ABSTRACT
Title
Adverse events and interactions due to Chinese Herbal Drugs in Italy. A three-year pharmacoepidemiology, pharmacogenomic and pharmacovigilance survey.
Authors
A. Vannacci1,2, F. Lapi1,2,3, E. Gallo1,2, A. Pugi1,2, E. Lucenteforte1,2, R. Bonaiuti1,2, V. Mascherini1,4, R. Raschetti5, F. Menniti-Ippolito5, A. Mugelli1,2, F. Firenzuoli4
1 Department of Preclinical and Clinical Pharmacology, Center for Molecular Medicine (CIMMBA), University of Florence, Florence
2 Tuscan Regional Centre of Pharmacovigilance, Florence
3 Regional Authority for Healthcare Services of Tuscany, Epidemiology Unit, Florence
4 Tuscan Regional Centre for Herbal Medicine, Florence
5 National Institute of Health, National Centre of Epidemiology, Rome.
1 Department of Preclinical and Clinical Pharmacology, Center for Molecular Medicine (CIMMBA), University of Florence, Florence
2 Tuscan Regional Centre of Pharmacovigilance, Florence
3 Regional Authority for Healthcare Services of Tuscany, Epidemiology Unit, Florence
4 Tuscan Regional Centre for Herbal Medicine, Florence
5 National Institute of Health, National Centre of Epidemiology, Rome.
Abstract
Purpose
While acupuncture is the best-known Chinese medical treatment in the West, herbal medicine is traditionally one of the more important treatment modalities used in Traditional Chinese Medicine (TCM). Treatment of patients with TCM is usually based on a combination of acupuncture, herbal medicine and dietary therapy. Many studies were performed to assess the possible role of acupuncture in several medical conditions but little is known on the use of other TCM modalities. Additionally, while acupuncture is substantially safe, several concerns may be raised regarding the safety of Chinese Herbal Medicines (CHM). In fact CHMs are composed of several different herbs tailored to the individual patient, and although massive databases of genomic, proteomic and chemical data are now available to study and identify the structure of active compounds from herbal drugs, still little is known on pharmacognosy and pharmacogenomics of most CHMs.
Methods
Here we report preliminary results of a three-year research aimed to assess pharmacoepidemiology of CHM in Italy, conducted by means of a Prescription Event Monitoring (PEM) survey.
Phases of the research include:
1.Realization of a National Registry for CHM practitioners.
2.Epidemiological survey on the prevalence of use of CHM.
3.Short-, medium- and long-term evaluation of the efficacy and safety of CHMs in the frame of the PEM Survey.
4.Pharmacological researches aimed at describing pharmacodynamic, pharmacokinetic and pharmacogenetic issues of main CHMs.
Results and Conclusion
Results of the first year of the project will be reported in the current communication, with particular regard to the set up of a national registry of CHM qualified practitioners, and to preliminary results of the epidemiological survey on the prevalence of CHM use Italy. Research supported by a Young Researchers’ grant from Italian Ministry of Health.
While acupuncture is the best-known Chinese medical treatment in the West, herbal medicine is traditionally one of the more important treatment modalities used in Traditional Chinese Medicine (TCM). Treatment of patients with TCM is usually based on a combination of acupuncture, herbal medicine and dietary therapy. Many studies were performed to assess the possible role of acupuncture in several medical conditions but little is known on the use of other TCM modalities. Additionally, while acupuncture is substantially safe, several concerns may be raised regarding the safety of Chinese Herbal Medicines (CHM). In fact CHMs are composed of several different herbs tailored to the individual patient, and although massive databases of genomic, proteomic and chemical data are now available to study and identify the structure of active compounds from herbal drugs, still little is known on pharmacognosy and pharmacogenomics of most CHMs.
Methods
Here we report preliminary results of a three-year research aimed to assess pharmacoepidemiology of CHM in Italy, conducted by means of a Prescription Event Monitoring (PEM) survey.
Phases of the research include:
1.Realization of a National Registry for CHM practitioners.
2.Epidemiological survey on the prevalence of use of CHM.
3.Short-, medium- and long-term evaluation of the efficacy and safety of CHMs in the frame of the PEM Survey.
4.Pharmacological researches aimed at describing pharmacodynamic, pharmacokinetic and pharmacogenetic issues of main CHMs.
Results and Conclusion
Results of the first year of the project will be reported in the current communication, with particular regard to the set up of a national registry of CHM qualified practitioners, and to preliminary results of the epidemiological survey on the prevalence of CHM use Italy. Research supported by a Young Researchers’ grant from Italian Ministry of Health.