dogs. The aim of this case series was to evaluate the effect of the preparation in a larger number of dogs with atopic dermatitis. MATERIAL AND METHODS: Ten atopic dogs received the oral homoeopathic combination preparation daily for 3 weeks according to the manufacturer's specifications. The diagnosis of atopic dermatitis was made previously by medical history, clinical examination and exclusion of differential diagnoses. Skin infections with bacteria and yeasts were excluded by clinical examination and cytological evaluation of impression smears. In food-allergic dogs, an elimination diet was fed at least 2 months prior and during the entire study period. Patients with suspected or confirmed flea allergy received flea control for at least 1 month prior to and during the study. The clinical signs were evaluated before and after therapy using a validated Pruritus Visual Analogue Acale (PVAS) and the Canine Atopic Dermatitis Lesion Index (CADLI). The coat quality was assessed by the owners. Possible adverse effects were recorded at the recheck. RESULTS: There were no significant changes in the lesion score (Wilcoxon test, p = 1.0), pruritus score (paired t test, p = 0.34) and coat quality (paired t test, p = 0.34) over the duration of treatment. Only one patient showed a slight improvement in itching and coat quality. No side effects were observed. CONCLUSION AND CLINICAL RELEVANCE: In this case series, the tested homoeopathic preparation did not show a positive effect on the clinical signs of canine atopic dermatitis.

Analysis on the current quality standards of Chinese materia Medica used in COVID-19 prevention and treatment.

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.

The characteristics and regularities of cardiac adverse drug reactions induced by Chinese materia medica: A bibliometric research and association rules analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Chinese materia medica (CMM) has been widely used as an approach of ethnomedicine worldwide. Recently, there are growing concerns related to the potential cardiotoxicity of herbal medicines but comprehensive studies are limited. METHODS: Comprehensive literature retrieval via publicly available electronic databases was performed to identify the case reports that focused on cardiac adverse reactions (ADRs) triggered by oral CMMs. And a bibliometric survey was conducted to analyze the most commonly suspected risk factors in terms of responsible CMMs, susceptible patients and clinical administration of cardiac ADRs. Moreover, the techniques of data mining were utilized to investigate the regularities and association between the ADRs status and major contributory factors. RESULTS: The available evidence of current research indicated that many influential factors were strongly associated with cardiac ADRs caused by oral CMMs inevitably, including pediatric patients, poisonous CMMs (especially herbs of Aconitum species), overdose and self-medication. Specifically, the timely and effective resuscitation could attribute their favorable capacity to reduce mortality for cardiac ADRs. Notably, the cardiac ADRs cases had often concomitant the ADRs of the nervous system and digestive system. CONCLUSION: The comprehensive features and risk factors of cardiac ADRs induced by oral CMMs can be discovered and elucidated through the approaches of bibliometric research, association rules analysis, and data mining technology, which raise the profile and awareness of the rational applications of CMMs and pharmacovigilance within relevant heart side effects.

Homeopathy-medicine induced severe alcoholic hepatitis.

We present a teetotaler with compensated non-alcoholic fatty-liver-disease related cirrhosis who presented with acute worsening of his chronic liver disease. The acute event was not discernible even after extensive work up and finally a transjugular liver biopsy revealed features suggestive of severe alcoholic hepatitis. The patient and the family denied occult alcohol use when questioned over multiple times and finally, the culprit 'alcohol' was found to be the homoeopathy medicines that the patient was consuming over a month for treatment of Gilbert's syndrome. We retrieved and tested the homoeopathy drug for alcohol content and found an alarming 18% ethanol in the same, confirming our diagnosis.

Differences in healthcare utilisation between users and non-users of homeopathic products in Spain: Results from three waves of the National Health Survey (2011-2017).

OBJECTIVE: To compare the differences in the use of healthcare services: visits to the doctor and hospitalisation, performance of routine tests, and preventive influenza vaccination, between users and non-users of homeopathic products. METHODS: We used the microdata for adults over 15 years old from three waves of the Spanish National Health Survey, corresponding to the years 2011, 2014 and 2017. We proposed a comparative design of a quasi-experimental type, considering as the treatment group the respondents who said that they had used homeopathic products in the past two weeks; and another group, for control, comprising respondents who said that they had not used this type of products, but only conventional medicines, with observable characteristics similar to those of the treatment group. We used a model for rare events logistics regression (relogit) to estimate the probability of using homeopathy. From the propensity score and a vector of control variables, we used techniques of genetic matching to match individuals from the treatment group with similar individuals belonging to the control group. RESULTS: There are no statistically significant differences between users and non-users of homeopathy in visits to the general practitioner (P>|z| 0.387), to the specialist (P>|z| 0.52), in hospitalisations (P>|z| 0.592) or in the use of emergency services (P>|z| 0.109). Nor were there any statistically significant differences in the performance of routine tests, except for the faecal occult blood test, which is more prevalent in users of homeopathic products. 20.9% of users of homeopathy had done this test compared with 15.3% of non-users (P>|z| 0.022). There are also significant differences in vaccination against influenza with 12.6% of homeopathy users stating that they had been vaccinated in the last influenza campaign, against 21.0% of non-users (P>|z| <0.001). The health conditions which homeopathy users reported were constipation (OR: 1.65 CI: 1.16-2.36), malignant tumour (OR: 1.60 CI: 1.09-2.36) osteoporosis (OR: 1.49 CI: 1.05-2.10), varicose veins (OR: 1.35 CI: 1.05-1.74) and allergy (OR: 1.35 CI: 1.06-1.72). CONCLUSIONS: Differences in the use of healthcare resources between users and non-users of homeopathic products have not been found to be statistically significant in Spain. It has been shown that most homeopathic products are used as a complement to treatment with conventional medicine. Nevertheless, our results highlight some warning signs which should raise the attention of healthcare authorities. The use of these therapies in patients with malignant tumours and the rejection of vaccines are warning signs of a possible health hazard in the long term.

Safety of complementary and alternative medicine in children: A 16-years retrospective analysis of the Italian Phytovigilance system database.

BACKGROUND: Dietary supplements and homeopathic medicines are largely used in children as complementary and alternative medicine (CAM) to treat different health conditions. Safety of CAM is unknown when they are marketed. This study analysed suspected CAM-related adverse reaction (AR) in pediatric population. METHODS: The Italian Phytovigilance system was searched for reports of suspected AR related to CAM use in children (0-18 years) from 2002 to 2018. AR reports were evaluated and information about patient's demographic characteristics, suspected CAM, conventional medications, and ARs were collected. In particular, we evaluated whether patient's and CAM characteristics, and concomitant drugs could be potential predictors of ARs seriousness. RESULTS: We evaluated 206 pediatric CAM-related AR reports, of which 69 were serious. Patients were mostly treated with only one CAM (n = 193), and 39% of AR reports were related to products containing 2-5 components. Most reported ARs were related to dietary supplements (57.18%), and skin and subcutaneous tissue disorders (40.29%) were the most involved System Organ Class. CAM-related AR reported as serious were higher in subjects exposed to homeopathic medicines (ROR 3.13 [1.88-5.22]), to CAM in presence of concomitant medications (ROR 1.77 [1.01-3.10]), to CAM containing 2-4 components (ROR 2.18 [1.13-4.22]), and to more than three concomitant CAM (ROR 7.81 [1.97-32.69]). CONCLUSION: We provide new insights on factors that might increase the risk of serious AR associated with CAM use in children: products containing more than two components and simultaneously administered with conventional medications can represent a potential risk in children.

Toxicological assessment compilation of selected examples of raw materials for homeopathic medicinal products.

The considerable number of homeopathic medicinal products (HMP) on the German market and the staggering breadth of active substances of various origin along with the specific legal requirements of adequate safety principles posed the need to compile data on toxicologically evaluated raw materials. In line with the European regulatory framework, HMP applications must consider appropriate safety standards in analogy to conventional human medicinal products. This review presents an option for a systematic and scientifically substantiated approach for regulatory use. Furthermore, this paper provides a multitude of data for selected raw materials processed in HMP with up to now rather scarce knowledge and, thus, aims at filling data gaps on acceptable amounts per day (AAD). The inclusion of raw materials into the compilation was determined considering the frequencies of their occurrence in HMP in Germany along with the availability of appropriate safety assessments. This safety evaluation compilation represents a practical, fairly comprehensive and systematic set of more than 170 raw materials. It is designed to both effectively support regulatory decision making and to be recognized and exploited by applicants, stakeholders and the scientific community.

Efficacy and safety of Kangfuxin liquid combined with aminosalicylic acid for the treatment of ulcerative colitis: A systematic review and meta-analysis.

BACKGROUND: To systematically evaluate the clinical efficacy and safety of Kangfuxin liquid (KFXL) combined with aminosalicylic acid (ASA) in treating ulcerative colitis (UC). METHODS: The PubMed, Cochrane Library, Embase, CBM, Wan fang, the Chinese Scientific Journal Database (VIP), and Chinese National Knowledge Infrastructure (CNKI) databases were systematically searched for randomized controlled trials of KFXL combined with ASA for UC from the inception dates to March 3, 2017. Two researchers independently screened the literature, extracted data, and evaluated the methodological quality according to the inclusion criteria. The meta-analysis was performed using Review Manager software (RevMan, Version 5.3, Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014), and the risk of bias was assessed using the Cochrane Collaboration Tool. RESULTS: A total of 39 randomized controlled trials (RCTs) involving 3204 patients fulfilled the inclusion criteria. Compared with ASA alone, KFXL combined with ASA significantly improved the clinical effectiveness rate [RR = 1.19, 95% CI: (1.16, 1.23), P < .00001], reduced the relapse rate [RR = 0.26, 95% CI: (0.18, 0.38), P < .00001], reduced the inflammation factor levels of TNF-a, IL-1, IL-6, IL-8, and C-reactive protein, reduced the coagulation index of fibrinogen, increased the coagulation index of prothrombin time, and mean platelet volume, and reduced the clinical symptoms of abdominal pain, diarrhoea, pus and bloody stool, and tenesmus. However, KFXL combined with ASA did not increase the adverse event incidence [RR = 0.74, 95% CI (0.42, 1.32), P = .31], and no severe adverse events were reported. CONCLUSION: KFXL combined with ASA has good therapeutic effect for UC and might be a safe approach in managing UC. More high-quality, multicenter randomized, double-blind trials with a large sample size are required to generate a high level of clinical evidence.

Anisocoria Secondary to Anticholinergic Mydriasis from Homeopathic Pink Eye Relief Drops.

A woman, aged 70 years, developed anisocoria after applying homeopathic eye drops (Similasan Pink Eye Relief) to her left eye. Her pupil was dilated for two weeks and did not respond to light or near stimuli for one week. Both 0.1% and 1% pilocarpine failed to constrict her left pupil, and magnetic resonance imaging of her brain did not reveal any abnormality. The eye drops she had used contain belladonna extracts which have a natural atropine component. This case demonstrates the importance, when evaluating a patient presenting with anisocoria, of knowing the chemical ingredients of the homeopathic eye drops, which often are not listed.

[Homeopathic drug products and outpatient clinics: are they deceiving the public?] / I prodotti e gli ambulatori omeopatici non ingannano il pubblico?

After more than two centuries since the inception of homeopathy, it can now be stated that active ingredients of homeopathic drug products are approaching zero. Homeopathy has never been shown to be effective, and several Cochrane reviews failed to provide evidence for the effectiveness of homeopathy. In addition, according to the World Health Organization, when homeopathic medicine is used as an alternative to other effective treatments, it may cause harm resulting in increased mortality. On the basis of these considerations, it is of utmost importance that millions of Italian people taking homeopathic remedies be informed on the negative judgment by the scientific community, so that allocation of limited healthcare resources can be better redirected to increase patient access to treatments not otherwise available due to restrictions on healthcare budgets (e.g. hepatitis C medications).