Toxic optic neuropathy following ingestion of homeopathic medication Arnica-30.

We report a case of acute, bilateral and severe vision loss after inadvertent consumption of a large quantity of the homoeopathic medication Arnica-30. Severe vomiting which required hospitalization preceded visual symptoms. In the acute stage, pupillary responses to light were absent and fundus examination was normal. Vision loss followed a fluctuating course, with profound loss noted after 6 weeks along with bilateral optic disc pallor. Neuro-ophthalmic examination and detailed investigations were performed, including magnetic resonance imaging, electroretinography (ERG) and visual evoked potentials (VEP). Ocular coherence tomography (OCT) showed gross thinning of the retinal nerve fiber layer. While a differential diagnosis of posterior ischemic optic neuropathy was kept in mind, these findings supported a diagnosis of bilateral toxic optic neuropathy. Arnica-30 is popularly used to accelerate wound healing, including after oculoplastic surgery. While homeopathic medicines are generally considered safe due to the very low concentrations involved, Arnica-30 may be neurotoxic if consumed internally in large quantities.

Use of complementary and alternative medicine in children with recurrent acute otitis media in Italy.

Controlling environmental factors, chemoprophylaxis, immunoprophylaxis and surgery are considered possible means of preventing recurrent acute otitis media (RAOM), but there are no available data concerning the paediatric use of complementary and alternative medicine (CAM). We evaluated the uses of CAM (homeopathy and/or herbal medicine) as means of preventing AOM in children with a history of RAOM. Eight hundred and forty Italian children with RAOM (≥3 episodes in six months) aged 1-7 years were surveyed in 2009 using a face-to-face questionnaire, filled by parents or caregivers, that explored the prevalence, determinants, reasons, cost, and perceived safety and efficacy of CAM. About one-half (46%) of the children used CAM, significantly more than the number who used immunoprophylaxis (influenza vaccine 15%; p<0.05), PCV-7 34%; p<0.05) or chemoprophylaxis (2%; p<0.001). Use of CAM in the family was the only important factor positively associated with the use of CAM in children (adjusted OR 7.94; 95% CI: 5.26-11.99). The main reasons for using CAM were a fear of the adverse effects of conventional medicine (40%) and to increase host defences (20%). CAM was widely seen as safe (95%) and highly effective (68%). CAM prescribers were paediatricians in 50.7% of cases; self-initiation was reported by 23% of respondents. CAM expenditure was between Euro 25 and Euro 50/month in 27.6% of cases and ≥ Euro 50/month in 16%. Children with RAOM should be considered among the categories of subjects likely to be using CAM. Together with the fact that paediatricians are the main prescribers, this is worrying because of the current lack of evidence regarding the efficacy, safety and cost-effectiveness of CAM in the prevention of RAOM.

Fast Dissolving/Disintegrating Dosage Forms of Natural Active Compounds and Alternative Medicines.

Fast Dissolving/Disintegrating Dosage Forms (FDDFs) are a group of dosage forms which dissolve or disintegrate quickly, leading to fast distribution of active ingredients at the site of administration; thereby providing ease of oral ingestion of solid unit dosage forms and have the potential to enhance transmucosal absorption. With time, the use of FDDFs in alternative systems has significantly increased. Homeopathic systems and traditional Chinese medicine have embraced FDDFs for the delivery of active compounds. Most of the patents in this area are from China or by the Chinese innovators. In Europe and US, FDDFs have been extensively studied for the delivery of natural active compounds. It was fascinating to know that some new dosage forms and new routes of delivering active compounds are also making their way to the family of FDDFs. The dose of active compound, size of dosage forms, standardization of extracts, polyherbal mixtures, stability of active compounds, safety, efficacy and pharmacokinetics are challenging issues for developing FDDF herbal formulations or phytopharmaceuticals.

Treatment with Lycopodium clavatum 200dH Intensifies Kidney and Liver Injury in Mice Infected with Toxoplasma gondii.

The effects of infection with Toxoplasma gondii vary from asymptomatic to the development of alterations in various organs (including the liver and kidneys) which may be irreversible, and lead to the death of the host. Whereas homeopathy is an alternative and effective method for treating various diseases, including those caused by protozoa, we questioned the effect of using Lycopodium clavatum in mice infected with T. gondii. One hundred male Swiss mice, 60 days old, were divided into four groups (n = 25/group): NIC (uninfected and untreated control), IC (infected and treated with un-dynamized 7% alcohol solution [vehicle]), G48 (infected and treated 48 h before infection and treated three more times; at 2, 4, and 6 days post-infection (dpi) with L. clavatum 200dH), and G72 (infected and treated for 3 consecutive days before infection with L. clavatum 200dH). In this study, physiological, histopathological, and immunological parameters were evaluated. The L. clavatum 200dH intensified renal damage in mice infected with T. gondii from 7 dpi, causing severe and progressive alterations during this period, such as various degrees of inflammation, edema, atrophy, and tubular cystic dilation, degenerated tubules with intra-cytoplasmic vacuoles and coalescing spots, severe vascular lesions, glomerulonephritis, and peri-glomerular congestion. In the G72 animals, which received L. clavatum 200dH, more severe cortex damage was observed (91.66-96.66%) as compared to the IC group (55-80%) and more renal corpuscle, and renal tubule injury was observed (80 ± 5 to 96.7% ± 2.89 of the total area) during all periods, as compared to the IC group (p < 0.05). Both groups presented high liver enzyme levels, and the highest values for AST were observable at 60 dpi. We observed significant increases of type I and III collagen, as well as high levels of TGF-ß1 in both organs of the treated animals, the main factor involved in fibrosis in areas damaged by the process. L. clavatum 200dH intensifies kidney and liver alterations in mice infected with T. gondii. Our results reinforce caution when indicating administration schemes and dosages for ultra-diluted drugs.

Medicated or not medicated hypnotic substance use: strategies in sleep disorders among patients of community pharmacy.

The principal outcome was to identify which hypnotics substances, medicated (benzodiazepines, antihistamine, antidepressant…) or not medicated (herbal medicine, homeopathy, melatonin…), were consumed by community pharmacy patients who reported taking something for sleep disorder, and which factors can influence the consumption of medicated substance rather than nonmedicated substance. Data were collected via a network of 73 partner pharmacies around Nantes, France. Patients who reported taking a substance to sleep completed a questionnaire that collected data relative to the different substances consumed by that person for sleep, and the desired effect. Substances were classified in Hypnotic Drug Substances and nonmedicated hypnotic substances. A logistical regression was done in order to highlight the factors associated with the consumption of Hypnotic Drug Substance rather than nonmedicated hypnotic substances. Six hundred and forty-seven patients were included, with an average age of 58 years and 74% female. The principal strategy employed to combat sleep disorder was the consumption of Hypnotic Drug Substance (54%), followed by herbal medicine (32%) and homeopathy (19%). The factors positively associated with the consumption of a Hypnotic Drug Substance are age, living alone, being out of work, or in the process of looking for a job and being a parent. In our survey, the use of Hypnotic Drug Substance to help patients with sleep is far from systematic. On the other hand, among patients who consume HDS, misuse is still significant, particularly in terms of the duration of consumption.

Surveillance of suspected adverse reactions to natural health products in Italy.

PURPOSE: Natural health products are promoted to the public as equally or more effective and less toxic than conventional drugs. However, some 'natural' medicines, and in particular some herbal medicines, are known to have adverse effects. The Italian Pharmacovigilance System, in charge of the Italian Medicines Agency, collects spontaneous reports only for registered drugs. The awareness of the need of surveillance of the safety of natural health products has stimulated the implementation of a suspected adverse reaction reporting system in Italy. The system has been set up by the Italian National Institute of Health. METHODS: An ad hoc reporting form can be downloaded from different institutional web sites. Voluntary reports of suspected adverse reactions are sent to the National Institute of Health and are evaluated by a multidisciplinary group of experts. RESULTS: From April 2002 to March 2007, 233 spontaneous reports of suspected adverse reactions to natural health products were collected. A large proportion of suspected adverse reactions were serious: hospitalization was reported in 35% of forms; 6% reported life threatening clinical events and two fatal events were notified. About 50% of suspected adverse reactions were related to gastrointestinal, skin, psychiatric and nervous system disorders. Mainly herbal products (66%) were involved. Twenty-one cases of hepatitis of various seriousness were reported. Twenty-one reports were associated with 27 homeopathic preparations, mostly preparations containing mixtures of substances. Fourteen reports regarded suspected reactions to products containing propolis. CONCLUSION: Safety and efficacy of 'natural' medicines have not been thoroughly investigated. It is important to improve communication with the public on safety issues. Encouraging spontaneous reporting can contribute to improve awareness among health personnel and patients about the benefit-harm profile of these remedies.

Complementary and alternative remedies: an additional source of potential systemic nickel exposure.

BACKGROUND: Systemic contact dermatitis from nickel has been reported from a number of sources including medical devices and following experimental oral exposure. OBJECTIVE: To identify other potential sources of systemic nickel exposure. METHODS: The internet and published medical literature were searched for complementary and alternative remedies which contain nickel. RESULTS: We identified and evaluated sources of nickel exposure in 4 homeopathic preparations, which are advertised to treat common skin diseases, as well as in a number of other homeopathic remedies, several herbal products and multivitamin mineral complexes. CONCLUSION: Complementary and alternative remedies are an additional source of systemic nickel exposure and at highest doses the potential risk for systemic contact dermatitis in nickel allergic patients should be considered.

A case of oesophageal ulcer developed after taking homeopathic pill in a young woman.

Oesophageal ulcers occur mainly as a result of gastro-oesophageal reflux disease (GERD). However, pill-induced oesophageal ulcers are a fairly common event. The lesion is mainly due to entrapment of the pill and/or its chemical composition thereof. This case report describes an oesophageal mucosa ulcer occurred in a healthy 35-year old woman who had no previous history of oesophageal disorders and received homeopathic medication. The present case reveals that pill entrapment can occur even in the oesophagus of healthy young individuals and that oesophageal mucosal ulcer can be triggered by substances generally thought devoid of any potentially mucosal aggressive effect.

A systematic review: Are herbal and homeopathic remedies used during pregnancy safe?

BACKGROUND: Herbal and homeopathic remedies have been used to assist with child bearing and pregnancy for centuries. Allopathic ('Western') medicine is traditionally avoided during pregnancy because of limited drug trials and the suspected teratogenic effects of these medications. This has led to an increase in the use of herbal and homeopathic remedies, asthey are viewed to have no teratogenic effect on the developing foetus. Health providers are faced with questions from their clients regarding the safety of these remedies, but much of the evidence about these herbal and homeopathic remedies is anecdotal and few remedies havebeen tested scientifically. OBJECTIVES: By conducting a systematic review, the primary objective was to evaluate maternal and neonatal outcomes of ingested herbal and homeopathic remedies during pregnancy. METHOD: A systematic review was conducted to synthesise all the evidence with the purpose of evaluating the safety of herbal and homeopathic remedies based on adverse maternal and neonatal outcomes. Only randomised and quasi-randomised controlled trials that met allinclusion criteria were included in the review. RESULTS: The ingestion of ginger for nausea and vomiting during pregnancy was shown to have no harmful maternal or neonatal effects. Ingestion of castor oil for induction of labour showed a tendency towards an increase in the incidence of caesarean section and meconiumstained liquor, warranting further research into its safety issues. CONCLUSION: Larger randomised controlled trials need to be conducted, especially in South Africa, to establish the safety and efficacy of commonly-used remedies.

Utilization and Safety of Common Over-the-Counter Dietary/Nutritional Supplements, Herbal Agents, and Homeopathic Compounds for Disease Prevention.

Dietary supplements are commonly used by patients as part of their medical care plan. Often clinicians may not be aware of their use, because patients do not always consider these to be medications. All clinicians need to continually ask patients about their use of dietary supplements when collecting a medication history. Dietary supplements and prescription medications often share similar enzymatic pathways for their metabolism. These interactions may lead to severe adverse reactions. This article reviews available evidence for a variety of dietary supplements in select disease categories.

The safety of herbal medicinal products derived from Echinacea species: a systematic review.

Echinacea spp. are native to North America and were traditionally used by the Indian tribes for a variety of ailments, including mouth sores, colds and snake-bites. The three most commonly used Echinacea spp. are E. angustifolia, E. pallida and E. purpurea. Systematic literature searches were conducted in six electronic databases and the reference lists of all of the papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting programmes of the WHO and national drug safety bodies. Twenty-three manufacturers of echinacea were contacted and asked for data held on file. Finally our own departmental files were searched. No language restrictions were imposed. Combination products and homeopathic preparations were excluded. Data from clinical studies and spontaneous reporting programmes suggest that adverse events with echinacea are not commonly reported. Gastrointestinal upsets and rashes occur most frequently. However, in rare cases, echinacea can be associated with allergic reactions that may be severe. Although there is a large amount of data that investigates the efficacy of echinacea, safety issues and the monitoring of adverse events have not been focused on. Short-term use of echinacea is associated with a relatively good safety profile, with a slight risk of transient, reversible, adverse events. The association of echinacea with allergic reactions is supported by the present evaluation. While these reactions are likely to be rare, patients with allergy or asthma should carefully consider their use of echinacea. The use of echinacea products during pregnancy and lactation would appear to be ill-advised in light of the paucity of data in this area.

The potential impact of the use of homeopathic and herbal remedies on monitoring the safety of prescription products.

The purpose of this paper is to explore the possibility that adverse reactions and drug interactions arising from the use of homeopathic and herbal medicines could lead to confusion when adverse reactions to conventional medicines are reported. An extensive literature review was conducted on the occurrence of adverse reactions and drug interactions following the use of homeopathic or herbal remedies, and the potential for these to confound adverse event reporting to conventional medicines considered. The survey demonstrates the potential for herbal remedies and homeopathic products, to produce adverse drug reactions or drug interactions, and shows the scope for potential for confusion with those arising from conventional medicines. There is a need for greater awareness that adverse reactions apparently due to a conventional medicine, might in reality be due to a herbal medicine or a drug interaction between a herbal medicine and a conventional drug, particularly when a health professional is unaware of the extent of a patient's self-medication with alternative therapies.

Luffa operculata effects on the epithelium of frog palate: histological features.

UNLABELLED: Luffa operculata is the botanical name of buchinha-do-norte or cabacinha, which is a medicinal plant widely used for the treatment of rhinitis and rhinosinusitis. In Europe and USA, it is available in homeopathic medicines. In Brazil, Luffa operculata dry fruit infusion is inhaled or instilled into the nose releasing profuse mucous secretion, thus relieving nasal symptoms. Nevertheless, this often may cause irritation, epistaxis or anosmia. STUDY DESIGN: Experimental. MATERIAL AND METHOD: The effects of Luffa operculata were evaluated in different concentration infusions, in isolated frog palate preparation, testing 46 palates after immersion. Four groups (n = 10) were tested with the infusion prepared with frog Ringer (isotonic): control; 60 mg/L; 600 mg/L; and 1200 mg/L. An additional group was tested using the infusion with water (600 mg/L H2O, n = 6). Epithelial samples were harvested to be studied under light microscopy and electron transmission microscopy. RESULTS: In treated palates, light microscopy findings were dose-dependent standard toxic changes. Electron transmission microscopy showed enlargement of intercellular spaces and tight junctions disruption, pointing to ion-fluid transport abnormalities. CONCLUSIONS: Luffa operculata infusion in currently used doses can promote significant structural and ultrastructural changes in the epithelium of this ex vivo model of respiratory mucosa.

Efficacy of a homeopathic Crataegus preparation compared with usual therapy for mild (NYHA II) cardiac insufficiency: results of an observational cohort study.

OBJECTIVES: To compare the efficacy of the homeopathic Crataegus preparation Cralonin for non-inferiority to standard treatment for mild cardiac insufficiency. METHODS: Multicentre non-randomised cohort study in patients aged 50-75 years in New York Heart Association class II. Patients received Cralonin (n=110) or ACE inhibitor/diuretics (n=102) for 8 weeks. To adjust for confounding by baseline factors, populations were stratified according to propensity score. After adjusting, there were no statistically significant differences between treatment groups. Treatment efficacy was assessed on 15 variables. A stringent non-inferiority criterion for the upper limit of the 97.5% one-sided confidence interval of the treatment difference was set to 0.2x the standard deviation (S.D.). RESULTS: Both treatment regimens improved scores on most variables studied, with the greatest effect on double product after exercise (average score reduction 15.4% with Cralonin vs. 16.0% for the control group). Stringent non-inferiority of Cralonin was demonstrated on 7 variables. Medium-stringent (0.5xS.D.) non-inferiority was indicated by 13 variables (exceptions: systolic blood pressure (BP) during exercise and diastolic BP at rest; for these, differences between treatments were not significant). Both treatments were well tolerated. CONCLUSION: The Crataegus-based preparation Cralonin is non-inferior to usual ACE inhibitor/diuretics treatment for mild cardiac insufficiency on all parameters except BP reduction.

Co-ingestion of herbal medicines and warfarin.

BACKGROUND: A large proportion of patients use herbal remedies with a potential to interact with prescribed drugs. Such interactions can be dangerous, particularly if the therapeutic window of the prescribed drug is small, as with warfarin. AIMS: Our aim was to estimate the prevalence of the use of herbal medicines by patients taking warfarin (co-ingestion). DESIGN OF STUDY: Postal questionnaire. SETTING: General practices in the South West of England. METHOD: Thirty-five general practices in Devon and Somerset identified 2600 patients taking warfarin and sent postal questionnaires to them. RESULTS: One thousand, three hundred and sixty usable responses were received (response rate = 54.2%). One or more of the specified herbal remedies thought to interact with warfarin were taken by 8.8% of all patients. Complementary or homeopathic treatments not specified in the survey questionnaire were taken by 14.3% of responders. Overall, 19.2% of responders were taking one or more such medicines. The use of herbal medicines had not been discussed with a conventional healthcare professional by 92.2% of patients. Twenty-eight point three per cent of responders thought that herbal medicines might or definitely could interfere with other drugs prescribed by their doctor, however, patients taking any non-prescribed medication were less likely to believe this (chi2 = 20, degrees of freedom = 1, P<0.001). CONCLUSION: A substantial proportion of patients taking warfarin in southwest England self-medicate with both herbal medicines that are thought to interact with warfarin and with others of unknown effect, usually without informing their healthcare team. Patients have a responsibility to mention such non-prescribed medication to their general practitioners, and general practitioners also have a responsibility to ask whether such co-ingestion is occurring.

A follow-up survey of the use of complementary and alternative medicines by surgical patients.

This study investigated the use of complementary and alternative medicines by surgical patients at the University of Colorado Health Sciences Center, Denver. Elective surgical outpatients were randomly surveyed with anonymous self-report questionnaires during day-surgery admission about alternative medicines taken during the 2 weeks before surgery; 496 of 500 questionnaires were completed and returned. Of the patients, 37% reported 62 types of herbs, 59% reported 14 types of vitamins, 45% reported 36 types of of dietary supplements, and 1% reported taking 5 types of homeopathics. A total of 73.4% of patients took alternative medicines preoperatively (range, 1-44 medicines). After a literature review, the alternative medicines were categorized for potential interactions with anesthetic drugs. Alternative medicines that have inhibitory effects on the coagulation cascade were reported by 40% of surgical patients. The following percentages of patients took medicines that affect blood pressure, 32%; affect cardiac function, 20%; cause sedation, 17%; or have potential to alter electrolyte levels, 9%. Herbs recognized to interact with pharmaceuticals were consumed by 23% of patients. Further research, education, and improved communication are needed to safely integrate alternative medicines for surgical patients.