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HOT FLASH NEWS FLASH!

Thursday, October 14, 2010 9:51 AM
  • Drugs for menopausal symptoms have serious risks according to the experts
  • Natural products for menopausal symptoms haven’t produced significant results
  • A special extract of Siberian rhubarb has been found that reduces symptoms as well as the drugs without any of the side effects or risks
For years, women suffering from menopausal symptoms have had to make a choice when it came to treatment—often referred to as a “treatment trade-off” —either use drugs that work and have side effects or try natural products that are safe, but still leave women with symptoms. We know that hormone-replacement drugs work very well for symptoms, but many women are concerned about the risk of side effects. On the other hand, most women who have tried natural remedies also know that they generally don’t work very well. Safe? Sure. Effective? Not really. Finally, women no longer have to choose between treatment trade-offs. We are excited to announce a new formula that’s been shown to be as effective as the drug treatments with the safety of a natural product.

Menopausal symptoms can be very intense and even debilitating. Here’s a short list: hot flashes, night sweats, irritability and mood swings, depression, irregular heart beat, sleep problems, anxiety, joint pain, loss of libido, and vaginal dryness—and that’s just the beginning; there are about 25 other documented symptoms. While menopause is defined as the permanent end of menstruation and fertility, officially at 12 months after a woman’s last menstrual period; symptoms can begin occurring 4 to 5 years before and last as many as 10 years after. Because of the duration and intensity of symptoms, hormone replacement therapy has been very popular because it works. Unfortunately, it works at a cost.

The cost or risks associated with hormone replacement therapy really came to light in the massive Women’s Health Initiative (WHI) study launched in 1991 and schedule to run for 15 years. With any drug treatment, much of the drug’s value is based on the benefits versus the risks. As the data rolled in for the hormone replacement part of the study, the Data and Safety Monitoring Board made a surprising decision. They recommended stopping that part of the trial due to the “hazard ratios” being too high, showing that the risks outweighed the benefits. This in spite of the data that the drugs could reduce hot flashes by about 75%! Most of the press on the matter focused on the increased risk of breast cancer, but there were plenty of other concerns as well. A report in JAMA in 2002 showed an increased risk to heart disease, stroke, and pulmonary embolism. Other “common” side effects (according to drugs.com) from Premarin, one of the most widely prescribed HRT drugs, may include:

“Back pain; bloating; breast pain; depression; diarrhea; dizziness; flu syndrome; gas; hair loss; headache; increased cough; increased/decreased interest in sex; indigestion; infection; irregular vaginal bleeding or spotting; itching; joint pain; lightheadedness; leg cramps; muscle aches; nausea; nervousness; pain; runny nose; sinus inflammation; sleeplessness; sore throat; stomach pain; upper respiratory tract infection; vaginal inflammation; weakness; weight changes”

And those aren’t even the “severe” side effects. As a result of all these findings, many women stopped using hormone replacement drugs and researchers noted in the following years a decreasing incidence of breast cancer. As early as 1998, an article in the Journal of the National Cancer Institute (NCI) stated that “strategies that do not cause breast cancer are urgently needed for the relief of menopausal symptoms…”
There were two key components in the NCI’s statement: they wanted something that worked without all the risks. Natural products flooded the market in hopes of capitalizing on this unmet need. Unfortunately, while most of these products proved to be safe, they just didn’t reduce symptoms enough to convince most women to switch. The products would typically contain things like black cohosh, dong quai, yam, soy isoflavones, chaste berry, and many others, but double-blinded research was either nonexistent or not impressive. Research, if you could find it, showed at best a hot flash reduction by about 45%, but typically only in the very short-term with studies lasting only 4 weeks.
While companies continued to manufacture products with little to no research supporting their use, a novel formulation in Germany was being used beginning in 1993 with great success. The unique ingredient was a specific extract from Siberian rhubarb root (rheum rhaponticum), known in the research as ERr731. The extract has various unique compounds known as hydroxystilbenes derived from the plant’s naturally occurring resveratrol. ERr731 has been validated in 3 multi-center, prospective, randomized, double-blind, placebo-controlled, phase III clinical trials, with 1 and 2 year open observational trials and the involvement of 70 gynecological centers. The studies showed a 72% reduction in hot flashes, with similar reductions in night sweats, irritability, anxiety, depression, mood swings, sleep troubles, joint pain, sexual problems and vaginal dryness. Most impressive was the observation that the more severe the symptoms, the more effective they found the treatment. In addition, the safety profile revealed what the National Cancer Institute had been asking for. To quote the investigators of a 96 week study: “there was no clinically relevant change in safety parameters, and no adverse events were observed with relation to the long-term use of ERr 731.”

Finally ladies, you no longer have to accept the treatment trade-off for menopausal symptoms. You can now have the symptom relief equivalent to HRT and the demanded safety. The protocol couldn’t be easier; you just take 1 tablet per day and will typically see relief with the first bottle. Investigators have seen that taking it at the same time every day, preferably with a meal, seems to provide the best results.

…and men, stay tuned for Part II of the rhubarb story to see how it can help you too.

 


JAMA. 2002;288:321-333
Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women
Principal Results From the Women's Health Initiative Randomized Controlled Trial
Writing Group for the Women's Health Initiative Investigators

Arch Intern Med. 2009 Oct 12;169(18):1684-91.
New-onset breast tenderness after initiation of estrogen plus progestin therapy and breast cancer risk. Crandall CJ, et al Department of Medicine, UCLA
“New-onset breast tenderness during conjugated equine estrogens plus medroxyprogesterone therapy was associated with increased breast cancer risk”

Lancet. 2009 Oct 10;374(9697):1243-51. Epub 2009 Sep 18.
Oestrogen plus progestin and lung cancer in postmenopausal women (Women's Health Initiative trial): a post-hoc analysis of a randomised controlled trial.
Chlebowski RT,et al; Women's Health Initiative Investigators.
“Although treatment with oestrogen plus progestin in postmenopausal women did not increase incidence of lung cancer, it increased the number of deaths from lung cancer”

J Natl Cancer Inst 1998;90:814-23
“Strategies that do not cause breast cancer are urgently needed for the relief of menopausal symptoms and the long-term prevention of osteoporosis and heart disease.”

N Engl J Med 2009; 360:573-587February 5, 2009
Breast Cancer after Use of Estrogen plus Progestin in Postmenopausal Women
Rowan T. et al for the WHI Investigators
“This finding supports the hypothesis that the recent reduction in the incidence of breast cancer among women in certain age groups in the United States is predominantly related to a decrease in the use of combined estrogen plus progestin.”

J Natl Cancer Inst 1998;90:814-23
“We conclude that existing evidence supports a causal relationship between use of estrogens and progestins, levels of endogenous estrogens, and breast cancer incidence in postmenopausal women.”

J Clin Oncol 2006;24:e49-e50
Clarke CA, Glaser SL, Uratsu CS, Selby JV, Kushi LH, Herrinton LJ. Recent declines in hormone therapy utilization and breast cancer incidence: clinical and population-based evidence.

N Engl J Med 2007;356:1670-1674
Ravdin PM, Cronin K, Howlander N, et al. A sharp decrease in breast cancer incidence in 2003 in the United States.

Breast Cancer Res Treat 2008;107:427-430
Katalinic A, Rawal R. Decline in breast cancer incidence after decrease in utilisation of hormone replacement therapy.

Med J Aust 2008;188:641-644
Canfell K, Banks E, Moa AM, Beral V. Decrease in breast cancer incidence following a rapid fall in use of hormone replacement therapy in Australia.

Bull Cancer (Paris) 2008;95:11-15
Allemand H, Seradour B, Weill A, Ricordeau P. Decline in breast cancer incidence in 2005 and 2006 in France: a paradoxical trend.

Cochrane Database Syst Rev. 2004 18(4)
Meta-analysis: Placebo RCTs ranging from 3 -12 months from Maclennan et al.

Gynecological Endocrinology Jan 2005;20(1):13-21
Meta-analysis: Placebo RCTs ranging from 3 -12 months from Albertazzi P.

Alt Ther Health Med Kaskzin-Bettag et al. 2008 Efficacy fo the Special Extract ERr731 from Rhapontic Rhubarb for Menopausal Complaints: A 6-month Open Observational Study

Menopause Kaskzin-Bettag et al., 2007 The Special extract ERr731 of the roots of Rheum rhaponticum decreases anxiety and improves health state and general well-being in perimenopausal women.

Menopause Heger et al., 2006 Efficacy and safety of a special extract of Rheum rhaponticum (ERr731) in perimenopausal women with climacteric complaints: a 12-week randomized, double-blind, placebo-controlled trial

Menopause Hasper et al.,2008 Long-term efficacy and safety of the special extract ERr731 of Rheum rhaponticum in perimenopausal women with menopausal symptoms

Alt Ther Health Med Kaskzin-Bettag, 2009 Confirmation of the Efficacy of ERr731 in Perimenopausal Women with Menopausal Symptoms

Copyright ©2010 Charles Poliquin

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