VANCOUVER (PasseportSanté.net) February 15, 2005 – During the Second International Symposium of the Canadian Society for Natural Health Products Research (NHRSDC), DD Sylvie Dodin, doctor and researcher1, unveiled the unpredictable difficulties that can arise during a clinical trial of a natural health product (NHP).
Ethical question: there will be no easy one!
All clinical trials must respect certain ethical rules which are verified by a committee.
In the case of a test conducted by DD Dodin and dealing with the comparative effects of omega-3 fatty acids and a placebo on depression, this committee raised the question of a higher risk of suicide if the subjects took a placebo rather than an antidepressant.
The problem is that it is very difficult, if not impossible, to recruit people interested in testing a natural product under such conditions since they then have one in two possibilities of consuming an antidepressant.
What to do then? Quite “simply” convince the ethics committee that the increased risk of suicide is minimal. What DD Dodin and his team did, but by devoting two months to a systematic review of the data on the subject. The selection and exclusion criteria were also tightened as well as the consent form, and the research team made themselves available to participants 24 hours a day for emergency calls.
Question of money: the competition is very strong!
We know that pharmaceutical companies offer compensation of approximately $ 1,500 to people who take part in a study on a drug, but did you know that they offer doctors $ 5,000 to $ 10,000 per person recruited?
Such budgets do not exist for NHP studies, so very few physicians agree to involve their patients. The majority of recruitment is therefore only done through newspapers. And not all who volunteer are eligible: thus to recruit 179 participants in one of the studies led by DD Dodin, his team carried out 1,413 interviews and blood tests! In total, the recruitment process took 18 months.
Question of dose: hypericin please!
When DD Dodin set out to prepare a study on the effects of St. John’s Wort on depression, she knew several obstacles would arise.
However, there is one that she hadn’t expected: the hypericin content2 of the extract from the company that had agreed to provide the supplement turned out to be ten times lower than expected, ie 0.029% instead of 0.3%!
It was therefore necessary to analyze several batches of three other manufacturers before finding one offering a constant and adequate content of hypericin: these expensive tests resulted in unforeseen expenses.
In research, the use of a well-identified product with an adequate concentration is fundamental.
Françoise Ruby – PasseportSanté.net
1. DD Sylvie Dodin has been an associate professor in the Department of Obstetrics and Gynecology at Laval University and clinical researcher at the Saint-François-d’Assise Hospital Research Center of the Center hospitalier universitaire de Québec since 1992. She has also held a position since 1992. 2002, of the Lucie and André Chagnon Chair for the advancement of an integral approach to health.
2. Hypericin is not the active ingredient in St. John’s Wort (ie, it does not have an antidepressant effect), but rather its marker. A marker is a very characteristic component of a plant that is used to set a standard to ensure that the extract contains the right plant in the right concentration. As with many herbal remedies, the active ingredient in St. John’s Wort is not known. The extracts are generally standardized to 0.3% hypericin or 5% hyperforin.
