Evidence map›Paper›PMID 28965336›Full record

ArticleDrugs - real world outcomes2017

Use and Safety of Anthroposophic Medicinal Products: An Analysis of 44,662 Patients from the EvaMed Pharmacovigilance Network.

Harald Johan Hamre, Anja Glockmann, Kirsten Heckenbach, Harald Matthes

Open access · goldAbstract read
In one paragraph

Article in Drugs - real world outcomes, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
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  3. Neurodoron® for Stress Impairments: A Prospective, Multicenter Non-Interventional Trial.Evidence-based complementary and alternative medicine : eCAM · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Harald Johan HamreInstitute for Applied Epistemology and Medical Methodology, University of Witten/Herdecke, Zechenweg 6, 79111, Freiburg, Germany. harald.hamre@ifaemm.de.ORCID http://orcid.org/0000-0003-1098-1079
Anja GlockmannInstitute for Applied Epistemology and Medical Methodology, University of Witten/Herdecke, Zechenweg 6, 79111, Freiburg, Germany.ORCID http://orcid.org/0000-0003-2257-3507
Kirsten HeckenbachResearch Institute Havelhöhe, Community Hospital Havelhöhe, Kladower Damm 221, 14089, Berlin, Germany.
Harald MatthesResearch Institute Havelhöhe, Community Hospital Havelhöhe, Kladower Damm 221, 14089, Berlin, Germany.ORCID http://orcid.org/0000-0002-4053-4379
Forschungsinstitut Havelhöhe · DEWitten/Herdecke University · DE

Funding

Christophorus Stiftung 272 CSTEkhagastiftelsen 2014-63Mahle-Stiftung 160035Software AG-Stiftung P 11437
6 · The paper itself

Abstract

backgroundThere is a need for data on the clinical safety of anthroposophic medicinal products (AMPs).

objectivesThe main objective of this analysis was to determine the frequency of adverse drug reactions (ADRs) to AMPs, relative to the number of AMP prescriptions.

methodsEvaMed (Evaluation of Anthroposophic Medicine) was a prospective pharmacovigilance study with the patients of 38 physicians in outpatient care in Germany. Diagnoses and prescriptions were extracted from the electronic medical records. All physicians documented ADRs of Grades III-IV and serious ADRs, seven 'prescriber physicians' also documented non-serious ADRs of any intensity. Patients were eligible for this analysis if they had one or more AMP prescription in the years 2001-2010, followed by one or more physician visit.

resultsA total of 44,662 patients with 311,731 AMP prescriptions, comprising 1722 different AMPs, were included. One hundred ADRs to AMPs occurred, caused by 83 different AMPs. ADR intensity was mild, moderate, and severe in 50% (n = 50/100), 43%, and 7% of cases, respectively; one ADR was serious. Among patients of prescriber physicians, ADRs of any intensity occurred in 0.071% (n = 67/94,734) of AMP prescriptions and in 0.502% (n = 65/12,956) of patients prescribed AMPs. In subgroup analyses according to age, specific AMPs or AMP groups, dosage forms, and concentrations (altogether 11 groups), the highest ADR frequency was 0.290% of prescriptions (for one specific AMP). Among all patients, serious ADRs occurred in 0.0003% (n = 1/311,731) of prescriptions and 0.0022% (n = 1/44,662) of patients.

conclusionIn this analysis from a large sample, ADRs to AMP therapy in outpatient care were rare; ADRs of high intensity as well as serious ADRs were very rare.

Identifiers

PMID28965336
PMCPMC5684047
OpenAlexW2757034969

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.