Rhodiola Extract Improves Burnout Fatigue, Attention, and Cortisol Response

The Journal of the American Botanical Council

Issue: 82 Page: 28-29

Rhodiola Extract Improves Burnout Fatigue, Attention, and Cortisol Response

HerbalGram. 2009;82:28-29 American Botanical Council

Reviewed: Olsson EMG, von Scheele B, Panossian AG. A randomized, double-blind, placebo-controlled, parallel-group study of the standardized extract SHR-5 of the roots of Rhodiola rosea in the treatment of subjects with stress-related fatigue. Planta Med. 2009;75:105-112.

Psychological stress can induce fatigue syndrome, which is characterized by long-term exhaustion, physical weakness, depression, lack of drive, poor concentration, and difficulty sleeping. Consumers often treat stress-related fatigue with stimulants. Rhodiola (Rhodiola rosea, Crassulaceae) root extract has stimulant and stress-protective (or adaptogenic) properties. The objective of this study was to determine whether daily intake of a proprietary rhodiola extract would produce any positive effects on attention, quality of life, and symptoms of fatigue and depression in subjects with stress-related fatigue.

Sixty men and women (20-55 years) living in and around Stockholm, Sweden, responded to an advertisement to participate in this randomized, double-blind, placebo-controlled study. Included subjects had “fatigue syndrome” as classified by the World Health Organization’s International Classification of Diseases. The project was approved by the Swedish Medical Product Agency and the University of Uppsala. The subjects had daily symptoms of fatigue, enduring for at least 2 weeks, related to a specific stressor that had been present for at least 6 months, and their daily functioning was negatively affected by stress. The symptoms could not be related to substance abuse or psychiatric or other primary disorders.

The diagnosis of fatigue syndrome differs from that of chronic fatigue syndrome. Fatigue syndrome requires the identification of specific stressors while chronic fatigue syndrome focuses on the immune system and symptoms of pain in the lymph nodes, joints, and muscles.

Subjects were given 120 placebo or identical-appearing tablets of a proprietary Rhodiola rosea root extract (576 mg extract/day, SHR-5, Swedish Herbal Institute, Gothenburg, Sweden). The extract was a 4:1 concentrate made by using a 70% ethanol solvent; it contained 4.0 mg/tablet of rhodioloside along with quantified but unspecified amounts of tyrosol, rosavin, and triandrin.

The primary endpoint was a reduction in fatigue symptoms assessed according to the Pines’ burnout scale. Attention was evaluated by the Conners’ computerized continuous performance test II (CCPT II) for features such as omissions, commissions, variability, and response reaction time standard error (Hit RT SE). The reduction in depressive symptoms was estimated using the Montgomery-Asberg depression rating scale (MADRS), quality of life was measured using the SF-36 questionnaire, and the cortisol (a stress hormone) response to awakening was determined from saliva samples. Saliva sampling was chosen because it is a simple, non-invasive, non-stressful method that participants could do at home. Saliva samples were collected using Salivette cotton rolls, which participants were instructed to place in the mouth for at least 1 minute or until the cotton roll was soaking wet, at 0, 15, 30 and 60 minutes after awakening.

One person dropped out of the treatment group; each group had 3 men. The placebo group had much better compliance than the rhodiola group (P = 0.07). The number of tablets remaining in the container was 0-75 tablets in the rhodiola group and 0-29 tablets in the placebo group. There was a significant improvement in fatigue symptoms, quality of life, depression, and attention in both groups. The authors state that these improvements could be due to a placebo effect, a general effect of taking the tests twice, or a regression towards the mean. However, the rhodiola group benefited more than the placebo group on assessment of fatigue symptoms (P = 0.047) and attention (omissions—not responding when a response is required [P = 0.02], variability [P=0.005], and Hit RT SE [P=0.001] that indicate a more stable work pace). The cortisol response to awakening stress (awakening is a mild stressor) was reduced significantly following 28 days of treatment with the rhodiola extract in comparison with the control group (P = 0.038). No adverse events occurred during the study, and no major side effects that could be clearly linked to the rhodiola preparation were reported by any of the subjects.

The authors conclude that repeated administration of rhodiola extract SHR-5 exerts an anti-fatigue effect that increases mental performance, particularly the ability to concentrate, and decreases cortisol response to awakening stress in burnout patients with fatigue syndrome. According to the authors, this study is the first to show that this proprietary rhodiola extract benefits patients with chronic stress-induced fatigue. Additionally, this study is the first to suggest clinically that Rhodiola rosea root benefits stress-induced disorders by modulating cortisol. There are data suggesting that the inhibitory effect of Rhodiola rosea on the increased basal level of cortisol results in an improvement in cognitive function. This proposal is consistent with other studies suggesting that optimal corticosteroid levels are a requirement for efficient cognitive function, as significant changes (up or down) in circulating levels of corticosteroids correlate with cognitive impairment.1 Modulation of cortisol content is believed to be a key mechanism of action of phytoadaptogens.

The authors suggest that the reason a potential effect on depressive symptoms was lacking—as has been documented in a previous trial designed to measure the effect of this specific rhodiola extract on depressed patients2—may have been due to the inadequate duration and because subjects with depression as a major symptom were excluded from this trial. The authors do not hypothesize why the rhodiola group had poorer compliance or whether the findings would have been more robust if compliance were improved. It should be noted that the effects seen in this study may be specific to the proprietary rhodiola product used and the specific dose.

—Heather S. Oliff, PhD

References

1. Herbert J, Goodyer IM, Grossman AB, et al. Do corticosteroids damage the brain? J Neuroendocrinol. 2006;18:393-411.
2. Darbinyan V, Aslanyan G, Amroyan E, Gabrielyan E, Malmstrom C, Panossian A. Clinical trial of Rhodiola rosea L. extract SHR-5 in the treatment of mild to moderate depression. Nord J. Psyc. 2007;61:343-348.

Source: http://cms.herbalgram.org/herbalgram/issue82/article3409.html

American Botanical Council, 6200 Manor Rd, Austin, TX 78723
Phone: 512-926-4900 | Fax: 512-926-2345 | Email: abc@herbalgram.org

COLD-fX® Special Extract from American Ginseng Root Shown Safe for Children with Upper Respiratory Tract Infections

The Journal of the American Botanical Council

Issue: 81 Page: 30-31

COLD-fX® Special Extract from American Ginseng Root Shown Safe for Children with Upper Respiratory Tract Infections

HerbalGram. 2009;81:30-31 American Botanical Council

Reviewed: Vohra S, Johnston BC, Laycock KL, et al. Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules. Pediatrics. Aug 2008;122(2): e402-e410.

Upper respiratory tract infections (URIs) are more common in children than in adults, and parents often treat their children’s symptoms with herbs and other natural health products (NHPs, the regulatory term used in Canada for vitamins, minerals, herbs, homeopathic remedies, etc.). One of the most popular products used for enhancing immunity and preventing and treating URIs in Canada is a special, patented extract of American ginseng root (Panax quinquefolius, Araliaceae) called COLD-fX® (CV Technologies, Inc., Edmonton, Alberta, Canada) consisting of only the saccharide fraction of the root (i.e., furanyl-, oligo- and polysaccharides). Unlike conventional ginseng extracts, this preparation does not contain ginsenosides, the characteristic active triterpene glycosides in various species of the genus Panax that are the subject of most chemical and pharmacological research on this highly-researched genus.

In Canada, COLD-fX is approved by the Natural Health Products Directorate of Health Canada for the prevention and treatment of URIs related to cold and flu, based on a previous review of published clinical trials and laboratory research. Although the safety and efficacy of COLD-fX has been studied for the treatment and prevention of URIs in adults, the authors of this phase II randomized, double-blind, dose-finding, 3-arm clinical trial claim that it is the first to examine safety, dose, and efficacy in children.

There were 2 dosing arms and a placebo arm. The objectives were to document the safety and efficacy of weight-based dosing schedules and to determine the treatment effect of COLD-fX on the severity and duration of pediatric URIs. Children aged 3-12 years old were recruited between November 2005 and February 2006 from 2 teaching hospitals at the University of Alberta (Edmonton, Alberta, Canada). A computerized random number generator was used for randomization.

Parents of the subjects contacted the study nurse upon the onset of symptoms. If the study nurse determined that the symptoms were those of a URI, then the pharmacy was contacted and the study medications (COLD-fX or placebo) were dispensed and sent by courier. The weight-based COLD-fX standard dose (n=13) was 26 mg/kg on day 1, 17 mg/kg on day 2, and 9 mg/kg on day 3. Children who received the standard adult dose (600 mg on day 1, 400 mg on day 2, and 200 mg on day 3) weighed over 45 kg. The weight-based COLD-fX low-dose group (n=14) received 13 mg/kg on day 1, 8.5 mg/kg on day 2, and 4.5 mg/kg on day 3. Children in the low dose group also weighed less than 45 kg. The placebo group (n=15) received a liquid solution similar in appearance to the COLD-fX formulation. The placebo or COLD-fX formulations were dispensed into 3 equal portions to be taken 3 times daily for 3 days. The children received other medications and tests as determined by their physicians. The severity and duration of the URIs were measured using the Canadian Acute Respiratory Infection Flu Scale (CARIFS) score, a validated 18-item scale that covers 3 domains: symptoms, function, and parental impact. The severity and duration of the treatment effect was measured as the average length of time in days from treatment onset to resolution of symptoms, defined as a 25% decrease from the baseline CARIFS score.

No serious adverse events were reported. A total of 31 subjects reported 51 adverse events. Out of these, 8 were classified as moderate: 2 in the low-dose group (fever and secondary bacterial throat infection), 6 in the placebo group, and none in the standard dose group. In addition, 11 adverse events were classified as possibly related to the intervention. Those receiving the standard dose had fewer of these adverse events than either those receiving low-dose or placebo, but there was no statistically significant between-group difference.

The severity and duration of treatment effect was 1.5 days for the standard dose group, 1.9 days for the low dose group, and 1.9 days for the placebo group. This is all-the-more impressive given that those in the standard dose group were the sickest group at the outset. Nevertheless, the study group was too small for this trend to reach statistical significance. From this information, however, the authors were able to calculate that repeating the study with 48 children in each treatment arm could confirm whether COLD-fX shortens the duration of colds in children. The use of antipyretics (fever-reducing medications) was highest in the low-dose group (P=0.48). Otherwise, there was no significant difference in the use of cold and flu remedies, antibiotics, or asthma medications among the groups.

The authors conclude that the standard weight-based dose of COLD-fX used in this study is safe and well-tolerated in children and appropriate for larger, phase III clinical trials. The difference in the use of NHPs and asthma medication was not significant among the treatment arms, but the authors recommend that future investigators caution subjects not to use other NHPs during the study and to include a specific measure of asthma status. The authors also recommend rigorous stepwise clinical trials from phase I to phase III on NHPs, which could help to avoid expensive negative phase III trials. Future research on the efficacy of COLDfX in the treatment of pediatric URIs is warranted. In addition, the authors recommend studies evaluating daily use of COLD-fX in children for preventing URIs.

In February 2007 the American Botanical Council published an extensive clinical monograph on COLD-fX (also known by the name of its extract, CVT-E002), available on the ABC Web site at http://cms.herbalgram.org/herbclip/306/review44663.html.

—Marissa Oppel, MS

Source: http://cms.herbalgram.org/herbalgram/issue81/article3372.html

American Botanical Council, 6200 Manor Rd, Austin, TX 78723
Phone: 512-926-4900 | Fax: 512-926-2345 | Email: abc@herbalgram.org

Biological Activity of Curcuminoids from Turmeric Assessed in Patients with Advanced Pancreatic Cancer

The Journal of the American Botanical Council

Issue: 81 Page: 23

Biological Activity of Curcuminoids from Turmeric Assessed in Patients with Advanced Pancreatic Cancer

HerbalGram. 2009;81:23 American Botanical Council

Reviewed: Dhillon N, Aggarwal BB, Newman RA, et al. Phase II trial of curcumin in patients with advanced pancreatic cancer. Clin Cancer Res. 2008;14(14):4491–4499.

Pancreatic cancer is almost always lethal, and most patients die within 1 year of diagnosis. The only drugs approved by the Food and Drug Administration that are currently available for treatment are gemcitabine and erlotinib. Both of these drugs elicit responses in only a small percentage of patients (less than 10%), and their effect on survival is measured in weeks. Thus, effective treatments are urgently needed. Many studies have shown that nuclear transcription factor-κB (NF-κB) is activated in patients with pancreatic cancer; therefore, an agent that targets NF-κB may prove effective in the treatment of this disease.

Previous laboratory research has shown that curcuminoids, a group of compounds derived from the traditional herb and spice turmeric (Curcuma longa, Zingiberaceae), suppress NF-κB activation, cell growth associated with apoptosis (programmed cell death), and the growth of human pancreatic cancer xenografts in mice. These curcumoinds are curcumin, desmethoxycurcumin, and bisdesmethoxycurcumin. Phase I human clinical trials of curcuminoids have shown that they are safe at doses up to 8 g/day but that their oral bioavailability may be poor. Thus, this phase II clinical trial was undertaken to determine whether orally administered curcuminoids have biological activity in patients with advanced pancreatic cancer.

Twenty-five patients (13 men, 12 women; aged 43-77) with histologically confirmed pancreatic cancer and a Karnofsky performance score greater than 60 were enrolled in this nonrandomized, open-label, phase II trial, which was conducted at the University of Texas

M.D. Anderson Cancer Center in Houston, Texas. As controls, cytokine levels were measured in 48–62 healthy volunteers depending on the cytokine assessed. The patients ingested a daily dose of 8 g of curcuminoids in capsule form (1 capsule = 1 g curcuminoids [900 mg curcumin, 80 mg desmethoxycurcumin, and 20 mg bisdesmethoxycurcumin]; Sabinsa Corp., Piscataway, NJ). Concomitant chemotherapy or radiotherapy was prohibited, but supportive care was allowed. Disease staging, a physical examination, and blood sampling were performed at baseline and at 4 and 8 weeks. Blood samples were used to measure the following values: cytokine concentrations (interleukin-6, -8, -10, and interleukin-1 receptor antagonist), carcinoembryonic antigen concentrations, and peripheral blood mononuclear cell expression of NF-κB and cyclooxygenase-2 (COX-2). The adverse events were assessed on the basis of the National Cancer Institute Expanded Common Toxicity Criteria (http://ctep.cancer.gov/forms/CTCAEv3.pdf), and tumor response was evaluated on the basis of the Response Evaluation Criteria in Solid Tumors.

Twenty-four patients were available for the toxicity evaluation, and 21 patients were available for evaluation of the response to treatment with curcuminoids. Circulating concentrations of curcumin in blood serum were low, which indicated poor oral bioavailability. However, 2 patients exhibited a favorable response to curcuminoids. Pancreatic cancer remained stable in 1 of these patients for greater than 18 months. “Marked” tumor regression (73%) and significant (P < 0.05) increases in serum interleukin-6, -8, and -10 and in interleukin-1 receptor agonist were observed in the other patient. NF-κB activation decreased with curcuminoids treatment, but not significantly compared with the healthy controls. COX-2 expression decreased significantly (P < 0.03) with curcumin treatment. Blood concentrations of curcumin peaked at 22–41 ng/mL and remained relatively constant over the first 4 weeks of the study. Carcinoembryonic antigen concentrations decreased gradually over 1 year in 1 patient, which indicated an improvement in cancer status. No treatment-related toxicity was observed. The results of this study indicate that orally administered curcuminoids are tolerated well at doses of 8 g/day for up to 18 months and have “biological activity in some patients with pancreatic cancer.” Although curcumin was poorly absorbed, biological activity (i.e., tumor regression and increase in cytokine concentrations) was evident at steady-state. Because curcumin is hydrophobic (i.e., not water soluble), it cannot be administered intravenously unless encapsulated in a liposome, which would presumably result in higher circulating concentrations of curcumin in the blood. The authors intend to conduct clinical trials in pancreatic cancer patients with the use of liposomal curcuminoids, which they hope will result in more consistent blood concentrations of curcumin and a better pharmacologic effect. —Brenda Milot, ELS Source: http://cms.herbalgram.org/herbalgram/issue81/article3376.html American Botanical Council, 6200 Manor Rd, Austin, TX 78723 Phone: 512-926-4900 | Fax: 512-926-2345 | Email: abc@herbalgram.org

Korean White Ginseng Improves Cognitive Performance in Patients with Alzheimer’s Disease

The Journal of the American Botanical Council

Issue: 82 Page: 32-33

Korean White Ginseng Improves Cognitive Performance in Patients with Alzheimer’s Disease

HerbalGram. 2009;82:32-33 American Botanical Council

Reviewed: Lee S-T, Chu K, Sim J-Y, Heo J-H, Kim M. Panax ginseng enhances cognitive performance in Alzheimer disease. Alzheimer Dis Assoc Disord. 2008;22(3):222-226.

The modern pharmacologic effects of ginseng and its components, ginsenosides, have been demonstrated in the cardiovascular, endocrine, and immune systems.1 Also, ginseng has been reported to increase the cognitive performance of healthy persons.2-5 For Alzheimer’s disease, investigators have examined the neuroprotective and tropic effects of ginseng in experimental models. The authors of this study report on their investigation of Korean white ginseng (Panax ginseng, Araliaceae)* in enhancing the cognitive function in patients with Alzheimer’s disease.

They conducted a prospective, open-label study at the Seoul National University Hospital in South Korea from June 2004 until October 2005. Ninety-seven patients who met NINDS-ADRDA (National Institute of Neurological Disorders and Strokes, and Alzheimer’s Disease and Related Disorders Association) criteria for probable Alzheimer’s disease were included (aged 47 to 83 years).

The authors excluded patients who had evidence of other neurodegenerative disorders or cognitive impairments resulting from acute cerebral trauma, dysthmia (a chronic mild state of depression), hypoxic cerebral damage, vitamin deficiency, infection, cerebral neoplasia (growth of new tissue, e.g., a tumor, in the brain), metabolic disease, mental retardation, oligophrenia (subnormal mental development), or a coexisting medical condition that could prevent them from completing the study.

The patients were randomly assigned to the ginseng group (n=58; 20 men and 38 women) or to the control group (n=39; 15 men and 24 women). The ginseng group was treated with Korean white ginseng powder (4.5 g/day of 6-year-old root powder from Hongcheon and Heongsung provinces in South Korea, powdered and encapsulated by Nonghyup Co., South Korea) for 12 weeks. According to the authors, the ginseng contained total 8.19% of ginsenosides† plus essential oils, diacetylenic compounds, acidic polysaccharides, phenolic compounds, peptidoglycans, amino acids, vitamins, and carbohydrates.

To evaluate possible dose-response effect, an additional 9 patients were administered a higher dose of ginseng (9 g/day).

After the 12-week period of ginseng treatment, all patients were monitored for another 12 weeks.

To evaluate cognitive functions, the authors used scores on the mini-mental state examination (MMSE) and Alzheimer’s disease assessment scale (ADAS), including the ADAS cognitive subscale (ADAS-cog) and noncognitive subscale (ADAS-noncog). Efficacy variables included changes of MMSE and ADAS from baseline scores at 4, 12, and 24 weeks after the start of treatment.

The efficacy analyses were primarily preformed on an intention-totreat (ITT) basis; a per-protocol analysis was also done. Intergroup comparisons for changes from baseline in ADAS and MMSE scores were performed using the Student’s t test. They used repeated measures analysis of variance to compare the raw MMSE and ADAS scores in addition to the comparison of changes from baseline. Statistical significance was accepted for P values less than 0.05.

At 4 weeks, 91 patients (54 in the ginseng group, 37 in the control group) were reevaluated and included in the efficacy analysis. Eighty-two patients (50 in the ginseng group, 32 in the control group) completed 12 weeks of treatment, and 58 patients (36 in the ginseng group, 22 in the control group) were reevaluated at 24 weeks after the treatment began.

Baseline characteristics including age, sex, ADAS-cog, ADAS-noncog, MMSE, and clinical dementia rating scale scores were similar between the 2 groups.

At 4 weeks, the ginseng group showed an improvement in MMSE score by 1.0 ± 2.4 points from baseline, according to efficacy analysis, whereas the control group changed by –0.58 ± 2.4 points (P = 0.033 between the 2 groups). At 12 weeks, the ginseng group improved by 1.8 ± 2.8 points, whereas the control group changed by only –0.03 ± 3.1 (P = 0.009 between the 2 groups). However, after the 12-week period of ginseng discontinuation, no difference was observed between the 2 groups (control = 0.88 ± 2.5, ginseng = 0.56 ± 3.6, P = 0.673).

ADAS-cog scores were also improved in the ginseng group at 4 weeks and at 12 weeks after the ginseng treatment compared with the control group on ITT basis. And, again, after the ginseng had been discontinued for 12 weeks, the differences between the ginseng and control groups disappeared. In contrast, say the authors, the ADAS-noncog scores, which represent neuropsychiatric symptoms, showed no significant difference between the ginseng and control groups on ITT basis at 4 weeks, 12 weeks, or at 24 weeks.

According to the authors, the repeated measures analysis of variance revealed that at 4 weeks, the ginseng group showed an improvement in ADAS-cog score compared with the control group, after adjusting the baseline values. At 12 weeks, the ginseng group showed improvements in both ADAS-cog and MMSE scores, after adjusting the baseline values.

The ADAS-cog and ADAS-noncog and MMSE changes for the 9 patients treated with 9 g/day of the ginseng powder for 12 weeks were not different compared with those treated with 4.5 g/day of ginseng.

Adverse events (reported by 7 of the 58 patients in the ginseng group and 6 of the 39 patients in the control group) were mild and transient.

Among the limitations of this study are the small number of patients involved, the short duration, and the fact that, because this was an open-label study, the effect of the ginseng was not relative to a placebo.

The authors report that these results suggest that Korean white ginseng is clinically effective in the cognitive performance of patients with Alzheimer’s disease and that longer-term, placebo-controlled, double-blind studies are warranted.

—Shari Henson

References

1. Attele AS, Wu JA, Yuan CS. Ginseng pharmacology: multiple constituents and multiple actions. Biochem Pharmacol. 1999;58:1685-1693.
2. Kennedy DO, Scholey AB. Ginseng: potential for the enhancement of cognitive performance and mood. Pharmacol Biochem Behav. 2003;75:687-700.
3. D’Angelo L, Grimaldi R, Caravaggi M, et al. A double-blind, placebo-controlled clinical study on the effect of a standardized ginseng extract on psychomotor performance in healthy volunteers. J Ethnopharmacol. 1986;16:15-22.
4. Sorensen HSJ. A double masked study of the effects of ginseng on cognitive functions. Curr Ther Res. 1996;57:959-968.
5. Kennedy DO, Scholeya AB, Wesnes KA. Dose dependent changes in cognitive performance and mood following acute administration of ginseng to healthy young volunteers. Nutr Neurosci. 2001;4:295-310.

* Korean white ginseng is the dry natural cultivated ginseng root, with the skin peeled or scraped, and usually ground into powder for use in capsules and tablets, or extracted with water and ethanol. It differs from Korean red ginseng root in that it is not treated by steaming the fresh white roots, a process that turns the roots a caramel color and causes changes in the ginsenoside profile. In Korea and China, Panax ginseng is widely termed Asian ginseng.

† This appears to be a relatively high concentration of ginsenosides; the normal range for Asian ginseng root is usually between 3-5%. Thus, the generalizability of the results of this trial may be limited by what appears to be about double the normal ginsenoside content in these ginseng roots.

Source: http://cms.herbalgram.org/herbalgram/issue82/article3408.html
American Botanical Council, 6200 Manor Rd, Austin, TX 78723
Phone: 512-926-4900 | Fax: 512-926-2345 | Email: abc@herbalgram.org

Study Shows Pycnogenol Naturally Reduces Blood Pressure And Counteracts Kidney Damage Caused By Hypertension

Research reveals Pycnogenol® lowers elevated urinary protein levels and improves blood flow to the kidneys

GENEVA, Switzerland – An estimated one in ten adults suffers from kidney disease, according to the National Institute of Diabetes and Digestive and Kidney Diseases. A leading cause of kidney disease is hypertension, which effects one out of every four U.S. adults. Chronically high blood pressure damages capillaries of the kidneys which in turn affects the organ’s ability to filter waste and remove excess fluids from the body. A study published in the March 2010 issue of the Journal of Cardiovascular Pharmacology and Therapeutics reveals Pycnogenol® (pic-noj-en-all), an antioxidant plant extract from the bark of the French maritime pine tree, counteracts kidney damage caused by hypertension, lowering urinary proteins and improving blood flow to the kidneys.

“Kidney disease is a common problem for people with hypertension and is an equally ‘silent’ threat to the body. There are no warning signals and inefficient fluid removal may further increase the blood pressure, causing a vicious circle to set in,” said Dr. Gianni Belcaro, a lead researcher of the study. “The results of this study demonstrated Pycnogenol®’s ability not only to reduce blood pressure, but also to relieve the kidney damage caused by chronic hypertension.”

The randomized, controlled study conducted by the G D’Annunzio University in Italy investigated 55 hypertensive patients who showed early signs of impaired kidney function, as judged by elevated amounts of proteins found in their urine. The patients were divided into two groups. Both groups were treated with anti-hypertensive medication Ramipril and one group of 29 patients took Pycnogenol in addition to the Ramipril. Urine was collected during a 24 hour period for quantification of protein (albumin) at baseline and again after six months of treatment.

All patients included in the study had an average urinary protein level of 89 mg per 24-hour period, significantly exceeding the 30 mg measure, up to which kidney function is considered sufficient. After six months of treatment with Ramipril, average protein levels decreased to 64 mg per 24-hour period, remaining well above an acceptable level. Conversely, the group taking Pycnogenol® as an adjunct to Ramipril had an average of only 39 mg per 24-hour period, a decrease of nearly double compared with anti-hypertensive medication taken alone.

The study also found a statistically significant decrease in patients’ blood pressure when taking Pycnogenol® in conjunction with Ramipril. When treated exclusively with Ramipril, systolic blood pressure values dropped by more than 30 percent and diastolic blood pressure values dropped approximately eight percent. The addition of Pycnogenol® decreased both systolic and diastolic pressures by an additional three to six percent. Pycnogenol® was also found to lower the patients’ elevated levels of inflammatory marker CRP, a blood protein associated with the risk for acute cardiovascular events such as heart attack, reducing values to a healthy level.

“While Ramipril represents an effective treatment for hypertension and its interrelated effects on kidney function, Pycnogenol® as an adjunct to the medication produced significantly greater results, particularly for kidney function restoration” said Dr. Belcaro. “Pycnogenol® continues to demonstrate its abilities as a natural solution for the complete cardiovascular system.”

Previous studies have revealed Pycnogenol® to favorably affect the normalization of blood pressure by releasing arterial constriction.

Source:Nutrition Horizon

Sector:Herbals & Plant Extracts

Whole Foods Market “Organic” food made in China

Vitamin D May Reduce Falls in Elderly Nursing Home Residents

January 29, 2010 — Vitamin D supplementation and pharmacist review of medications may help reduce falls in elderly nursing home residents, according to the results of a systematic review reported online January 20 in the Cochrane Database of Systematic Reviews.

“Falls in nursing care facilities and hospitals are common events that cause considerable morbidity and mortality for older people,” write Ian D. Cameron, MBBS, PhD, from Sydney Medical School, the University of Sydney in Ryde, Australia, and colleagues.

The goal of this review was to determine the efficacy of interventions aiming to reduce falls by older people in nursing care facilities and hospitals. The reviewers searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2009); the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 2); MEDLINE, EMBASE, and CINAHL (all to November 2008); trial registers; and bibliographies of retrieved articles.

Criteria for inclusion in the review were randomized controlled trials of interventions designed to reduce falls in older people in nursing care facilities or hospitals, with main study endpoints of fall rate and the risk of falling. Methodologic quality of the trials was independently evaluated by 2 reviewers, who also extracted and pooled data where appropriate.

There were 41 trials, enrolling a total of 25,422 participants, meeting selection criteria. Findings from 7 trials testing supervised exercise interventions in nursing care facilities were inconsistent. Overall, multifactorial interventions were not associated with a significantly lower rate of falls in 7 trials enrolling a total of 2997 participants or with a lower risk of falling in 8 trials enrolling a total of 3271 participants.

However, multifactorial interventions provided by a multidisciplinary team were associated with lower rate of falls in nursing home residents (rate ratio [RaR], 0.60; 95% confidence interval [CI], 0.51 – 0.72; 4 trials, n = 1651) and risk of falling (risk ratio [RR], 0.85; 95% CI, 0.77 – 0.95; 5 trials, n = 1925), based on a post hoc subgroup analysis.

Vitamin D supplementation in nursing home residents was associated with a lower rate of falls (RaR, 0.72; 95% CI, 0.55 – 0.95; 4 trials, n = 4512) but not with the risk of falling (RR, 0.98; 95% CI, 0.89 – 1.09; 5 trials, n = 5095).

Multifactorial interventions in hospitals for patients with a length of stay of 3 weeks or more were associated with a lower rate of falls (RaR, 0.69; 95% CI, 0.49 – 0.96; 4 trials, n = 6478) and the risk of falling (RR, 0.73; 95% CI, 0.56 – 0.96; 3 trials, n = 4824). In addition, supervised exercise interventions were associated with a significant decrease in the risk of falling (RR, 0.44; 95% CI, 0.20 – 0.97; 3 trials, n = 131).

“There is evidence that multifactorial interventions reduce falls and risk of falling in hospitals and may do so in nursing care facilities,” the review authors write. “Vitamin D supplementation is effective in reducing the rate of falls in nursing care facilities. Exercise in subacute hospital settings appears effective but its effectiveness in nursing care facilities remains uncertain.”

Limitations of this review include those inherent in the selected studies, such as lack of blinding, confounding because of differences in treatment and control groups at entry, differences in underlying care programs, poorly defined inclusion and exclusion criteria and falling events, and differences in ascertainment of falls.

“Falls prevention programmes that include exercises for frail nursing care facility residents should carefully assess each individual’s suitability, as there is the possibility that exercise programmes may increase their risk of falls,” the review authors conclude. “The choice of type of exercises may be important in avoiding an increase in falls. The rate of falls and number of fallers should be monitored before and after adopting an intervention because it might increase falls.”

South Eastern Sydney and Illawarra Area Health Service, Australia; Rehabilitation Studies Unit, Faculty of Medicine, University of Sydney, Australia; University of Otago, New Zealand; National Ageing Research Institute, Australia; and Accident Compensation Corporation, New Zealand, supported this review. The review authors have disclosed no relevant financial relationships.

Cochrane Database Syst Rev. Published online January 20, 2010. Abstract

For more information on falls in the elderly is available from the Centers for Disease Control.
Clinical Context

Older persons in nursing care facilities and hospitals often fall, with possible complications including loss of independence, injury, and even mortality. Effective interventions to prevent falls are important for the health of these individuals as well as for public health and reduction of healthcare costs.

Interventions to lower fall risk should be evidence-based so that staff time and resources are allocated appropriately and so that older persons and their families are not subjected to the stress of ineffective interventions. This review aimed to inform best practice and to identify issues of importance for future research regarding strategies of fall prevention.

Study Highlights

• The objective of this Cochrane review was to examine the efficacy of interventions designed to reduce falls among older people in nursing care facilities and hospitals.
• Literature searched included the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (January 2009); the Cochrane Central Register of Controlled Trials (The Cochrane Library 2008, Issue 2); and MEDLINE, EMBASE, and CINAHL, all to November 2008.
• The reviewers also searched trial registers and references cited in identified articles.
• Selection criteria were randomized controlled trials of interventions designed to lower fall risk in elderly nursing home residents or hospital inpatients, with primary outcomes of fall rate and the risk of falling.
• 2 reviewers independently examined trial quality and extracted data, which were pooled when feasible.
• Inclusion criteria were met by 41 trials with a total of 25,422 participants.
• For supervised exercise interventions in nursing care facilities, 7 trials yielded inconsistent results.
• Overall, multifactorial interventions in nursing care facilities did not reduce fall rate in 7 trials (total n = 2997) or risk of falling in 8 trials (total n = 3271).
• A post hoc subgroup analysis showed that multifactorial interventions provided by a multidisciplinary team were associated with lower fall rate (RaR, 0.60; 95% CI, 0.51 – 0.72; 4 trials, n = 1651) and risk of falling (RR, 0.85; 95% CI, 0.77 – 0.95; 5 trials, n = 1925) in residents of nursing care facilities.
• In residents of nursing care facilities, vitamin D supplementation was associated with decreased fall rate (RaR, 0.72; 95% CI, 0.55 – 0.95; 4 trials, n = 4512).
• However, vitamin D supplementation did not reduce the risk of falling in residents of nursing care facilities (RR, 0.98; 95% CI, 0.89 – 1.09; 5 trials, n = 5095).
• In nursing care facilities, a clinical medication review by a pharmacist appeared to be effective in reducing the rate of falls.
• In hospitals, multifactorial interventions for patients with length of stay of 3 weeks or more were associated with a lower rate of falls (RaR, 0.69; 95% CI, 0.49 – 0.96; 4 trials, n = 6478) and risk of falling (RR, 0.73; 95% CI, 0.56 – 0.96; 3 trials, n = 4824).
• However, the reviewers could not make recommendations regarding any particular component of these multifactorial intervention programs.
• Supervised exercise interventions in hospitals were associated with a significant reduction in the risk of falling (RR, 0.44; 95% CI, 0.20 – 0.97; 3 trials, n = 131).
• The reviewers concluded that multifactorial interventions reduce falls and the risk of falling in hospitals and may do so in nursing care facilities.
• They also concluded that vitamin D supplementation effectively reduces the rate of falls in nursing care facilities.
• Although exercise in subacute hospital settings appears to be effective, it remains uncertain whether it is effective in nursing care facilities.
• Review limitations are those of the included studies, such as lack of blinding, confounding, and poorly defined inclusion and exclusion criteria and falling events.

Clinical Implications

• A Cochrane systematic review shows that for elderly persons in nursing care facilities, vitamin D supplementation effectively reduces the rate of falls. A clinical medication review by a pharmacist may also be effective in reducing the rate of falls. However, the value of exercise in reducing fall risk remains uncertain in this setting.
• In hospitals, multifactorial interventions reduce falls and the risk of falling in elderly persons. Exercise in subacute hospital settings also appears to be effective in reducing the risk of falling, based on this Cochrane systematic review.

Source: Medscape CME

Authors:

Laurie Barclay, MD
Freelance writer and reviewer, Medscape, LLC
Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

Brande Nicole Martin
CME Clinical Editor, Medscape, LLC
Disclosure: Brande Nicole Martin has disclosed no relevant financial information.

Laurie Barclay, MD
Freelance writer and reviewer, Medscape, LLC
Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

Laurie E. Scudder, MS, NP
Accreditation Coordinator, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC; Nurse Practitioner, School-Based Health Centers, Baltimore City Public Schools, Baltimore, Maryland
Disclosure: Laurie E. Scudder, MS, NP, has disclosed no relevant financial relationships.

Association of vitamin B-6 status with inflammation, oxidative stress, and chronic inflammatory conditions: the Boston Puerto Rican Health Study1,2,3

Jian Shen, Chao-Qiang Lai, Josiemer Mattei, Jose M Ordovas and Katherine L Tucker

1 From the Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging at Tufts University Boston MA (JS C-QL JM JMOKLT)the Bouvé College of Health Sciences at Northeastern University Boston MA (KLT).

2 Supported by the National Institutes of Health, National Institute on Aging grant 01AG023394-02 and National Heart, Lung, and Blood Institute grant HL54776; and the US Department of Agriculture, Agricultural Research Service contracts 53-K06-5-10 and 58-1950-9-001.

3 Address correspondence to J Shen, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, 711 Washington Street, Boston, MA 02111-1524. E-mail: jian.shen@tufts.edu.

Background: Low vitamin B-6 status has been linked to an increased risk of cardiovascular diseases. The cardioprotective effects of vitamin B-6 independent of homocysteine suggest that additional mechanisms may be involved.

Objective: Our objective was to examine the cross-sectional association of vitamin B-6 status with markers of inflammation and oxidative stress.

Design: We measured plasma pyridoxal-5′-phosphate (PLP), C-reactive protein (CRP), and an oxidative DNA damage marker, urinary 8-hydroxydeoxyguanosine (8-OHdG), in Puerto Rican adults who were living in Massachusetts (n = 1205, aged 45–75 y).

Results: There was a strong dose-response relation of plasma PLP concentration with plasma CRP. Increasing quartiles of PLP were significantly associated with lower CRP concentrations (geometric means: 4.7, 3.6, 3.1, and 2.5 mg/L; P for trend < 0.0001) and with lower urinary 8-OHdG concentrations (geometric means: 124, 124, 117, and 108 ng/mg creatinine; P for trend: 0.025) after multivariate adjustment. These negative associations persisted after plasma homocysteine was controlled for. Plasma PLP concentrations were significantly correlated with plasma fasting glucose (r = –0.1, P = 0.0006), glycated hemoglobin (r = –0.08, P = 0.006), and homeostasis model assessment of β cell function (r = 0.082, P = 0.005). Metabolic syndrome, obesity, and diabetes were also significantly associated with low plasma PLP concentrations (P = 0.011, 0.0007, and 0.004, respectively).

Conclusions: Low vitamin B-6 concentrations are associated with inflammation, higher oxidative stress, and metabolic conditions in older Puerto Rican adults. Our data suggest that vitamin B-6 may influence cardiovascular disease risk through mechanisms other than homocysteine and support the notion that nutritional status may influence the health disparities present in this population.

Source: American Journal Clinical Nutrition  www.ajcn.org/cgi/content/abstract/91/2/337

What is sustainable healthcare?

Sustainability is a robust concept that has proven its worth across a range of different industries including energy, agriculture, forestry and even construction and tourism.

Contemporary healthcare in western countries is presently dominated by use of pharmaceutical drugs—and most indicators would suggest that these approaches have had very limited value in dealing with some of the greatest scourges facing human health, including chronic diseases, psychiatric diseases and even certain infectious diseases.

From a cost/benefit perspective, pharmaceutical-based approaches to healthcare do not fare favourably and a sea change is required if mainstream western healthcare is to deal with the ever increasing burden on the healthcare system, particularly given that this burden will be exacerbated by an ageing population.

The dichotomy between complementary & alternative medicine (CAM) and orthodox/allopathic healthcare approaches has led to increased vilification of protagonists of each approach. The use of scientific methods of evaluation that do not lend themselves well to CAM approaches have meant that the ‘medical establishment’ has been able to increasingly marginalise CAM approaches. This has occurred while the establishment has provided no significant improvement in its offering to the majority of the population that is either forced to accept or choose to accept pharmaceutical-based medicine as the most effective and scientifically-validated form of medicine.

Encouraging a paradigm shift that requires all forms of healthcare to be bound by principles of sustainability is one of the surest means of providing a level playing field for all healthcare modalities which encourages those approaches that are compatible with the complex biological and energetic systems of which are bodies are comprised.

Sustainability principles, including those applying to engineering and design, should also be applied to healthcare facilities. To read an evaluation of the state-of-the-art on this subject, read an article by Dominic Stalker, a work experience science student who worked with the ANH during the summer of 2008 entitled Engineering sustainability into hospitals.
Definition of Sustainable Healthcare

The ANH first defined sustainable healthcare in 2006 in the UK practitioner journal Nutrition Practitioner. The definition is as follows:

“A complex system of interacting approaches to the restoration, management and optimisation of human health that has an ecological base, that is environmentally, economically and socially viable indefinitely, that functions harmoniously both with the human body and the non-human environment, and which does not result in unfair or disproportionate impacts on any significant contributory element of the healthcare system.”

Read Dr Robert Verkerk’s article published by the Australasian College of Nutritional and Environmental Medicine (ACNEM).

The article was written following an inaugural lecture at the National Institute for Integrative Medicine, hosted by Australian associations ACNEM and AIMA.

Looking through the window—the paradigm shift is the other side of the wall…

Executive Summary of the ANH Sustainable Healthcare Campaign

For more than two decades the orthodox (allopathic or western) healthcare establishment has vigorously attacked the scientific basis, efficacy and safety of the diverse range of modalities befitting approaches that are commonly placed under the banner of complementary and alternative medicine (CAM). Simultaneously, the CAM community, the natural products industry, health freedom organisations and large numbers of consumers and protagonists of CAM, have argued that these attacks are unjustified and have reciprocated by exposing the apparent lack of efficacy and poor safety record of orthodox healthcare.

These differences of opinion are so deep-seated that the polarity between the two contrasting approaches has become increasingly reinforced. The relative lack of resources within the CAM community, the natural products industry and the health freedom movement, by comparison with the pharmaceutical industry and orthodox medical system which it supports, means that it is by and large proving very difficult to improve the acceptability of CAM modalities in mainstream healthcare.

All the available indicators suggest that orthodox healthcare, which is dominated by interventions with new-to-nature pharmaceutical drugs, is not sustainable. ‘Evidence-based medicine’ (EBM) is increasingly being used both as a means of justifying pharmaceutical intervention as the world’s dominant approach to healthcare and its ever-wider application to discredit or even outlaw particular CAM approaches.

The Alliance for Natural Health (ANH) proposes that the application of the principles of sustainability to healthcare may be one of the most effective ways of altering the perception of established and emerging CAM modalities from the vantage point of government authorities and the current medical establishment. In addition, such an approach could significantly assist a transition in mainstream healthcare that is characterised by improved take up of biologically compatible modalities, as found within CAM. Such a transition would, among other things, allow for much greater use of preventative approaches, especially among children, young adults and non-diseased sub-populations, better diagnosis of disease, widespread adoption of lifestyle and nutrition-based approaches, greatly reduced dependence on new-to-nature medications and marked changes in medical training. With the identification of scientifically established criteria for sustainability in healthcare, only those approaches meeting the criteria stipulated would be accepted. Sustainability has become one of the key technological drivers in a range of other industries where social or environmental degradation has been implicated, and it is incongruous that the principles of sustainability have yet to be applied to healthcare.

The ANH, its affiliates and strategic partners are well set to help trigger the transition towards sustainable healthcare. The transition will continue to require funding of independent research in academic institutions, extensive public and government-targeted awareness campaigns and the establishment of scientifically monitored pilot programmes designed to demonstrate both feasibility and sustainability.

A transition towards sustainability would also help to eliminate the existing polarity between orthodox healthcare and CAM approaches and would inevitably prefer those approaches that function harmoniously with biological systems and human metabolism, rather than those that oppose them.

** Sustainable Health aritcles on this page provide by ANH-Europe.

Green Tea May Be Useful at Preventing Prostate Cancer

Johnson JJ, Bailey HH, Mukhtar H. Green tea polyphenols for prostate cancer chemoprevention: a translational perspective. Phytomed. 2010;17: 3-13.

It was estimated that in 2008, approximately 200,000 new cases of prostate cancer (PCa) would be diagnosed, resulting in roughly 30,000 deaths. Worldwide, the highest rates of PCa occur in “the West” (i.e., the United States, Canada, Australia, and Western Europe), and the lowest rates occur in Asia. A variety of genetic and environmental factors are thought to contribute to the development of PCa. It has become increasingly evident that dietary constituents have the ability to “target multiple deregulated signaling pathways while allowing normal processes to continue.” Furthermore, migratory studies have shown that Asian men who move to the United States and adopt a western diet have a greater incidence of PCa than do their native Asian counterparts. Thus, many epidemiologists have suggested that lifestyle and dietary factors play a role in the development of PCa. Asian populations are known to consume large quantities of green tea (Camellia sinensis), and a major constituent of green tea—epigallocatechin-3-gallate (EGCG)—has been shown in cell culture models to decrease cell viability and to promote apoptosis in PCa cell lines but not in noncancerous cell lines and in animal models, to delay the development and progression of PCa. The objective of the present study was to review the available data on the effects of green tea on PCa chemoprevention.

Conflicting results have been observed in epidemiologic studies. Of 6 epidemiologic studies of green tea reviewed, the majority showed a significant decrease in the risk of developing PCa with increasing intakes of green tea; however, other studies showed no significant decrease. EGCG is the most abundant catechin in green tea and has been studied extensively. In preclinical studies, several mechanisms of action for the chemopreventive effects of EGCG have been observed. For example, EGCG has been shown to target inflammatory pathways (e.g., nuclear factor-kappa B and cyclooxygenase-2), MAP kinases, insulin-like growth factor, androgen receptors, and detoxification enzymes. Preclinical pharmacokinetic studies of green tea have shown that the availability of green tea catechins (GTCs) is low (from 2% to 13%) after oral consumption. Many of these studies used a standardized pharmaceutical-grade preparation known as Polyphenon E® (200 mg of EGCG, 37 mg of epigallocatechin, and 31 mg of epicatechin per capsule; Mitsui Norin, Ltd.; Tokyo, Japan); Polyphenon E has been granted investigational new drug (IND) status by the FDA, with each capsule containing 80-98% total catechins by weight, standardized to EGCG that comprises 50-75% of the substance.

N.B. The structure of epicatechin-3-gallate provided in this publication has been inadvertently misrepresented as identical to that of EGCG.

Thus far, three clinical trials on the role of different forms of green tea on the prevention (n = 1) or treatment (n = 2) of PCa have been published.1-3 Two of these trials were conducted in patients with hormone-refractory PCa. The patients were treated with green tea powder (1 g 6 times daily; n = 42) in the study by Jatoi et al1 and with capsules of green tea extract (250 mg twice daily; n = 19) in the study by Choan et al.2 Both studies showed little to no therapeutic effect, although one patient in the study by Jatoi et al had a significant decrease from baseline in his prostate specific antigen (PSA) level, although this effect was not sustained beyond 2 months. Bettuzzi et al3 conducted a randomized clinical trial of the safety and efficacy of green tea in a chemoprevention trial in patients with prostatic intraepithelial neoplasia. Patients received either placebo (n = 30) or 600 mg GTCs (n = 30) daily (three 200-mg capsules); each capsule contained 5.5% epigallocatechin, 12.2% epicatechin, 51.9% EGCG, 6.1% epicatechin-3-gallate (a total of 75.7% GTCs), and <1% caffeine. After 1 year of treatment, 1 patient in the green tea group and 9 patients in the placebo group developed PCa. The total PSA level was not “noticeably” different between the 2 groups of patients. A 2-year follow-up in a subset of these participants showed that the chemopreventive effect of green tea catechins was “long lasting.” The authors conclude that the results of this clinical trial “are encouraging and provide rationale for additional clinical trials evaluating the efficacy of green tea polyphenols as a cancer chemoprevention agent.” A very recent study of the effects of short-term supplementation with the active compounds in green tea (EGCG; Polyphenon E) on serum biomarkers in men with prostate cancer showed a significant reduction in serum levels of PSA, hepatocyte growth factor, and vascular endothelial growth factor and no elevation in liver enzymes.

According to the authors, it has become evident over time that standardized green tea polyphenols should be used, as opposed to green tea infusions, for interventional purposes to ensure the content of polyphenols being investigated. Evidence collected thus far on the effects of green tea polyphenols on PCa prevention and treatment “suggests that green tea may be a promising agent for PCa chemoprevention and further clinical trials of participants at risk of PCa or early stage PCa are warranted.”

—Brenda Milot, ELS

References

1Jatoi A, Ellison N, Burch PA, et al. A phase II trial of green tea in the treatment of patients with androgen independent metastatic prostate carcinoma. Cancer. 2003;97:1442-1446.

2Choan E, Segal R, Jonker D, et al. A prospective clinical trial of green tea for hormone refractory prostate cancer: an evaluation of the complementary/alternative therapy approach. Urol Oncol. 2005;23:108-113.

3Bettuzzi S, Brausi M, Rizzi F, Castagnetti G, Peracchia G, Corti A. Chemoprevention of human prostate cancer by oral administration of green tea catechins in volunteers with high-grade prostate intraepithelial neoplasia: a preliminary report from a one-year proof-of-principle study. Cancer Res. 2006;66:1234-1240.

4McLarty J, Bigelow RL, Smith M, Elmajian D, Ankem M, Cardelli JA. Tea polyphenols decrease serum levels of prostate-specific antigen, hepatocyte growth factor, and vascular endothelial growth factor in prostate cancer patients and inhibit production of hepatocyte growth factor and vascular endothelial growth factor in vitro. Cancer Prev Res. 2009;2(7):673-682.

Source: American Botanical Council, 6200 Manor Rd, Austin, TX 78723
Phone: 512-926-4900 | Fax: 512-926-2345 | Email: abc@herbalgram.org

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