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Ergoloid Mesylates

Ergoloid mesylates (Brand names: Hydergine, Gerimal, Niloric, Redizork) (Chemical name: Dihydroergotoxine mesylate) are dihydrogenated ergot alkaloids used to combat decreased mental function as a result of senility or multiple small strokes.

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Ginkgo biloba - Complementary and Alternative Medicine - health benefits and dosage information
From American Family Physician, 9/1/03 by Victor S. Sierpina

Ginkgo biloba leaf extract is the most widely sold phytomedicine in Europe, where it is used to treat the symptoms of early-stage Alzheimer's disease, vascular dementia, peripheral claudication, and tinnitus of vascular origin. It also is one of the 10 best-selling herbal medications in the United States. (1) There are over 120 published clinical studies on ginkgo, primarily from Europe. The standardized preparation of Ginkgo biloba extract is EGb 761. In the United States, ginkgo is classified as a dietary supplement; the American brands that are comparable with EGb 761 that have been subjected to clinical studies are Ginkgold, Ginkoba, and Ginkai. (2) Standardized preparations contain 24 percent ginkgo flavonoid glycosides, 6 percent terpene lactones, and no more than 5 parts per million ginkgolic acids. (1,2)

Pharmacology

The mechanism of action of ginkgo is believed to be produced by its functions as a neuroprotective agent, an antioxidant, a free-radical scavenger, a membrane stabilizer, and an inhibitor of platelet-activating factor via the terpene ginkgolide B. (3-6) Other pharmacologic effects include the following: endothelium relaxation mediated by inhibition of 3',5'-cyclic GMP (guanosine monophosphate) phosphodiesterase (7,8); inhibition of age-related loss of muscarinergic cholinoceptors and a-adrenoceptors; and stimulation of choline uptake in the hippocampus. (1,9) Ginkgo extract also has been shown to inhibit beta-amyloid deposition. (10)

Uses and Efficacy

CEREBROVASCULAR DISEASE, DEMENTIA, AND MEMORY ENHANCEMENT

A systematic review (11) of eight randomized, double-blind, placebo-controlled studies concluded that ginkgo had modest effects on improving the symptoms of dementia and cerebral insufficiency equivalent to pharmacologic therapy with ergoloid mesylates (Hydergine). A later meta-analysis surveyed 50 articles to examine the effect of ginkgo on objective measures of cognitive function in patients with Alzheimer's disease. (12) [Evidence level A, meta-analysis] Four of these studies met inclusion criteria for adequate clinical trial design. (13-16) In the 212 subjects in the placebo and ginkgo groups, a significant overall effect size was found that was comparable with the benefits of donepezil (Aricept). (17) Efficacy was measured using the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and other standardized measures of cognition.

A review (18) of studies of at least six months in duration demonstrated that ginkgo extract and second-generation cholinesterase inhibitors were equally effective in treating mild to moderate Alzheimer's dementia. A systematic review (19) of nine studies on ginkgo use showed a safe and positive effect beyond placebo, but the investigators remained tentative in recommending it for treatment of dementia until better studies are conducted. A Cochrane meta-analysis of 33 trials concluded that ginkgo appears to be safe, and showed promising evidence of improvement of cognition and function among patients who received the herb. However, the three modern trials showed inconsistent results, suggesting that a large trial with modern methodology is needed to answer questions about treatment effects. (20) [Evidence level A, meta-analysis]

One of the studies analyzed in the Cochrane review (20) was a Dutch study (21) of 214 patients over 24 weeks using a medium dosage of ginkgo (160 mg per day), a high dosage of ginkgo (240 mg per day), or placebo in a crossover design. This study failed to show improvement in age-associated memory impairment or mild or moderate dementia in several neuropsychologic and behavior outcome measures. (21) However, this study included patients with age-associated memory impairment rather than just persons with dementia, which may have limited the statistical power of its conclusions about the role of ginkgo in dementia. (22)

A randomized, placebo-controlled trial (23) of the effects of ginkgo in healthy, noninstitutionalized adults without dementia or other known mental deficit found no benefit from six weeks of ginkgo therapy (120 mg per day) on several standardized neuropsychologic measures of memory and learning. However, a study (24) using a similar design with a higher dosage of ginkgo (180 mg per day) showed clinically significant cognitive benefits in healthy persons.

The National Institutes of Health and the National Center for Complementary and Alternative Medicine have sponsored a multi-center, six-year, randomized, two-arm, double-blind, placebo-controlled trial of 2,000 patients. The trial will evaluate the safety and efficacy of ginkgo in preventing dementia and age-related cognitive decline and is currently underway and headed by investigators at the University of Pittsburgh. Another phase III trial is underway at the Oregon Health Sciences Center, Portland, to study the effects of ginkgo on cognitively intact elderly patients older than 85 years, and the effect on their progression to mild cognitive impairment. This study will use volumetric quantitative magnetic resonance imaging measures of brain size and peripheral oxidative markers.

INTERMITTENT CLAUDICATION

Another indication for ginkgo is intermittent claudication from peripheral vascular disease. A meta-analysis of eight studies concluded that the effects of ginkgo, though statistically significant and positive on increasing pain-free walking, were of modest effect size and questionable clinical relevance. (25) [Evidence level A, meta-analysis] A trial (26) that compared dosages of 120 mg and 240 mg of ginkgo demonstrated a substantial therapeutic benefit on pain-free walking distance with the higher dosage. Two placebo-controlled trials, (27,28) with a total of 190 patients, showed improved walking distance and decreased pain in patients with peripheral vascular disease.

TINNITUS

Another common indication for ginkgo is tinnitus. A recent study (29) of 1,121 subjects conducted using questionnaires and telephone interviews, without the use of standard audiometric testing as an outcome measure, failed to show a benefit of ginkgo in the treatment of tinnitus. Another randomized, placebo-controlled trial (30) of 103 patients showed 50 percent of patients with new-onset tinnitus had improvement or disappearance of symptoms in 70 days compared with 119 days to improvement in those receiving placebo. A review (31) of five heterogenous randomized controlled trials concluded that extracts of ginkgo biloba are moderately effective in treating tinnitus.

OTHER USES

Studies have shown positive results from the use of ginkgo for the following conditions: sexual dysfunction secondary to the use of selective serotonin reuptake inhibitors, (32) mountain sickness and decreasing vasoactivity in response to cold, (33) macular degeneration, (34) asthma, (35) and hypoxia. (36) The World Health Organization has recommended the use of ginkgo in Raynaud's disease, acrocyanosis, and post-phlebitic syndrome. (2,7)

Warnings, Interactions, Adverse Effects

During the past 20 years, an estimated 2 billion daily doses (120 mg) of ginkgo have been sold. The most important potential clinical problem with ginkgo is caused by its inhibition of the platelet-activating factor; this makes the use of ginkgo in conjunction with warfarin (Coumadin), aspirin, or other antiplatelet agents a matter of clinical judgment. A recent safety study (37) of the interaction of ginkgo and warfarin showed no change in the international normalized ratio. Ginkgo should be discontinued between 36 hours and 14 days before surgery, based on either pharmacokinetics or consensus opinion. (38,39)

Herbal medications that may increase the risk of bleeding if used concurrently with ginkgo include the following: feverfew, garlic, ginseng, dong quai, red clover, and other natural coumarins. Several case reports of bleeding complications associated with ginkgo use include subdural hematoma, (40,41) subarachnoid hemorrhage, (42) intracerebral hemorrhage, (43) and hyphema (44); the causality of these events has not been established. One case report (45) discussed an elderly patient who developed elevated blood pressure while taking a thiazide diuretic and ginkgo. The patient's blood pressure returned to normal when both substances were discontinued. This reaction is paradoxical in light of the known pharmacologic actions of these agents. (45)

The unprocessed ginkgo leaf contains ginkgolic acids that are toxic. Hypersensitivity to ginkgo preparations is a contraindication to use. Ginkgo is generally well tolerated, with side effects being rare, usually mild, and including nausea, vomiting, diarrhea, headaches, dizziness, palpitations, restlessness, weakness, or skin rashes. Although no studies have been performed to support any restrictions on the use of ginkgo during pregnancy or lactation, it seems prudent not to administer ginkgo in the absence of any data. (1,2)

Dosage

For patients who have memory problems and dementia, the dosage of ginkgo is 120 to 240 mg daily, taken in two to three doses. The dosage for patients who have tinnitus and peripheral vascular disease is no more than 160 mg per day, taken in two or three doses. An initial period of six to 12 weeks is recommended to assess the effectiveness of ginkgo, although results have been seen as early as four weeks. (13,46,47) The monthly cost for the usual daily dose of 120 mg is approximately $15 to $20.

Final Comment

With an aging population seeking solutions to troubling problems such as dementia and vasculopathy, ginkgo offers some benefit as a mild vasoactive and neuroprotective phytomedicine. It offers a relatively safe, inexpensive, and modestly effective treatment option when selected by patients or prescribing physicians for multi-infarct or Alzheimer's dementia. Evidence indicates that it is effective in slowing disease progression and ameliorating symptoms.

While some studies show no benefit in Alzheimer's disease, others show that it is comparable in its efficacy with the second-generation cholinesterase inhibitors. Ginkgo should be discontinued before surgery, but the time period has not been determined conclusively. Ginkgo also has demonstrated benefits in patients with peripheral vascular disease and tinnitus. Name brands using the same extract as those used in clinical research studies are to be recommended as the most reliable in the current herbal market in the United States. Table 1 discusses the efficacy, safety, tolerability, and cost of ginkgo biloba.

The authors indicate that they do not have any conflicts of interests. Sources of funding: This manuscript was made possible in part by grant no. R25AT00586-01 from the National Center for Complementary and Alternative Medicine.

The opinions and assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the National Center for Complementary and Alternative Medicine or the National Institutes of Health.

REFERENCES

(1.) Blumenthal M. German Federal Institute for Drugs and Medical Devices. Commission E. The complete German Commission E monographs: therapeutic guide to herbal medicines. Austin, Tex.: American Botanical Council, 1998:11-12.

(2.) Blumenthal M. German Federal Institute for Drugs and Medical Devices. Commission E. Herbal medicine: expanded Commission E monographs. Newton, Mass.: Integrative Medicine Communications, 2000:160-9, 479-80.

(3.) Oberpichler H, Sauer D, Rossberg C, Mennel HD, Krieglstein J. PAF antagonist ginkgolide B reduces postischemic neuronal damage in rat brain hippocampus. J Cereb Blood Flow Metab 1990;10:133-5.

(4.) Sastre J, Millan A, Garcia de la Asuncion J, Pla R, Juan G, Pallardo, et al. A Ginkgo biloba extract (EGb 761) prevents mitochondrial aging by protecting against oxidative stress. Free Radic Biol Med 1998;24:298-304.

(5.) Van Beek T, Bombardelli E, Peterlongo G. Ginkgo biloba L. Fitoterapia 1998;69:195-244.

(6.) Ahlemeyer B, Kriegelstein J. Neuroprotective effects of Ginkgo biloba extract. In: Lawson LD, Bauer R. Phytomedicines of Europe: chemistry and biological activity. Washington, D.C.: American Chemical Society, 1998:210-20.

(7.) World Health Organization. WHO monographs on selected medicinal plants. Vol. 1, Ch. 16. Folium Gingko. Geneva: World Health Organization, 1999:154-67.

(8.) DeFeudis FV. Ginkgo biloba extract (EGb 761): pharmacological activities and clinical applications. Amsterdam: Elsevier, 1991:1187.

(9.) DeFeudis FV. Ginkgo biloba extract (EGb 761): from chemistry to the clinic. Wesbaden: Ullstein Medical, 1998.

(10.) Watanabe CM, Wolffram S, Ader P, Rimbach G, Packer L, Maquire JJ, et al. The in vivo neuromodulatory effects of the herbal medicine gingko biloba. Proc Natl Acad Sci U S A 2001;98:6577-80.

(11.) Kleijnen J, Knipschild P. Ginkgo biloba for cerebral insufficiency. Br J Clin Pharmacol 1992;34:352-8.

(12.) Oken BS, Storzbach DM, Kaye JA. The efficacy of Ginkgo biloba on cognitive function in Alzheimer disease. Arch Neurol 1998; 55:1409-15.

(13.) Hofferberth B. The efficacy of EGb 761 in patients with senile dementia of the Alzheimer type, a double-blind, placebo-controlled study on different levels of investigation. Hum Psychopharmacol 1994;9:215-22.

(14.) Kanowski S, Herrmann WM, Stephan K, Wierich W, Horr R. 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-infarct dementia. Pharmacopsychiatry 1996;29:47-56.

(15.) Le Bars PL, Katz MM, Berman N, Itil TM, Freedman AM, Schatzberg AF. A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo biloba for dementia. North American EGb Study Group. JAMA 1997;278:1327-32.

(16.) Wesnes K, Simmons D, Rook M, Simpson P. A double-blind placebo-controlled trial of Tanakan in the treatment of idiopathic cognitive impairment in the elderly. Hum Psychopharmacol. 1987; 2:159-69.

(17.) Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology 1998; 50:136-45.

(18.) Wettstein A. Cholinesterase inhibitors and Ginkgo extracts--are they comparable in the treatment of dementia? Comparison of published placebo-controlled efficacy studies of at least six months' duration. Phytomedicine 2000;6:393-401.

(19.) Ernst E, Pittler MH. Ginkgo biloba for dementia. A systematic review of double-blind, placebo-controlled trials. Clin Drug Invest 1999;17:301-8.

(20.) Birks J, Grimley E, Van Dongen M. Ginkgo biloba for cognitive impairment and dementia. Cochrane Database Syst Rev 2002; 4:CD003120.

(21.) van Dongen MC, van Rossum E, Kessels AG, Sielhorst HJ, Knipschild PG. The efficacy of ginkgo for elderly people with dementia and age-associated memory impairment: new results of a randomized clinical trial. J Am Geriatr Soc 2000;48:1183-94.

(22.) Weber W. Ginkgo not effective for memory loss in elderly. Lancet 2000;356:1333.

(23.) Solomon PR, Adams F, Silver A, Zimmer J, DeVeaux R. Ginkgo for memory enhancement: a randomized controlled trial. JAMA 2002;288:835-40.

(24.) Mix JA, Crews WD Jr. A double-blind, placebo-controlled, randomized trial of Ginkgo biloba extract EGb 761 in a sample of cognitively intact older adults: neuropsychological findings. Hum Psychopharmacol 2002;17:267-77.

(25.) Pittler MH, Ernst E. Ginkgo biloba extract for the treatment of intermittent claudication: a meta-analysis of randomized trials. Am J Med 2000;108:276-81.

(26.) 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 randomised, double-blind, multicentric clinical trial. Arzneimittelforschung 1999;49:900-4.

(27.) Peters H, Kieser M, Holscher U. Demonstration of the efficacy of ginkgo biloba special extract EGb 761 on intermittent claudicationa placebo-controlled, double-blind multicenter trial. Vasa 1998;27:106-10.

(28.) Bauer U. 6-Month double-blind randomised clinical trial of Ginkgo biloba extract versus placebo in two parallel groups in patients suffering from peripheral arterial insufficiency. Arzneimittelforschung 1984;34:716-20.

(29.) Drew S, Davies E. Effectiveness of Ginkgo biloba in treating tinnitus: double blind, placebo controlled trial. BMJ 2001;332:73.

(30.) Meyer B. Multicenter randomized double-blind drug vs. placebo study of the treatment of tinnitus with Ginkgo biloba extract [in French]. Presse Med 1986;15:1562-4.

(31.) Ernst E, Stevinson C. Ginkgo biloba for tinnitus: a review. Clin Otolaryngol 1999;24:164-7.

(32.) Cohen AJ, Bartlik B. Ginkgo biloba for antidepressant-induced sexual dysfunction. J Sex Marital Ther 1998;24:139-43.

(33.) Roncin JP, Schwartz F, D'Arbigny P. EGb 761 in control of acute mountain sickness and vascular reactivity to cold exposure. Aviat Space Environ Med 1996;67:445-52.

(34.) Evans JR. Ginkgo biloba extract for age-related macular degeneration. Cochrane Database Syst Rev 2003;(2):CD001775.

(35.) Li M, Yange B, Yu H, Zhang H. Clinical observation of the therapeutic effect of ginkgo leaf concentrated oral liquor on bronchial asthma. Chinese Journal of Integrative Medicine 1997;3:264-7.

(36.) Schaffler K, Reeh PW. Double blind study of the hypoxia protective effect of a standardized Ginkgo biloba preparation after repeated administration in healthy subjects [in German]. Arzneimittelforschung 1985;35:1283-6.

(37.) Engelsen J, Dalsgaard N, Winther K. The health care products Coenzyme Q10 and Ginkgo biloba do not interact with warfarin. Thromb Haemost 2001;(Supp)(Abstract No. P796).

(38.) Ang-Lee MK, Moss J, Yuan CS. Herbal medicines and perioperative care. JAMA 2001;286:208-16.

(39.) Leak JA. Herbal medicines: what do we need to know? ASA Newsletter February 2000. Retrieved June 10, 2003, from www.asahq.org/Newsletters/2000/02_00/herbal0200.html.

(40.) Rowin J, Lewis SL. Spontaneous bilateral subdural hematomas associated with chronic Ginkgo biloba ingestion. Neurology 1996; 46:1775-6.

(41.) Gilbert GJ. Ginkgo biloba. Neurology 1997;48:1137.

(42.) Vale S. Subarachnoid hemorrhage associated with Ginkgo biloba. Lancet 1998;352:36.

(43.) Matthews MK JR. Association of Ginkgo biloba with intracerebral hemorrhage. Neurology 1998;50:1933-4.

(44.) Rosenblatt M, Mindel J. Spontaneous hyphema associated with ingestion of Ginkgo biloba extract. N Engl J Med 1997;336:1108.

(45.) Shaw D, Leon C, Kolev S, Murray V. Traditional remedies and food supplements. A 5-year toxicological study (1991-1995). Drug Saf 1997;17:342-56.

(46.) Murray MT, Pizzorno JE. Encyclopedia of natural medicine. 2d ed. Rocklin, Calif.: Prima Pub., 1998.

(47.) Mills S, Bone K. Principles and practice of phytotherapy: modern herbal medicine. Edinburgh: Churchill Livingstone, 2000.

Address correspondence to Victor S. Sierpina, M.D., UTMB Family Medicine Dept., 301 University Blvd., Galveston, TX 77555-1123 (e-mail: vssierpi@utmb.edu). Reprints are not available from the authors.

VICTOR S. SIERPINA, M.D., is associate professor of family medicine at the University of Texas Medical Branch at Galveston. Dr. Sierpina received his medical degree from the University of Illinois, Abraham Lincoln School of Medicine, Chicago. He completed a residency in family practice at MacNeal Memorial Hospital, Chicago. He is board-certified by the American Board of Family Practice and the American Board of Holistic Medicine.

BERND WOLLSCHLAEGER, M.D., is in private practice in North Miami Beach, Fla. He also is an assistant professor of medicine and family medicine at the University of Miami School of Medicine. Dr. Wollschlaeger received his medical training in Germany and Israel, including special education in botanical medicine and homeopathy. He completed a residency at Jackson Memorial Hospital, Miami.

MARK BLUMENTHAL is founder and executive director of the American Botanical Council, Austin, Tex., and adjunct professor of medicinal chemistry at the University of Texas, College of Pharmacy, Austin. He is the senior editor of The Complete Commission E Monographs and the journal HerbalGram.

COPYRIGHT 2003 American Academy of Family Physicians
COPYRIGHT 2003 Gale Group

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