Thursday, February 6, 2014

Ginseng:  The Cure-All?


1. History
Ginseng has been used in East Asia and Chinese medicine for thousands of years. It comes from the root of a plant from the genus Panax, which is derived from the word panacea, which means "cure-all" in Greek.1  Asian or Korean ginseng, American ginseng, and Siberian ginseng are the most common types of ginseng used in the United States, although Siberian ginseng does not belong to the Panax genus and is not considered to be a true ginseng.1,2 Ginseng has been grown in Korea since “ancient times” and has been grown in the United States since around 1870.3
2. Medicinal and non-medicinal use
In Chinese medicine, ginseng was thought to bring “long life, strength, and wisdom to those who took it.”2 In Chinese medicine, it is also used to help treat asthma, indigestion, hypertension, diabetes, insomnia, heart problems, and is also used as an appetite stimulant and aphrodisiac.1
In the United States, Asian ginseng has been used to help treat anemia, diabetes, insomnia, impotence, as well as boosting immune response, alleviating mental and physical stress, and for cancer prevention.4  It is also marketed as a product that will boost energy, improve memory, and promote longevity.1
3. Major components hypothesized to be the active ingredients. Include chemical entities if applicable
The active ingredients in ginseng are triterpenoid saponins, which includes ginsenosides.4 There are at least 30 known ginsenosides that have been found. Ginseng also contains glycans (panaxans), polysaccharide fraction DPG-3-2, peptides, maltol, B vitamins, flavonoids, and volatile oil.2


4. Theorized mechanism of action
It is unclear how ginseng works, but it is referred to as an “adaptogen” that acts on multiple parts of the body to restore immune function and lower the risk of stress-related illness.1 It also seems to act as an antioxidant.2
5. Clinical issues; DDIs, suggested dose, adverse effects, pharmacokinetics, overdose, use in special population (pregnant women, elderly, etc.)
There are different forms and dosages of available, depending on the type of ginseng. Asian ginseng extract is standardized to be 4% ginsenosides and is given as 200 mg/day, while crude powdered root has been given at 2-3 g/day.4 According to the University of Maryland, for those that wish to improve physical/mental performance or for those that want to prevent illness, Asian ginseng should be taken every day for 2-3 weeks, stopped for 3 weeks, then continued  again.2
Adverse effects of ginseng can include insomnia, headache, changes in blood pressure, anorexia, rash, menstrual abnormalities, gastric upset, and CNS stimulation.4 Ginseng can interfere with the effects of ACE inhibitors, calcium channel blockers, anticoagulants, antiplatelet medications, caffeine, diabetes medication, immunosuppressants, stimulants, MAOIs, morphine, furosemide, and medications that are metabolized by the liver.2 Ginseng should not be given to children, to those with a history of breast cancer, pregnant women, or breastfeeding women as the side effects are unknown and there is concern about estrogenic effects.2,4
6. Efficacy vs. safety
There have been inconsistent and conflicting results on the efficacy of ginseng. Several small studies have found that ginseng is effective in helping to control glucose levels in diabetes patients, can help arousal in men with ED, can help improve mental and physical performance, and may slow tumor growth.2,4 However, there have also been studies that show no superiority over placebo.4 As it stands, it is unclear on the effectiveness of ginseng, but it seems that for most patients (besides the ones mentioned above), there are no severe risks to trying ginseng.
7.  Info. about the standard of the various preparations available
Standardized ginsenoside concentrations are available in preparations.  Ginseng extract may contain 4-7% of ginsenoside.  The content of panaxosides can vary from 1.9-9%.  One product that was FDA-approved in 2006, Cold-fX, claims it helps antiviral immunity.  The product is standardized to be consistent in having the same amount of active ingredients.  A study that compared products sold throughout Europe and the U.S. showed 6 of the 50 products sold did not contain any ginsenosides.  For American ginseng roots, preparation of a product by using fresh roots that had been stored for 180 days in sand without washing had a better quality compared to roots that had been stored in a plastic bag with a preservative after being washed.5  Ginseng is available as a standardized extract, fresh or dried root, tincture, and fluid extract, tablets, capsules, teas, and oils.7, 8
8.  Costs
Nature's Bounty Ginseng complex jelly capsules, 75 count: $11.99 (Rite-Aid)
Nature's Way Korean Ginseng, 65 count: $17.99 (CVS)
The Vitamin Shoppe Ginseng Complex- Herbs, 100 count: $16.99(Vitamin Shoppe)

 Compared to:
Use as a dietary supplement/weight loss:  Orlistat 60 mg, 60 count: $38.88 (Walmart); OTC
Use as a diabetes medication:  Metformin 500 mg:  FREE (Meijer, Family-Fare); Prescription
9.  Prevalence of use
Ginseng is included in many energy drinks, but the amount is below standard dosing is generally safe. Ginseng is used as a folk remedy in Native American populations for such therapeutic use as for digestion aide, earache, female infertility, fever, and earache, headache, and mild stimulant. Traditionally has been used for treatment of cancer, low back pain, asthma, coughs, shortness of breath, etc.  Study in 2006 of prevalence of use in Saudi Arabia, was 47% of the most used product as an herbal product. 5  Dr. Shimp mentioned that in 2007 in the United States, 14.1% of adults that utilized herbal products had used ginseng.
10.  Evidence-based studies
One study looked at a Traditional Chinese medicine called shengmai which is a ginseng combination, used to treat diseases that are associated with the individual having a weak pulse, i.e. cardiac or pulmonary conditions.  Its outcome was positive evidence and this medicine is increasing in popularity.5


A prospective study was conducted with administering 400 mg of ginseng every day for 8 weeks.  Significant increases in abstract thinking and faster responses for simple reaction, but there was no change in concentration nor memory. 9  

 In 2014, Korean red ginseng was used as a supplement in glucose control in newly diagnose type 2 diabetes patients, people with impaired fasting glucose, and impaired glucose tolerance. Measurements taken 30 and 60 minutes after intake of ginseng had significant decreases in blood glucose levels. 10


11.  Comparable prescription or nonprescription medications
Ginseng is in a class of herbs referred to as tonics or adaptogens, with the purpose of boosting physical and mental ability, along with increasing resistance to stress and sickness.9 Nonprescription medications that may have comparable effects, include Siberian ginseng, rose root, five flavor berry, and twisting-vine orchid.  
12.  Any regulatory issues
In 2002, the FDA had data showing pesticides in both domestic and imported bulk ginseng.6
Pharmacist’s Views
One pharmacist heard it was good for memory and energy, but he never saw studies that said it helps. He says it can't hurt and that no one asks about it at the pharmacy.
-Pharmacist at Village Apothecary on South University
Health Store Views
Used to boost energy and also useful for weight loss.  It’s safe to use and recommend for people that are interested in using it.
-Employee at the Vitamin Shoppe on Washtenaw
Sources:
9 - http://www.aafp.org/afp/2003/1015/p1539.html
10 - http://www-ncbi-nlm-nih-gov.proxy.lib.umich.edu/pubmed/24456363
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Wednesday, February 5, 2014

Ginkgo: What to Remember

1. History
Ginkgo biloba, also known as the maidenhair tree, is a species of tree native to China that is considered a living fossil. The species dates back to around 250 million years ago, surviving through the extinction of dinosaurs and the Ice Age.1 Ginkgo trees are known for their resilience, with trees located within 1-2km of the Hiroshima atomic bomb explosion still growing today. Ginkgo has been used medicinally for quite some time; records from 5000 years ago describe using ginkgo for asthma and bronchitis. In traditional Chinese medicine, it has been used to increase sexual drive, decrease urination frequency, and to treat cancer and infections.2 Currently, ginkgo leaf extract is the most common form used medicinally.


2. Medicinal use
To improve memory and concentration, treat dementia, confusion, ringing in the ears, premenstrual syndrome (PMS), blood circulation problems, vision problems, and vertigo
Non-medicinal use
Ginkgo nuts are used in Chinese and Japanese cooking and are served at special occasions.


3. Major components hypothesized to be the active ingredients.
Flavonoid glycosides (myricetin and quercetin) and terpenoids (ginkgolides, bilobalides)3


4. Theorized mechanism of action
It is thought to cause effects by improving blood flow throughout the body, but especially in the brain. It also has antioxidant and antiplatelet effects attributed to flavone and terpene lactones.3


5. Clinical issues; DDIs, suggested dose, adverse effects, PK, overdose, use in special populations
Ginkgo may induce or inhibit certain CYP 450 enzymes, such as 2C9 and 2C19. It may also interact with warfarin, trazodone, buspirone, alprazolam, ibuprofen, efavirenz, and fluoxetine.
Ginkgo is not to be used during pregnancy due to potential early induction of labor or prolonged bleeding. There is not enough data on breastfeeding to recommend it. Ginkgo may make diabetes management more difficult, cause seizures, reduce fertility, and prolong bleeding.
The suggested starting dose is no more than 120 mg daily of leaf extract. The dose varies depending on the indication, but the highest recommended dose is 600 mg daily. The leaf extract should be given in two or three divided doses.4


6. Efficacy vs. safety
Ginkgo leaf extract is safe to take by mouth, but may cause stomach upset and dizziness. The pulp and fruit may cause allergic reactions of the skin. The roasted seeds are possibly unsafe to take by mouth, potentially causing a weak pulse or difficulty breathing. The fresh seeds are poisonous. Meta-analysis of randomized, double-blind trials comparing ginkgo to placebo concluded that ginkgo use appears to be safe, with no major side effects compared to placebo. However, the authors felt that “the evidence that Ginkgo has predictable and clinically significant benefit for people with dementia or cognitive impairment is inconsistent and unconvincing.”5 Evidence showing that ginkgo can slow progression of Alzheimer’s dementia seems controversial.


7. Information about standard of the various preparations available
Standardized ginkgo extracts are available and often used in clinical trials. They contain 24 percent ginkgo flavonoid glycosides, 6 percent terpene lactones, and no more than 5 parts per million ginkgolic acids.6 However, ginkgo products available on the market can contain different doses and amounts of ingredients. Since it is regulated as a dietary supplement, not all products are tested for purity and efficacy.


8. Cost (compare to prescription medication)
~$12-18 for 200 capsules of ginkgo extract 60mg
~$100 for 60 capsules of rivastigmine 1.5mg
~$55 for 100 tablets of trimetazidine 35mg


9. Prevalence of use
One of the ten best-selling herbals in the U.S.6
Among healthy elderly (60-94 years old) in one study: 15.3%
Prescribing among nursing home residents diagnosed with epilepsy or seizures: 61.9%


10. Evidence-based studies
The National Toxicology Program did a study on whether ginkgo was carcinogenic in mice. They found an increase in liver and thyroid cancers. The NIH did a study on 75 year-old adults and found no improvement in preventing dementia or reducing blood pressure.7


11. Comparable prescription or non-prescription medications
Rivastigmine for treating Alzheimer’s related dementia - study found that rivastigmine should be preferred over ginkgo.8
Trimetazidine, betahistin, and ginkgo for reducing tinnitus symptoms - study found that all three significantly reduce symptoms, but trimetazidine is most effective.9


12. Any regulatory issues
It is regulated by the FDA as food rather than a drug, which means less stringent regulation.


References:


1. Nelson, B. (2000). History of ginkgo biloba. Retrieved 02/04, 2014, from http://www.herballegacy.com/Nelson_Ginkgo_History.html


2. Das, D. (2013). Ginkgo. Retrieved 02/04, 2014, from http://www.britannica.com/EBchecked/topic/233931/ginkgo


3. Diamond BJ, B. M. (2013). Ginkgo biloba: Indications, mechanisms, and safety. Psychiatric Clinics of North America, 36(1)


4. Ginkgo. (2013). Retrieved 02/04, 2014, from http://www.nlm.nih.gov/medlineplus/druginfo/natural/333.html


5. Birks, J., & Grimley Evans, J. (2007). Ginkgo biloba for cognitive impairment and dementia. Cochrane Dementia and Cognitive Improvement Group, 10(2)


6. 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.


7. National Toxicology Program. (2013). Ginkgo. (). NC: National Institute of Environmental Health Sciences.


8. Nasab, N., Bahrammi, M., Nikpour, M., Rahim, F., & Naghibis, S. (2012). Efficacy of rivastigmine in comparison to ginkgo for treating alzheimer's dementia. Journal of Pakistan Medical Association, 62(7)


9. Orhan, I., Aydın, S., Altın, G., & Yılmaz, F. (2013). An efficacy comparison of betahistin, trimetazidine and ginkgo biloba extract in patients with tinnitus. Journal of Ear, Nose, and Throat, 23(3)


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"Soy" much info. on soy!

Soy
1. History
Soy was introduced to United States in the early 1800s, but it originated in China as early as 2838 BC. The Chinese regarded soybean as one of the most important crop for their nation. Soybean had been a stable diet for the Chinese population for many years. It can be found in tofu, milk, sauce, oil, curd, livestock feeds etc.  As a food source, soy has been used in Asian cultures for thousands of years, with Asian populations consuming 60 to 90 g/day of soy The United States gained access to soybean through Samuel Bowen, a former East Indian Company sailor who visited China. During the Great Depression, Soy played a major role in regeneration of soil through nitrogen fixation technique. As Soybean become more and more popular in the US, we now produce 49% of the world’s soybeans. Soy foods have become increasingly popular among health-conscious individuals since the early 1990s. In 2000, approximately 27% of US consumers reported using soy products at least once a week. Soybean products are numerous and Because of its low cost, good nutritional value, and versatility, soy protein is used as part of food programs in less developed countries.
2. Medicinal and non-medicinal use
Soy is an important source of protein fiber and mineral. It has been used for menopausal symptoms, diabetes, osteoporosis and heart disease. It is also been showed to have anti-cancer effects although the mechanism on its activity is not completely clear. For non-medicinal use, it is used mainly as a food source, livestock feed, regenerating soil, infant formula, meat and dairy substitute etc.





*
*
3. Major component(s) hypothesized to be the active ingredient(s). Include chemical
entities if applicable
Soybeans are high in nutritional value and contain up to 35% oil, 24% carbohydrate, and 50% protein. Fatty acids in beans include linoleic (55%), palmitic (9%), and stearic (6%) acids. Soybeans are rich in minerals and trace elements, including calcium, iron potassium, amino acids, and vitamins, and are a good fiber source. Soybeans contain isoflavone compounds known as phytoestrogens.
4. Theorized mechanism of action
Cancer
Isoflavones are selective estrogen receptor modulators, but also possess nonhormonal properties. The weak estrogenic action of soy isoflavones and other phytoestrogens suggest that they could lessen the harmful effects of more potent endogenous estrogens on breast and endometrial cancer.
Soy isoflavones have estrogenic, antiandrogenic, and other activities that could prevent prostate cancer or slow its progression.
Genistein reduced the synthesis of prostate-specific antigen, a marker of prostate cancer development and progression. Genistein inhibits the growth of androgen-dependent and androgen-independent prostate cancer cells.
Genistein acts as an oxidant (stimulating nitrate synthesis) and blocks formation of new blood vessels (antiangiogenic effect). Some studies show that genistein acts as inhibitor of substances that regulate cell division and cell survival (growth factors).
Cardiovascular disease:
Soy isoflavones exhibit strong biological properties in animals, causing arterial vasodilation, the lowering of serum cholesterol, and the inhibition of atherosclerosis. All these effects were seen in animal studies and the results have not translated well to human studies.
Diabetes:
Soy isoflavone diet showed that it could help improve insulin secretion. The exact mechanism on how it improves insulin secretion is not known.
Menopausal symptoms:
Because of their weak estrogenic activity, soy isoflavones have been hypothesized to improve several estrogen-dependent conditions, including perimenopausal vasomotor symptoms (eg, hot flashes) and postmenopausal bone loss. Interest in the use of soy and its derivatives for the treatment of menopausal symptoms has been encouraged by observations of a lower prevalence of menopausal complaints, especially hot flashes, among women in Asian countries where soy is an important component of the traditional diet.
Osteoporosis:
The effects of soy protein on osteoporosis are controversial. There are meta analyses that showed that soy protein can protect against decrease in bone mineral density and also in some case increase BMD. In other cases it had been showed to have no effect at all.
5. Clinical issues; DDIs, suggested dose, adv
erse effects, pharmacokinetics, overdose, use
in special population (pregnant women, elderly...etc.)
Dosing:
Soy isoflavones from 40 to 120 mg. (Dose that was used for clinical trials)
Contraindications:
Women who have current or history of estrogen-dependent tumors (including breast cancer) should consult their physician prior to higher than dietary consumption of soy due to its possible effect on aggravating tumor.
Pregnancy/Lactation:
Generally regard as safe.
Interactions:
None well documented.
Adverse Reactions:
Soybeans and their products are generally well tolerated. Minor GI disturbances have been reported.
 
6. Efficacy vs. safety
Increased breast cancer risk and it is possible that isoflavones in soy may actually stimulate breast tumor growth through their estrogenic activity.
Generally regarded as safe.



7. Information about the standard of the various preparations available
No soy-containing products researched were verified for safety, efficacy or purity.
8. Cost (compare to prescription medication)
A 30-day supply of simvastatin at Walgreens costs about $15 with insurance, and $30 without. A 180-tablet bottle (60-day supply) at Vitamin Shoppe costs $23.65. Comparatively, the soy product has a lower cost per day than the simvastatin, however, the therapeutic impact on lower cholesterol may be questionable for soy.
A 4-week supply of alendronate at WalMart pharmacy costs $9, whereas Amazon.com sells “Jarrow Formulas – IsoRich Soy GMO free” for $13.29. Jarrow’s claims that their supplement is beneficial for cardiovascular function, menopausal support and bone health. Instructions are to mix 29g (31-day supply) of powder with milk or juice daily. Comparatively, alendronate sells for a cheaper cost per month for aiding in bone health.
9. Prevalence of use:
Dr. Shimp stated that soy supplements were more popular about 8-10 years ago when it first emerged as a supplement, but nowadays it’s not very prevalent anymore. Concerns with breast cancer risk (albeit conflicted studies) may also have factored into the decline of soy supplementation.
10. Evidence-based studies
A randomized placebo-control double blind study was done with women aged 45 to 60 within 5 years of menopause and with bone mineral density T score of -2.0 or higher. Patients were randomized to receive placebo or 200 mg of soy isoflavone tablets. The study showed that after 2 years, no significant differences were found between treatment (n=122) and placebo (n=126) group for changes in bone mineral density in the spine (-2.0% and -2.3%, respectively). This study also found that a significantly larger portion of the soy group experienced hot flashes and constipation compared with the control group.
Levis S, Strickman-Stein N, Ganjei-Azar P, Xu P, Doerge DR, Krischer J. Soy Isoflavones in the Prevention of Menopausal Bone Loss and Menopausal Symptoms: A Randomized, Double-blind Trial. Arch Intern Med. 2011;171(15):1363-1369. doi:10.1001/archinternmed.2011.330.
In a separate 2013 study with 128 patients (67 active, 61 placebo), Mainini et al. showed that treatment with 19.2 mg of soy isoflavones daily resulted in a significant reduction (p <0.05) of the number of hot flashes compared to placebo in one month and at 3 months. Additionally, they found no significant difference in total cholesterol, LDL, HDL, or triglycerides.
Nonhormonal management of postmenopausal women: Effects of a red clover based isoflavones supplementation on climacteric syndrome and cardiovascular risk serum profile
Mainini G., Torella M., Di Donna M.C., Esposito E., Ercolano S., Correa R., Cucinella G., Stradella L., Luisi A., Basso A., Cerreto F.V., Cicatiello R., Matteo M., De Franciscis P.
Clinical and Experimental Obstetrics and Gynecology 2013 40:3 (337-341)
In a meta analysis of PubMed, Taku et al. found that soy isoflavones significantly reduced total cholesterol and LDL, but did not change HDL and triglycerides, and that the change in LDL were higher in hypercholesterolemic patients than in normocholesterolemic patients.
Am J Clin Nutr. 2007 Apr;85(4):1148-56.
Soy isoflavones lower serum total and LDL cholesterol in humans: a meta-analysis of 11 randomized controlled trials.
Taku K, Umegaki K, Sato Y, Taki Y, Endoh K, Watanabe S.
A study was conducted in 2008 that suggested consuming soy legumes led to a decreased incidence of developing type 2 diabetes.


Am J Clin Nutr. 2008 Jan;87(1):162-7.
Legume and soy food intake and the incidence of type 2 diabetes in the Shanghai Women's Health Study.
Villegas R, Gao YT, Yang G, Li HL, Elasy TA, Zheng W, Shu XO.
In a meta analysis, soy consumption at the “level of Asian populations” have no detrimental risks to breast cancer or breast cancer recurrence. One 2014 study found that soy foods and isoflavones has modest reductions in the risk of breast cancer. This 2014 study also showed that soy had no influence on protection of bone health.
Curr Opin Clin Nutr Metab Care. 2012 Nov;15(6):586-91. doi: 10.1097/MCO.0b013e328359156f.
Soy products in the management of breast cancer.
Magee PJ, Rowland I.
Altern Ther Health Med. 2014 Jan;20 Suppl 1:39-51.
Soy foods and supplementation: a review of commonly perceived health benefits and risks.
D'Adamo CR, Sahin A.
11. Comparable prescription or non-prescription medications: See above
12. Any regulatory issues
FDA issued a statement in April 2013 stating that labeling requirements of soy and lowering CHD must have the word “may” or “might” on the product. Additionally, the substance claim must be “soy protein” not just soy. The disease must state “coronary heart disease” or “heart disease.” The fat component must be “cholesterol” or “saturated fat.”







Health store Views
A Vitamin Shoppe representative seemed to have scripted lines when answering questions. When asked about side effects of soy, she was very general, stating that “side effects vary from person to person.” She suggested we speak to our doctor for more information on that. We didn’t ask her knowledge level on it explicitly, but it seemed she wasn’t very well versed on the topic.

 A pharmacist at Village Apothecary Pharmacy on South University said that it's used to deal with hot flashes in menopause because it contains an estrogen/estrogen analog. He'll tell patients not to take soy and Rx hormones at the same time without talking to their doctor.
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