I always find it interesting the discussion that goes on around studies that look at these sorts of interventions. We have 1000s of studies that have looked at changing surrogate markers - this is just another one. Good for them getting it published in the
CMAJ.
I applaud all researchers who try to answer medical questions and these authors did a good job of looking at what happens to risk factors when subjects were randomized to the type of naturopathic care described. It is an interesting question - hardly earth
shattering but nonetheless, in my mind reasonable research.
The problem I see with this study really has nothing to do with the design but rather some of the wording in the paper
1) The title of the article is a best misleading
"Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial"
It wasn't that at all - the title should have been "Visits for naturopathic care for the reduction of cardiovascular risk factors - a randomized clinical trial"
2) The first line of the interpretation was "We found a significant reduction in the risk of cardiovascular disease following counselling about nutritional and physical activity provided by naturopathic doctors." They found nothing of the sort - they found
a reduction in the risk of cardiovascular risk factors NOT cardiovascular disease.
In my opinion, the main critique of this study should be the following - and by critique I mean more contextualizing
1) We have no idea if this intervention would lead to reduced cardiovascular disease. 15 large RCTs in a row (I haven't seen any showing a positive outcome but please let me know if I have missed any) over the last 3-5 years have shown little if any benefit
and even some harm from changing surrogate markers
LIPIDS
AIM-HIGH, HPS2-THRIVE (niacin)
ACCORD (fibrates)
dalOUTCOMES (dalcetrapib)
BLOOD PRESSURE
ALTITUDE (aliskiren)
VALISH, AASK, ACCORD (aggressive BP lowering)
DIABETES
ACCORD, ADVANCE, VADT (aggressive A1c lowering)
ROADMAP (olmesartan)
ORIGIN (insulin)
GENERAL
ACTIVE (irbesartan/afib)
2) The only dietary intervention that has really been evaluated for cardiovascular outcomes is the Mediterranean diet and and the most recent trial showed that over 5 years it reduced the number of cardiovascular events by around 1% compared to a low fat diet
- at least the dietary recommendations in this study were for this sort of nutrition intervention. The increased activity seems a reasonable suggestion as well.
3) Fish oil supplements which were recommended in this study have been a huge bust as far as I recall.
4) I have not seen any studies that have shown that using the concept of metabolic syndrome improves the ability to risk stratify over and above the individual risk factors and we really don't have a treatment for the "metabolic syndrome" other than what we
should advise for most people - eat in moderation, be more active, and maybe for some metformin/BP control and maybe a low dose statin.
Those are some of my thoughts.
James McCormack, BSc(Pharm), Pharm D
Faculty of Pharmaceutical Sciences
|
I think if there is any issue with the publication, then a response to author should be written and allow the author to reply. Gordon Guyatt is not the principle author (but realize his name is offered given his seniority in the EBM field) but I am sure that
if someone is moved to reply to author, and he is asked a question (s) for clarification, he will address concerns and questions.
From: Susan Fowler <[log in to unmask]>
Subject: Re: why did CMAJ publish this study?
To: [log in to unmask]
Received: Tuesday, May 14, 2013, 11:30 AM
Have you written Gordon Guyatt and asked him?
--
Susan Fowler, MLIS
Medical Librarian
Evidence at Becker:
http://beckerguides.wustl.edu/ebm
Systematic Reviews Guide:
http://beckerguides.wustl.edu/SystematicReviews
Becker Medical Library, Washington University in St. Louis
314-362-8092
[log in to unmask]" target="_blank" style="color: purple; text-decoration: underline; ">[log in to unmask]
The CMAJ just published a study on naturopathy. The press release I received about the paper said, “Treatment by naturopathic doctors shows reduction in cardiovascular risk factors. Randomized controlled trial.”
The trial showed nothing of the sort. I blogged about this last week:
The CMAJ knew that the study was useless. From an editorial that accompanied the study:
Is there something I'm missing here? Does a study that's not designed to measure anything have some use I'm overlooking?
|