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Search Term: " 3156 "
Antioxidants- How To Fight With The Free Radicals   
Date:
January 04, 2017 10:37 PM
Free radicals are of good concern to any individual who wants to stay healthy. You have possibly heard of how hazardous these substances are and how essential are antioxidants that battle them. Understanding free radicals involves mastering just a little bit about their chemical background. Your body is made up of numerous connected parts. The organs and tissues that form these parts are all made from cells. In original terms, each cell is an independent unit that processes its waste and ingests nutrients, additionally to performing several other functions.
How do cells perform? The answer varies depending on the distinct cell. Some produce the power utilized to move muscles, and others transport nervous impulses, but all are powered by chemical reactions. These reactions, or interactions among the electrons that surround every atom in the universe, also happen inside our bodies. Without the several various molecules or groups of atoms, that chemical reactions produce, we couldn't survive. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| STUDY DESIGN | BENEFITS | DOSAGE | REFERENCE | ||
| 1. Twelve-week, randomized, multicenter, double-blind clinical trial comparing the efficacy and tolerability of Remifemin® in the treatment of climacteric complaints compared with placebo. The primary efficacy measure was the change from baseline on the Menopause rating Scale 1. | · Remifemin® effectively relieved menopausal symptoms, particularly in women in the early stages of menopause* · Most significant reduction was in hot flash occurrence* · Other symptoms resulting in significant reduction include: psyche (irritability and memory), and atrophy (vaginal dryness)* · No significant adverse effects reported | 40mg qd | Osmers R, et al. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms. Obstet Gynecol. 2005 May; 105(5):1074-83. | ||
| 2. A review of 29 randomized controlled trials of complementary and alternative therapies for menopausal symptoms. | · Black cohosh is one of the only herbal remedies shown to be effective for menopausal symptoms, especially hot flashes* | | Kronenberg. F. Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002 Nov 19;137(10:805-13. | ||
| 3. Four-week, pilot study, open clinical trial of menopausal women with hot flashes, including women with a history of breast cancer. | · Remifemin® reduced mean daily hot flash frequency by 50% after 4 weeks* · Overall, participants reported less trouble with sleeping, less fatigue, and fewer night sweats* · No participants stopped therapy because of adverse effects | 40mg qd | Pockaj BA, et al. Pilot evaluation of black cohosh for the treatment of hot flashes in women. Cancer Invest. 2004;22(4):515-21 | ||
| 4. Double-blind study involving the use of Remifemin® in women ages 43 to 60 with menopausal complaints lasting 6 months. | · Majority of woman saw a 70% reduction of physical and emotional symptoms after 12 weeks, including hot flashes, night sweats, mood swings, and irritability* · Significant improvement was noted after 4 weeks use* · Remifemin® works safely and effectively to treat menopause symptoms without affecting hormone levels or vaginal cytology (pap smear)* | 40mg qd | Liske J, et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizome): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med. 2002 Mar; 11(2): 163-74 | ||
| 5. Double-blind, 6 month study in hysterectomized women under 40 with at least one ovary. | · As effective as estriol, conjugated estrogens, or hormone combinations at decreasing physical menopausal symptoms at 4, 8, 12, and 24 weeks* | 4mg dry extract bid (equivalent to 2 tablets Remifemin® bid | Lehmann-Willebrock E, Riedel HH. Clinical and endocrinologic studies of the treatment of ovarian insufficiency manifestations following hysterectomy with intact adnexa. Zentralbl Gynakol. 1988; 110(10):611-8 | ||
| 6. Women aged 45 to 58 with menopausal complaints were studied in a double-blind, 12 week, placebo-controlled trial. | · Remifemin® decreased physical symptoms of menopause by approximately 60% (Kupperman menopausal indeed)* · Daily hot flashes decreased by 86% in the Remifemin® group(from 4.9 to 0.7 per day)* · Emotional complaints were also dramatically reduced* | 4mg dry extract bid (equivalent to 2 tablets Remifemin® bid | Stoll W. Phytopharmacon influences atrophic vaginal epithelium: Double Blind study – Cimicifuga vs. estrogenic substances. 1987. | ||
Safety
| STUDY DESIGN | BENEFITS | DOSAGE | REFERENCE |
| 7. in vitro, MCF-7 cell culture model to determine estrogen-agopnist and antagonist activity of commercially available herbal menopause preparations containing red clover, soy black cohosh, or a combination of herbs. | · Remifemin® had no effect on estrogen-sensitive cells in vitro. · Results suggest safety for women with a history of breast cancer who cannot take estrogen. | In Vitro(10^3-10^5 dilutions) | Bodinet C, Freudenstein J. Influence of marketed herbal menopause preparations on MCF-7 cell proliferation. Menopause. 2004 May-Jun;11(3):281-9. |
| 8. Six-week, in vivo investigation of Remifemin®’s ability to stimulate estrogen-receptor positive cells in an animal model | · No estrogen stimulating effects were found. · Prolactin, follicle-stimulating hormone, and luteinizing hormone levels were unchanged. | 0.714m 7.14 or 71.4mg/kg/day | Freudenstein J, et al. Lack of promotion of estrogen-dependent mammary gland tumors in vivo by an isopropanolic Cimicifuga racemosa extract. Cancer Res. 2002 Jun 15;62(12):3448-52. |
| 9. Comprehensive review examining all published literature pertaining to pre-clinical and clinical safety of various forms of Cimicifuga racemosa, as well as FDA and World Health Organization (WHO) adverse event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical, anecdotal report. | · Uncontrolled reports, postmarketing surveillance, and human clinical trials of more than 2,800 patients demonstrate a low incidence of adverse events (5.4%). · Of the reported adverse events, 97% were minor and did not result in discontinuation of symptoms, and the only severe events were not attributed to Cimicifuga treatemtn. · Confirms the safety of specific Cimicifuga extracts, particularly isopropanolic preparations (Remifemin®), for use in women experiencing menopausal symptoms and as a safe alternative for women in whom estrogen therapy is contraindicated *. | Various | Low Dog T, et al. Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief. Menopause: Journal of the North American Menopause society. 2003;10(4):299-313. |
Relevant Reports and Guidelines
| ORGANIZATION | PUBLICATION | EXCERPT OF KEY CONTENT |
| American Botanical Council | The ABC Clinical Guide to Herbs including a black cohosh monograph issues September 2002 | “Of 10 clinical studies, including a total of 1,371 participants, nine of these studies demonstrated positive effects for menopausal symptoms. Numerous clinical trials with varied methods and designs have been conducted on the standardized isopropanolic/ethanolic extract of black cohosh root, Remifemin®, from 1981 to the present.” |
| National | Questions and Answers About Black Cohosh and the Symptoms of Menopause issued October 2002 | “Other preparations of black cohosh have been less well studied than Remifemin® …black cohosh is used primarily for hot flashes and other menopausal symptoms. A number of studies using various designs have been conducted to determine whether black cohosh affects the menopausal symptoms… To provide more definitive evidence on the effects of black cohosh on menopausal symptoms, NCCAM is funding a 12-month, randomized placebo controlled study to determine whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes.” |
| The North American Menopause Society | Alternatives to Hormone Replacement Therapy: Suggestions for the North American Menopause Siciety issued July 2002 | “Reseach suggests that mild hot flashes can be relieved by consuming a serving of soy foods daily or taking a supplement of black cohosh.” |
Responding to the need for alternative menopausal symptom relief*
Natural, Safe alternative to HRT for menopausal symptoms*
- Remifemin black cohosh was as effective as HRT for menopausal symptoms*
Superior Manufacturing Quality
- Prepared according to Good Manufacturing Practice (GMPs) which ensure delivery of a product with the highest quality and consistency
- Convenient dosing – one 20mg tablet twice a day (one in the MORNING, one in the EVENING)
- 100% RemiSure black cohosh – not a combination of herbs
VitaNet Recommends Remifemin
- Remifemin unique standardized isopropanolic extract is the most widely studied and clinically tested natural alternative treatment for relief of menopausal symptoms.
- Remifemin black cohosh proven effective in reducing menopause and peri-menopause symptoms, including hot flashes, right sweats, mood swings, and irritability without estrogenic effects.
- Used safely by millions of patients worldwide for over 40 years. Remifemin has been proven effective and is the most clinically studied natural intervention of menopause.
- Remifemin doesn’t have the side effects that are experienced with hormonal drugs prescribed for the relief of menopausal symptoms.
Lit source: Enzymatic therapy.
*this statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treate, cure, or prevent any disease.
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1358)
An Interview with Congressman Sam Farr, Representing California’s Central Coast.
Date:
May 30, 2006 02:36 PM
Author: 
Darrell Miller
(dm@vitanetonline.com)
Subject: An Interview with Congressman Sam Farr, Representing California’s Central Coast.
Ambassador to Health Profile
An Interview with Congressman Sam Farr, Representing California’s Central Coast.
Congressman Sam Farr, a fifth-generation Californian, represents the state’s beautiful central coast. His district encompasses the length of the big Sur coastline in Monterey County, the Monterey Bay National Marine Sanctuary, the Salinas Valley “Salad bowl,” the redwoods, mountains and beaches of Santa Cruz County, and the majestic rural landscape of San Benito County. The health and wealth of this region has been strengthened by Rep. Farr’s focus on the environment, education and the economy. Rep. Farr was raised in Carmel, California and graduated from Willamette University with a BS in biology. He later attended the Monterey Institute of International Studies and the University of Santa Clara. He is fluent in Spanish. As a tough advocate for the health food industry, he has lobbied for strict federal organic standards.
Todd: Congressman Farr, thank you for taking the time to speak with us! Id also like to thank you for all the great things you’ve done for our community, form funding marine sanctuaries and authoring the Ocean’s Act to expanding Pinnacles national Monument. The League of Conservation Voters and others have recognized you as an “Environmental Hero”. And, you’ve worked hard to support the economic vitality of central coast’s $3 billion agriculture industry which includes a substantial organic segment. Our backyard here is also the home of a robust group of nutritional supplement manufacturers. An estimated 187 million Americans are currently taking dietary supplements as part of their daily healthy diet. In California, we’ve got 792 natural product manufacturers and distributors. Where do you stand on the state of our industry?
Congressman Farr: Well, thank you for the introduction and for asking to talk to me about nutritional supplement issues. I am very supportive of this industry and include myself in the 187 million Americans taking dietary supplements. I think supplements offer many safe and viable tools to maintain your health. The continued growth of this industry is an indication of both consumer confidence in the products and the products’ ability to fill the gaps where conventional medical care falls short.
Todd: It is estimated that by 2030, more than 70 million Americans will be over the age of 65 and the cost of health care could reach $16 Trillion per year. A recent study by the Lewin Group showed that by taking certain dietary supplements, seniors can lead healthier, more productive, independent lives while saving billions in reduced hospitalizations and physician services. Do you share our view that a Wellness Revolution is needed to counter the dilemma of an aging population versus shrinking health care support in the future?
Congressman Farr: Our health care system is definitely facing a challenge, especially as the Baby Boomers hit their 60’s and Americans are living longer than ever before. As a Baby Boomer myself, I am well aware of America’s aging population and the impact that will likely have not only on our social institutions but also our fiscal well-being. I agree that dietary supplements do play and will play an even larger role in the future as more seniors look for a way to augment their diets in order to stay healthy and active longer than past generations.
Todd: Our industry is regulated by DSHEA (the Dietary Supplement Health and Education Act), which was passed unanimously by Congress in 1994 to create a reasonable regulatory framework for access to, information about, dietary supplements. But many say that the FDA and DSHEA weren’t adequately funded to do the job as tasked. “Supplements are unregulated” is a false argument we sometimes hear. To ensure that the FDA is able to carry out the law as Congress intended, Representatives Dan Burton (R-Ind.) and Frank Pallone (D-N.J.) introduced H.R. 2485, the DSHEA Full Implementation and Enforcement Act of 2005. Did you support this bill and where does it stand today?
Congressman Farr: I think the DSHEA is a critical law and was proud to support it when Congress considered it in 1993 and 1994. I would certainly support H.R. 2485 if it came up for a vote in Congress. Unfortunately this bill has not moved since it was first introduced and referred to the Subcommittee on health in the house energy and commerce committee. Since this is an election year we have a tight schedule with only about 60 legislative days scheduled before we adjourn. That means it’s likely Congress will only finalize bills such as the appropriation bills that fund government before adjournment.
Todd: Our business climate has included some valid and rigorous challenges to improve our industry, from good manufacturing practices (GMP), to allergy labeling, to implications of Prop-65 in California. It’s disconcerting that a new bill, H.R. 3156 The Dietary Supplement Access and Awareness Act would try to capitalize on misconceptions about the industry. In an era of declining health care and declining insurance coverage, this bill would regulate supplements as prescription drugs. Among other things, it would also require adverse event reports to be turned over to the FDA, even though other foods, including those with identical ingredients, do not have the same requirements. This has the potential to be the next Prop-65-like Lawsuit mill. The result of H.R. 3156 would be chilling. It will knock smaller producers out of the market. It will result in higher prices for all supplements. It will decrease the availability of health-giving supplements to the public. What’s your feeling on this?
Congressman Farr: I am similarly concerned about H.R. 3156 and would oppose it if it came up for a vote in Congress. Like H.R. 2485, this legislation has been referred to a subcommittee on Health in the House Energy and Commerce Committee without any further action. The supplement industry has worked in good faith with the FDA since passage of DSHEA and H.R. 3156 would re-invent a wheel that isn’t needed. Instead, adequate funding as proposed in H.R. 2485 would provide ample oversight for the industry.
Todd: According to a recent study, 72% of the general population believe the government should fund more research on health benefits of nutritional supplements. Do you agreen and what can be done to meet this need?
Congressman Farr: I definitely agree that the federal government should play a bigger role in support of research regarding the health benefits of nutritional supplements. As a member of the House Appropriation Committee, I sit on the subcommittee that has jurisdiction over the FDA’s budget and I know the tight fiscal restraints the agency is under. I’ve worked with my colleagues to provide adequate funding, but it’s an uphill battle especially when we’re in a “robbing Peter to pay Paul” kind of situation. I recommend that people within the industry organize and use your consumer base to actively lobby Congress for additional funds. I’m fond of reminding people that the squeaky wheel gets grease – so let every Congress member and Senator know how much this issue matters to you.
Todd: When there is overwhelming scientific evidence that nutritional supplements provides relief for a disease condition, it currently takes a lawsuit to get the FDA to relent and allow the claim. Even then, the FDA strictly limits the claim and requires a disclaimer that does more harm than good in communicating this important information to the public. There is a new bill, H.R. 4282, The Health Freedom Protection Act that would end FDA and FTC censorship of health information. As an example, the 50% of all adult males who suffer from an enlarged prostate could receive relief from that condition by consuming a simple and safe ingredient, saw palmetto derived from the fruit of the dwarf American palm tree. The FDA censors that information. The public deserves a better opportunity to be informed about omega-3 EFA and heart disease, folic acid and birth defects, phosphatidylserine and cognitive impairment. Do you agree and do you support this bill?
Congressman Farr: I agree the public needs to access to the best information possible so they can make well informed choices about their health. I likely would support H.R. 4282 if it came up for a vote in Congress. Unfortunately this bill is in a similar situation as other we’ve mentioned in this interview – and again because of the tight schedule of an election year, it’s unlikely action will happen this year.
Todd: According to the barometer study, 85% of the US population is currently using some type of dietary supplement. Do you? Looking at your busy schedule from co-chairing the House Oceans Caucus to your seat on the Travel and Tourism Caucus, you are one busy congressman! Are you popping nutritional supplements please tell us!
Congressman Farr: I do take some nutritional supplements, though they vary and since Ginkgo Biloba isn’t among them I cant remember their names off-hand! One product I do use faithfully is Airborne to help me combat germs and colds that I might get from sitting on an airplane. But, like many Americans my life is over-scheduled and combined with the amount of air-travel I do, I find nutritional supplements helpful as I try to stay healthy despite my hectic lifestyle.
Todd: Thank you Congressman Farr! Live long and prosper!
DSEA Release of Health/Cost Impact Study Conducted by the Lewin Group, Initial Results, Wash DC; Nov. 2, 2005
NNFA database. Adam.F on 3-15-06.
DSEA Nutritional Supplement Barometer Study, 2005 Report, Prepared by the Natural Marketing Institute (NMI).
Todd Williams; Source Naturals Marketing Programs Manager.
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Health and Wellness update at Vitanet
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=1288)
Date:
August 30, 2005 01:22 PM
Author: Darrell Miller
(dm@vitanetonline.com)
Kiss Herbal Supplements Goodbye
Healthful herbal therapies face a new attack in Congress.
If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny. – Thomas Jefferson
Our third president recognized the devastating health and liberty implications of allowing governments to dictate what people eat. One can only imagine the disgust with which Jefferson would regard elected officials who are currently betraying core American freedoms by working to revoke our rights to choose what foods we put in our bodies.
In 1994, the Dietary Supplement Health and Education Act (DSHEA) estabilished that dietary supplements are foods. Its passage was a shinning moment of democracy that resonated with Jefferson’s beliefs on health freedom, as millions of Americans raised their voices to preserve our right to safe, natural supplements.
DSHEA Under Attack
But now, as countless people use supplements to enhance their health, some officials are tampering with the DSHEA. HR 3156, the dietary supplement access & awareness act introduced by representative Susan Davis (D-CA), is designed to deny Americans access to the supplements they rely upon for good health. Should HR3156 pass, herbal supplements will be subject to risk benefits analysis, under which adverse event reporting will empower the FDA to ban herbal supplement sales.
Inexplicably, the bill pays no heed to the amount of herbal supplement associated with an adverse event. In other words, if someone ingests an unreasonably excessive amount of a herbal remedy, and as result experiences an adverse event, that would be enough for the FDA to ban that supplement—even if the overwhelming majority of consumers experienced positive benefits by using the supplement properly. This caveat, in addition to the relative ease with which an adverse event could falsely be linked to herbal supplements, has the potential to enable widespread, groundless bans of these health-enhancing, time-tested therapies.
Fight Back, Right Now!
We must act now to prevent the passage of HR 3156. For America’s sake, we must fight the forces in Congress that wish to ban our access to herbal supplements. In the name of democracy we must ensure that our elected officials are representing our interests and not furthering their own agendas. Without your immediate support, America’s health will be compromised as herbal supplements, one by one are banned under false pretenses.
To Quote Jefferson once again, “Never put off ‘till tomorrow what you can do today.” The need for your support is urgent, so please fax your representatives in congress today and urge them to oppose that passage of HR 3156. Contacting elected officials is fast and easy; visit www.NHA2005.com and use revolutionary technology that helps you compose faxes to congress. Become a good health ambassador; educate your friends on this gross impingement on our health freedom and encourage them to join the fight against health tyranny!
Fax the architects of HR 3156, Susan Davis (Fax: 202-225-2948), John Dingell (Fax: 202-226-0371) and Henry Waxman (Fax: 202-225-4099), and let them know that if they revoke your health freedom, you’ll vote for your health-care interests in the next election! It is only with your help that we can win the fight to keep safe, healthy supplements in our lives. For health, Freedom and liberty, visit www.NHA2005.com and Join the NHA Today.
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Vitanet ®
(https://vitanetonline.com:443/forums/Index.cfm?CFApp=1&Message_ID=749)
