L-05: CLINICAL TRIALS WITH NATURAL PRODUCTS IN CUBA. RESULTS AND PROJECTIONS

J Pharm Pharmacogn Res 3(suppl. 1): S5, 2015

Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015  September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.

Lecture

L-05: CLINICAL TRIALS WITH NATURAL PRODUCTS IN CUBA. RESULTS AND PROJECTIONS

Hernández A.

National Center Coordinating of Clinical Trials (CENCEC), Ave. 5ta A between/ 60 and 62 St., Miramar. Havana. E-mail: alberto@cencec.sld.cu

 

The current interest in natural products is marked. The increased use of them and the almost exponential increase in the market proves it. To this end, it has the “support” of ethnomedical use, the increase in pre-clinical studies, and the effort for quality in the pharmaceutical chemical area, but not to ignore, that to make only these types of studies is not sufficient for use as a medicament in humans. They must first be evaluated through clinical trial to demonstrate efficacy and safety, and later be registered and market them. An example of this. It is presented with the medicinal plants or phytomedicine. The world has changed since the first clinical trial with plants was published in 1971, to the present. Few publications were made in the world until 1999, 125 publications, and 4 per year. Better was between 2000 to 2013, 817 publications, 60.5 clinical trials  published per year, however systematic reviews do not show the best results, but the marketing of this type of product is growing. In Cuba since 1992 (first authorization of a clinical trial for a natural product) to date have authorized the execution of 51 clinical trial, 38 conducted by the National Coordinating Center for Clinical Trials, 74. 5% and 13 by other centers promoters, 24.5%. The 51 clinical trials have been of 25 products in 23 medical indications, (10 dermatological indications 7 respiratory distress trials in child and adult among others). These trials have been promoted by 16 centers, all Cubans. Of the 25 products, 10 are of vegetable origin, animal 7 and 8 mineral. More trials are phase II, 24, and 21 of phase III and three in phase I and three phase IV. Of them they have registered 10 products in 10 indications, as hypocholesterolemia, migraine, adult and child Distress, bone implant, among others.However, despite the quality of these clinical trial approved by the regulatory agency, and its marketing, Cuba does not escape the current situation facing the natural products in the world, distrust in it use, by a large group of prescribers, because scientific evidence is weak and there aren’t consistency in the results of clinical trials. In front of this situation, in March of this year was created, a multidisciplinary working group that  develop a “Strategy to minimize inconsistency in the results created phyto clinical trials”, which should bear fruit in the 4th quarter of 2015.

Citation Format: Hernández A (2015) Clinical trials with natural products in Cuba. Results and projections. [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S5. Abstract nr L-05.