Review Article - Complementary and Alternative Medical Therapies for Children with Attention-Deficit/ Hyperactivity Disorder (ADHD) by Janice Pellow, Elizabeth M. Solomon, Candice N. Barnard
Original Research - A Clinical Trial Testing the Safety and Efficacy of a Standardized Eucommia ulmoides Oliver Bark Extract to Treat Hypertension by Frank Greenway, MD; Zhijun Liu, PhD; Ying Yu, MS; Alok Gupta, MD
Abstract
BACKGROUND: A tea made from Eucommia ulmoides leaves and bark is part of the Japanese diet. Eucommia is an herbal medicine that, by increasing nitric oxide, reduced blood pressure (BP) in rats and humans in an uncontrolled clinical trial. OBJECTIVE: A controlled clinical trial was conducted to evaluate an aqueous bark extract of Eucommia standardized to eight percent pinoresinol di-beta-D-glucoside (PG) for BP reduction in humans. METHODS: Study 1: Twenty-four healthy adult subjects with a BP between 120-160/80-100 mmHg were randomized to Eucommia extract 500 mg three times daily for eight weeks. Automatic 24-hour ambulatory blood pressure monitoring (24-h ABPM) was utilized at baseline and after eight weeks. Study 2: The effect of the Eucommia extract on isoproterenol-stimulated lipolysis was evaluated in a human fat cell assay to determine whether Eucommia was a beta-adrenergic blocker. Study 3: Thirty healthy adult subjects with a BP between 120-160/80-100 mmHg were randomized to 1 g Eucommia extract three times daily for two weeks with 24-h ABPM at baseline and after two weeks. RESULTS: Study 1: There was no toxicity or any difference in BP between the two groups. Study 2: Eucommia at 0.5% w/v reduced isoproterenol-stimulated lipolysis from 2.67 to 1.4 times the buffer control (p<0.001). Study 3: The Eucommia extract was well-tolerated and reduced BP by an average of 7.5/3.9 mmHg (p<0.008). CONCLUSION: The standardized Eucommia extract reduced BP and has beta-adrenergic blocking activity. Eucommia may be an appropriate nutraceutical intervention for prehypertension. (Altern Med Rev 2011;16(4)338-347)
Original Research - The Effects of L-Theanine (Suntheanine) on Objective Sleep Quality in Boys with Attention Deficit Hyperactivity Disorder (ADHD): a Randomized, Double-blind, Placebo-controlled Clinical Trial Michael R. Lyon, MD, Mahendra P. Kapoor, PhD, Lekh R. Juneja, PhD
Abstract
INTRODUCTION: The purpose of this study was to investigate the efficacy and safety of L-theanine as an aid to the improvement of objectively measured sleep quality in a population of 98 male children formally diagnosed with attention-deficit/hyperactivity disorder (ADHD). METHODS: A randomized, double-blind, placebo-controlled trial was conducted involving boys, ages 8-12 years, who had been previously diagnosed with ADHD. An experienced physician confirmed the diagnosis of ADHD in each subject. Randomization was stratified based upon current use of stimulant medication to ensure an equal distribution of stimulant/non-stimulant treated subjects into active and placebo treated groups. Participants consumed two chewable tablets twice daily (at breakfast and after school), with each tablet containing 100 mg of L-theanine (total 400 mg daily Suntheanine, Taiyo Kagaku, Yokkaichi, Japan) or identical tasting chewable placebo for six weeks. Subjects were evaluated for five consecutive nights using wrist actigraphy at baseline, and again at the end of the six-week treatment period. The Pediatric Sleep Questionnaire (PSQ) was completed by parents at baseline and at the end of the treatment period. RESULTS: Actigraph watch data findings indicated that boys who consumed L-theanine obtained significantly higher sleep percentage and sleep efficiency scores, along with a non-significant trend for less activity during sleep (defined as less time awake after sleep onset) compared to those in the placebo group. Sleep latency and other sleep parameters were unchanged. The PSQ data did not correlate significantly to the objective data gathered from actigraphy, suggesting that parents were not particularly aware of their children’s sleep quality. L-theanine at relatively high doses was well tolerated with no significant adverse events. CONCLUSIONS: This study demonstrates that 400 mg daily of L-theanine is safe and effective in improving some aspects of sleep quality in boys diagnosed with ADHD. Since sleep problems are a common co-morbidity associated with ADHD, and because disturbed sleep may be linked etiologically to this disorder, L-theanine may represent a safe and important adjunctive therapy in childhood ADHD. Larger, long-term studies looking at the wider therapeutic role of this agent in this population are warranted. (Altern Med Rev 2011;16(4):348-354)
Editorial - Spare the Rod, Spoil the Industry by Al Czap, Publisher / Contributing Editor
Recent activity by the U.S. Food and Drug Administration (FDA) has demonstrated their seriousness in stepping up the level of enforcement for dietary supplement manufacturers.
On December 1, 2011, U.S. Marshals seized all the dietary supplements from Syntec, Inc., a Wisconsin manufacturer. Two reasons were given for this action. One was that the manufacturer did not comply properly with a warning letter issued in 2009, and continued to make disease claims for some of their products (i.e., the FDA alleged they were marketing some of their products to prevent, treat, or cure diseases). The second reason was a failure to address serious current Good Manufacturing Practices (GMP) violations noted during inspections in 2010 and 2011.
In November 2011, Quality Formulation Laboratories and American Sports Nutrition, as well as five individuals in ownership and management positions, were banned from manufacture or distribution of dietary supplements. The individuals were fined and sentenced to prison for a minimum of 34 months. In addition to cleanliness and GMP issues, the defendants, while acting under a civil consent decree, violated that decree by setting up another supplement plant to continue manufacturing in an effort to bypass the spirit of that decree.
These are but a few of the recent FDA actions of note. In speaking with members of the FDA, I was left with the impression that the level of demand for compliance is about to rise quickly. The failure of some industry members to comply with even basic GMP and hygiene procedures has now gone on for a sufficient amount of time. I believe the hammer is about to fall on more and more of these non-compliant industry members.
It would seem to me that, given the nervousness of some industry members, manufacturers, and distributors concerning the increased FDA activity, and the exposure of those members, consolidation of companies and labels might be in the near future for some dietary supplement industry players. There are people/companies who (1) are now aware that they are not compliant, and (2) are not willing or able to make the investment necessary for compliance. They will either shut down in the next year or two, or hold on until threatened with compliance issues or regulatory letters and fade at that point.
Make no mistake, the FDA and their compliance requirements are not going away. It will be the dietary supplement industry that will need to quit being the bad child, or the stick will loom ever larger.
Environmental Medicine - The Role of Persistent Organic Pollutants in the Worldwide Epidemic of Type 2 Diabetes Mellitus and the Possible Connection to Farmed Atlantic Salmon (Salmo salar) by Walter J. Crinnion, ND
Abstract
Rates of type 2 diabetes mellitus (T2DM), both in the United States and worldwide, have been rising at an alarming rate over the last two decades. Because this disease is viewed as primarily being attributable to unhealthy lifestyle habits, a great deal of emphasis has been placed on encouraging increased exercise, better dietary habits, and weight loss. Recent studies reveal that the presence of several persistent organic pollutants (POPs) can confer greater risk for developing the disease than some of the established lifestyle risk factors. In fact, evidence suggests the hypothesis that obesity might only be a significant risk factor when adipose tissue contains high amounts of POPs. Chlorinated pesticides and polychlorinated biphenyls, in particular, have been strongly linked to the development of metabolic syndrome, insulin resistance, and T2DM. In addition to reviewing the evidence associating POPs to these conditions, this article explores the possible contribution of farmed Atlantic salmon – a significant and common dietary source of POPs – with blood sugar dysregulation conditions. (Altern Med Rev 2011;16(4):301-313)
Environmental Medicine - A Review of the Use of Mercury in Historic and Current Ritualistic and Spiritual Practices by L. Charles Masur, MD
Abstract
Mercury (Hg) occurs naturally in the environment and has been used in numerous medicinal, commercial, and industrial applications over many centuries. Also, it has played significant historical, as well as current, ethno-medical and magico-religious roles in a number of different cultures. In recent times, awareness has emerged that exposure to mercury can have serious adverse health consequences. Accompanying this, contamination of the environment by mercury is causing public health and environmental concerns. As a result, major efforts are being undertaken by industry, private organizations, and government agencies to reduce or eliminate the use of and exposure to this toxic element. However, in spite of extensive educational and socio-cultural interventions, the use of mercury in ritualistic and spiritual practices is a continuing cause for concern. (Altern Med Rev 2011:16(4):314-320)
Monograph - Astaxanthin, Cell Membrane Nutrient with Diverse Clinical Benefits and Anti-Aging Potential by Parris M. Kidd, PhD
Abstract
Astaxanthin, a xanthophyll carotenoid, is a nutrient with unique cell membrane actions and diverse clinical benefits. This molecule neutralizes free radicals or other oxidants by either accepting or donating electrons, and without being destroyed or becoming a pro-oxidant in the process. Its linear, polar-nonpolar-polar molecular layout equips it to precisely insert into the membrane and span its entire width. In this position, astaxanthin can intercept reactive molecular species within the membrane’s hydrophobic interior and along its hydrophilic boundaries. Clinically, astaxanthin has shown diverse benefits, with excellent safety and tolerability. In double-blind, randomized controlled trials (RCTs), astaxanthin lowered oxidative stress in overweight and obese subjects and in smokers. It blocked oxidative DNA damage, lowered C-reactive protein (CRP) and other inflammation biomarkers, and boosted immunity in the tuberculin skin test. Astaxanthin lowered triglycerides and raised HDL-cholesterol in another trial and improved blood flow in an experimental microcirculation model. It improved cognition in a small clinical trial and boosted proliferation and differentiation of cultured nerve stem cells. In several Japanese RCTs, astaxanthin improved visual acuity and eye accommodation. It improved reproductive performance in men and reflux symptoms in H. pylori patients. In preliminary trials it showed promise for sports performance (soccer). In cultured cells, astaxanthin protected the mitochondria against endogenous oxygen radicals, conserved their redox (antioxidant) capacity, and enhanced their energy production efficiency. The concentrations used in these cells would be attainable in humans by modest dietary intakes. Astaxanthin’s clinical success extends beyond protection against oxidative stress and inflammation, to demonstrable promise for slowing age-related functional decline. (Altern Med Rev 2011;16(4):355-364)