Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents)

Brazilian Journal of Medical and Biological Research

Volumn 33, Issue 2, 2000, Pages 179-189

  Calixto, J B ^a  

^a FEDERAL UNIVERSITY OF SANTA CATARINA   (Brazil)

Author keywords

Efficacy; Herbal medicine; Market; Quality control; Regulatory guidelines; Safety

Indexed keywords

CYTOTOXIC AGENT; DIGITALIS; EPHEDRINE; GINKGO BILOBA EXTRACT; HERBACEOUS AGENT; PYRROLIZIDINE ALKALOID;

CARDIOVASCULAR DISEASE; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL; DEPRESSION; DIET SUPPLEMENTATION; DRUG EFFICACY; DRUG LEGISLATION; DRUG MARKETING; DRUG SAFETY; HERBAL MEDICINE; HUMAN; HYPERICUM PERFORATUM; MEDICINAL PLANT; PHYTOTHERAPY; QUALITY CONTROL; REVIEW; SIDE EFFECT; STANDARDIZATION; TRADITIONAL MEDICINE;

DIGITALIS; GINKGO BILOBA; SAINT JOHNS WORT;

EID: 0034006856     PISSN: 0100879X     EISSN: 1414431X     Source Type: Journal    
DOI: 10.1590/S0100-879X2000000200004     Document Type: Review

References (58)

1. Farnsworth NR & Morris RW (1976). Higher plants - the sleeping giant of drug development. American Journal of Pharmaceutical Education, 148: 46-52.
2. De Smet PAGM (1997). The role of plant-derived drugs and herbal medicines in healthcare. Drugs, 54: 801-840.
3. Cragg GM, Newman DJ & Snader KM (1997). Natural products in drug discovery and development Journal of Natural Products, 60: 52-60.
4. Shu YZ (1998). Recent natural products based drug development: A pharmaceutical industry perspective Journal of Natural Products, 61: 1053-1071.
5. Akerele O (1993) Summary of WHO guidelines for the assessment of herbal medicines. HerbalGram, 28: 13-19.
6. Editorial (1994). Pharmaceutical from plants: great potential, few funds. Lancet, 343: 1513-1515.
7. Brevoort P (1995). The U.S. botanical market. An overview. HerbalGram, 36: 49-59.
8. Blumenthal M (1999). Harvard study estimates consumers spend $5.1 billion on herbal products? HerbalGram, 45: 68.
9. Blumenthal M (1999). Herb industry sees mergers, acquisitions, and entry by pharmaceutical giants in 1998. HerbalGram, 45: 67-68.
10. Brevoort P (1996), Botanical (herbal) medicine in the United States. Pharmaceutical News, 3: 26-28.
11. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR & Delbanco TL (1993). Unconventional medicine in the United States. New England Journal of Medicine, 328: 246-252.
12. Fisher P & Ward A (1994), Complementary medicine in Europe. British Medical Journal, 309: 107-111.
13. Grünwald J (1995). The European phytomedicines market: figures, trends, analysis. HerbalGram, 34: 60-65.
14. Roberts JE & Tyler VE (1998). Tyler's Herbs of Choice. The Therapeutic Use of Phytomedicinals. The Haworth Press, Inc., New York.
15. Blumenthal M, Brusse WR, Goldberg A, Gruenwald J, Hall T, Rigg ns CW & Rister RS (1998). The Complete German Commission E Monographs. Therapeutic Guide to Herbal Medicines. The American Botanical Council, Austin, TX, USA.
16. Bulletin of the World Health Organization (1993). Research guidelines for evaluating the safety and efficacy of herbal medicine. Geneva, 1-86.
17. Bulletin of the World Health Organization (1998). Regulatory situation of herbal medicines. A worldwide review. Geneva, 1-43.
18. Keller K (1996). Herbal medicinal products in Germany and Europe: experiences with national and European assessment. Drug Information Journal, 30: 933-948.
19. Schulz V, Hansel R & Tyler VE (1996). Rational Phytotherapy. A Physicians' Guide to Herbal Medicine. 3rd edn. Springer-Verlag, Berlin.
20. Zeisel SH (1999). Regulation of "nutraceuticals". Science. 285: 1853-1855.
21. Petrovick PR, Marques LC & Paula IC (1999). New rules for phytopharmaceutical drug registration in Brazil Journal of Ethnopharmacology, 66: 51-55.
22. Eskinazi D, Blumenthal M, Farnsworth N & Riggins CW (1999). Botanical Medicine: Efficacy, Quality Assurance, and Regulation. Mary Ann Liebert, Inc. Publisher, New York.
23. Brautigam MRH, Blommaert FA, Verleye G, Castermans J, Steur ENHJ & Kleinen J (1998). Treatment of age-related memory complaints with Ginkgo biloba extract: a randomized double blind placebo-controlled study. Phytomedicine, 5: 425-434.
24. Kanowski S, Herrmann WM, Stephan K, Wierich W & Hörr R (1997). 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 multi-nfarct dementia Phytomedicine, 4: 3-13.
25. Kleijnen J (1992). Kripschild P Ginkgo biloba. Lancet, 340: 1136-1139.
26. Ernst E, Rand JI & Stevinson C (1998). Complementary therapies for depression - An overview. Archives of General Psychiatry, 55: 1026-1032.
27. Harrer G, Schimidt U, Kuhn U & Biller A (1999). Comparison of equivalent between the St. John's wort extract LoHyp-57 and fluoxetine. Arzneimittel-Forschung/Drug Research, 49: 289-296.
28. Josey ES & Tackett RL (1999), St. John's wort: a new alternative for depression? International Journal of Clinical Pharmacology and Therapeutics, 37: 111-119.
29. Laakmann G, Schule C, Baghai T & Kieser M (1998). St. John's wort in mild to moderate depression: the relevance of hyperforin for the clinical efficacy. Pharmacopsychiatry, 31: 54-59.
30. Linde K, Raminez G, Mulrow CD, Pauls A, Weidenhammer W & Melchart D (1996). St. John's wort for depression - an overview and meta-analysis of randomized clinical trials. British Medical Journal, 313: 253-258.
31. Vitiello B (1999). Hypericum perforatum extracts as potential antidepressants. Journal of Pharmacy and Pharmacology, 51: 513-517.
32. Woelk H, Burkard G & Grünwald J (1994). Benefits and risks of the Hypericum extract Ll 160: drug monitoring study with 3250 patients Geriatric Psychiatry and Neurology, 7 (Suppl 1): S34-S38.
33. Armstrong NC & Ernst E (1999). The treatment of eczema with Chinese herbs: a systematic review of randomized clinical trials. British Journal of Clinical Pharmacology, 48: 262-264.
34. Bauer R & Tittel G (1996). Quality assessment of herbal preparations as a precondition of pharmacological and clinical studies. Phytomedicme, 2: 193-198.
35. Bell LP, Hectorne K, Reynolds H, Balm TK & Hunninghake DB (1989). Cholesterol-lowering effects of psyllium hydrophilic mucilloid. Adjunct therapy to a prudent diet for patients with mild to moderate hypercholesterolemia. Journal of the American Medical Association, 261: 3419-3423.
36. Bensoussan A, Talley NJ, Hing M, Menzies R, Guo A & Ngu M (1998). Treatment of irritable bowel syndrome with Chinese herbal medicine: a randomized controlled trial. Journal of the American Medical Association, 280: 1585-1589.
37. Borchers AT, Hackman RM, Keen CL, Stern JS & Gershwin ME (1997) Complementary medicine: A review of Immunomodulatory effects of Chinese herbat medicines. American Journal of Clinical Nutrition, 66: 1303-1312.
38. Diehm C, Trampisch HJ, Lange S & Schmidt C (1996). Comparison of leg compression stocking and oral horse-chestnut seed extract therapy in patients with chronic venous insufficiency. Lancet, 347: 292-294.
39. Fairfield KM, Eisenberg DM, Davis RB, Libman H & Phillips RS (1998). Patterns of use, expenditures, and perceived efficacy of complementary and alternative therapies in HIV-infected patients. Archives cf Internal Medicine, 158: 2257-2264.
40. Grasso M, Montesano A, Buonaguidi A, Castelli M, Lania C, Rigatti P, Rocco F, Cesana BM & Borghi C (1995). Comparative effects of alfuzosin versus Serenoa repens in the treatment of symptomatic benign prostatic hyperplasia Archives of Experimental Urology, 48: 97-103.
41. Högel J & Gaus W (1995). Studies on the efficacy of unconventional therapies Arzneimittel-Forschung/Drug Research, 45: 88-92.
42. Johnson ES, Kadam NP, Hylands DM & Hylands PJ (1985). Efficacy of feverfew as prophylactic treatment of migraine British Medica Journal, 291: 569-573.
43. Masshour NH, Lin GI & Frishman WH (1998). Herbal medicine for the treatment of cardiovascular disease Archives of Internal Medicine, 158: 2225-2234.
44. Morris J, Burke V, Mon TA, Vandogen R & Beilin LJ (1995). Effects of garlic extract on platelet aggregation: a randomized placebo-controlled double-blind study. Clinical and Experimental Pharmacology and Physiology, 22: 414-417.
45. Murphy JJ, Heptinstall S & Mitchell JRA (1988). Randomised double-blind placebo-controlled trial of feverfew in migraine prevention. Lancet, 2: 189-192.
46. Vogler BK, Pittler MH & Ernest E (1998). Feverfew as a preventive treatment for migraine: a systematic review. Cephalalgia, 18: 704-708.
47. Warshafsky S, Kamer RS & Sivak SL (1993). Effect of garlic on total serum cholesterol: a meta-analysis. Archives of Internal Medicine, 119: 599-605.
48. Wilt TJ, Isham A, Stark G, MacDonald R, Lau J & Mulrow C (1998). Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review Journal of the American Medical Association, 280: 1604-1609.
49. Bagheri H, Broué P, Lacroix I, Larrey D, Olives JP, Vaysse Ph, Ghisolfi J & Montastru JL (1998). Fulminant hepatic failure after herbal medicine ingestion in children. Térapie, 53: 77-83.
50. Brinker F (1998). Herb Contraindications and Drug Interactions 2nd edn. Eclectic Medical Publications, Sandy, OR.
51. Brown RG (1992). Toxicity of Chinese herbal remedies Lancet, 340: 673.
52. D'Arcy PF (1993). Adverse reactions and interactions with herbal medicines. 2. Drug interactions. Adverse Drug Reactions and Toxicological Reviews, 12: 147-162.
53. De Smet PAGM (1995). Health risks of herbal remedies. Drug Safety, 13: 81-93.
54. Farnsworth NR (1993). Relative safety of herbal medicines. HerbalGram, 29 (Special Suppl): 36A-36H.
55. Drew A & Myers SP (1997). Safety issues in herbal medicine: implications for the health professions. Medical Journal of Australia, 166: 538-541.
56. Lazarowych NJ & Pekos P (1998), Use of fingerprinting and marker compounds for identification and standardization of botanical drugs: strategies for applying pharmaceutical HPLC analysis to herbal products. Drug Information Journal, 32: 497-512.
57. Li F, Sun S, Wang J & Wang D (1998). Chromatography of medicinal plants and Chinese traditional medicines. Biomedical Chromatography, 12: 78-85.
58. Foster S & Tyler VE (1998). Tyler's Honest Herbal. A Sensible Guide to the Use of Herbals and Related Remedies. The Howorth Press, New York.