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1.
J Urol ; 205(3): 855-863, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33103943

RESUMO

PURPOSE: No large-scale comparison of the 4 most established surgical approaches for lower urinary tract symptoms due to benign prostate obstruction in terms of long-term efficacy is available. We compared photoselective vaporization, laser enucleation and open simple prostatectomy to transurethral resection with regard to 5-year surgical reintervention rates. MATERIALS AND METHODS: A total of 43,041 male patients with lower urinary tract symptoms who underwent transurethral resection (34,526), photoselective vaporization (3,050), laser enucleation (1,814) or open simple prostatectomy (3,651) between 2011 and 2013 were identified in pseudonymized claims and core data of the German local health care funds and followed for 5 years. Surgical reinterventions for lower urinary tract symptoms, urethral stricture or bladder neck contracture were evaluated. Surgical approach was related to reintervention risk using the Kaplan-Meier method and Cox proportional hazards models. RESULTS: A total of 5,050 first reinterventions were performed within 5 years of primary surgery (Kaplan-Meier survival without reintervention: 87.5%, 95% CI 87.2%-87.8%). Photoselective vaporization carried an increased hazard of reintervention (HR 1.31, 95% CI 1.17-1.46, p <0.001) relative to transurethral resection, open simple prostatectomy carried a lower hazard (HR 0.43, 95% CI 0.37-0.50, p <0.001) and laser enucleation of the prostate did not differ significantly (HR 0.84, 95% CI 0.66-1.08, p=0.2). This pattern was more pronounced regarding reintervention for lower urinary tract symptom recurrence (photoselective vaporization: HR 1.52, 95% CI 1.35-1.72, p <0.001; laser enucleation of the prostate: HR 0.84, 95% CI 0.63-1.14, p=0.3; open simply prostatectomy: HR 0.38, 95% CI 0.31-0.46, p <0.001 relative to transurethral resection). CONCLUSIONS: Five-year reintervention rates of transurethral resection and laser enucleation did not differ significantly, while photoselective vaporization had a substantially higher rate. Open simple prostatectomy remains superior to transurethral resection with respect to long-term efficacy.


Assuntos
Sintomas do Trato Urinário Inferior/etiologia , Sintomas do Trato Urinário Inferior/cirurgia , Hiperplasia Prostática/complicações , Adulto , Idoso , Seguimentos , Humanos , Terapia a Laser/métodos , Masculino , Pessoa de Meia-Idade , Tratamentos com Preservação do Órgão/métodos , Prostatectomia/métodos , Reoperação , Ressecção Transuretral da Próstata/métodos
2.
J Manag Care Pharm ; 18(6): 427-38, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22839683

RESUMO

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Terapias Complementares/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Padrões de Prática Médica , Medicamentos sob Prescrição/efeitos adversos , Adolescente , Adulto , Criança , Pré-Escolar , Registros Eletrônicos de Saúde , Prescrição Eletrônica , Feminino , Alemanha , Humanos , Masculino , Médicos , Estudos Prospectivos , Adulto Jovem
3.
Forsch Komplementmed ; 19(6): 293-301, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-23343584

RESUMO

BACKGROUND: The use of preparations from Bryophyllum pinnatum for tocolysis (or to arrest labor) is supported by observations obtained mainly at empirical level, but also by preclinical experiments performed with uterus strips and myometrium cell lines. Furthermore, a retrospective matched-pair study revealed good tolerability and effectiveness. In anthroposophic medicine, however, Bryophyllum species are used for a broad spectrum of diagnoses. Here, we characterize the prescribing pattern of Bryophyllum preparations in a network of anthroposophic physicians in Germany. METHODS: 38 primary-care physicians in Germany participated in the EvaMed network, a multi-center observational study. They documented anonymized prescriptions, diagnoses and demographic data (age and gender) for each consecutive patient between 01.01.2004 and 01.01.2010. Diagnoses were coded according to the 10th revision of the International Classification of Diseases (ICD-10). In the present analysis, all prescriptions of any Bryophyllum preparation in the resulting data bank were identified and the corresponding diagnoses were analyzed retrospectively. RESULTS: A total of 4,038 prescriptions of Bryophyllum preparations were identified in the EvaMed data bank. A variety of preparations could be found, 77.7% of which were prepared from Bryophyllum plants exclusively and 22.5% were combinations. Bryophyllum preparations were often prescribed to treat 'mental and behavioral disorders' (ICD-10 F00-F99, 35.7%) and 'diseases of the skin and subcutaneous tissue' (L00-L99, 16.0%), followed by 'symptoms, signs, and abnormal clinical and laboratory findings, not elsewhere classified diseases' (R00-R99, 15.2%) and 'diseases of the nervous system' (G00- G99, 9.7%). CONCLUSION: By revealing the use of Bryophyllum preparations in so many other indications than preterm delivery, our data clearly show the urgent need to conduct additional clinical trials.


Assuntos
Medicina Antroposófica , Kalanchoe , Fitoterapia , Extratos Vegetais/uso terapêutico , Padrões de Prática Médica , Adolescente , Adulto , Idoso , Criança , Doenças do Tecido Conjuntivo/tratamento farmacológico , Feminino , Alemanha , Humanos , Masculino , Transtornos Mentais/tratamento farmacológico , Pessoa de Meia-Idade , Doenças do Sistema Nervoso/tratamento farmacológico , Trabalho de Parto Prematuro/tratamento farmacológico , Gravidez , Estudos Retrospectivos , Dermatopatias/tratamento farmacológico , Tela Subcutânea , Tocolíticos/uso terapêutico , Adulto Jovem
4.
Artigo em Inglês | MEDLINE | ID: mdl-23304204

RESUMO

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.

5.
BMC Neurol ; 11: 99, 2011 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-21824429

RESUMO

BACKGROUND: Dementia is a major and increasing health problem worldwide. This study aims to investigate dementia treatment strategies among physicians specialised in complementary and alternative medicine (CAM) by analysing prescribing patterns and comparing them to current treatment guidelines in Germany. METHODS: Twenty-two primary care physicians in Germany participated in this prospective, multicentre observational study. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients had at least one diagnosis of dementia according to the 10th revision of the International Classification of Diseases during the study period. Multiple logistic regression was used to determine factors associated with a prescription of any anti-dementia drug including Ginkgo biloba. RESULTS: During the 5-year study period (2004-2008), 577 patients with dementia were included (median age: 81 years (IQR: 74-87); 69% female). Dementia was classified as unspecified dementia (57.2%), vascular dementia (25.1%), dementia in Alzheimer's disease (10.4%), and dementia in Parkinson's disease (7.3%). The prevalence of anti-dementia drugs was 25.6%. The phytopharmaceutical Ginkgo biloba was the most frequently prescribed anti-dementia drug overall (67.6% of all) followed by cholinesterase inhibitors (17.6%). The adjusted odds ratio (AOR) for receiving any anti-dementia drug was greater than 1 for neurologists (AOR = 2.34; CI: 1.59-3.47), the diagnosis of Alzheimer's disease (AOR = 3.28; CI: 1.96-5.50), neuroleptic therapy (AOR = 1.87; CI: 1.22-2.88), co-morbidities hypertension (AOR = 2.03; CI: 1.41-2.90), and heart failure (AOR = 4.85; CI: 3.42-6.88). The chance for a prescription of any anti-dementia drug decreased with the diagnosis of vascular dementia (AOR = 0.64; CI: 0.43-0.95) and diabetes mellitus (AOR = 0.55; CI: 0.36-0.86). The prescription of Ginkgo biloba was associated with sex (female: AOR = 0.41; CI: 0.19-0.89), patient age (AOR = 1.06; CI: 1.02-1.10), treatment by a neurologist (AOR = 0.09; CI: 0.03-0.23), and the diagnosis of Alzheimer's disease (AOR = 0.07; CI: 0.04-0.16). CONCLUSIONS: This study provides a comprehensive analysis of everyday practice for treatment of dementia in primary care in physicians with a focus on CAM. The prescribing frequency for anti-dementia drugs is equivalent to those found in other German studies, while the administration of Ginkgo biloba is significantly higher.


Assuntos
Terapias Complementares/estatística & dados numéricos , Demência/tratamento farmacológico , Ginkgo biloba , Fitoterapia/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Fatores Etários , Idoso de 80 Anos ou mais , Protocolos Clínicos , Demência/diagnóstico , Feminino , Alemanha , Humanos , Masculino , Atenção Primária à Saúde , Fatores Sexuais
6.
Altern Ther Health Med ; 17(2): 18-28, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21717821

RESUMO

BACKGROUND: Although the treatment of children has been a core domain ofanthroposophic medicine since its inception, a systematic analysis of anthroposophic therapies in pediatric primary care is still lacking. This study describes the spectrum of diagnoses and therapies observed in children treated in everyday anthroposophic practice. METHODS: Thirty-eight primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. RESULTS: In 2005, a total of 57 893 prescriptions for 18 440 children under 12 years of age (48.1% female) were issued. In total, 50.3% of the prescriptions were classified as CAM remedies alone, 22.6% as conventional pharmaceuticals alone, and 27.1% as a combination of both. Anthroposophic remedies accounted for 41.8% of all medications prescribed. The odds ratio (OR) for receiving an anthroposophic remedy was significantly higher for the first consultation (OR= 1.19; confidence interval [CI]: 1.16-1.23). Anthroposophic remedies were prescribed most frequently for disorders of the conjunctiva (OR = 2.47; CI: 2.27-2.70), otitis media (OR = 1.50; CI: 1.43-1.59), acute upper respiratory tract infections (OR= 1.28; CI: 1.23-1.33), other respiratory diseases (OR= 1.15; CI: 1.07-1.24), digestive system and abdominal symptoms (OR= 1.39; CI: 1.28-1.51), general symptoms and signs (OR= 1.25; CI: 1.16-1.36), .and pneumonia (OR= 1.36; CI: 1.25-1.49). The likelihood of being prescribed an anthroposophic remedy decreased with patient age (OR= 0.96; CI: 0.95-0.96) and was lower in patients treated by a pediatrician (OR= 0.43; CI: 0.42-0.44). Of the 2475 therapeutic procedures prescribed (29% anthroposophic), the most frequent were physiotherapy, speech therapy, ergotherapy, and logopedics. CONCLUSION: The present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for children. The findings show that practitioners of anthroposophic medicine take an integrative approach by combining conventional and anthroposophic treatments.


Assuntos
Doença Aguda/terapia , Medicina Antroposófica , Serviços de Saúde da Criança/estatística & dados numéricos , Doença Crônica/terapia , Naturologia/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde/estatística & dados numéricos , Criança , Pré-Escolar , Intervalos de Confiança , Feminino , Alemanha/epidemiologia , Humanos , Lactente , Masculino , Naturologia/métodos , Razão de Chances , Estudos Prospectivos , Qualidade de Vida , Resultado do Tratamento
8.
BMC Geriatr ; 10: 48, 2010 Jul 21.
Artigo em Inglês | MEDLINE | ID: mdl-20663129

RESUMO

BACKGROUND: Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM) like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. METHODS: Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. RESULTS: In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female) were included. The most frequent diagnoses were hypertension (11.1%), breast cancer (3.5%), and heart failure (3.0%). In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic). The adjusted odds ratio (AOR) for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79), treatment by an internist (AOR = 1.49; CI: 1.40-1.58), female patients (AOR = 1.35; CI: 1.27-1.43), cancer (AOR = 4.54; CI: 4.12-4.99), arthropathies (AOR = 1.36; CI: 1.19-1.55), or dorsopathies (AOR = 1.34; CI: 1.16-1.55) and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98). The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39), diabetes mellitus (AOR = 0.17; CI: 0.14-0.22), or metabolic disorders (AOR = 0.17; CI: 0.13-0.22). CONCLUSION: The present study is the first to provide a systematic overview of everyday anthroposophic medical practice in primary care for elderly patients. Practitioners of anthroposophic medicine prescribe both conventional and complementary treatments. Our study may facilitate further CAM-research on indications of, for example, dementia or adverse drug reactions in the elderly.


Assuntos
Medicina Antroposófica , Assistência ao Paciente/métodos , Preparações Farmacêuticas/administração & dosagem , Atenção Primária à Saúde/métodos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Assistência ao Paciente/tendências , Atenção Primária à Saúde/tendências , Estudos Prospectivos , Fatores de Tempo
9.
BMC Fam Pract ; 10: 78, 2009 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-20003298

RESUMO

BACKGROUND: The management of hypertension is a key challenge in modern health systems. This study aimed to investigate hypertension treatment strategies among physicians specialized in complementary and alternative medicine (CAM) in Germany by analysing prescribing patterns and comparing these to the current treatment guidelines issued by the German Hypertension Society. METHODS: In this prospective, multicentre observational study, which included 25 primary care physicians specialized in CAM treatment, prescriptions and diagnoses were analysed for each consecutive hypertensive patient using routine electronic data. Data analysis was performed using univariate statistical tests (Chi square test, Cochran-Armitage trend test). Multiple logistic regression was used to determine factors associated with antihypertensive medication. RESULTS: In the year 2005, 1320 patients with 3278 prescriptions were included (mean age = 64.2 years (SD = 14.5), 63.5% women). Most patients were treated with conventional antihypertensive monotherapies (n = 838, 63.5%). Beta-blockers were the most commonly prescribed monotherapy (30.7%), followed by ACE inhibitors (24.0%). Combination treatment usually consisted of two antihypertensive drugs administered either as separate agents or as a coformulation. The most common combination was a diuretic plus an ACE inhibitor (31.2% of dual therapies). Patient gender, age, and comorbidities significantly influenced which treatment was prescribed. 187 patients (14.2%) received one or more CAM remedies, most of which were administered in addition to classic monotherapies (n = 104). Men (OR = 0.66; 95% CI: 0.54-0.80) and patients with diabetes (OR = 0.55; 95% CI: 0.42-0.0.73), hypercholesterolaemia (OR = 0.59; 95% CI: 0.47-0.75), obesity (OR = 0.74; 95% CI: 0.57-0.97), stroke (OR = 0.54; 95% CI: 0.40-0.74), or prior myocardial infarction (OR = 0.37; 95% CI: 0.17-0.81) were less likely to receive CAM treatment. CONCLUSIONS: The large majority of antihypertensive treatments prescribed by CAM physicians in the present study complied with the current German Hypertension Society treatment guidelines. Deviations from the guidelines were observed in one of every seven patients receiving some form of CAM treatment.


Assuntos
Anti-Hipertensivos/uso terapêutico , Terapias Complementares , Hipertensão/tratamento farmacológico , Padrões de Prática Médica/estatística & dados numéricos , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Combinada , Uso de Medicamentos , Feminino , Alemanha , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Observação , Estudos Prospectivos , Fatores Sexuais
10.
Forsch Komplementmed ; 16(5): 325-33, 2009 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-19887811

RESUMO

BACKGROUND: Although anthroposophic medicine has been used for more than 80 years and global interest in complementary treatments is increasing, a comprehensive and long-term description of everyday anthroposophic care is still lacking. Our study aims to evaluate how anthroposophic medicine is practised under everyday conditions. METHODS: A total of 38 primary-care physicians in Germany participated in this prospective, multi-centre observational study. Prescriptions, diagnoses, and non-pharmacological therapies were reported for each consecutive patient. RESULTS: In 2005, 95,116 prescriptions for 32,839 patients (56.2% children, 57.3% female) were recorded. The median duration of consultation depended on physician specialization (general practitioners: 9.5 min; paediatricians: 8.1 min). The most frequent single diagnoses were acute upper respiratory tract infections (URTI), otitis media, and bronchitis in children; hypertension, breast cancer, and depressive episodes in adult females; and hypertension, URTI, and asthma in adult males. Anthroposophic remedies accounted for 41.8% of all drugs prescribed. The odds ratio (OR) for receiving an anthroposophic remedy was very high for cancer (OR = 4.5; 95% CI: 4.2-4.8) and >1 for dorsopathies (OR = 1.5; CI: 1.3-1.6), otitis media (OR = 1.3; CI: 1.2-1.3), and URTI (OR = 1.1; CI: 1.1-1.2). Of the 5,289 therapeutic procedures prescribed, 27% were anthroposophic. CONCLUSION: A broad range of anthroposophic remedies and non-pharmacological therapies are prescribed for a specific set of diseases in everyday anthroposophic practice. Particularly, patients <60 years received anthroposophic care. Our findings will help in the planning and implementation of further studies.


Assuntos
Medicina Antroposófica , Terapias Complementares/métodos , Diagnóstico , Padrões de Prática Médica , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Tratamento Farmacológico , Feminino , Saúde Holística , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Encaminhamento e Consulta/normas , Adulto Jovem
11.
BMC Public Health ; 9: 274, 2009 Jul 31.
Artigo em Inglês | MEDLINE | ID: mdl-19643033

RESUMO

BACKGROUND: Recent studies have shown that adverse drug reactions (ADRs) are underreported. This may be particularly true of ADRs associated with complementary and alternative medicine (CAM). Data on CAM-related ADRs, however, are sparse.Objective was to evaluate the impact of an educational intervention and monitoring programme designed to improve physician reporting of ADRs in a primary care setting. METHODS: A prospective multicentre study with 38 primary care practitioners specialized in CAM was conducted from January 2004 through June 2007. After 21 month all physicians received an educational intervention in terms of face-to-face training to assist them in classifying and reporting ADRs. The study centre monitored the quantity and quality of ADR reports and analysed the results.To measure changes in the ADR reporting rate, the median number of ADR reports and interquartile range (IQR) were calculated before and after the educational intervention. The pre-intervention and post-intervention quality of the reports was assessed in terms of changes in the completeness of data provided for obligatory items. Interrater reliability between the physicians and the study centre was calculated using Cohen's kappa with a 95% confidence interval (CI). We used Mann Whitney U-test for testing continuous data and chi-square test was used for categorical data. The level of statistical significance was set at P < 0.05. RESULTS: A total of 404 ADRs were reported during the complete study period. An initial 148% increase (P = 0.001) in the number of ADR reports was observed after the educational intervention. Compared to baseline the postinterventional number of ADR reportings was statistically significant higher (P < 0.005) through the first 16 months after the intervention but not significant in the last 4-month period (median: 8.00 (IQR [2.75; 8.75]; P = 0.605). The completeness of the ADR reports increased from 80.3% before to 90.7% after the intervention. The completeness of the item for classifying ADRs as serious or non-serious increased significantly (P < 0.001) after the educational intervention. The quality of ADR reports increased from kappa 0.15 (95% CI: 0.08; 0.29) before to 0.43 (95% CI: 0.23; 0.63) after the intervention. CONCLUSION: The results of the present study demonstrate that an educational intervention can increase physician awareness of ADRs. Participating physicians were able to incorporate the knowledge they had gained from face-to-face training into their daily clinical practice. However, the effects of the intervention were temporary.


Assuntos
Terapias Complementares , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Educação Médica Continuada , Atenção Primária à Saúde/organização & administração , Humanos , Estudos Prospectivos
12.
Drug Saf ; 32(8): 691-706, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19591533

RESUMO

BACKGROUND: The use of complementary therapies by patients has increased over the past 20 years, both in terms of self-medication and physician prescriptions. Among herbal medicines, those containing extracts of Asteraceae (Compositae), such as Echinacea spp., Arnica montana, Matricaria recutita and Calendula officinalis, are especially popular in the primary-care setting. However, there remains a gap between the growing acceptance of these remedies and the lack of data on their safety. OBJECTIVE: The aim of this study was to analyse prescribing patterns and adverse drug reactions (ADRs) for Asteraceae-containing remedies in Germany. METHODS: Primary-care physicians, all of whom were members of the German National Association of Anthroposophic Physicians were invited to participate in this prospective, multicentre, observational study. During the study period (September 2004 to September 2006), all prescriptions and suspected ADRs for both conventional and complementary therapies were documented using a web-based system. The study centre monitored all ADR reports and conducted a causality assessment according to Uppsala Monitoring Centre guidelines. Relative risks (RRs) and proportional reporting ratios (PRRs) were calculated. RESULTS: Thirty-eight physicians, 55% of whom were general practitioners and 45% were specialists, fulfilled the technical requirements and were included in the investigation. Because documenting all ADRs (i.e. serious and nonserious) was time consuming, only a subgroup consisting of seven physicians agreed to report nonserious in addition to serious ADRs. During the study period, a total of 50 115 patients were evaluated and 344 ADRs for conventional and complementary remedies were reported. Altogether, 18 830 patients (58.0% female, 60.3% children) received 42 378 Asteraceae-containing remedies. The most frequently prescribed Asteraceae was Matricaria recutita (23%), followed by Calendula officinalis (20%) and Arnica montana (20%). No serious ADRs for Asteraceae-containing remedies were reported. In the analysis of the subgroup of seven physicians who also documented nonserious ADRs, 11 nonserious ADRs for Asteraceae-containing remedies occurred in 6961 patients, resulting in an RR of 0.13 (95% CI 0.07, 0.23). The majority of reported ADRs for Asteraceae-containing remedies were classified as uncommon. A subgroup analysis comparing phytotherapeutic and homoeopathic preparations did not reveal any relevant differences. The PRR for Asteraceae-containing remedies with respect to all other prescriptions was 1.7 (95% CI 1.0, 2.0) for the system organ class 'skin and subcutaneous tissue disorders' (six ADRs) and 1.0 (95% CI 0.3, 3.6) for 'gastrointestinal disorders' (three ADRs). Neither result was significant according to the PRR criteria developed by Evans et al. CONCLUSION: This is the first study to provide a systematic overview of prescribing patterns and ADRs for Asteraceae-containing remedies in the German primary-care sector. Asteraceae-containing remedies were used frequently in this context, especially among children. Our results indicate that treatment with Asteraceae-containing remedies is not associated with a high risk of ADRs.


Assuntos
Asteraceae/química , Extratos Vegetais/efeitos adversos , Padrões de Prática Médica , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Criança , Terapias Complementares/efeitos adversos , Terapias Complementares/métodos , Feminino , Alemanha , Homeopatia/métodos , Humanos , Masculino , Pessoa de Meia-Idade , Fitoterapia/efeitos adversos , Fitoterapia/métodos , Extratos Vegetais/uso terapêutico , Atenção Primária à Saúde , Estudos Prospectivos , Adulto Jovem
13.
Forsch Komplementmed ; 14(4): 207-15, 2007 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-17848797

RESUMO

BACKGROUND: Upper respiratory tract infections (URTI) are among the leading reasons for doctor consultations. This study investigates the prescribing practices of medical doctors specialized in anthroposophic medicine in the treatment of URTI with a special focus on the prescription of antibiotics, complications, recurrence rates and costs. MATERIALS AND METHODS: Starting in May 2004 all prescriptions within a 1-year period by 35 primary care practitioners in Germany were analysed. Data were extracted from practice software with special interfaces with additional linking of medications and diagnoses by practitioners. RESULTS: 21,818 prescriptions for 12,081 patients (73.7%children) with 19,050 cases of URTI were analysed. The most common diagnosis was common cold (63.3%), followed by acute tonsillitis (12.9%). 63.0% were treated purely with complementary medicine. Antibiotics were given in 6.3% of cases (minimum: common cold 1.9%, maximum: tonsillitis 24.3%). Predictive factors for antibiotic prescribing were the diagnoses tonsillitis (odds ratio [OR]: 6.7; 95% confidence interval [CI]:4.5-9.9) and sinusitis (OR: 1.9; 95% CI: 1.1-3.1), concomitant disease (OR: 1.2; 95% CI: 1.0-1.4), complications (OR: 7.2; 95% CI:5.5-9.4) and the specialty paediatrics (OR: 2.1; 95% CI: 1.7-2.6). In cases that were initially treated with only complementary medicine, antibiotics were eventually prescribed in 0.7%. Overall complication rates were 2.9% and follow-up visits occurred in 6.3%. Patients had an average of 2.4 URTI/year (adults 1.7,children 2.7). Treatment costs did not differ between complementary care and antibiotics. CONCLUSION: Prescription practices in the treatment of URTI by anthroposophic practitioners were documented through the processing of routine medical data with minimal additional data. The therapy was found to be in accordance with the guidelines, however, the prescription rate for antibiotics was well below the German average.


Assuntos
Antibacterianos/uso terapêutico , Terapias Complementares/estatística & dados numéricos , Prescrições de Medicamentos/estatística & dados numéricos , Infecções Respiratórias/tratamento farmacológico , Adolescente , Adulto , Criança , Pré-Escolar , Terapias Complementares/economia , Bases de Dados Factuais , Prescrições de Medicamentos/economia , Feminino , Alemanha , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Infecções Respiratórias/diagnóstico
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