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Study Looks at Deep Brain Stimulation in Bipolar Patients

Rating

4 Star

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Study Looks at Deep Brain Stimulation in Bipolar Patients

Our Review Summary

This solid story on a very small study of deep brain stimulation gives readers a lot of the information they need, but it also likely will lead to some confusion about what the study found. With a little more work clarifying the potential benefits of the treatment and a better discussion of the potential side effects, this story would have provided much more helpful information on a breaking study.

 

Why This Matters

Deep brain stimulation has been touted for a number of disorders, including Parkinson’s disease. Because it is expensive and invasive, studies typically only include a few patients at a time, making it difficult to draw broad conclusions from any one study. This story takes the appropriate cautionary tone, giving readers a glimpse of the treatment’s potential while staying well clear of any hype.

The treatment of depression and bipolar disorder has improved in the past decades.  However despite the relative success of newer medications and a better understanding of the pathophysiology of the disorders, many patients do not obtain either an improvement in symptoms or have relapses while undergoing treatment.  Deep brain stimulation has shown some promise in several studies over the past ten years but the jury is still out on its effectiveness and durability.  This study is not a landmark but rather one more piece of information.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

We would have liked to have seen a little more information on costs, but we are glad that costs are mentioned up high. In the third sentence, the story says, “The surgery necessary to allow deep brain stimulation is extremely expensive” Later it says, “The cost of the surgery is about $50,000”. It would have been interesting to note whether deep brain stimulation is covered by Medicare or any insurance companies for treatment of any disorders, including Parkinson’s.

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

Not Satisfactory

The story attempts to quantify the benefits in both relative and absolute terms, but it leaves readers confused because of the shifting nature of the study cohort. It looks as if the study started with 17 patients but then later it says that the study looked at 14 patients. It says, “The researchers found that 18 percent of patients went into remission after 24 weeks, 36 percent (of 14 patients) after one year. After two years, of the 12 patients still in the study, seven patients (58 percent) were in remission.” The change in the number appears to be because the researchers stopped doing the deep brain stimulation on three patients, a fact that is not fully explored in the story. This all would have been more easily explained and less confusing if the story had just stuck with the absolute numbers. If you try to do the math on 18 percent of 14 patients, for example, you get 2.52 patients. Was it two patients? Was it three?

Why not just tell readers x number out of x number?

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

Not Satisfactory

There’s just one line in the story about harms: “Patients didn’t suffer from side effects, she noted.” The story also says, “The workings of deep brain stimulation as a whole are a mystery, although Mayberg said it may work by changing the brain’s rhythms.” If how it works is a mystery, we think a little more space should have been devoted to potential harms. There were a total of 8 adverse events related to either the surgery or the device, two of which were deemed serious (infection). The story misses these events entirely.

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

Satisfactory

The story cautiously explains the evidence and the reasons for the optimism around the evidence. It shows that the study is in a very small group of people — just 17. But it also shows that the study followed them for two years.

However, while providing some of the important caveats, it fails to note that there were no control subjects.  While the results may appear encouraging, they are by no means definitive without a control group.

Nonetheless, we’ll give the story the benefit of the doubt on this one.

Does the story commit disease-mongering?

Satisfactory

The story does not engage in disease mongering and makes it clear that it is “too early to know for sure if the treatment is appropriate to be used for any kind of depression.”

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

Satisfactory

The story says that the St. Jude Medical Neuromodulation company “provided consulting fees to Mayberg and some of the other study authors” and “is currently recruiting patients for a study that could pave the way for its approval as a treatment for depression.” The story also quotes Samuel James Collier, M.D., assistant professor of psychiatry, University of Texas Southwestern Medical Center at Austin, who provides a welcome dose of skepticism to the story, saying “Medications and ECT — electroconvulsive therapy — are clearly safer, better tolerated, and do not embody a large surgical risk. …I can’t think of a scenario where deep brain stimulation would be considered even remotely before medications and ECT were exhausted.”

 

Does the story compare the new approach with existing alternatives?

Satisfactory

The story alludes to other treatment options, including medications and electroconvulsive therapy, and it quotes an outside expert saying that these are preferable.

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

Satisfactory

The story makes it clear that the treatment is widely available, saying, “Deep brain stimulation has been around for more than 20 years…and is commonly used to treat Parkinson’s disease.”

Does the story establish the true novelty of the approach?

Not Applicable

There are no claims of novelty made in the story.

Total Score: 7 of 9 Satisfactory

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