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Safety and Regulation


Issue 29

SRINIVASAN and colleagues, Texas Tech Health Sciences Center and Veterans Affairs, Amarillo 79106-1797 USA write that Kombucha tea is a health beverage made by incubating the Kombucha "mushroom" in tea and sugar. They write that although therapeutic benefits have been attributed to the drink, neither beneficial effects nor adverse side effects have been reported in the scientific literature. RESULTS: The authors report side effects probably related to Kombucha tea consumption in four patients, two of whom presented with allergic reaction symptoms, one with jaundice and another with nausea, vomiting and head and neck pain. In all four patients, Kombucha tea was consumed just prior to the onset of symptoms, which ceased when tea drinking stopped. This suggests a probably aetiologic association.
Srinivasan R et al. Probably gastrointestinal toxicity of Kombucha tea: is this beverage healthy or harmful? J Gen Intern Med. 12(10): 643-6. Oct 1997.

ISRAEL and YOUNGKIN, St David's Medical Center, Austin Texas 78765-4039 USA write that consumer use of alternative medicines in the United States is growing rapidly, including herbal therapies as adjunct or alternative for perimenopausal and menopausal complaints. The authors review (74 references) and write of their significant concern regarding the safety of these herbs. As many women are using herbal therapies, clinicians must be knowledgeable regarding their use, quality and safety. They state that there are presently no government standards regarding the quality of herbal products in the United States, and that some products are either unsafe or that little is known of them scientifically. The authors examine selected herbal therapies touted in the lay press for common perimenopausal and menopausal complaints and offer advice regarding their use and safety based upon scientific sources.
Israel D and Youngkin EQ. Herbal therapies for perimenopausal and menopausal complaints. Pharmacotherapy 17(5): 970-84. Sep-Oct 1997.

BENZI and CECI, European Agency for the Evaluation of Medicinal Products (EMEA), London UK write that herbal medicines are now assuming large utilisation within primary healthcare of individuals and communities along with the growing interest in traditional and alternative medicine systems in many developing nations. While consumer surveys indicate a positive public attitude toward complementary medicine, the regulation of herbal medicines is largely variable dependent upon ethnological, medical and historical background within each country. WHO Guidelines for the Assessment of Herbal Remedies, adopted by the International Conference of Drug Regulatory Authorities (Ottawa, October 1991), have within them the basic legislative elements for registration procedures for herbal medicines. WHO suggested that different States ought to: attribute correct importance regarding utilisation of traditional medicine systems perform a systematic inventory and assessment of medical plants used by traditional practitioners and peoples and to intensify activities to facilitate cooperation between providers of traditional and modern medicine, particularly regarding the use of scientifically proven, safe and effective traditional remedies. The goal is to facilitate the scientific evaluation and eventual integration of traditional medicine into the national healthcare system, which will assist an eventual rational use of traditional medicine through the development of technical guidelines and international standards.
Benzi G and Ceci A. Herbal medicines in European regulation. Pharmacol Res. 35(5): 355-62. May 1997.

COMMENTS: I sincerely hope that traditional herbal medicines are 1) saved from scavenging commercial concerns 2) saved from extinction from rapacious developers and 3) actually integrated into mainstream medicine. Considering the trends happening today, these goals appear to be ridiculously utopian. How best to hide them away somewhere safe? Any suggestions?