Plain English Summary
Background and study aims
Many patients undergoing surgery use naturopathic drugs (a form of alternative medicine). Several of these have been reported to increase bleeding in patients . The Swedish Medical Products Agency recommends that patients stop taking the naturopathic medicines echinacea, fish oil, ginkgo biloba, ginseng, St. John’s wort, valeriana and garlic two weeks before they have surgery. The primary aim of this pilot study is to examine the effects of these naturopathic drugs on the ability of the blood to clot using two different methods; the multiple electrode platelet aggregometer (Multiplate) and the viscoelastic rotational thromboelastometer (ROTEM). A secondary aim was to evaluate the effect of in vitro added ASA prior to Multiplate analyses in blood from healthy volunteers who had ingested Omega-3 in normal dose.
Who can participate?
Adult healthy volunteers
What does the study involve?
Participants all take a standard recommended dose of one of the neuropathic drugs to be tested for seven days. Blood samples are taken throughout the study period to assess platelet function and coagulation (both important for blood clotting),
What are the possible benefits and risks of participating?
There are no benefits, except for free naturopathic drugs, of participating in this study. The naturopathic drugs in this study can be bought over the counter without prescription and our assessment is that the drugs studied are harmless.
Where is the study run from?
Skåne University Hospital, Lund (Sweden)
When is the study starting and how long is it expected to run for?
August 2014 to April 2015
Who is funding the study?
Who is the main contact?
Dr Thomas Kander
Effects of naturopathic medicine on Multiplate and ROTEM: a prospective experimental pilot study on healthy volunteers
Current study hypothesis as of 31/01/2020:
The aim of this pilot study was to examine the effects of the 7 different naturopathic drugs listed
by the Swedish Medical Products Agency, utilizing the multiple electrode platelet aggregometer
(Multiplate) and the viscoelastic rotational thromboelastometer (ROTEM) in healthy humans
after 7 consecutive days of peroral intake. A secondary aim was to evaluate the effect of in vitro
added Asprin (ASA) to blood samples prior to Multiplate analyses
Previous study hypothesis:
The aim of this pilot study was to examine the effects of the 7 different naturopathic drugs listed by the Swedish Medical Products Agency, utilising the multiple electrode platelet aggregometer (Multiplate) and the viscoelastic rotational thromboelastometer (ROTEM) in healthy humans after 7 consecutive days of peroral intake.
Regional Ethical Review Board, Lund, Sweden, ref: 2010/482.
Single-centre experimental study
Primary study design
Secondary study design
Non randomised study
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Study on healthy volunteers
Thirty five healthy volunteers gave signed consent to ingest one of the listed naturopathic drugs for 7 days. Each naturopathic drug was taken in a recommended standard dose by 5 volunteers. ROTEM clot initiation (CT), clot formation (CFT), α-angle (AA) and clot structure (MCF) were analysed with tissue factor activated (EXTEM) and native (NATEM) assays. The Multiplate platelet aggregation area under curve (AUC) was measured with adenosine diphosphate (ADP), collagen (COL) and arachidonic acid (ASPI) assays.
Primary outcome measure
Platelet function measured with Multiplate
Secondary outcome measures
Coagulation evaluation measured with ROTEM
Primary and secondary outcomes were measured continuously during the recruitment, i.e. 1 November -- 30 November, 2014
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Adult healthy volunteers
Target number of participants
Participant exclusion criteria
2. Intake of any kind of anticoagulant or antithrombotic medicine including recent intake of aspirin and non-steroid anti-inflammatory drugs
3. Pregnancy or planned surgery
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Skåne University hospital
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
We are planning to publish the results of this study in a scientific journal during 2015.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26887420