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Patrick Holford, YorkTest and a Migraine Study

Former Visiting Professor Patrick Holford but still Head of Science and Education at Biocare has an enthusiasm for interventions that we wish we might share but, too frequently, when we examine the studies on which he relies, the results do not support his claims or the scope of his optimism.

In a recent newsletter, Patrick Holford was rather excited about a recent study: Randomised controlled trial of food elimination diet based on IgG antibodies for the prevention of migraine like headaches. For reasons that may become clear, he neglected to mention the full title of the paper.

Last month a study published in the Nutrition Journal showed that 85% of people affected by debilitating migraines had their symptoms reduced, and quality of life improved, when their food triggers were discovered and avoided. Having a hidden food allergy is one of five common causes of migraines.

This recent study tested migraine sufferers for food allergy using YorkTest’s FoodScan test. Eighty four of the volunteers were put on their food allergy free diet, while 83 were given a sham ‘allergy’ diet based on fake test results. At the end of four weeks those on the real allergy free diets had had 23% less migraines than those on the sham diet.

You might be a little surprised that Holford was quite so excited by this result after 4 weeks of assessment that the newsletter was subject-lined, “Relieve your migraine without painkillers” and headlined, “What’s causing migraines?”. Holfordwatch consulted the original study and can not agree that Holford provides a useful interpretation of its outcome.[1] According to the reported results, it seems as if even the study’s authors might quibble with Holford’s optimism:

The results indicated a small decrease in the number of migraine like headaches over 12 weeks, although this difference was not statistically significant (IRR 1.15 95% CI 0.94 to 1.41, p = 0.18). At the 4 week assessment, use of the ELISA test with subsequent diet elimination advice significantly reduced the number of migraine like headaches (IRR 1.23 95%CI 1.01 to 1.50, p = 0.04). The disability and impact on daily life of migraines were not significantly different between the true and sham diet groups. [Emphasis added.]

There are many other problems with this paper (eg, the participants are effectively self-selected from a group that is pre-disposed to believe that food intolerance influences migraine; there is no clinical verification of the migraine-like headaches description; respected experts in allergy and immunology caution against the notion that Yorktest’s IgG Food Intolerance test is diagnostic of food intolerance or clinically relevant; the number of study drop-outs compromises the power of the study effect). The study lacks scientific rigour to the extent that the only surprise is that a journal reviewer changed his opinion between 1st and 2nd review:

This paper has strong deficiencies in respect to the study design, recruitment, compliance, and no medical control and assessment of the subjects, not meeting the criteria for a scientific paper. Due to the huge amount of uncertainties, also acknowledged by the authors, this paper has no new information to offer and is of limited interest.
Level of interest: Reject as not of sufficient priority to merit publishing in this journal. [1st review]

Such flaws in the design and other areas can not be corrected merely by re-writing yet the reviewer accepts the revisions (eg, the revised title now refers to “migraine-like headaches” rather than “migraine”) and changes the review comment to:

Level of interest: An article whose findings are important to those with closely related research interests. [2nd review]

Recall that the research finding is not, as Holford leads, “[You can relieve] your migraine without painkillers” but that the study revealed that at 12 weeks (the study’s stated primary outcome): “this difference was not statistically significant“. Holford’s account is partial and inaccurate. This is lamentable when one considers that he claims to be a valuable intermediary between the public and the practical reporting of health research. It is unsettling when one considers that there is considerable apprehension that some patients and healthcare providers might be persuaded by such claims to lobby for such ineffective tests and diets to be funded by the NHS despite their lack of clinical relevance or efficacy.

Notes

[1] Holfordwatch notes that Yorktest provided a similarly partial account of the study findings in their September 2011 news items and that the media that ran the Yorktest release on this study did not investigate the findings but reproduced this and other unduly favourable interpretations (the rollcall of shame includes: Metro, Red Online, Top Sante, Women’s Fitness, Women’s Weekly, OK Magazine, Woman’s Weekly, Female First.

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Filed under food intolerance, IgG tests, intolerance, patrick holford, yorktest

Joanna Blythman: Please Read the Data Appendices About Organic Food Before Conjuring ‘Cancerous Conspiracies’: Part 1

Dear Daily Mail Editors: congratulations on a very dramatic headline. A cancerous conspiracy to poison your faith in organic food: that is pure genius, building nicely on the recent reprimand to ‘the authorities’ for making us Scared to death? The REAL worry is today’s culture of fear. You will understand how many readers chuckled to read that the Daily Mail, of all newspapers, is accusing others of scare-mongering. Continue reading

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A Tale of Two WorkForces in the Same Workplace: Different Rules for Dietitians and Nutritionists in the NHS?

Last week the newspapers covered the story of Katie Peck who is both a degree-credentialled nutritionist and a Registered Dietitian. What is particularly interesting about this story is not the nature of some of her advice but that had she been recruited to work as a nutritionist, rather than RD, in her role at an NHS Diabetes Clinic, then there would not have been a hearing involving the Health Professions Council (HPC) and it is plausible that there would be no mechanism to allow scrutiny of the evidence-base for her advice to patients (the hearing has been adjourned until December, Mrs Peck denies any wrong-doing).

So, if you were to dispense some advice that your colleagues claim to lack an appropriate evidence base as an RD, then you might be asked to account for your actions before the HPC. However, if you dispense the same advice as a nutritionist (and, let’s imagine a scenario where this is a BANT rather than Nutrition Therapy Council nutritionist), then the route for challenging the advice is unclear at best. Continue reading

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Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 3

Jerome Burne and Bio-Identical Hormone Replacement Therapy: Parts 1 and 2 covered some difficulties with Kent Holtorf’s review article, Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?, relating to a potential conflict of interest (despite a statement to the contrary) and the completeness and quality of the review. For this final examination of Jerome Burne’s Should middle-aged women be taking natural HRT?, we focus on a paper for which we had to guess the identity: Unequal risks for breast cancer associated with different hormone replacement therapies: results from the E3N cohort study. (Again, This Really Is Not Good Enough or TRINGE.) Continue reading

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Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 2

Jerome Burne is co-author of Food Is Better Medicine Than Drugs (FIBMTD) with Former Visiting Professor Patrick Holford. FIBMTD has a chapter on Balancing Hormones in the Menopause -The HRT scandal vs natural control: there is a brief discussion of “Natural progesterone – a safer way with hormones”.

Progesterone is given in amounts equivalent to that normally produced by a woman who is ovulating (between 20 and 40 mg a day) and, unlike oestrogen or synthetic progestins, it has no known cancer risk – in fact…quite the opposite. [pg. 167, the reference for this bold assertion is a self-help book, not a journal paper or similar, if you were curious. And, no, no specific page reference or indication that this is a study/trial, in vitro, in vivo or animal.]

Mid-May we noticed that Burne had left a long comment, recommending his own research, on a post about The Alternative that Isn’t: Bioidentical Hormones at Science-Based Pharmacy. Gazing into our crystal ball, we anticipated that a Burne special on the topic must be in progress and so were not surprised to read today’s Should middle-aged women be taking natural HRT? in the Daily Mail. The shorthand version of the remainder of this post is:

No. Not if you are relying upon the Holftorf review to provide a comprehensive overview of the relevant evidence on efficacy and safety.

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Science: So What Is Recruiting a Dialogue Manager

From the Science: So What Campaign. Initially part-time (with hours to be agreed), this is a job opportunity for someone with experience of science writing and a strong interest in social media and science communication. Continue reading

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Jerome Burne and Bio-Identical Hormone Replacement Therapy: Part 1

After L’Affaire Economist, (parts 1, 2, 3) HolfordWatch really wanted to be able to commend Jerome Burne for something. We have noticed that although his last few articles in the Daily Mail haven’t actually carried links to the research upon which he relies, he has provided enough detail to allow the careful reader to identify the papers. It would, of course, be good if we did not have to resort to a treasure hunt to identify the primary sources but that is probably a confluence of out-moded thinking by both journalists and newspaper.

Today, Burne gave generous amounts of detail as to one of the major sources for his claims in his article: Should middle-aged women be taking natural HRT?. HolfordWatch was poised to congratulate Burne for semi-identifying this work up until we actually read the paper that he describes as a “major review”: Are Bioidentical Hormones (Estradiol, Estriol, and Progesterone) Safer or More Efficacious than Commonly Used Synthetic Versions in Hormone Replacement Therapy?. Leaving aside the lack of appropriate rigour in the paper, we noticed that, despite his usual exquisite sensitivity in such matters, Burne seems to be overlooking the “review” author’s failure to declare what might appear, to others, as a substantial conflict of interest. Continue reading

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