Health News Review

Unwarranted leaps of faith were taken from a preliminary safety trial in just 6 people.

Our Review Summary

Stating that “success” in a study of 6 people “suggests larger trials will confirm effectiveness” is not good journalism.

The harms of the intervention were also largely ignored.

So were the costs.

These are big issues.

Although this piece mentions the pilot nature of the study, the hopeful language and parallels to other therapeutic uses of DBS lead the reader to assume it is likely to work. We don’t know that and won’t for some time.


Why This Matters

New treatments are needed for severe anorexia, but reporting on small, preliminary trials should remain grounded in evidence, not in enthusiasm.


Criteria

Not Satisfactory

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

No discussion of costs, which are significant.

In this 2008 Chicago Tribune blog post, the cost of DBS was estimated at $150,000 or more per patient in some uses. There would also be additional costs for ongoing monitoring and follow-up once the device was implanted.

Not Satisfactory

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

Not Satisfactory

The story – awkwardly – in the second sentence, states that this was a trial in 6 people that “found at least half put on weight and showed improvements in mood.”

At least half of 6?  Does that mean 3?  4?

Later, much deeper in the story, it explains that “after nine months, three patients weighted more than before treatment” – so we guess the answer to “at least half” was, indeed, three. But then it says “Around half also had better moods and less obsessive-compulsive behaviour.”  Again, around half of 6?

Why not give the precise number of people?

And why did the story never give the precise amount of weight gain (in pounds or percentage of ideal body weight ) that was actually observed.

Without that, again, readers are lead to believe the weight gain was substantial.

Not Satisfactory

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story minimizes potential harms, stating “Implanting the DBS device requires minimally invasive surgery which can be completely reversed if problems occur.”  There was no other discussion of potential harms.

In fact, the researchers reported:

“DBS was associated with several adverse events, only one of which (seizure during programming, roughly 2 weeks after surgery) was serious. Other related adverse events were panic attack during surgery, nausea, air embolus, and pain.”

Not Satisfactory

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

There were two references to this being a “small study” but no amplification of what that really means.  Instead, the story allowed a leap of faith when it stated:

“This success, in a small study designed as a pilot to test the safety of the technique, suggests larger trials will confirm the effectiveness of the deep brain stimulation (DBS) device, the researchers wrote in the medical journal The Lancet.”

 

Observations from a safety phase of a trial can’t do very much to “confirm” the long-term effectiveness of an approach.

This story does not point out that there is no control group and that this was done in a study center.  These finidngs are not even clearly ready for replication let alone effectiveness studies.

Satisfactory

Does the story commit disease-mongering?

Satisfactory

There was no disease-mongering in the story.

Satisfactory

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story quoted two independent experts.

Satisfactory

Does the story compare the new approach with existing alternatives?

Satisfactory

The story stated:

“Treatment usually focuses on changing behaviour, but experts say up to 20 percent of patients get no benefit from such treatments and are at risk of dying prematurely.”

Satisfactory

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story gave some hint of availability by reporting:

“DBS is used to treat several neurological illnesses including Parkinson’s disease and chronic pain. Scientists are also investigating its use in depression and epilepsy, but this was the first time it had been used in patients with anorexia.”

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

For the same reason as our “Availability” criterion score above, we’ll give a Satisfactory grade because of this line:

“DBS is used to treat several neurological illnesses including Parkinson’s disease and chronic pain. Scientists are also investigating its use in depression and epilepsy, but this was the first time it had been used in patients with anorexia.”

Satisfactory

Does the story appear to rely solely or largely on a news release?

Satisfactory

It does not appear that story relied solely or largely on a news release.

Total Score: 6 of 10 Satisfactory


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