To its credit, this story delivers something we don’t often see in health news: an anecdote from a patient who wasn’t helped by the treatment being profiled. That’s a welcome inclusion in a field that too often hypes the benefits of treatments with unjustifiably frothy language.
But that bright spot couldn’t completely make up for a number of deficiencies in the coverage. Our wish list includes an independent expert comment from a clinician who treats Parkinson’s patients, some discussion of the limitations of this 10-person study, and a more detailed description, with numbers, of how much the patients benefited.
Because Parkinson’s disturbs gait and balance, patients are at greater risk of falling. Any intervention that would reduce that risk could be a boon to treatment. In addition, many patients have adverse effects with levodopa, the pharmacologic mainstay, so non-pharmacologic interventions to improve symptoms would be helpful.
Though the device remains experimental, the story says it is similar to other TENS (Transcutaneous Electrical Nerve Stimulation) devices. A typical cost for TENS according to an internet search varies from $40 to $200 — a figure that the story could easily have provided. Some insurers may cover this cost, but possibly not for conditions where there is not a clearly demonstrated benefit.
We’d like to point out this story’s reporting on a patient who didn’t receive any benefit from the device. These kinds of anecdotes are rare and valuable in health stories, which too often focus on patients who achieve spectacular, unrepresentative results. The reality for many patients is often more prosaic, as this quote nicely conveys: “I have become hardened in the sense that I do not have too great expectations. But I still believe that something will be found at some point which could be useful. There is extensive research in this field and I hope that it eventually will come up with a result.”
That being said, we have to rate this story Not Satisfactory because it never quantifies the apparent benefit, summarizing it instead in general terms: “According to the research institute, the experiments showed that the active noise stimulation improved both the patients’ balance and the combined symptoms.” Patients need to know something about degree of benefit to determine if this is something that may be worth exploring.
The story makes no mention of harms, though the study itself says that the intervention resulted in increased nausea in two patients.
There is not enough detail as to just what the evidence is here. Although we see from the story that there was a study involving 10 patients, it’s not clear how the results were disseminated or whether they’ve undergone any independent quality control via peer review. (As it turns out, the study was published in December in the journal Brain Stimulation.) And while the story describes in broad terms how the researchers tested the device, it offers no caveats or discussion of limitations. We’d note that a study involving only 10 patients is certainly limited in what it can tell us about the effectiveness of this device. In addition, the researchers noted that the balance measurements they took of the study patients were surrogates or proxies for the outcome that really matters to Parkinson’s patients: falls. It’s not clear whether the improvements the researchers saw will translate to reduced risk of falls for Parkinson’s patients.
The story makes no reference to the incidence of Parkinson’s, and there are no ‘alarm statements’ about the condition.
The story provides useful comments from the primary study investigator, but that’s not quite enough to earn a satisfactory rating here. At the least, we’d expect a comment from a clinician who cares for Parkinson’s patients to provide some independent insight on this treatment.
The story says that levodopa is commonly used to treat the symptoms associated with Parkinson’s, and notes that the drug’s efficacy tends to wane over time.
The story makes clear that the device is experimental and, as a result, not available to the public. For comparative purposes, the story could have cited the cost of other devices that use the TENS technology.
The story notes that the TENS technology has found use in other areas of medicine.
The story does draw considerably from this news release, as noted below:
The researchers have also tested the method on ten Swedish Parkinson’s patients, in both medicated and unmedicated states. According to Sahlgrenska, on one day the patients received an active noise stimulation and on another day inactive treatment, not knowing which day the current was active. According to the research institute, the experiments showed that the active noise stimulation improved both the patients’ balance and the combined symptoms.
The researchers have now tested the same method on ten Swedish Parkinson’s patients.
The patients were studied in both medicated and unmedicated states. On one day, the patients received an active noise stimulation and on another day inactive treatment, blinded to which day the current was active. The experiments show that the active noise stimulation improved both the patients’ balance and the combined symptoms.
However, because the story includes quotes from the primary investigator and a study subject, we can be sure that the press release wasn’t the only source of information.