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Few days ago I had the pleasure of watching a nutricentre webcast for Linda Lazarides, author and course director at the School of Modern Naturopathy
Lazardies dedicated the first 20 minutes or so for her take on how to integrate clinical trials in nutritional medicine. I am not qualified to assess a person as Lazardies, but I must declare my humble opinion. Lazardies take on the integration of medical research in nutrition is thought provoking and insightful (which is expected from a person of her stature). I see her opinion as one of the missing links I was searching for to formulate my own opinion for the proper scientific methodology to formulate and advance nutritional therapy.
Lazarides mentioned three points relating to clinical trials, yet the third is the most poignant and deserves deep thinking. Please note that I am extensively rephrasing:
Let assume you read a trial for giving pyridoxine (vitamin B6) for premenstrual syndrome (PMS) and the trial shows benefit. Would this lead to you recommending vitamin B6 to PMS sufferers?
If you are interested in Lazarides answer than continue reading. However, I will first mention Lazarides first two points.
1. Clinical trials assess efficacy, that is if a drug is effective in reaching a predetermined goal or not. But, often people equate efficacy with ‘cure’. For example if a clinical trial concludes that that vitamin B6 is effective in PMS, many assume vitamin B6 would cure PMS when all what the clinical trial states that Vitamin B6 can improve PMS. This improvement could be merely masking patients discomfort while the disease process is worsening.
2. Clinical trials only tell us that an intervention or drug is more effective than the other arm of the trial which is usually a placebo. The tested intervention or drug can be toxic or harmful. Drugs do not need to have any curative value.
Now back to the answer to the main question:
Would you recommending pyridoxine to PMS sufferers based on a trial that shows benefit?
Lazarides states that such a clinical trial should not push us to start to treat PMS with pyridoxine. All what this clinical trial should tell us is that PMS has a nutritional bases. Therefore, for patients suffering from PMS, a full nutritional assessment should be performed. Yes, we should focus on pyridoxine, but never limit ourselves to it.
An unanswered question that poses itself based on Lazarides opinion is if all what nutritional clinical trials suggest is a nutritional link to a disease and that the next step is performing a full nutritional assessment, what should be the scientific basis for this nutritional assessment? My humble answer is to perform systematic reviews that do not preclude qualitative studies. For this, I would point you to a two page article by Robbert van Haselen titled: ‘Medical Study Formats: An Overview’ published in the Nov 2010 issue of the Journal of Biomedical Therapy
What do you think?
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