Life 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.
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.
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.
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.
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.
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.
There is no disease mongering in this news release.
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.
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.
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.
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.
The news release does not use unjustifiable, sensational language.