EDIT:
30 June 2010 - @zeno001 just tweeted@zeno001 Poor clinical trial not sufficient proof for #ASA - Vitabiotics and diabetes: http://bit.ly/bmu4rs http://twitter.com/zeno001/status/17369803811
I never actually saw the advert that they refer to (amazingly it wasn't actually me that put in the complaint to the ASA!), I heard about this product because someone asked me about it and I looked at the website. What's also noticeable about the ASA complaint is that this event has taken place because of the actions of ONE person.
-------------- Original post ---------------
All views are my own, may be wrong, may be changed with new evidence and additionally I am not medically trained so nothing here should ever be taken as medical advice.
UK pharmacist Boots apparently sells Diabetone tablets (for around £10 for 30 tablets) and the tablets are also available online.
Company website: http://www.vitabiotics.com/Diabetone/
According to the Diabetone website the product is "supported by original published nutritional research" having been formulated to contain the nutrients of "special relevance to people with diabetes". However the actual claims made are that the product may enhance wellbeing in people with diabetes; the product doesn't appear to have any effect on blood glucose management etc.
The short version of this blog post is that this conclusion is drawn from a single study of 29 people with Type 2 diabetes - it's a pilot study, which indicated some improvements in wellbeing when taking the supplements compared with placebo, but I think possibly a bit more research is needed before anyone can really conclude that these pills are doing that much.
The longer version is below...
There's some sensible stuff on the 'More information' section about eating healthily, and some indications that people with diabetes may have reduced levels of certain vitamins etc. (I've no particular dispute with this but wonder if, assuming the deficit is minor couldn't it be remedied with dietary changes or if it's more serious perhaps a 'once-a-day' multivitamin tablet mightn't be enough... also some deficiencies could even be because of a problem in absorption from the intestine and I don't think a tablet's going to help much there).
The FAQ is also very good, highlighting that advice should be sought from healthcare professionals and that Diabetone is "not a treatment for diabetes or metabolic control, but intended to help maintain overall health and wellbeing." This is based on research which suggests "that a multinutrient supplement [Diabetone] may [help] enhance wellbeing" and there's some vague stuff about it being "important for people with diabetes to maintain healthy insulin metabolism and research shows that certain nutrients can help to maintain normal, healthy glucose metabolism."
Only one reference ("Enhanced Wellbeing of Adults with Type 2 Diabetes following Multi-Vitamin and Mineral Supplementation") is cited, however no link is given to the original article. Google's very helpful for this sort of thing though.
Assuming that's the right paper, it was published in 2007, in 'Integrative Medicine Insights' which I hadn't heard of (the word Diabetone does not feature in PubMed, although apparently any of the journal's NIH funded articles would be indexed in PubMed) - here's an abstract and the full PDF is also linked below.
The research article itself is a pilot study, of 29 subjects with Type 2 diabetes who had fairly good baseline levels of blood glucose and blood pressure. The main things looked at were to see if Diabetone has any effect on the sorts of blood parameters that are important in diabetes (including fasting glucose levels, HbA1c and lipids) which it apparently doesn't.
"In our pilot study, a multinutrient supplement failed to significantly improve the glycemic and lipemic profile of patients with type 2 diabetes with relatively good baseline glycemic and blood pressure control. In most studies which have demonstrated such improvements in diabetes, nutrients were administered at higher doses than in our study."
The secondary outcome was wellbeing, as assessed by the wellbeing questionnaire W-BQ 22.
The conclusion, adapted on the website is "Findings from this pilot study suggest that a multinutrient supplement may enhance the wellbeing of diabetic patients, even in the absence of a significant improvement in clinical parameters."
Well OK it *might*... but I think drawing this conclusion about the pills based on a pilot study is a little premature.
More information on getting a varied diet can be found at the website of the Food Standards Agency (see the menu on the left hand side).
Reference
Marakis, G, Walker, AF., Simpson, HCR, Byng, M and Robinson PA (2007) Enhanced wellbeing of adults with Type 2 diabetes following multi-vitamin and mineral supplementation for three months in a randomised, double-blind, cross-over pilot study. Integrative Medicine Insights, 2: 7-14. Download PDF
PubMed Diabetone hits - 0
Mentions of Diabetone in ClinicalTrials.gov - 0
Mentions of Diabetone in Controlled-trials.com - 0
Always get medical advice from medically qualified people, and not me :)
Sunday, 7 March 2010
4 comments:
Comment policy: I enthusiastically welcome corrections and I entertain polite disagreement ;) Because of the nature of this blog it attracts a LOT - 5 a day at the moment - of spam comments (I write about spam practices,misleading marketing and unevidenced quackery) and so I'm more likely to post a pasted version of your comment, removing any hyperlinks.
Comments written in ALL CAPS LOCK will be deleted and I won't publish any pro-homeopathy comments, that ship has sailed I'm afraid (it's nonsense).
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There are also two brands, both labelled Diabetone. One is by Biogenesis and is designed to work with blood sugar balance http://www.bio-genesis.com/productpages/diabetone-plus/diabetone-plus.html. They have a long listing of published research to back up the ingredients in their product.
ReplyDeleteThe other is the one you saw online, which appears to be a multivitamin, and is by Vitabiotics. For the record, while it didn't use Vitabiotics product, a link to a randomized, double blind, placebo controlled trial on multis in diabetics can be found at http://www.ncbi.nlm.nih.gov/pubmed/12614088. It showed that it reduced the incidence of infection (pretty quantifiable) and absenteeism due to such, and yes, improved "well-being".
Thanks for the comment. Where can research specifically on the Biogenesis product be found, and what is its quality?
ReplyDeleteWhen composing my blogpost I searched on PubMed (free) and OVID Medline (not free) for 'Diabetone' and found nothing. No mention at all.
The Biogenesis product seems to be no different from other similarly-named products (eg Diamaxol) for which there isn't much evidence, just a bunch of herbs and vitamins shoved together in a bottle.
The literature cited in the Clinicians' Report for the Biogenesis comprises a series of papers for individual components that can be found in the Diabetone product. The evidence for cinnamon is out of date as it's been superseded by a Cochrane review which didn't find strong evidence in favour.
There doesn't seem to be any research on the product as a whole, ie what happens when someone takes all of those supplements/herbs together. This is quite an omission I think.
The Barringer trial mentioned also had some limitations, small size for one and there's a risk of bias where the participants are volunteering their own infection scores. As the editorial accompanying the article noted:
"Barringer and colleagues’ trial has several limitations. The small size (130 participants) led to imbalances between the two treatment groups at baseline. Specifically, the experimental group was somewhat better nourished and more educated than the placebo group. Secondary multivariate analyses would have addressed this concern, but potential confounding by other unmeasured variables cannot be excluded. The small sample size also limited the statistical power to examine possible effects among elderly persons. A second limitation, which the authors noted, is that most participants correctly guessed their randomized assignment. Thus, despite the investigators’ efforts, the trial was not truly blinded. This is of particular concern given the subjective nature of reporting of the study outcomes. However, the finding of no difference between the two groups on physical and mental subscales— even more subjective assessments—suggests that the lack of blinding did not play a major role in the resulting effects of supplementation on infection."
I'm not against vitamins, or herbs for that matter, just against over-extrapolation or cherrypicking of data.
So, if not diabetone, then do you know of any other multivitamin that helps general weakness arising out of Type 2 Diabetes?
ReplyDeleteThe first thing to do is find out if you are actually deficient in any vitamins - it might be that your doctor can order a blood test to check levels directly and a dietitian can check your diet to see if there might be any deficiencies (and offer suggestions of any dietary changes that might help). If you are not vitamin deficient there is no benefit (and possibly some harm) to taking extra unnecessary vitamins, although I don't think the generic multivitamins would cause problems beyond unnecessary expense.
DeleteYou might not be particularly deficient in any vitamins or you might be mildly deficient but have none of the symptoms ("asymptomatic" = without symptoms) that would suggest a vitamin deficiency.
If you are deficient in one or more vitamins be sure, before you buy any vitamin pills, that the problem can actually be solved by vitamin pills as opposed to vitamin injections. For example, if you have a problem in absorbing a vitamin from your gut then no amount of vitamin pills will help - you may need vitamin injections.
An example of this in Type 2 diabetes can occurs in some people who are using metformin. It can interfere with the absorption of Vitamin B12 and generally the solution for this is intramuscular injections of the vitamin every few months, sometimes with added calcium supplementation. But for goodness sake don't assume that if you're taking metformin that you're vit B12 deficient - it's always best to check with a doctor.
I don't think Diabetone will harm anyone, it just amuses me that the tiny test they offer for its benefits seems only to have shown that people liked it more than the other pill, so they're selling it as a sort of wellness thing. That just made me laugh :)