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Breast Milk

Some mothers are unable to successfully provide breast milk to their infants, and thus use pasteurized donor milk, which is considered an acceptable and even recommended source for preterm infants in particular. There are regulated milk banks of donor milk, which is available. These regulated milk banks screen donors and pasteurize milk to remove potential pathogens. The demand for this is great enough that there are several human milk sharing websites that connect donors and recipients that allow purchase of the milk directly from the donor. However, the method of milk collection and transport of the milk is at the discretion of the seller.

clip_image002An investigation was conducted and published in the journal, Pediatrics, in which researchers compared the bacterial and viral contamination in 101 Internet samples that were obtained from individual sellers. These were then compared to 20 samples that were obtained from a licensed milk bank before pasteurization.
One finding was that the Internet shipments of samples varied with longer transit times and also had increased bacterial counts. Gram-negative organisms and Staphylococcus species were more frequently found and in higher numbers in the Internet samples than the licensed milk bank samples. None of the samples tested positive for HIV, but 21% of the Internet samples and 5% of the milk bank samples did test positive for cytomegalovirus. Some of the milk sellers claimed organic. This did not correlate with lower bacterial or viral counts.

Commentary: There are many important health benefits short term and long term to support the use of human breast milk feeding of infants. It is especially beneficial in preterm infants. However, given that it is a bodily fluid, it does have the potential to transmit infectious agents. Based on the results of this study, I would recommend avoiding raw breast milk purchased from unregulated Internet sites as it may put infants at risk for infection and this could even outweigh the benefits. This study did not address environmental contamination of breast milk that is a result of our modern world. I am definitely not an expert on this topic, but I have read from experts, that even given the environmental pollutant contamination of human breast milk, the benefits of human breast milk for infants, does indeed outweigh the concerns and risks of these pollutants as we understand it today. It’s shameful to me, that we have allowed our world to progress in such a way that historically, one of the most pure and critically important nutrient sources also then exposes infants and young children to pollutants at such a young age.

Reference

Keim S, et al. Microbial contamination of human milk purchased via the Internet. Pediatrics 2013 Nov; 132:e1227.

clip_image002This small randomized, double-blind, placebo-controlled clinical trial was conducted in 30 breast cancer patients to assess curcumin’s ability to reduce the severity of radiation dermatitis. Women with non-inflammatory breast cancer or carcinoma in situ and were receiving radiotherapy, were randomized to receive either 2.0 grams three times per day of curcumin or placebo during their course of radiation treatments. The Radiation Dermatitis Severity (RDS) score was assessed weekly along with the presence of moist desquamation, redness, the McGill Pain Questionnaire-Short Form and Symptom Inventory questionnaires. The average age of the women was 58.1 and 90% were Caucasian.

Curcumin reduced RDS at the end of radiation therapy compared to placebo. The mean RDS scores for curcumin patients were 0.8 lower than the placebo-treated patients, i.e. 2.6 vs. 3.4. There were also fewer curcumin treated patients with moist desquamation (28.6% vs. 87.5%). There were no significant differences in pain scores in total sensory pain or intensity of pain at the treatment site and oral curcumin did not reduce erythema. Curcumin was not effective at reducing the severity of radiation dermatitis in those women who had a total mastectomy prior to radiotherapy.

Commentary: Radiation dermatitis is one of the most common side effects patients acquire from radiotherapy. It occurs in approximately 95% of women receiving radiotherapy for breast cancer and 10% of those are severe cases. Current conventional treatments include washing with lukewarm water and mild soap; applying unscented lanolin-free, water-based moisturizers, hyaluronate cream and possibly topical corticosteroids. Practitioners of natural medicine have been using many options including topical aloe preparations, topical vitamin E, and topical calendula lotion. Calendula lotion in particular has one French study demonstrating efficacy.

Oral curcumin has low bioavailability and according to at least one publication, an oral dose less than 4.0 grams is not detectable in the blood. In the current study, patients had to take 12 capsules per day to achieve the 6.0 grams per day. There are at least 3 technologies that enhance the bioavailability and thus would then require much less number of capsules. These 3 technologies include lecithin bound to curcumin- a “phytosome” process, (ex/ Meriva), curcuminoids/ turmeric essential oil/ lecithin (ex/BCM-95), and a curcumin nanoparticular colloidal dispersion (ex/ Theracurmin).

Reference

Ryan J, Heckler C, Ling M, et al. Curcumin for radiation dermatitis: A randomized, double-blind, placebo-controlled clinical trial of thirty breast cancer patients. Radiation Research 2013;180:34-43.

Researchers for the Iowa Women’s Health Study assessed health related issues including dietary habits and intake, and the relationship with type I (estrogen related) and type II (estrogen independent) endometrial cancer. A total of 23,039 were evaluated with an average age at study onset of 62 years. A total of 592 invasive endometrial cancers were identified, 506 type I and 89 type II. After an adjustment calculation was made for body mass index, due to the association of obesity and endometrial cancer, those women who consumed the most sugar sweetened beverages compared with women who consumed the least, had a 78% higher risk for type I endometrial cancer. Fruit juice and sugar free beverages were not associated with the risk for type I endometriosis and none of the dietary ingredients studied were associated with the risk for type II endometrial cancer.

Commentary: You would not be surprised to know that sugar-sweetenedsugar drinks beverages are a major source of sugar in the diet of U.S. women (and men and children). These beverages affect insulin and glucose levels more significantly than the sugars in whole foods. The intake of sugar sweetened beverages seems to parallel the rise in obesity. What is interesting here is that increased consumption of sugar sweetened beverages contribute to the risk for type I endometrial cancer, independent of body weight/obesity. That said, women who are obese and women with polycystic ovarian syndrome are at increased risk, and therefore our advice to avoid sugar sweetened beverages for these women can hold even more punch (and not the sweetened party drink!!!)

Reference

Inoue-Choi M, Robien K, Mariana A, et al. Sugar-sweetend beverage intake and the risk of type I and type II endometrial cancer among postmenopausal women. Cancer Epidemiol Biomarkers Prev 2013;22(12): 2384-2394

Soy and Breast Density

soy foodsThis randomized, double-blind, placebo-controlled study conducted in 80 women aged 45 and older and with amenorrhea of > 12 months with vasomotor symptoms (hot flashes and/or night sweats). Women were randomized to receive either 250 mg of standardized soy extract equal to 100 mg/day of isoflavones or placebo for 10 months. There were 40 women in each group. The follow-up period was a duration of 10 months. A total of 32 women in the isoflavone group and 34 women in the placebo group completed the study. No participants were on hormone therapy (HT) or any phytoestrogen within the preceding 6 months.

The purpose of the study was to evaluate the effects of soy isoflavones on breast tissue in postmenopausal women. Breast density was evaluated with mammography and breast parenchyma was evaluated with ultrasound. Each were done at baseline and 10 month follow-up.

At baseline, there were no significant differences between the isoflavone group and the placebo group. After 10 months, the groups did not differ in mammographic density or breast parenchyma by ultrasound. The use of soy isoflavones at 100 mg/day for 10 months did not affect breast density in postmenopausal women.

Commentary: Breast density as characterized on mammography is an independent risk factor for breast cancer. In addition, breast density limits the accuracy of mammography. Results of other randomized, placebo-controlled studies analyzing soy and breast density also did not find breast modifications with soy. An additional insight offered by the results of this study, is that the breast ultrasound also did not detect any increase in fibrosis or fibroglandular tissue with the use of soy isoflavones.

Breast density is influenced by many factors including age, parity, menopause status, body composition, exogenous and endogenous hormones, and genetic factors. The results of the current study lend yet one more comforting piece of data on the safety of soy foods and soy isoflavone extracts on breast health.

Reference

Delmanto A, Nahas-Neto J, Traiman P, et al. Effects of soy isoflavones on mammographic density and breast parenchyma in postmenopausal women: a randomized, double-blind, placebo-controlled clinical trial.

This double-blinded, placebo-controlled randomized clinical trial evaluated the efficacy and safety of green tea extract on uterine fibroid burden and quality of life in reproductive aged women with symptomatic uterine fibroids.

A total of 39 reproductive aged women ages 18-50 y.o. with symptomatic uterine fibroids were recruited. Eligible women included those with a follicle-stimulating hormone (FSH) less than 10mIU/L, at least moderately severe uterine fibroid related symptoms with a score of > 25 on the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire subscale (UFS-QOL). All the women had at least one fibroid measuring 2 cm or larger based on transvaginal and/or transabdominal ultrasound and a total uterine volume of > 160 mL by vaginal and abdominal ultrasound.

Twenty two were randomized to receive green tea extract and 17 to receive placebo.

Study subjects were randomized to oral green tea Green tea in teapotextract (45% epigallocatechin gallate= EGCG) or placebo of brown rice, daily, for 4 months. Each green tea capsule contained 95% polyphenols and 45% EGCG. Women received two capsules daily of either green tea or placebo.

Uterine fibroid volumes were measured at beginning and end of the study. The fibroid specific symptom severity and quality of life questionnaires were scored at each monthly visit.

The mean change in both the volume and number of uterine fibroids was assessed by transvaginal ultrasound (TVU) and/or transabdominal ultrasound at baseline and at the end of the 4 month treatment period.

The secondary measure at each visit was the mean change in fibroid specific health related quality of life (UFS-QOL), and the health related quality of life (HRQL) questionnaire. Blood loss was also assessed monthly with a menstrual log and visual assessment of quantity.

Of the 39 women, 33 were compliant and completed the five visit study over the 4 month period. Of the final 11 women who completed the placebo group, fibroid volume increased by 24.3% over the study period. Of the final 22 women in the green tea extract group, a significant uterine fibroid total volume reduction of 32.6% was observed. The green tea extract group also had a significant reduction in fibroid specific symptom severity of 32.4% and a significant improvement in HRQL of 18.53% compared to the placebo group. Anemia improved significantly by 0.7 g/dL in the green tea group and the average blood loss significantly decreased from 71 mL/month to 45 mL/month. There were no adverse effects or endometrial hyperplasia or pathology in either group.

Commentary:

Green tea, especially its epigallocatechin gallate (EGCG) constituent has anti-inflammatory, antiproliferative and antioxidant effects. The study’s authors attributed the reduction in fibroid size from EGCG due to an inhibitory effect on leiomyoma tumor cell proliferation and apoptosis induction.

More than half of women ages 35-49 in the U.S. are affected by uterine fibroids and are more prevalent in African American women. These benign growths can cause acute and chronic pelvic pain, excessive uterine bleeding, dyspareunia, iron deficiency anemia, miscarriage, infertility, constipation and/or irregular bowel habits and urinary incontinence. The impact of these complications on a woman’s health can be significant and currently, there is no effective long-term medical treatment for these common benign tumors. Short term conventional management options include gonadotropin-releasing hormone analogues but are only approved for short term preoperative adjuvant use due to their risk of significant and irreversible bone loss, osteoporosis and other major side effects. Progestogen or hormonal contraceptive management is sometimes helpful to control bleeding. If symptoms impact quality of life significantly, or fibroid removal could improve miscarriage and/or fertility, or there is medical urgency due to bleeding, then management options range include hysteroscopic resection of submucosal fibroids, hysterectomy, myomectomy, uterine artery embolization or image-guided focused ultrasound thermal therapy. Milder cases usually involve just observation, especially in asymptomatic fibroids, or the patient putting up with her symptoms.

This study, of a simple and safe botanical option such as green tea extract, is a welcomed noninvasive intervention for treatment and/or prevention of uterine fibroids and could be a game changer for many women suffering from uterine fibroids.

Reference

Roshdy E, Rajaratnam V, Maitra S, et al. Treatment of symptomatic uterine fibroids with green tea extract: a pilot randomized controlled clinical study. Int J Womens Health. 2013;5:477-486.

uterine painEndometriosis is one of the most common gynecological diseases and can cause chronic pelvic pain and chronic lower abdominal pain, menstrual cramps, pain with vaginal penetration during sex, abnormal bleeding and infertility. Available conventional therapies include hormonal therapies, pain medication and surgery. A natural substance that is free of side effects, and one that shows efficacy would be a very appealing option. A well known supplement, N-acetylcysteine (NAC), which is the acetylated form of the amino acid cysteine, occurs naturally in some substances such as garlic.

This observational cohort study was designed to compare the progression of ovarian endometriomas in N-acetyl cysteine (NAC) treatment patients and untreated control patients. Patients were given either NAC 600 mg three times daily, 3 consecutive days per week or not, for an observation period of 3 months. At the end of the 3 month observation period, endometriomas (ovarian cysts or chocolate cysts related to endometriosis), were evaluated by pelvic ultrasound, by a trained physician, who was blinded as to which group the patients had been in.

A total of 92 Italian women, 47 in the NAC treated group and 45 in the untreated group were ultimately included. Women were enrolled to select inclusion criteria: 1) an ultrasound diagnosis of ovarian endometrioma 2) no hormonal treatment in the previous 2 months 3) laparoscopic surgery scheduled due to the presence of either a large endometrioma 30 mm or greater, pain or infertility.

In the NAC treated group, 24 patients cancelled their scheduled laparoscopy due to a decrease or disappearance of cysts, pain reduction or pregnancy. Again, in the NAC treated group, 14 women had decreased ovarian cysts (-1.5 mm average), 8 had a complete disappearance, 21 had pain reduction and 1 became pregnant. In the control group, only 1 patient cancelled surgery. There were 4 endometriomas that disappeared. Overall, more cysts reduced and fewer cysts increased in size in the NAC group. There were 4 newly formed cysts in the NAC group vs. 4 in the untreated group. After the observation period, a total of 8 pregnancies occurred in the NAC treated group and 6 in the untreated group.

Commentary: Up to 10% of reproductive aged women have endometriosis. In women with infertility, the numbers may be as high as 50%. The results of this study are impressive and actually compares to the results reported in a randomized placebo controlled study on 100 women treated for 4 months with oral contraceptives. In addition, there was one pregnancy during the study period and more after, which is of course a contrast with women who stay on oral contraceptives to manage their endometriosis. NAC does not negatively affect fertility, and if one looks to other research on insulin resistance and PCOS, we will find that NAC improves ovulation and thus fertility, similar to metformin, in PCOS patients. Previous evidence shows that NAC modulates the pathogenesis of endometriosis via several pathways. NAC decreases abnormal cell proliferation, decreases the invasive behavior of the endometriosis cells, decreases inflammatory substances, regulates expression of inflammation related genes, and stimulates cell differentiation. I will be interested in using NAC for not only treatment of current endometriomas, as well as endometriosis, as well as prevention of recurrence after a surgery.

Reference:

Porpora M, Brunelli R, Costa G, et al. A promise in the treatment of endometriosis: an observational cohort study on ovarian endometrioma reduction by N-acetylcysteine. Evidence-Based Complementary and Alternative Medicine. 2013; April. Article ID 240702, 7 pages http://dx.doi.org/10.1155/2013/240702

A randomized double blind placebo controlled trial was conducted in patients with chronic primary insomnia in West Bengal, India. Individuals were randomly assigned to receive 1 tablet of an herbal combination or 10 mg of zolpidem for 2 weeks. The herbal combination contained 300 mg valerian extract (standardized to 0.8% total valerenic acid), 80 mg passionflower extract (standardized to 4% isovitexin), and 30 mg hops extract (standardized to 0.35% rutin). Dosing was 1 tablet at bedtime and a sleep diary was conducted along with the Insomnia Severity Index and Epworth Sleepiness Scale.

Individuals ranged in age from 20-80 y.o. Of the 91 patients enrolled, 78 completed the study with 39 in each group. Eligibility was determined if they had an average of < 6 hours of sleep per night and a score of > 7 on the Insomnia Severity Index. Patients were excluded if they were taking medications that affect sleep, had a psychiatric diagnosis, had a history of substance abuse, had a dependence on sedative-hypnotic drugs, or if they worked night shifts.

The average sleep duration increased significantly from 3.4 to 5.9 hours in the herbal combination group and from 3.5 to 5.7 hours in the zolpidem group after the 2 week study period, which was considered similar results for both treatments. The average amount of time it took to fall asleep, called sleep latency, was also similar in both groups and decreased significantly from 84.0 to 23.6 minutes in the herbal group and from 90.0 to 26.4 minutes in the zolpidem. Night time awakenings decreased and quality of life scores improved in both groups, compared to baseline and with no significant differences between the two treatment groups. Daytime sleepiness was not a problem in either group, adverse events were similar in both groups, and no serious adverse events were reported in either group.

Commentary: Chronic insomnia is fraught with significant quality of life issuesmore insomnia including mood and cognitive changes. The results of this study indicate that this combination of valerian, hops and passion flower is a safe and effective alternative to zolpidem, at least for short term treatment of insomnia. Chronic insomnia is more common in women, with an exacerbation in perimenopause and early menopause. This herbal combination, along with seeing their insomnia as a perimenopause/menopause symptom and addressing the core physiological changes, bodes well for using these three herbs to treat insomnia.

Reference

Maroo N, Hazra A, Das T. Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: A randomized controlled trial. Indian J Pharmacol. January-February 2013;45(1):34-39.

Iron deficient anemia affects 38% of pregnant women around the world and is clearly one of the reasons prenatal iron supplements are recommended. Researchers in this systematic review and meta-analysis analyzed 48 randomized trials of iron supplementation, involving 17,793 women and 44 cohort studies of maternal anemia and birth outcomes involving 2 million women.

Iron supplementation was associated with a significant reduction in risk for low birth weight in the randomized trials. However, iron supplementation did not have a significant effect on the risk for preterm birth or small for gestational age births. In the other studies, first or second trimester iron deficient anemia was associated with significantly higher risk for babies with low birth weight.

clip_image002Commentary: Iron deficient anemia is one of the simplest conditions to test for and diagnose, and simple and inexpensive to treat. It should especially be treated during pregnancy due to the potential impact on the birth weight, size, and preterm births. There are of course other key supplements that determine a healthy pregnancy, developing fetus and infant. These include, but are not limited to folic acid, omega-3 fatty acids from fish oil, probiotics, and more. Some women will acquire nausea from iron supplements. This can often be mitigated by taking iron in some different forms that are easier on the digestive tract including iron aspartate, ferrous succinate and ferrous fumarate. In addition, taking the iron with vitamin C enhances iron absorption and taking iron with food tends to minimize or even bypass nausea, constipation, or gas, a frequent occurrence with iron supplements.

Reference

Haider B, et al. Anaemia, prenatal iron use, and risk of adverse pregnancy outcomes: Systematic review and meta-analysis. BMJ 2013 June 21:346.

Coenzyme Q10 deficiency has been implicated in fibromyalgia (FM). Past studies have demonstrated significant improvement in FM after oral CoQ10 supplementation. In the current study, the effects of oral CoQ10 was evaluated in four case reports of women with fibromyalgia.

Four women, ages 49, 43, 65 and 66 were diagnosed with FM using conventional American College of Rheumatology diagnostic criteria. All patients had high scores of pain, fatigue and sleep problems. All four women were treated with 300 mg/day of CoQ10 given in three divided doses of 100 mg, three times daily for 9 months. After 9 months, they were re-evaluated. A statistically significant improvement of pain, fatigue, sleep and tender points were observed. All women reported an improvement in pain, fatigue, sleep and tender points. Woman covering his face with her hands and crying

Commentary: Fibromyalgia is an all too common chronic pain syndrome that includes chronic pain, fatigue, headache, sleep disturbances and depression. CoQ10 supplementation of cultured blood cells from individuals with FM resulted in a restoration of the mitochondrial dysfunctions found within these blood cells. In addition, a 2002 study saw a benefit of CoQ10 supplementation in FM patients and the group of researchers in the current study, also found clinical improvement in patients with oral CoQ10 in two other published results in 2011 and 2012.

CoQ10 deficiency is considered a potential intervention for FM due to its ability to improve mitochondrial function and also it’s ability as a free radical scavenger. Oxidative stress is one of the proposed mechanisms involved in the symptoms of FM. CoQ10 can induce biochemical changes that allow for recovery from inflammation, antioxidant enzymes, mitochondrial genesis and activated protein kinase activity. Through these mechanisms, CoQ10 may be able to restore mitochondrial function and reduce the lipid peroxidation and DNA damage caused by oxidative stress, resulting in improvement in symptoms of fibromyalgia.

Reference

Alcocer-Gomez E, Cano-Garcia F, Cordero M. Effect of coenzyme Q10 evaluated by 1990 and 2019 ACR diagnostic criteria for fibromyalgia and SCL-90-R: Four case reports and literature review. Nutrition 2013;29:1422-1425

A multicenter, double-blind, placebo-controlled trial was conducted by Mayo Clinic researchers involving patients who had a cancer diagnosis within the previous two years of entry into the study. These cancer patients reported moderate fatigue and were given American ginseng root capsules, two capsules of 500 mg each twice daily or placebo. After 4 weeks, the patients who received ginseng reported somewhat less fatigue than placebo patients but after 8 weeks, there was a statistical and clinically significant difference between the ginseng group and placebo group. The results were even more clinically important for 83 patients who received ginseng and were undergoing chemotherapy or radiation during the study. They had significant improvements at 4 and 8 weeks.

HeadacheCommentary: Fatigue is a symptom of many patients with cancer, and fatigue during cancer treatments of chemotherapy and/or radiation is one of the most common side effects of these treatments. Ginseng has a long tradition of being used for fatigue and is one of the most well known adaptogens– i.e. plants that help us to adapt to stressors and help restore our homeostasis, including improving our energy.

Reference

Barton DL et al. Wisconsin ginseng (Panax quinquefolius) to improve cancer-related fatigue: A randomized, double-blind trial, N07C2. J Natl Cancer Inst 2013 Aug 21; 105:1230.

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