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University offers muddled summary of dementia study in mice using ‘healing’ sound waves

Rating

2 Star

Treating dementia with the healing waves of sound

Our Review Summary

animal researchThis release by Tohoku University in Japan promotes a dementia-related study in mice, specifically a technique called low-intensity pulsed ultrasound, or LIPUS. It notes that previous research has looked at focused ultrasound on the brains of mice that were genetically engineered to simulate having Alzheimer’s disease, but notes LIPUS is a whole-brain ultrasound approach.

The research suggests the technique “improved blood vessel formation and nerve cell regeneration without having obvious side effects.” While the release itself was clear that the research was performed on mice, the headline is not; it seems to present as fact the existence of a safe, sound-based “healing” treatment for dementia patients, when this is absolutely not the case. (There currently is no known safe and effective treatment for dementia.) Headlines are extremely important to get right, since many media outlets today are pinched for resources and time and often follow the framing of news releases when publishing stories about studies.

The image accompanying the release is also misleading since it features a young man wearing headphones, when the study was not done in humans.

 

Why This Matters

About 47 million people lived with dementia in 2015, and more than 131 million people may be living with dementia by 2050, according to the World Alzheimer Report 2016. Safe and effective treatments for the disease have yet to bear out in any clinical trials involving humans, despite a lot of initially promising research involving animal models. If a reliable treatment could be created to improve, stabilize, or even just slow down cognitive decline in dementia patients, perhaps millions of people and their families would stand to benefit. This release is part of an ongoing and problematic trend in medical writing that leaves room for readers (be they journalists or the public) to assume that animal-model-based research is a reliable indicator of what happens in humans. In fact, most of this kind of research doesn’t lead to quality treatments in people — most of them do not make it through clinical trials due to lack of efficacy, detrimental side effects, and other issues.

Criteria

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

Not Applicable

We don’t see any dollar signs, but we mark this one “not applicable” because the research is at such an early phase and just making the transition from animal models to clinical trials. And though it’s unreasonable to speculate how much a LIPUS device or treatment may cost, if it pans out to be safe and effective, ultrasound scans can cost anywhere between about $70 and $500 per body part in 2018 dollars, according to a 2005 study.

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

Not Satisfactory

We are not given enough detail about the findings nor given any evidence that this treatment will be of benefit to humans. We only get a cursory mention of benefits here for the mice in the experiments: “whole-brain LIPUS therapy markedly improves cognitive dysfunctions without serious side effects.” But the study is full of detailed numbers. For instance, LIPUS apparently improved the brain’s blood flow in mice modeled to have vascular dementia by a significant single-digit percentage, roughly doubled the memory performance of those mice in one experiment, and possibly halved the grade or severity of brain lesions.

A more important issue with this release is the vagueness of its headline — i.e. “Treating dementia with the healing waves of sound.” This could be read as teasing a beneficial treatment for humans, yet using what is a very early animal-model-based study. The headline should have qualified the mouse-based nature of the research, even if it wouldn’t have been as interesting to journalists looking for a research study to cover.

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

Not Satisfactory

The release notes there were no “obvious side effects” in the mice. But we really have no idea if there would be harms in humans or even primate models. Ultrasound applied to the head has been shown to warm up tissues in the brain, though what possible harm this may cause is uncertain. High-energy frequencies (greater than those used by LIPUS) can cause a raft of detrimental effects, though, including temporary suppression of brain cell function and brain damage.

The study goes into further detail on harms in the mice models by stating “LIPUS-treated mice showed no signs of cramps, paralysis, cerebral hemorrhage, hypothermia, hyperthermia, or increased mortality compared with control mice.” However, you can’t ask a mouse how it feels, and it’s uncertain how often LIPUS may be needed in a mouse, let alone a person, to reap any potential benefits.

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

Not Satisfactory

While the headline teases a possible therapy for what is currently two incurable diseases, its main text focuses on the mouse-model-based study. Still, we’re not given any indication of how the work was done. The research is built on prior studies of ultrasound use on the brains of porcupinesmice, and rats — not humans. A maximum of 25 mice were used for an experiment within the study, though more often less than a dozen were used. This is a small sample size that led to wide margins of error (so the same experiments on larger numbers of mice may produce different results).

The release also ignored what is perhaps the most significant aspect of the study, which was its floating of a possible mechanism for how ultrasound might help mice brains afflicted with models for dementia: affecting a number of genes in mice that promote the creation of nitric oxide, which can increase blood flow and encourage the immune system to remove debris (perhaps including plaques associated with Alzheimer’s disease). The release wording suggests readers would just accept the “magic” of the healing waves of sound without an explanation of mechanism of action.

Does the news release commit disease-mongering?

Satisfactory

The release doesn’t engage in disease mongering. It provides some context about the prevalence of dementia worldwide.

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

Satisfactory

In the release, the Japan Agency for Medical Research and Development is listed as the funder. However, we note that the study’s supplementary study materials say the research was supported “in part” by the organization, which suggests there may have been other funding sources (though the authors declared no conflict of interest).

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

Satisfactory

The release states that “there are currently no curative treatments available for vascular dementia or Alzheimer’s disease, the most common causes of dementia.”

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

Satisfactory

The release states that clinical trials are underway, which tells us (not quite clearly) that the LIPUS treatment isn’t yet available to the public.

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

Not Satisfactory

The release notes how this study builds on previous LIPUS work (on the heart, nerve cells, and brain regions of mice) and goes after a whole-brain approach instead of targeting just one part of the brain with ultrasonic waves. However, a quick search of other studies show that ultrasound has been used before to explore its potentially therapeutic effects on mouse models for dementia; one of the more notable studies was published by a research group in Australia in 2015, though neither the release nor the study reference it.

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

Not Satisfactory

We found this quote from the lead author partly unjustifiable: “The LIPUS therapy is a non-invasive physiotherapy that could apply to high-risk elderly patients without the need for surgery or anaesthesia, and could be used repeatedly.” The quote is caveated — i.e. “could apply” — but it’s still a major leap to connect early results from animal-model research to a real-world treatment, especially the suggestion that it won’t harm anyone and remain effective with repetition (something the study doesn’t really address, as the treatment is front-loaded three times within five days). Also, most medical research doesn’t pan out; treatments often fail to work in clinical trials involving humans, or the potential harms detected tend to outweigh the possible benefits.

A more responsible quote would have noted that a human treatment is the ultimate hope, but that much more research remains to show that it works in humans and that it’s safe when repeated, either in mice or humans.

Total Score: 4 of 9 Satisfactory

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