Posted 12 May 2016
Self-proclaimed nutrition expert Patrick Holford addressed Cape Town residents on Sunday 8th May 2016 at a City-sponsored event on diabetes and healthy lifestyle choices. This event is discussed by Naib Mian in a GroundUp article. We have previously asked whether Holford is scientifically incompetent, or simply a liar, a peddler of snake oil supplements. Holford is a self-styled nutritionist, has no formal degree from an established accredited institution, and is not a doctor. Dr Ben Goldacre, author of the books Bad Science and Bad Pharma, devoted a whole chapter to Holford, and on his website.
But this is what is relevant: Patrick Holford addressed the city on diabetes. Through Brunel Laboratoria, (sic) he promotes/sells a product in South Africa, called Cinnamon, for diabetes.
This product, a combination of ingredients, has never been tested in a single clinical study that can be found – you be the guinea pig! The main ingredient in this product is Cinnulin PF. Evidence that this ingredient is beneficial for diabetes is utterly inadequate, as explained below.
Even if evidence that Cinnulin PF is effective was adequate, according to the manufacturer, Integrity Nutraceuticals, the recommended serving dose is 250 mgs twice daily (= 500 mg daily). Patrick Holford recommends 75 mg twice daily (one capsule twice daily, amount per 2 capsules: 150mg). What?!! Is Holford recommending less than half the dose recommended by the researcher and manufacturer? Holford’s product also contains niacin and chromium, but does not adequately explain the large difference between Holford’s dose and the manufacturer!
Although no claim is made for the product on the Brunel website, he has submitted a dossier to the Medicines Control Council (MCC) applying for registration for this product as a complementary medicine (CAM) as part of the first call up (proclaimed in the 15 November 2013 Regulations). This includes products “claiming to be complementary medicines for [viral illnesses including] HIV, diabetes, heart conditions and cancer”. The first call up is for high risk conditions, i.e., there must be good evidence to support the claims – the diseases are high risk.
The product, Cinnnamon, contains “Cinnulin PF®, a patented, water-soluble extract of cinnamon”.
Interestingly, Patrick Holford also sells a product, with very similar packaging, at Dis-Chem called Cinnachrome, which makes claims to be beneficial for diabetes. On the Dis-Chem website, the image shows Cinnachrome but the product is titled Cinnamon. This product has not applied for registration under the first call up. Possibly the name of the product is being changed? (Note: During the registration application process, the name of every product has to be recommended for approval by the Naming and Scheduling Committee of the MCC.)
On his website, Patrick Holford makes claims as to why this product works: “Cinnamon helps to regulate the body’s production of insulin – the bad guy when it comes to weight gain and the fight against weight-loss. And what’s more, upping your intake of cinnamon to 6 g a day can also slow down digestion thereby further balancing blood sugar levels and in turn preventing weight gain” and “Holford’s Cinnachrome, containing a blend of cinnamon extracts, chromium and the vitamins B3, taken daily can help to restore blood sugar levels; improve the symptoms of diabetes and balance mood and appetite”.
What is the evidence that cinnamon, or more specifically “Cinnulin PF®” can influence insulin or be effective in diabetes?
One of the most respected sources for assessing evidence for “natural” medicines (CAMS) is the highly reputable Natural Medicines Comprehensive Database (“Unbiased, Scientific Clinical Information on Complementary, Alternative, and Integrative Therapies”).
Their summary for the effectiveness for cinnamon in diabetes is succinct:
“Effectiveness: INSUFFICIENT RELIABLE EVIDENCE to RATE
Diabetes: There is contradictory evidence about the effectiveness of cassia cinnamon for treating type 1 or type 2 diabetes. Some clinical research shows that taking cassia cinnamon in doses ranging from 120 mg to 6 grams daily for up to 3 months significantly decreases fasting blood glucose, glycosylated hemoglobin (HbA1C), total cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and blood pressure compared to placebo in patients with type 2 diabetes. However, other clinical studies show no significant effect on insulin sensitivity, blood glucose, HbA1C, cholesterol, triglycerides, or blood pressure compared to placebo in patients with type 2 diabetes when cassia cinnamon was used in doses of 1 gram to 3 grams daily up to 4 months. [references removed]
The Cochrane Collaboration is a vehicle for assessing all previous research around a topic, condition, or treatment. In 2012, the Cochrane Collaboration reviewed all the studies that evaluated the use of cinnamon in diabetes and concluded: “There is insufficient evidence to support the use of cinnamon for type 1 or type 2 diabetes mellitus. Further trials, which address the issues of allocation concealment and blinding, are now required. The inclusion of other important endpoints, such as health-related quality of life,diabetes complications and costs, is also needed”.
To add to this, there are other further peer-reviewed reviews both arriving at the same conclusion.
“Clinical trials that studied the hypoglycaemic effects of Cinnamon, bitter gourd, fenugreek and ivy gourd showed conflicting results. Direct comparison between studies remains a challenge in view of the baseline heterogeneity of subjects, differences in substrate preparation, variable end points and poor trial design. Short durations of study and small number of subjects studied is universal”. Medagama et al.
In other words, some studies support the claims, many others do not, and therefore weighing up the evidence, there is no consensus … To put this in context – if 5 studies shows that x does work and 10 shows that it does not, is if fair to say that x works? We actually have no way of knowing for certain, and the qualities of the different studies have to be considered carefully.
PubMed comprises more than 26 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites. Searching PubMed for “Cinnulin PF” finds exactly 6 related articles. Two studies on cells, one on rats, one on hamsters, and two on humans (2006 -22 subjects with prediabetes given 500 mg/day, and 2009 – 22 subjects 250 mg twice daily, with impaired fasting blood glucose). Interestingly, Richard A Anderson was an author on both studies in humans. The latter study was sponsored by Integrity Nutraceuticals International. The paper states: “Tim N Ziegenfuss served as a consultant to Integrity Nutraceuticals International from 10/2005 to 10/2006 and Richard Anderson has a USDA Cooperative Research and Development Agreement with Integrity Nutraceuticals”. We do not suggest that the study is therefore necessarily compromised. Integrity Nutraceuticals International is the manufacturer of Cinnulin PF.
One of the fiercest critics of Holford, and a website that meticulously examines a range of Holford’s claims, is Holford Watch. Here they state the following:
“Unlike the case for too many of Holford’s recommendations, there are some trials (albeit of variable quality) on which to base an assessment. However, unaccountably, for a product that he recommends to the interested population for “natural blood sugar balance”, the studies that he cites mostly concern diabetics or rodents. In addition, it is not always clear that there is any correlation between the substance that has been evaluated in trials and that which is included in his formulation”, and,
“Given the dearth of scientific or clinical evidence, it is unfortunate that he continues to market this as a product to “support natural blood sugar balance” whether or not somebody is on a low GL diet or actually diabetic”.
With this in mind, it is unfathomable that Patricia de Lille, could have invited Holford to address Cape Town residents at a City-sponsored (i.e. paid for by tax-payers) event on diabetes (and healthy lifestyle choices).
Let us not forget how disastrous it was a previous time a politician (President Mbeki) got involved in medicines-related issues.