Adverse drug reactions for CAM and conventional drugs detected in a network of physicians certified to prescribe CAM drugs.
ABSTRACT Within recent years, the increasing popularity of complementary and alternative medicine (CAM) has led health care authorities to focus on the safety of these drugs. One reason for the low awareness of adverse drug reactions (ADRs) associated with CAM might be that users and physicians believe that there are no risks associated with CAM drugs. Recent studies have shown that ADRs are under-reported and are considered a leading cause of morbidity and mortality. The Evaluation of Anthroposophical Medicine (EvaMed) Pharmacovigilance Network was formed in 2004 at the Havelhoehe Research Institute in Berlin and is composed of 38 CAM physicians located in 12 of the 16 federal states in Germany for the purpose of using EvaMed data to evaluate the prescribing patterns, effectiveness, and safety of CAM therapies.
To describe and quantify the volume and severity of ADRs for CAM and conventional (CON) drugs in a proprietary database created from prescriptions and patient data of primary care CAM physicians who participate in the EvaMed Network.
This was a prospective, multicenter, observational study based on the ADR reports and electronic prescription data of 38 individual physicians (21 general practitioners, 9 pediatricians, 4 internists, 2 gynecologists, 1 dermatologist, and 1 neurologist) participating in the EvaMed Network. In addition to standard medical education, all physicians had 5 years practical experience and an additional qualification for anthroposophic medicine, which is a subcategory of CAM. All 38 physicians documented ADRs deemed serious, defined as life threatening or resulting in death, disability/incapacity, or inpatient hospital days. Due to the time-consuming nature of documenting ADRs, only a subgroup of 7 physicians (4 in general practice and 1 each in internal medicine, pediatrics, and gynecology) agreed to report both nonserious and serious ADRs. Therefore, the incidence and frequency of ADRs were evaluated in this subgroup. The study period was January 2004 through June 2009. ADRs were documented by the physicians using an electronic case report form in the EvaMed software, which was linked to the physicians' existing electronic medical record (EMR) systems and incorporated into their daily routines to avoid missing data or double entries. The participating physicians were compensated €15 (approximately US$20) for each ADR report. All ADR reports were monitored at the Havelhoehe Research Institute by 2 physicians who evaluated patient characteristics, present visit diagnosis, target drugs, associated drug classes and type of drugs, type of ADR, actions taken for the ADR, and outcome of the ADR.
There were 1,018,626 drugs (54.8% CAM) prescribed by the 38 physicians for 88,431 patients, and 412 ADRs reported for 389 patients; 124 (30.1%) ADRs were for CAM drugs. The majority were reported in children (69.2%, n = 285) and females (56.3%, n = 232). All serious ADRs (n = 14) were associated with CON drugs. In the subgroup of 7 physicians who agreed to report all ADRs, a total of 327 serious and nonserious ADRs were reported for 392,243 prescribed drugs (0.08%) and for 308 of 25,966 patients (1.2%). ADRs were reported for 241 of 16,032 children (aged 17 years or younger; 1.5%) versus 67 of 9,934 adults (0.7%). Of the 327 total ADRs, 10 (3.1%) were serious. There were 95 ADRs for 213,900 CAM prescriptions (4.4 per 10,000) versus 232 for 178,343 CON prescriptions (13.0 per 10,000). The CAM drug with the highest frequency of ADRs was Pelargonium sidoides root (0.21%, 4 of 1,940 prescriptions). The most frequently reported ingredient in CAM was ivy leaves with an ADR frequency of 0.17% (n = 11 of 6,575 prescriptions). The most reported drug connected with ADRs was amoxicillin (1.36%, n = 31 of 2,276 prescriptions). The most common ADR medical management was withdrawal of the drug (82.3% overall, 83.9% CAM, 81.6% CON).
A sample of 38 CAM physicians reported the occurrence of at least 1 ADR for 0.4% of treated patients in a 5.5-year study period. There were no serious ADRs reported for CAM drugs. In a subsample of 7 physicians who agreed to report all nonserious and serious ADRs, 1.2% of patients experienced at least 1 ADR; rates of ADRs per 10,000 prescriptions were 4.4 for CAM drugs and 13.0 for CON drugs.
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ABSTRACT: Although over-the-counter traditional Chinese herbal medicine (COTC) is commonly used to treat everyday illness in many parts of the world, no population-based study has been done to examine the prevalence and factors associated with COTC-related adverse events. A cross-sectional telephone survey was conducted among Hong Kong Chinese adults in 2011 (n = 1100) with informed verbal consent. Stepwise logistic regression of demographic, attitudinal and behavioral variables was used to determine factors associated with past-year adverse events. Of study respondents, 71.7% (789/1100) reported past-year COTC use and 2.3% (25/1100) reported at least one COTC-related adverse event in the past year. Of the 27 adverse events cases reported among COTC users, the most common were allergic reactions (n = 11) dizziness (n = 5), and gastro-intestinal problems (n = 4). Pills/capsules were the dosage form that caused the highest proportion of adverse events (n = 10), followed by plasters (n = 7), creams/ointments (n = 5), and ingestible powders (n = 2).Although COTC users reporting adverse events were more likely to report greater practices to avoid adverse events (OR = 6.47; 95% CI: 1.38-30.3); they were also more likely to possess lower education levels (OR = 9.64, 95% CI: 2.20-42.3) and to have received COTC information from non-reliable, mass-media information sources such as magazines (OR = 3.32; 95% CI: 1.01-8.50) or television (OR = 2.93; 95% CI: 1.03-10.7). Package labels were also felt to be unclear by 42.9% of COTC users. A large proportion of COTC users demonstrated low levels of COTC-related knowledge, while the main impediment to greater information-seeking was the belief that reliable COTC information is not obtainable from Western health professionals. Despite global movements toward more stringent complementary medicine regulation, the limited accessibility of reliable information and widespread misperceptions among consumers present major challenges for the safe use of complementary medicine.BMC Complementary and Alternative Medicine 11/2013; 13(1):336. · 1.88 Impact Factor
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ABSTRACT: Background. In Europe, mistletoe extracts are widely used as a complementary cancer therapy. We assessed the safety of subcutaneous mistletoe as a conjunctive therapy in cancer patients within an anthroposophic medicine setting in Germany. Methods. A multicentre, observational study was performed within the Network Oncology. Suspected mistletoe adverse drug reactions (ADRs) were described by frequency, causality, severity, and seriousness. Potential risk factors, dose relationships and drug-drug interactions were investigated. Results. Of 1923 cancer patients treated with subcutaneous mistletoe extracts, 283 patients (14.7%) reported 427 expected effects (local reactions <5 cm and increased body temperature <38°C). ADRs were documented in 162 (8.4%) patients who reported a total of 264 events. ADRs were mild (50.8%), moderate (45.1%), or severe (4.2%). All were nonserious. Logistic regression analysis revealed that expected effects were more common in females, while immunoreactivity decreased with increasing age and tumour stage. No risk factors were identified for ADRs. ADR frequency increased as mistletoe dose increased, while fewer ADRs occurred during mistletoe therapy received concurrent with conventional therapies. Conclusion. The results of this study indicate that mistletoe therapy is safe. ADRs were mostly mild to moderate in intensity and appear to be dose-related and explained by the immune-stimulating, pharmacological activity of mistletoe.Evidence-based Complementary and Alternative Medicine 01/2014; 2014:724258. · 2.18 Impact FactorThis article is viewable in ResearchGate's enriched formatRG Format enables you to read in context with side-by-side figures, citations, and feedback from experts in your field.
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ABSTRACT: Background. Depression is a major reason for counselling in primary care. Our study aims at evaluating pharmacological treatment strategies among physicians specialised in anthroposophic medicine (AM). Methods. From 2004 to 2008, twenty-two German primary care AM-physicians participated in this prospective, multicentre observational study. Multiple logistic regression was used to determine factors associated with a prescription of any antidepressant medication. Results. A total of 2444 patients with depression were included (mean age: 49.1 years (SD: 15.4); 77.3% female). 2645 prescriptions of antidepressants for 833 patients were reported. Phytotherapeutic preparations from Hypericum perforatum were the most frequently prescribed antidepressants over all (44.6% of all antidepressants), followed by amitriptyline (16.1%). The likelihood of receiving an antidepressant medication did not depend on comorbidity after controlling for age, gender, physician specialisation, and type of depression (adjusted OR (AOR) = 1.01; CI: 0.81-1.26). Patients who had cancer were significantly less likely to be prescribed an antidepressant medication than those who had no cancer (AOR = 0.75; CI: 0.57-0.97). Conclusion. This study provides a comprehensive analysis of everyday practice for the treatment of depression in AM -physicians. Further analysis regarding the occurrence of critical combinations is of high interest to health services research.Evidence-based Complementary and Alternative Medicine 12/2012; 2012:508623. · 2.18 Impact FactorThis article is viewable in ResearchGate's enriched formatRG Format enables you to read in context with side-by-side figures, citations, and feedback from experts in your field.