After the 12 week treatment period, the Kupperman index for the red ginseng group significantly reduced from 18.93 to 13.32 compared with the placebo from 15.21 to 15.10. The Menopause Rating Scale score dropped significantly from 12.45 to 8.32 in the ginseng group compared with 10.23 to 9.26 in the placebo group. The hot flash score also reduced significantly in the red ginseng group.

Red ginseng also elicited a significant decrease in total cholesterol from 138.11 to 108.82 compared with the placebo, from 128.52 to 128.03. The drop in LDL was also significant in the red ginseng group compared to placebo but there were no significant differences between the two groups for HDL cholesterol or C-reactive protein. The estrogen levels were not considered to be affected by red ginseng. On the other hand, the carotid intima-media thickness was significantly reduced in the red ginseng group compared with the placebo group.

Commentary: This is not the first randomized, controlled trial using ginseng in menopause symptoms but it is the first double-blind randomized controlled trial to investigate the effect of red ginseng for 12 weeks on menopausal symptoms in postmenopausal women. In the previous trial published in 1999, there were no clear effects on hot flashes but there was an effect on quality of life. In the current study however, there was a clear effect in reducing the menopause symptoms rated on the Kupperman Index and the Menopause Rating Scale, including hot flashes. These are two of the most common research tools in evaluating menopause symptoms.

The positive results of red ginseng for hot flashes in the current study versus the negative results in the previous trial could be explained by the difference in ginseng used. Red ginseng has physiologically active components that are not present in raw white ginseng or the plain Panax ginseng. Another significant difference in the two studies is the 3gmper day of the red ginseng versus the 200 mg of ginseng in the previous study.

Reference

Young Kim S, Kyo Seo S, Mi Choi Y, et al.  Effects of red ginseng supplementation on menopausal symptoms and cardiovascular risk factors in postmenopausal women: a double-blind randomized controlled trial.  Menopause 2012;19(4):461-466

While 100 women completed the trial, 19 did not meet the criteria for postmenopause based on FSH levels therefore, data for 81 women were used to analyze the results.

After the 12 weeks of treatment, PGS reduced the number of hot flashes by 4.3 per day and the placebo reduced it by 2.5 per day. Both groups were significantly improved compared to prior to the PGS or the placebo, but the pomegranate group was not statistically significant compared to the placebo group. Interestingly though, 12 weeks after the treatment was stopped, the reduction of hot flashes was significantly different between the PGS and the placebo. The overall total score of the Menopause Rating Scale did decrease in the PGS group from 16.0 to 9.0 at week 12 and from 18.0 to 14.5 in the placebo group. In looking at just the somatic symptoms, the PGS group did have a stronger response that was attributed mainly to an improvement in sleep disorder issues. There was no effect of PGS on hormone levels.

Summary: The not so good news is that pomegranate seed oil in this dose, in this study, did reduce the frequency of hot flashes significantly, but so did the placebo. The better news is that when looking at the overall Menopause Rating Scale sum score, including the severity of hot flashes, there was a trend toward a reduction in menopausal symptoms compared with placebo, although it did not reach the level of significance. In addition, the frequency of sleeping disorders did decrease significantly with the pomegranate seed oil, and after 12 weeks, at the end of the treatment, the difference between PGS and placebo in the reduction of hot flashes was significant. It’s hard to understand the meaning of that, but there is some suggestion of some sustainable, lingering effect of the PGS. Other good news is that they studied it at all, and this is actually the first prospective randomized, placebo-controlled, double-blinded trial that has investigated the effects of pomegranate seed oil on hormone levels in women who are postmenopausal.

Reference

Auerbach L, Rakus J, Bauer C, et al. Pomegranate seed oil in women with menopausal symtpoms: a prospective randomized, placebo-controlled, double-blinded trial. Menopause 2012; 19(4):426-432

In the Nurses’ Cohort Study that followed 81,722 women from 1984 to 2010, questionnaires were assessed every 2 to 4 years. The Mediterranean diet includes a high intake of fruits, vegetables, nuts, whole grains, fish and moderate alcohol. The study found an inverse association between all 4 low-risk lifestyle factors and a lower risk of sudden cardiac death. Women at low risk for all 4 lifestyle factors had a 92% lower risk of sudden cardiac death than women at low risk for none of the lifestyle factors.

Commentary: Researchers commented that 79% of sudden cardiac death may be due to unhealthy lifestyle practices in women who do not have a diagnosis of coronary heart disease. Sudden cardiac death causes more than 50% of all the cardiac deaths and is occurs more often in women. These study results will hopefully motivate us to live healthier lifestyles.

Reference

Chiuve S, Fung T, Rexrode K, et al. Adherence to a low-risk, healthy lifestyle and risk of sudden cardiac death among women. JAMA 2011;306(1):62-69.

Women were randomized to receive a single high dose of vitamin D of 300,000 I.U. or placebo 5 days before the anticipated onset of their next menstrual period. The primary measured outcome was the intensity of the menstrual pain and the secondary outcome was the use of NSAIDS. After two months/two menstrual periods, the pain scores decreased 41% in the vitamin D group and there was no difference in the placebo group. The greatest reduction in pain was seen in the women in the vitamin D group who had the most severe pain at baseline. In addition, none of the women in the vitamin D group needed NSAIDS to manage their pain at 1 and 2 months while 40% of the women in the placebo group used an NSAID at least one time.

Commentary: Acute menstrual pain, called dysmenorrhea, affects almost half of menstruating women. The menstrual pain is thought to be triggered by excessive uterine production of prostaglandins, synthesized from omega-6 fatty acids before menses that control vasoconstriction and uterine contractions. It is thought that vitamin D may act as an anti-inflammatory and may regulate prostaglandin pathways. What we don’t know is how many menstrual cycles the effect of that one dose of vitamin D might offer these results. We also do not know if this dosing of vitamin D would help women who had higher blood levels of vitamin D to begin with. It is interesting that the study participants had levels below 45 ng/mL, which is not deficient or insufficient. Most clinicians use the cut-off that if below 20ng/mL you are deficient and below 30 ng/mL you are insufficient.

Reference

Antonino L, Antonino C, Salvatore B. Improvement of Primary Dysmenorrhea Caused by a Single Oral Dose of Vitamin D: Results of a Randomized, Double-blind, Placebo-Controlled Study Arch Intern Med. 2012;172(4):366-367.

Past research has shown that moderate alcohol consumption is associated with a modest increase in the risk for breast cancer. The risk associated with low level alcohol consumption and long time drinking patterns has not really been determined. In this current report, investigators analyzed data from the Nurses’ Health study, from 1980 to 2008. More than 74,000 nurses provided seven updates about their alcohol consumption and during this time period, 7690 cases of invasive breast cancer were diagnosed.

After adjusting for other breast cancer risk factors such as estrogen replacement therapy, it was determined that even low levels of alcohol at 3-6 glasses of wine per week, were associated with a small but significant elevated relative risk for breast cancer (1.15). The relative risk was higher in women who consumed two or more drinks per day (1.51). There was no difference in aged groups of 18-40 or > 40 or as to whether the alcohol was beer, wine, or liquor.

Commentary: It is fairly common knowledge that 7 drinks per week or more increase the risk of breast cancer. This new research is now pointing out that even lower amounts of alcohol, 3-6 per week, are associated with an increase risk, although considered a slight or modest increase. This advice has made it into my clinical practice and I encourage all women, and especially breast cancer survivors, to reduce their alcohol to none or less than 3 per week. What about the cardiovascular benefits of alcohol you might ask? My response is that we don’t actually have that many proven tools to lower our risk of breast cancer, but we do however have many known strategies to lower our risk of cardiovascular disease—, let alone several strategies or associations that have been shown at least in some research, to lower the risk of both including, weight management, high fiber diets, moderate exercise most days of the week, green tea, fish/fish oils and vitamin D. For now, my advice is to lower our alcohol to less than 3 drinks per week.

Reference

Chen W, et al. Moderate alcohol consumption during adult life, drinking patterns, and breast cancer risk. JAMA 2011; 2(306):1884.

The incidence of type A influenza was significant and widespread in Japan through the study period of November 2008 to February 2009. A total of 2050 schoolchildren were included in the final analysis. The number of episodes of clinical influenza that were reported was 241, and 204 of those were confirmed by an antigen test. There were 185 cases of influenza A, 18 of influenza B and 1 case of combined.

More than 50% of the 2050 respondents drank green tea more than 6 days/week and 77.3% of the students drank < 1 cup a day and 1 to < 3 cups per day with approximately equal numbers of students in each group.

The consumption of 1-5 cups of green tea on an almost daily basis of 6 or more days/week was inversely associated with the incidence of influenza in this group of elementary schoolchildren. There was no evidence that more than 5 cups per day had any benefit for some reason.

Commentary: I am aware of six other studies on the prevention of influenza with green tea, including the previous blog posting in February, on my blog site. Collectively, these studies show that green tea inhibits the influenza virus in the laboratory, enhances systemic immunity in humans, and prevents the occurrence of cold and flu symptoms in adults. Drinking green tea and gargling with green tea are the methods that have been studied but for those of you who do not like or do not want to take the time to drink green tea, green tea capsules are another way to get the potential benefits of green tea.

Reference

Park M, Yamada H, Matsushita K, et al. Green tea consumption is inversely associated with the incidence of influenza infection among schoolchildren in a tea plantation area of Japan. J Nutrition 2011;141:1862-1870.

About two hundred health care workers in three different healthcare facilities in Japan were randomized to receive either a placebo or a combination of green tea catechins and theanine that contained 378 mg/day of catechins and 210 mg/day of theanine, both constituents found in green tea.

Of these eligible health care workers, 98 received the green tea and 99 received the placebo. The incidence of clinical signs and symptoms of influenza infection was significantly lower in the green tea (4.1%) group compared with the placebo group (13.1%).

Commentary:

The catechins and theanine in green tea have shown previous promise as a strategy for preventing influenza infections. In the laboratory, experiments have shown that green tea catechins can prevent influenza infection. A small study was then done that reported that gargling with tea catechins extracts was effective in preventing influenza infection in the elderly individuals in nursing homes. Green tea extracts have also been shown to enhance systemic immunity and prevent upper respiratory infections and influenza symptoms in adults. Based on this preliminary research, the more substantial randomized, double-blind study was done on the effectiveness of green tea catechins and theanine in preventing influenza infections. This is an extremely useful, simple, safe method of reducing the incidence of influenza. I will be advising my patients to take a standardized extract of green tea capsule regularly and/or drinking green tea liberally, especially during flu season.

Reference

Matsumoto K, Yamada H, Takuma N, et al. Effects of green tea catechins and theanine on preventing influenza infection among healthcare workers: a randomized controlled trial. BMC Complementary and Alternative Medicine 2011; 11:15

As soy isoflavone intake increased, the risk of death decreased. Women at the highest levels of soy isoflavone intake (> 16.3 mg isoflavones/day) had a 54% reduction in risk of death.

Commentary: This is the third epidemiologic study to report no adverse effects of soy foods on the prognosis of breast cancer. Soy foods, which contain isoflavones, a phytoestrogen, show both antiestrogenic and estrogen-like properties. The confusion and controversy has been that many studies have shown that isoflavones may protect against an initial breast cancer but in a very few laboratory studies certain isoflavone components of soy have been able to enhance the proliferation of breast cancer cells in select doses, and have been able to both promote and inhibit mammary tumor growth in rats.

However, in 2009, some clarity began to emerge for breast cancer patients. In breast cancer survivors, one study in Asian women (the Shanghai Breast Cancer Survival Study) and the other in U.S. women (the Life after Cancer Epidemiology study), suggest that soy containing foods do not negatively affect breast cancer prognosis, do not counteract the effect of the breast cancer drug tamoxifen and may in fact provide potential benefits in decreasing risk of recurrence or death from breast cancer.

The current study has explored this issue further, by examining data from a randomized controlled trial, the WHEL study. The results of this study, and the two previous in 2009, should give practitioners and women alike, great reassurance in the safety of soy consumption for women with who have/have had a diagnosis of breast cancer. We no longer need to advise against soy consumption for breast cancer survivors. This is great news given all the potential health benefits of soy for bone health, cardiovascular health and soy as a part of a whole foods and healthy diet.

Reference

Caan B, Natarajan L, Parker B, et al. Soy food consumption and breast cancer prognosis. Cancer Epidemiol Biomarkers Prev 2011;20(5):854-858.

One the potentially big problems with this study is that the researchers did not report the actual mortality rates. Instead they compared what is called "adjusted" mortality rates between supplement users and nonusers. This was done by adjusting for a wide range of factors including weight, intake of calories, cigarette smoking, blood pressure, educational level, diabetes, use of hormone-replacement therapy, physical exercise and fruit and vegetable intake. For each of these factors, those who took supplements were in the categories that would be considered healthier– for example— less diabetes, less obesity, more physically active, less smokers and more fruits and vegetables in their diet. These healthier people would be expected to have lower death rates than those individuals who did not take vitamins. What this does statistically is that the mortality rate of the supplement users would then be adjusted upward compared to the mortality rate of non supplement users. It is very possible that the researchers “over-adjusted” the collection of data, skewing the death rate among supplement users look higher than it really was. This conclusion is supported by the fact that when the researchers adjusted the data based only on age and intake of calories, there was in fact no statistically significant difference in mortality rate between supplement users and nonusers.

Studies that are observational, as this one was, are always weaker studies than randomized controlled trials. You can never prove cause and effect with observational studies, and it would be a mistake to make meaningful conclusions from this study due to its observational nature and possible over adjustment of the data. Another issue to ponder is that the individuals taking supplements were not more likely healthy, but perhaps less healthy. In other words… we might wonder why they were taking supplements to begin with. Perhaps they had a chronic health problem or a family health history that the researchers did not use as an identifier. What if they had a family history of heart disease for example and that is why they were taking supplements. These individuals could then easily have an increased mortality rate due to their family history.

The scientific literature is robust with randomized clinical trials demonstrating the diverse range of benefits of taking vitamins and minerals. It is always important to recognize the potential benefit and risk of any intervention whether it be over the counter or prescription drugs, vitamins, minerals or herbs. For now, women should not be discouraged to take vitamins and minerals, but individual assessment and need is best determined by a licensed practitioner trained in the use of these therapies. The medical degree that offers the most training in this area of medicine is a naturopathic doctor degree. Licensed graduates from the accredited naturopathic medical schools receive extensive training in nutrition and the use of vitamins and minerals for prevention and treatment.

Reference

Mursu J, Robien K, Harnack L, et al. Dietary supplements and mortality rate in older women. The Iowa Women’s Health Study. Arch Intern Med 2011;171(18): 1625-1633.

In this trial, oral supplementation of SB oil in people with dry eyed participants for 3 months did not result in any changes in the fatty acid composition of the tears, but it did have a positive effect on osmolarity and symptoms of dry eye including burning and redness.

Commentary: The risk of dry eye is associated with older age and in hormonal changes associated with menopause. Dry eyes can be caused by a deficiency of fluid and disturbances in the tear flow or excess evaporation of the tear film. Both types are associated with increased osmolarity of the tear film and inflammation of the surface of the eye. This hyperosmolarity can activate inflammation and interference of tear film production and stability. Sea buckthorn oil is rich in several different oils and contains a high proportion of linoleic, alpha linolenic and oleic acids as well as tocols, phytosterols and carotenoids. Because the fatty acid composition of the tear film did not change when given SB oil, but yet some symptoms did improve, there must be some other mechanism at play. These potential mechanisms include the anti-inflammatory effects of fatty acids, the carotenoids and/or the tocopherols found in the SB oil.

Previous research has shown that SB oil inhibits the rise in tear film osmolarity that occurs during the winter cold and has a positive effect on dry eye symptoms. There have been only a few other oils studied for dry eye syndrome including fish oil, evening primrose oil and flax seed oil.

Reference

Jarvinen R, Larmo P, Setala N, et al. Effects of oral se buckthorn oil on tear film fatty acids in individuals with dry eye. Cornea 2011;30;9:1-13-1018.