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Clinical attempts on the PSN: hard, lasts researcher's life!

VANCOUVER (Network Proteus) in February 15th, 2005 - During the second international Colloquium of the Canadian Company of search on the products of health natural (SCRPSN), Dre Sylvie Dodin, doctor and chercheure1, raised the fogging on the unpredictable difficulties which can appear during a clinical attempt concerning a product of health natural (PSN).

Question of ethics: there will not be of easy !

All the clinical attempts have to respect certain rules of ethics which are verified by a committee.

In the case of an attempt led by Dre Dodin and concerning the effects compared by some acids boldface oméga-3 and of a placebo on the depression, this committee lifted the question of a risk of higher suicide if the subjects took a placebo rather than an antidepressant.

The problem it is because he is very difficult, otherwise impossible, to recruit persons interested to test a natural product in such conditions because they have then a possibility on two to consume an antidepressant.

That to make then ? Quite "simply" convince the committee of ethics that greater risk of suicide is small. What Dre Dodin and his team made, but by dedicating two months to a systematic review of the data on the subject. The criteria of selection and exclusion were also tightened as well as the form of assent, and the team of search made available on the participants twenty four hours a day for the emergency calls.

Question of money : the competition is very strong !

We know that the pharmaceutical companies offer a compensation about 1 500 $ to people who participate in a study on a medicine, but do you know that they offer to the doctors from 5 000 $ to 10 000 $ a person recruited ?

Such budgets do not exist for the studies on the PSN, what makes that very few doctors agree to make it their patients participate. The majority of the recruitment are thus made only by means of logs. And all the persons who propose are not acceptable: so to recruit 179 participants in one of the studies steered by Dre Dodin, his team had to study 1 413 files! On the whole, the process of recruitment set 18 months.

Question of dose: of the hypéricine PLEASE !

When Dre Dodin began the preparation of a study on the effects of the St.-John's wort on the depression, she knew that several obstacles would appear.

However, there is one that she had not foreseen: the content hypéricine2 of the extract of the company which had agreed to supply the supplement showed itself ten times lower than that waited, that is 0,029 % instead of 0,3 % !

It was thus necessary to analyze several batches of three other manufacturers before finding an offering a constant and adequate content hypéricine: these expensive attempts entailednot foreseen spendings.

In search, the use of a well identified product and the concentration of which is adequate is fundamental.

Françoise Ruby - Network Proteus

1. Dre Sylvie Dodin is a teacher aggregated into the Department of obstetrics and gynaecology of the University Laval and researcher clinicienne in the center of search for the Hospital Saint-François-d'Assise of the Teaching hospital of Quebec since 1992. She is also a holder, since 2002, of the Pulpit Lucie and André Chagnon for the promotion of a complete approach in health.

2. The hypéricine is not the liveingredient of the St.-John's wort, (that is she has no antidepressant effect), but rather its marker. A marker is a very characteristic component of a plant which we use to fix a standard allowing to make sure that the extract contains well the good plant, in an adequate concentration. As it is the case for number of healing plants, the live ingredient of the St.-John's wort is not known. Extracts are generally normalized in 0,3 % of hypéricine or in 5 % of hyperforine.

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