Dr. Tori Hudson, N.D.

I have recently been introduced to a new product, shea nut extract, for the treatment of osteoarthritis. Shea nuts have been used in food and Traditional African Medicine for generations, in West Africa in particular. A Danish company has developed a method to greatly concentrate and enhance the triterpenes found in shea nut, yielding a 70% triterpene extract. This high triterpene shea nut extract was allowed into the US in 2004, by the FDA and designated as a new dietary ingredient.

My interest in this product is spurred on by the multiple mechanisms in which these triterpenes seem to impact the joint: regulating cytokines, reducing TNF-a, IL-6, reducing osteocalcin, improving circulation of the joint matrix, slowing inflammatory bone loss, reducing cartilage destruction and restoring collagen.

In one randomized placebo controlled trial, 117 patients with radiographic and clinical evidence of osteoarthritis of the knee or hip were given shea nut extract or placebo for 15 weeks.[1] TNF-alpha reduced 17.9% overall and 23.9% in the group with elevated levels. IL-6 fell by 30.9%; C-reactive protein reduced by 20.6%; CTX-II, a cartilage marker fell by 28.7% in patients with elevated levels vs. an increase in placebo of 17.6%; and osteocalcin reduced by 9.2% in the elevated group indicating bone repair mechanisms.

Animal studies are also being conducted by the manufacturers of high triterpene shea nut extract showing comparable anti-inflammatory effects of ibuprofen but no adverse effects as are often seen in ibuprofen. Other studies are in development and I look forward to those publications.

I have surveyed some retailers and consumers in the natural products market who have been aware of and using high triterpene shea nut extract for several months and been pleased to hear of the consistent anecdotal, yet positive reports. For practitioners, shea nut extract yielding 70% triterpenes is available as BSP 201. I look forward to increasing my own clinical usage of this product and hope to see the same positive results in my patients. With its multiple mechanisms of actions, early research, and anecdotal reports, shea nut extract leaves me optimistic.

Reference:

[1] Cheras PA, Myers SP, Outerbridge K, & Nielsen G. Randomised Placebo Controlled Trial on the Safety and Efficacy of BSP-201 in Osteoarthritis. Australian Centre for Complementary Medicine Education and Research (ACCMER). Sept. 4, 2007

This double-blind, randomized clinical trial, studied the effect of Hypericum perforatum extract (St. John’s wort extract) compared with placebo, on symptoms and quality of life of 47 symptomatic perimenopausal women aged 40 to 65 with three or more hot flashes per day. Women were randomly assigned to receive a St. John’s wort extract (900 mg three times per day) or placebo. The women used a daily diary to record hot flash severity and frequency during the week before the study group selection process and again for a week before the end of the three month follow-up. The Menopause-Specific Quality of Life questionnaire was also used.

RESULTS: After 12 weeks of treatment, a non-significant difference in favor of the St. John’s wort group was observed in the daily hot flash frequency and the hot flash score. However, after those three months of treatment, women in the St. John’s wort group reported significantly better quality of life scores, and significantly fewer sleep problems compared to placebo.

Commentary: St. Johns wort research is expanding into the realm of use for perimenopause and menopause symptoms. Other recent studies have reported improvement in psychological, well-being and quality of life in symptomatic perimenopausal and menopausal women. In the current study, while not especially helpful for hot flashes, there was an improvement in quality of life scores and sleep problems. I commonly use St. Johns wort with black cohosh for women with hot flashes and mood issues during perimenopause and menopause. The research on each and even two studies using the combination of the two reveal that these two plants in combination are a premium option for perimenopausal and menopausal women with some of the most common of symptoms.

Reference

Al-Akoum M, Maunsell E, Verreault R, Provencher L, Otis H, Dodin S. Effects of Hypericum perforatum (St. John’s wort) on hot flashes and quality of life in perimenopausal women: a randomized pilot trial. Menopause. 2009 Mar-Apr;16(2):307-14

The study was designed to compare the blood pressure lowering effects of sour tea (ST) -Hibiscus sabdariffa with black tea (BT) in type II diabetics with mildly high blood pressure.

Patients were randomly assigned to drink one cup of Hibiscus or black tea two times per day for one month. Each infusion contained one tea sachet weighing 2 gm, placed in a tea pot with 240 ml boiling water and steeped for 20-30 minutes and then added one cube of sugar.

The average systolic blood pressure (SBP) in the hibiscus group decreased from 134.4 +/- 11.8 mm Hg at the start of the study to 112.7 +/- 5.7 mm Hg after 1 month. The average SBP changed from 118.6 +/-14.9 to 127.3 +/- 8.7 mm Hg in the black tea group during the same time period. There were no statistically significant effects on the mean diastolic blood pressure in either group.

Commentary:

It’s always gratifying to see a simple, safe, inexpensive herb studied for such a common problem. Hibiscus has been used historically for high blood pressure and contains several important ingredients including alkaloids, anthocyanins and quercetin. It is thought that the antioxidant and diuretic effects are the most important mechanisms.

References

Mozaffari-Khosravi H, Jalali-Khanabadi B, Afkhami-Ardekani M, et al. The effects of sour tea (Hibiscus sabdariffa) on hypertension in patients with type II diabetes. J Human Hypertension 2009;23:48-54.

This prospective study of 512 women with early breast cancer evaluated the role of serum vitamin D levels as a potential factor influencing breast cancer prognosis.

The average age was 50 and the average vitamin D levels was 58.1 nmol/L. Vitamin D levels were deficient (<50 nmol/L) in 192 women, insufficient (50 to 72 nmol/L) in 197 women and sufficient (> 72 nmol/L in 123 women. The average follow-up was 11.6 years with 116 women having distant recurrences and 106 women who died. Vitamin D levels were significantly lower in women with high grade tumors. Those women with vitamin D deficiency had an increased risk of distant recurrence and of dying, compared with those women who had sufficient serum vitamin D levels.

Commentary: This study is one more reason to test vitamin D levels- I would recommend it for all current or past breast cancer patients. In terms of using vitamin D levels to determine the initial risk for breast cancer, the evidence has been mixed, with some showing an association between latitude and risk of breast cancer, some showing an inverse relationship between vitamin D intake and breast density (a strong risk factor for breast cancer), but other studies showing vitamin D intake or blood levels of vitamin D inconsistently related to risk/incidence.

There have been some other attempts to use vitamin D levels as a prognostic indicator for breast cancer and mortality. Low vitamin D levels have been associated with increased breast cancer mortality and have also been shown to be significantly lower in women with locally advanced or metastatic disease compared with those women who have early breast cancers. Taking a vitamin D supplement to increase blood levels of vitamin D is one of the least expensive, safe strategies to reduce the risk of recurrence of breast cancer, as stated in this current study. For the rest of us… the research is full of good news about vitamin D and our health with studies demonstrating that higher blood levels of vitamin D is associated with lower rates of heart disease, ovarian cancer, multiple sclerosis, osteoarthritis and rheumatoid arthritis, bacterial vaginosis, and as mentioned, breast cancer.

It should be noted that the current studies, and in fact many studies, report vitamin D levels in the units of nmol/L. Other studies report ng/ml. This is a very important difference. It is important to compare one’s lab unit results for vitamin D levels with the proper target number and unit used. For reference, 75 nmol/L is equal to 30 ng/mL. In the current study, those women who had a vitamin D deficiency and reported as < 50 nmol/L would be equivalent to < 20 ng/ml.

References

Goodwin P, Ennis M, Pritchard K, et al. Prognostic effects of 25hydroxyvitamin D levels in early breast cancer. J Clinical Oncology 2009;27(23): 3757-3763

An association between vitamin D deficiency and many mood disorders has been suggested in several studies. These associations include major depressive disorder, seasonal affective disorder (SAD), premenstrual syndrome and other depressive disorders.

Peer-reviewed research studies were located in various data-bases searching for studies investigating vitamin D and depression, seasonal affective disorder, PMS, postpartum depression, perinatal depression, depressive disorder or mood disorder in women. Eleven studies were initially identified, but five were eliminated because they did not meet the inclusion criteria. Of these six studies, four reported significant results showing an association between low serum 25 (OH) D levels and symptoms of a mood disorder, SAD, major depressive disorder, or PMS. One study of major depression and one on SAD did not report an association. Only one of the four positive studies was a randomized controlled trial.

Vitamin D receptors are involved in the regulation of glucocorticoid signaling and dysfunctional glucocorticoid signaling and increased glucocorticoids have been implicated in major depressive disorder. Other biochemical mechanisms may also exist, associating vitamin D with mood disorders.

I look forward to more research on specific mood disorders in women and vitamin D levels.

References:

Murphy P, Wagner C. Vitamin D and mood disorders among women: an integrative review. J Midwifery Women’s Health 2008;53:440-446.

Nausea and vomiting are the most common unpleasant symptoms during pregnancy. 50% to 90% of women experience these complications.

This study was a single-blind controlled randomized clinical trial in women up to 20 weeks of pregnancy in Iran. 32 women received ginger and 35 received placebo. One ginger (250 mg) or placebo capsule four times per day was given over the course of four days. A four page questionnaire was used for each woman, one page per day for the four days. Women were also asked to record nausea intensity twice a day. At the end of four days, a researcher completed the questionnaire based on the woman’s responses.

Nausea intensity improved in 84% of those who used the ginger and in 56% of the women in the control group. The incidence of vomiting in the control group was 9% decreased and 50% decreased in the ginger group.

Commentary: At least four previous published studies have shown success in the use of ginger for nausea and vomiting of pregnancy. Doses of 1,000 mg – 1,500 mg per day have been used previously. The current study showed not only a positive effect, but women were satisfied with that effect and no complications were observed during the treatment period.

References

Ozgoli G, Goli M, Simbar M. Effects of ginger capsules on pregnancy, nausea and vomiting. J Alternative and Complementary Medicine 2009;15(3):243-246

A recent study was done on students with PMS living in Tehran. Eighty-five women completed the study. Participants were given 40 mg three times daily of a standardized ginkgo extract or a placebo from day 16 of the cycle to day 5 of the next cycle. Self-administered questionnaires were used and a diagnosis of PMS had been established according to conventionally accepted criteria.

After the treatment period, there was a significant decrease in the overall severity of symptoms and physical and psychological symptoms in both the Ginkgo group (23.68%) and the placebo group (8.74%). The average decrease in the severity of symptoms was significantly more in the Ginkgo group compared to the placebo group.

Comments: The results of this study demonstrated that ginkgo was more effective than placebo in reducing the severity of symptoms and the severity of physical and psychological symptoms in young women in Iran, with PMS. A previous study also found benefits with ginkgo and PMS, especially with breast tenderness and fluid retention. They also saw significant improvements in irritability and aggression, compared with placebo. The current study confirms the benefits of a standardized extract of ginkgo for the treatment of PMS. Based on the published -research to date, standardized extracts of – Vitex agnus castus (chaste tree berry), Hypericum perforatum (St. Johns wort) and Ginkgo biloba (ginkgo), appear to be the most effective botanical treatments for PMS. I would encourage women and their practitioners to seek PMS formulas that have at minimum, these three botanicals in the formulation.

References

Ozgoli G, Selselei E, Mojab F, Majd H. A randomized, placebo-controlled trial of ginkgo biloba in the treatment of premenstrual syndrome.

In a randomized trial of more than 5400 women with cardiovascular disease or risk factors, women were randomized to placebo or a combination of folic acid 2.5 mg/day, Vitamin B6, 50 mg/day and Vitamin B12, 1mg/day_. The women were over the age of 40, and two thirds of them had a history of cardiovascular disease and the remainder had three or more risk factors.  Researchers performed a new analysis of the Women’s Antioxidant and Folic Acid Cardiovascular Study (WAFACS) to assess whether B vitamins lowered the incidence of age-related macular degeneration (AMD). With an average follow-up of 7 years, the incidence of AMD was 2% in the B vitamin group vs. 3% in the placebo group.

Commentary: We know that elevated homocysteine levels are associated with the risk for AMD and B vitamins lower homocysteine levels. The current study suggests that supplementation with these three B vitamins can lower the risk for AMD, although it is not clear if this result is indeed related to homocysteine lowering or some other mechanism.

References

Christen W,et al. Folic acid, pyridoxine, and cyanocobalamin combination treatment and age-related macular degeneration in women: The women’s antioxidant and folic acid cardiovascular study. Arch Intern Med 2009. Feb 23;169:335

Chinese women suffering from moderate to severe premenstrual syndrome (PMS) were studied in a prospective, double-blind, placebo controlled, parallel-group, multi-center clinical trial. A Vitex agnus castus extract, contained 4.0 mg of dried ethanolic (70%).

The mean total Premenstrual Syndrome Diary (PMSD) score decreased from 29.23 at baseline to 6.41 at the end of the third cycle for the Vitex group and from 28.14 at baseline to 12.64 at the end of the third cycle for the placebo group. The difference in the PMSD score from baseline to the third cycle was significantly lower in the treatment group than in the placebo group. The Premenstrual Tension Syndrome Self-Rating Scale (PMTS) decreased from 26.17 at baseline to 9.92 for the treatment group and from 27.10 to 14.59 for the placebo group; similar positive results to the PMSD scores.

Comments: I’ve long used Vitex for the treatment of PMS and in my opinion, it is the single most important plant for the treatment of PMS. The effect of Vitex is on the hypothalamus-hypophysis axis and results in an increased secretion of luteinizing hormone which then favors a progesterone effect. Several other placebo controlled studies have found that Vitex reduced a variety of PMS symptoms. The current study adds to the clinical relevance of this plant in the treatment of moderate to severe symptoms of PMS.

References

He Z, Chen R, Zhou Y, et al. Treatment for premenstrual syndrome with Vitex agnus castus: A prospective, randomized, multi-center placebo controlled study in China. Maturitas 2009; 63:99-103

Folic acid update

It has been known for a considerable amount of time, that folic acid when given to women planning for pregnancy and during pregnancy, can lower the risk for neural tube defects. Based on the research up to that time, the US Preventive Services Task Force (USPSTF) first published their recommendations in 1996. This has recently been updated and the USPSTF has issued a new statement in May, 2009. Based on the observational evidence and randomized controlled trials published since 1996, the USPSTF found convincing evidence that supplements containing 0.4 to 0.8 mg of folic acid during the preconception period lowers the risk for neural tube defects.[1]

There now appears to be additional benefits for folic acid before conception and during pregnancy, possibly the prevention of cleft lip (BMJ 2007;334:464) and most recently, lowering the rates of severe congenital heart defects. In a Quebec study, investigators observed a drop in the prevalence of severe congenital heart defects after mandatory folic acid fortification of grains. The average prevalence of severe congenital heart defects at birth was 1.64 per 1000 births during the 9 years before the folic acid food fortification began and the rate fell by 6.2% yearly during the seven years studied, after the mandatory fortification.[2]

Following the recommendation that all women of child bearing age should take a daily supplement containing 0.4 mg to 0.8 mg per day of folic acid is good, safe medicine and perhaps even more beneficial than previously thought.

References

[1] Woffe T, Takacs-Witkop C, Miller T, Syed S. Folic acid supplementation for the prevention of neural tube defects: An update of the evidence for the U.S. Preventive Services Task Force. May 2009.150; (9): 632-639

[2] Ionescu-Ittu R, et al. Prevalence of severe congenital heart disease after folic acid fortification of grain products: Time trend analysis in Quebec, Canada. BMJ 2009;338:b1673