PMID- 17147463
OWN - NLM
STAT- MEDLINE
DCOM- 20070226
LR  - 20181113
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 29
IP  - 12
DP  - 2006
TI  - Use and safety of anthroposophic medications in chronic disease: a 2-year 
      prospective analysis.
PG  - 1173-89
AB  - BACKGROUND AND OBJECTIVE: Anthroposophic medications (AMED) are prescribed by 
      physicians in 56 countries worldwide and are used for the treatment of a variety 
      of conditions. However, safety data on long-term use of AMED from large 
      prospective studies are sparse. The objective of this analysis was to determine 
      the frequency of patient-reported and physician-assessed adverse drug reactions 
      (ADRs) to AMED in outpatients using AMED for chronic diseases over a 2-year 
      period. METHODS: We conducted a prospective observational cohort study involving 
      131 medical practices in Germany. In total, 662 consecutive outpatients aged 1-75 
      years were enrolled in the study. The patients were using AMED for mental 
      (primarily depression and fatigue), musculoskeletal, respiratory, neurological 
      and other chronic diseases. Main outcome measures were use of AMED and ADRs to 
      AMED. RESULTS: Throughout the 2-year follow-up, patients used 949 different AMED 
      for a total of 11 487 patient-months. The origin of AMED was mineral (8.1%, 77 of 
      949 AMED), botanical (41.8%), zoological (7.8%), chemically defined (10.5%) and 
      mixed (31.7%). Most frequently used AMED ingredients were Viscum album (11.5%, 76 
      of 662 patients), Bryophyllum (9.4%), Arnica (7.9%) and Silicea (7.7%). Non-AMED 
      products were used by 94.2% of patients for a total of 11 202 patient-months; 
      45.2% of this use was accounted for by medication for the CNS, the cardiovascular 
      system and the alimentary tract and metabolism. A total of 1861 adverse events 
      (AEs) were documented. The most frequent AEs were non-specific symptoms, signs 
      and findings (International Classification of Diseases [10th Edition] R00-R99: 
      27.6%, 513 of 1861 AEs), musculoskeletal (M00-M99: 16.9%), respiratory (J00-J99: 
      8.2%) and digestive diseases (K00-K93: 6.6%). No serious AEs attributable to any 
      medication occurred. Out of the 1861 reported AEs, 284 (15.3%) AEs were suspected 
      by the physician or the patient to be an adverse reaction to non-medication 
      therapy (n = 42 AEs), non-AMED (n = 187) or AMED (n = 55 AEs in 29 patients). 
      Twenty of these 29 patients had confirmed ADRs to 21 AMED. These ADRs were local 
      reactions to topical application (n = 6 patients), systemic hypersensitivity (n = 
      1) and aggravation of pre-existing symptoms (n = 13). In ten patients, AMED was 
      stopped due to ADRs; two patients had ADRs of severe intensity. Median number of 
      days with ADRs was 7 (range 1-39 days). All ADRs subsided, none were serious. The 
      frequency of confirmed ADRs to AMED was 2.2% (21 of 949) of all different AMED 
      used, 3.0% (20 of 662) of AMED users and one ADR per 382 patient-months of AMED 
      use. CONCLUSION: In this 2-year prospective study, AMED therapy was generally 
      well tolerated.
FAU - Hamre, Harald J
AU  - Hamre HJ
AD  - Institute for Applied Epistemology and Medical Methodology, Freiburg, Germany. 
      harald.hamre@ifaemm.de
FAU - Witt, Claudia M
AU  - Witt CM
FAU - Glockmann, Anja
AU  - Glockmann A
FAU - Troger, Wilfried
AU  - Troger W
FAU - Willich, Stefan N
AU  - Willich SN
FAU - Kiene, Helmut
AU  - Kiene H
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Plant Preparations)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Child
MH  - Child, Preschool
MH  - Chronic Disease
MH  - Cohort Studies
MH  - *Complementary Therapies
MH  - Drug Hypersensitivity/epidemiology
MH  - *Drug Therapy
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Follow-Up Studies
MH  - Germany/epidemiology
MH  - Humans
MH  - Infant
MH  - Male
MH  - Middle Aged
MH  - *Phytotherapy
MH  - Plant Preparations/adverse effects/therapeutic use
MH  - Prospective Studies
MH  - Treatment Outcome
EDAT- 2006/12/07 09:00
MHDA- 2007/02/27 09:00
CRDT- 2006/12/07 09:00
PHST- 2006/12/07 09:00 [pubmed]
PHST- 2007/02/27 09:00 [medline]
PHST- 2006/12/07 09:00 [entrez]
AID - 29128 [pii]
AID - 10.2165/00002018-200629120-00008 [doi]
PST - ppublish
SO  - Drug Saf. 2006;29(12):1173-89. doi: 10.2165/00002018-200629120-00008.