Safety Assessment of Newly Marketed Herbal Medicines—Methodological Approach (Ginkgo biloba Example in Bulgaria)

REFERENCES

• Blumenthal M. Market report: herbal market levels after five years of boom. HerbalGram 1999; 47: 64–5
   Google Scholar
• Eisenberg D M, Kessler R C, Foster C, Norlock F E, Calkins D R, Delbanco T L. Unconventional medicine in the United States: prevalence, costs and patterns of use. N Engl J Med 1993; 328: 246–52
   PubMed Web of Science ®Google Scholar
• Eisenberg D M, Davis R B, Ettner S L, et al. Trends in alternative medicine use in the United States, 1990–1997. JAMA 1998; 280: 1569–75
   PubMed Web of Science ®Google Scholar
• WHO. Regulatory situation of herbal medicines: a worldwide review. 1998, WHO/TMR/98.1
   Google Scholar
• WHO. Legal status of traditional medicine and complementary/alternative medicines: a worldwide review. WHO/TMR. 2001
   Google Scholar
• WHO. Guidelines for the assessment of herbal medicines. 1991, WHO/TMR/91.4
   Google Scholar
• EMEA. Herbal Medicinal Products Working Party. Position paper on the risks associated with the use of herbal products containing Aristolochia species. October, 2001, EMEA website: www.eudra.org/emea.html
   Google Scholar
• Barnes J, Mills S Y, Abbot N C, Willoughby M, Ernst E. Different standards for reporting ADR to herbal remedies and conventional OTC medicines. Br J Clin Pharmacol 1998; 45: 496–500
   PubMed Web of Science ®Google Scholar
• Silano M, De Vincenzi M, De Vincenzi A, Silano V. The new European legislation on traditional herbal medicines: main features and perspectives. Fitoterapia 2004; 75(2)107–16
   PubMed Web of Science ®Google Scholar
• European Commission. Directive 2004/24 of the European Parliament and of the Council amending Directive 2001/83/EC as regards traditional herbal medicinal products. Off J Eur Union 30 April, 2004
   Google Scholar
• Bulgarian Drug Agency. Information for the licensed for sale medicinal products, www.bda.bg
   Google Scholar
• Krushkov I, Lambev I. Pharmacotherapeutical handbook, 5th ed. Medpress, Sofia, Bulgaria 2002
   Google Scholar
• Danchev N, Karaivanova M, Konstantinov S, et al. Pharmacology (second part). 1st ed. ASSI, Sofia, Bulgaria 2003
   Google Scholar
• Van Dongen M CMJ, van Rossurn E, Kessels A GH, Sielhorst H JG. The efficacy of Ginkgo for elderly people with dementia and age-associated memory impairment: new results of a randomised clinical trial. J Am Geriatr Soc 2000; 48(10)1183–94
   PubMed Web of Science ®Google Scholar
• Kanowski S, Herrmann W M, Wierich W. Proof of efficacy of the Ginkgo biloba special extract EGb 761 in outpatients suffering from mild to moderate primary degenerative dementia of the Alzheimer type or MID. Phytomedicine 1997; 4(1)3–13
   PubMed Web of Science ®Google Scholar
• LeBars P L, Katz M M, Berman N, Freedman A M. A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. JAMA 1997; 278(16)1327–32
   PubMed Web of Science ®Google Scholar
• Hofferberth B. The efficacy of EGb 761 in patients with senile dementia of the Alzhaimer type, a double-blind, placebo-controlled studies on different levels of investigation. Hum Psychopharmacol 1994; 9: 215–22
   Web of Science ®Google Scholar
• Vesper J, Hansgen K-D. Efficacy of Ginkgo biloba in 90 outpatients with cerebral insufficiency caused by old age. Phytomedicine 1994; 1: 9–16
   PubMedGoogle Scholar
• Grassel E. Effect of Ginkgo biloba extract on mental performance. Double-blind study using computerized measurement conditions in patients with cerebral insufficiency. Fortschr Med 1992; 110(5)73–6
   PubMedGoogle Scholar
• Bruchert E, Heinrich S E, Ruf-Kohler P. Efficacy of EGb 761 in older patients with cerebral insufficiency. Munch Med Wschr 1991; 133(l)9–14
   Google Scholar
• Halama P. Judgment of well being and psychometric test in patients from a neurological practice treated with Ginkgo. Munch Med Wschr 1991; 133(Suppl 1)S19–22
   Google Scholar
• Rai G S, Shovfin C, Wesnes K A. A double-blind, placebo-controlled study of Ginkgo biloba extract (Tanakan) in elderly outpatients with mild to moderate memory impairment. Curr Med Res Opin 1991; 12(6)350–5
   PubMed Web of Science ®Google Scholar
• Schmidt U, Rabinovici K, Lande S. Effect of a Ginkgo biloba special extract on well being in cerebral insufficiency. Manch Med Wschr 1991; 133(1)15–8
   Google Scholar
• Eckmann V F. Cerebral insufficiency—treatment with Ginkgo biloba extract. Time of onset of the effect in a double blind study involving 60 inpatients. Fortcshr Med 1990; 108(29)557–60
   PubMedGoogle Scholar
• Hofferberth B. The effect of Ginkgo biloba extract on neurophysiological and psychometric measurement results in patients with cerebro-organic syndrome. A double-blind study versus placebo in Germany. Arzneimittelforschung 1989; 39(8)918–22
   PubMed Web of Science ®Google Scholar
• Vorberg G, Schenk N, Schimdt U. The efficacy of a new Ginkgo biloba extract in 100 patients with cerebral insufficiency. Herz Gefabe 1989; 9: 396–401
   Google Scholar
• Schweizer J, Hautmann C. Comparison of two dosages of Ginkgo biloba extract EGb 761 in patients with peripheral arterial occlusive disease Fontaine's stage IIb. A randomized, double-blind, multicentric clinical trial. Arzneimittelforschung 1999; 49(II)900–4
   PubMedGoogle Scholar
• Peters H, Kieser M, Holscher U. Demonstration of efficacy of the Ginkgo biloba special extract EGb 761 on intermittent claudication—a placebo-controlled, double-blind, multicentric trial. VASA 1998; 27(2)105–10
   Google Scholar
• Gertsch J H, Basnyat B, Johnson E W, Onopa J, Holck P S. Randomised, double blind, placebo controlled comparison of Ginkgo biloba and acetazolamide for prevention of acute mountain sickness among Himalayan trekkers: the prevention of high altitude illness trial (PHAIT). BMJ 2004; 328(7443)797–9
   PubMed Web of Science ®Google Scholar
• Roncin J P, Schwartz F. EGb 761 in control of acute mountain sickness and vascular reactivity to cold exposure. Aviation Space Environ Med 1996; 67(5)445–52
   PubMed Web of Science ®Google Scholar
• Drew S, Davies E. Effectiveness of Ginkgo biloba in treating tinnitus: double blind, placebo-controlled trial. BMJ 2001; 322(7278)73–8
   PubMed Web of Science ®Google Scholar
• Dubreuil C. Therapeutic trial in acute cochlear deafness Comparative study with Ginkgo biloba extract and nicergoline. Presse Med September 25, 1986; 15(31)1559–61
   PubMed Web of Science ®Google Scholar
• Cohen A J, Bartlik B. Ginkgo biloba for antidepressant—induced sexual dysfunction. 1998; 24(2)139–43
   Google Scholar
• Halama P. What does the special extract do (EGb 761)? Treatment with Ginkgo biloba in patients with cerebral insufficiency and refractory depressive symptoms. Results of a placebo-controlled randomised DB pilot study. Therapiewoche 1990; 40(51/52)3760–5
   Google Scholar
• De Feudis F. Ginkgo biloba Extract (EGb 761): From Chemist to the Clinic Wiesbaden. Ullstein Medical Verlagsgesellschaft, Germany 1998
   Google Scholar
• De Feudis F. Ginkgo biloba Extract (EGb 761): Pharmacological Activities and 350 Clinical Applications. Elsevier, Editions Scientifiques, ParisFrance 1991
   Google Scholar
• Foster S. Ginkgo—Ginkgo biloba. American Botanical Council, Austin, TX 1996, Botanical Booklet No. 304
   Google Scholar
• Fowler J S, Wang G J, Volkow N D, et al. Evidence that Ginkgo biloba extract does not inhibit MAO A and B in living human brain. Life Sci 2000; 66(9)PL141–6
   PubMed Web of Science ®Google Scholar
• Matthews M K. Association of Ginkgo biloba with intracerebral hemorrhage (letter). Neurology 1998; 50: 1933–4
   PubMed Web of Science ®Google Scholar
• Porsolt R D, Roux S, Drieu K. Evaluation of a Ginkgo biloba extract (EGb 761) in functional tests for MAO inhibition. Arzneimittelforschung 2000; 50(3)232–5
   PubMedGoogle Scholar
• Rosenblatt M, Mindel J. Spontaneous hyphema associated with ingestion of Ginkgo biloba extract (letter). N Engl J Med 1997; 336(15)1108
   PubMed Web of Science ®Google Scholar
• Rowin J, Lewis S L. Spontaneous bilateral subdural hematomas associated with chronic Ginkgo biloba ingestion. Neurology 1996; 46(6)1775–76
   PubMed Web of Science ®Google Scholar
• Vale S. Subarachnoid hemorrhage associated with Ginkgo biloba (letter). Lancet 1998; 352(9121)36
   PubMed Web of Science ®Google Scholar
• WHO. Benefit-Risk Balance for Market Drug: Evaluating Safety Signals. Geneva 1998, Report of CIOMS Working Group IV
   Google Scholar
• Benichou Ch. Adverse Drug Reactions-Practical Guide to Diagnosis and Management. 1st ed. Roussel Uclaf, Paris 1994
   Google Scholar
• National Peoples Assembly. Law on drugs and pharmacies in human medicine, Sofia, Governmental Newspaper 10/2000, 59/2002
   Google Scholar
• MoH, Regulation 17/2001 for the rules and order of drug registration. Sofia, Governmental newspaper 55/2001
   Google Scholar
• MoH, Regulation 7/2000 for the obligatory information printed on the packages and leaflets of the medicinal products. Sofia, Governmental newspaper 54/2000, 52/2001
   Google Scholar
• Tyler V E. What pharmacists should know about herbal remedies?. J Am Pharm Assoc 1996; 36: 29–37
   Google Scholar
• Ernst E, Dixon A. Alternative medicines in Europe. Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality, E Mossialos, M Mrazek, T Walley. Open University Press, London 2004; 307–22
   Google Scholar
• WHO. Traditional medicines strategy 2002–2005. WHO/DAP, Geneva 2002
   Google Scholar