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Company release on green tea for Down syndrome good on transparency, avoids hype

FORT LAUDERDALE, Fla., July 26, 2016 /PRNewswire/ — New research published in Lancet Neurology and reported by CNN has found using a green tea extract (decaffeinated) in combination with cognitive training improves some measures of cognition and behavior in subjects with Down syndrome.

Eighty-seven volunteers aged 16 to 34 with Down syndrome were enrolled in the phase 2, randomized, controlled trial. The study was conducted at the IMIM-Hospital del Mar Medical Research Institute in Barcelona, Spain.

Participants were randomly assigned to take the decaffeinated green tea extract or placebo for one year. All subjects also underwent cognitive training during the 12-month trial.

After one year of treatment, functional brain scans (fMRI) showed that epigallocatechin-3-gallate (EGCG)-treated subjects had improved neuronal connectivity in certain brain regions. Participants who took the green tea extract also scored significantly better on assessments of visual recognition memory, inhibitory control, and adaptive behavior compared with those who took the placebo.

“It’s an important trial,” says Dr. Steven Hirsh, director of clinical research for Life Extension in Fort Lauderdale, Fla. “The findings are very noteworthy and support further study in randomized controlled trials with larger sample sizes and durations. It is very encouraging that this catechin, EGCG, from green tea extract, has the potential to benefit people with Down syndrome.”

Down syndrome is a genetic condition that affects about 250,000 Americans. Individuals with Down syndrome have an extra full or partial copy of chromosome 21.

The team of researchers, led by Dr. Rafael de la Torre, program director of IMIM Hospital del Mar Medical Research Institute and study co-principal investigator, and Dr. Mara Dierssen, group leader at Center for Genomic Regulation, Barcelona, Spain, and study co-principal investigator, proposed that EGCG might have conferred these benefits by inhibiting an enzyme called DYRK1A, which has been implicated in Down syndrome and neurodegenerative conditions including Alzheimer disease.

The level of DYRK1A-positive cells is elevated in certain regions of Alzheimer disease patients’ brains, and is roughly 20-fold higher in the frontal cortex, compared to normal brains. DYRK1A is implicated in the formation of neurofibrillary tangles (via tau hyperphosphorylation) and amyloid plaques, both of which are features of Alzheimer disease.

Tea catechins may also modulate the damaging effects of amyloid-beta. Several animal studies have found that EGCG and related compounds from tea suppress amyloid-beta-induced cognitive dysfunction and neurotoxicity. Other possible mechanisms by which EGCG may influence cognition include epigenetic regulation, restoration of mitochondrial function, and anti-oxidative functions.

In an earlier pilot study supported by Life Extension, Drs. de la Torre and Dierssen’s team showed that three months of EGCG treatment improved symptoms in individuals with Down syndrome, and in mice with a Down-syndrome-like condition characterized by overexpression of DYRK1A.

“We are excited that the benefits observed in the early pilot and preclinical research extended to this larger trial,” says Luke G. Huber, ND, MBA, vice president of product innovation and scientific development at Life Extension. “This new research adds to the growing body of evidence that suggests compounds in green tea, such as EGCG, may support cognitive health.”

In acknowledging the novelty of their findings and calling for more research, the Spanish research team noted that “…this study is the first well-powered trial that shows improvement in adaptive behavior (functional academics) and brain-related changes in young adults with Down’s syndrome. However, more research is needed to clarify the nature of the beneficial association between the EGCG and cognitive training intervention (ie, synergistic or additive).”

References:

  1. de la Torre R, de Sola S, Hernandez G, et al. Safety and efficacy of cognitive training plus epigallocatechin-3-gallate in young adults with Down’s syndrome (TESDAD): a double-blind, randomised, placebo-controlled, phase 2 trial. The Lancet Neurology. 2016;15(8):801-810.
  2. Senthilingam M. Cable News Network (CNN) U. S. Edition [online]. Can green tea boost your brainpower and treat disease? http://www.cnn.com/2016/06/16/health/green-tea-health-brain-down-syndrome/. Last updated 6/20/2016. Accessed 7/1/2016. 2016.
  3. CDC. Centers for Disease Control and Prevention. Birth Defects. Key Findings: Prevalence of Down syndrome in the United States. http://www.cdc.gov/ncbddd/birthdefects/features/key-findings-down-syndrome-prevalence.html. Last updated 2/29/2016. Accessed 7/18/2016. 2016.
  4. NDSS. What Is Down Syndrome? 2012; http://www.ndss.org/Down-Syndrome/What-Is-Down-Syndrome/. Accessed 6/8/2016.
  5. Stotani S, Giordanetto F, Medda F. DYRK1A inhibition as potential treatment for Alzheimer’s disease. Future medicinal chemistry. 2016;8(6):681-696.
  6. Souchet B, Latour A, Gu Y, et al. Molecular rescue of DYRK1A overexpression in cystathionine beta synthase-deficient mouse brain by enriched environment combined with voluntary exercise. Journal of molecular neuroscience : MN. 2015;55(2):318-323.
  7. Becker W, Soppa U, Tejedor FJ. DYRK1A: a potential drug target for multiple Down syndrome neuropathologies. CNS & neurological disorders drug targets. 2014;13(1):26-33.
  8. Wegiel J, Gong CX, Hwang YW. The role of DYRK1A in neurodegenerative diseases. The FEBS journal. 2011;278(2):236-245.
  9. Bhat RV, Budd Haeberlein SL, Avila J. Glycogen synthase kinase 3: a drug target for CNS therapies. Journal of neurochemistry. 2004;89(6):1313-1317.
  10. Avila J, Hernandez F. GSK-3 inhibitors for Alzheimer’s disease. Expert review of neurotherapeutics. 2007;7(11):1527-1533.
  11. Jope RS, Roh M-S. Glycogen Synthase Kinase-3 (GSK3) in Psychiatric Diseases and Therapeutic Interventions. Current Drug Targets. 2006;7(11):1421-1434.
  12. Kim TI, Lee YK, Park SG, et al. l-Theanine, an amino acid in green tea, attenuates β-amyloid-induced cognitive dysfunction and neurotoxicity: reduction in oxidative damage and inactivation of ERK/p38 kinase and NF-κB pathways. Free Radical Biology and Medicine. 2009;47(11):1601-1610.
  13. Rezai-Zadeh K, Arendash GW, Hou H, et al. Green tea epigallocatechin-3-gallate (EGCG) reduces β-amyloid mediated cognitive impairment and modulates tau pathology in Alzheimer transgenic mice. Brain research. 2008;1214:177-187.
  14. Haque AM, Hashimoto M, Katakura M, Hara Y, Shido O. Green tea catechins prevent cognitive deficits caused by Abeta1-40 in rats. The Journal of nutritional biochemistry. 2008;19(9):619-626.
  15. De la Torre R, De Sola S, Pons M, et al. Epigallocatechin-3-gallate, a DYRK1A inhibitor, rescues cognitive deficits in Down syndrome mouse models and in humans. Molecular nutrition & food research. 2014;58(2):278-288.

 

SOURCE Life Extension

Life Extension-supported study published in Lancet Neurology finds green tea extract improves cognition in Down Syndrome

Our Review Summary

Hand on the tea fieldLife Extension is a health supplement company that helped support a double-blind, randomized, placebo-controlled phase 2 trial looking at the benefits of epigallocatechin-3-gallate (EGCG), a constituent of green tea extract, in young adults with Down syndrome.

For a news release provided by a company, the language used to describe its results is measured, with no touting of its products between the lines. The release is up-front about the company’s status as funder of the research and explains how the findings are novel. However, readers are given a somewhat bare bones description of the trial that uses vague wording and lacks numerical estimates of costs and benefits. We’re only told that participants in the therapy arm improved in “some measures” of cognition and behavior, while scoring “significantly better” on other assessments. There is no mention of the study’s limitations or the treatment’s adverse effects.

We also would have liked more context on Down syndrome, such as existing therapy options, including other drugs already on the market.

 

Why This Matters

Down syndrome is the most common genetic chromosomal disorder and cause of learning disabilities in children, causing lifelong developmental delays. In some people, it can cause a number of health problems and conditions. Unfortunately, there is no cure or a single, standard treatment for Down syndrome. Treatments are individual, based on one’s physical and intellectual needs. Most interventions are therapies, ranging from physical/occupational to emotional/behavioral.

According to the National Institutes of Health, some people with Down syndrome take amino acid supplements or drugs that affect their brain activity, but many recent clinical trials of these treatments were poorly controlled and revealed adverse effects. Newer, more specific psychoactive drugs have been developed, but no controlled clinical studies of these medications for Down syndrome have demonstrated their safety and efficacy.

As a result, research providing an effective, non-toxic option to treat Down syndrome is newsworthy, especially if the study is already in the phase II clinical phase.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The release doesn’t mention the cost of the green tree extract used in the study. By going to the manufacturer’s website we found that a bottle of Life Extension Decaffeinated Mega Green Tea Extract with 100 capsules — about a month’s supply – is priced at $22.50.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release doesn’t provide any context for understanding the clinical importance of the observed changes in memory, control, and adaptive behavior. Vague language (“some measures of cognition and behavior”) is used to describe the benefits experienced by subjects in the study. We are told that participants taking the supplement showed improvements in neuronal connectivity and had “scored significantly better on assessments of visual recognition memory, inhibitory control and adaptive behavior,” compared to those who took the rice flour pills.

But we aren’t told the extent of the benefit, how long the benefits lasted and how many people even took the supplements out of the original 87 volunteers. And the use of the word “significantly” here could be confusing for readers, since it’s meant as “statistically significant” instead of the colloquial use of the term, which could mean “impressively” or “largely.”

We are told that participants underwent a series of “assessments” for cognition and behavior, but we don’t know how these evaluations were conducted and what exactly these neuropsychological measures were.

We think quantification of potential benefits and a description of the measurement tools used are necessary in a news release, which is why we are giving it an Unsatisfactory rating here.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Although adverse effects were reported by by study participants (e.g bone and joint pain, headache, physical weakness and celiac disease), researchers commented in the study that these conditions were not related to treatment, since “no differences were noted in adverse effects between the two treatment groups.”

But if there are no side effects, then a simple acknowledgement that “there were no adverse effects” would still be in order, and the release didn’t provide this.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The news release does a good job mentioning the study inclusion criteria and pointing out that the study was a phase 2, randomized, controlled trial. It also gets points for drawing attention (a little obliquely) to some of the trial limitations when it calls for “further study in randomized controlled trials with larger sample sizes and durations.”

The limitations identified in the study include the relative small study size and the acknowledgement that the “choice of their assessment instruments” could have caused them to have overlooked some of the supplement’s effects.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in this news release.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The news release makes it clear that the study was supported by Life Extension and discloses Life Extension’s involvement in an earlier pilot study. The two sources quoted in the news release have ties to Life Extension – a fact the news release also makes clear in their titles.

We applaud the news release for disclosing this information, which is why we give it a Satisfactory rating here.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Researchers point out in their journal article that there is no approved intervention to improve cognitive deficits in individuals with Down’s syndrome. General treatment approaches include early intervention and educational, physical, speech-language, occupational and emotional/behavioral therapies, according to the National Institutes of Health. Regarding drugs and supplements, the agency adds, “No controlled clinical studies of these medications for Down syndrome have demonstrated their safety and efficacy, however.”

But the release contains none of this context and makes no mention of potential treatment alternatives, which is why we rate it Not Satisfactory here.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

The news release could have been more explicit in pointing out that green tea extract supplements are easily available online or at the local health foods store. However, we give it here the benefit of the doubt, since it disclosed Life Extension’s support in this study. Furthermore, the availability of green tea is not in question.

We rate this one Not Applicable.

Does the news release establish the true novelty of the approach?

Satisfactory

The news release does a satisfactory job providing context and detailing what this study brings to the current body of literature. An earlier pilot study supported by Life Extension looked at mice with a “Down-syndrome-life condition” and EGCG intervention. The current study is the first trial to show improvement in adaptive behavior and brain-related changes in young adults with Down’s syndrome, according to researchers. The news release then cautions that more research is needed to understand the correlation between EGCG and cognitive training intervention.

For these reasons, we give the news release a Satisfactory rating here.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The news release does not use unjustifiable, sensational language.

Total Score: 5 of 9 Satisfactory

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