In this release from medical journal publisher Elsevier, researchers at the Cleveland Clinic recommend using sterotactic radiosurgery as a first-line treatment for trigeminal neuralgia (TN), a very painful nerve disorder of the face. The study involved 50 people and used patient submitted questionnaires to evaluate the success of the treatment. The release doesn’t offer any numbers to put the effectiveness in context; we’re only told that volunteers “reported an improved quality of life and lower rates of depression after radiosurgery.”
The release also omits costs and harms and is unclear about the availability of the surgery. While the intervention is said to be effective, more details are needed before readers accept the news release’s claim that “Doctors should consider radiosurgery for patients with trigeminal neuralgia.”
Trigeminal neuralgia is a nerve pain syndrome with an unknown cause. It’s symptoms can vary from mildly intense to quite severe pain. For some, symptoms resolve on their own over time and for others, symptoms can persist. There are a number of medications that are used for treating trigeminal neuralgia. These medicines can help but may have side effects. The treatment described in this piece, radiosurgery, involves radiation treatment and may be considered a second-line treatment after medicines have failed to help or have caused intolerable side effects. Though the study does not compare radiosurgery to alternative treatments, outcomes show that symptoms decrease after treatment.
Since the study did not compare stereotactic radiation with other types of treatment, it is hard to say that this study supports a role for using this treatment earlier in the course of a patient’s symptoms.
We know surgery has many costs involved but none of them are discussed in this news release. The release mentions performing a “cost-based analysis” at the end but this is insufficient to give credit here.
There are no numbers to back up the claims in the release. The release does not share information about the actual scores from patients in this study. In addition to providing data on the EuroQOL 5-Dimension questionairre scores before and after treatment, the release should have also provided information about what constitutes a meaningful change in the EQ-5D score.
It would be most useful to know why radiosurgery is typically a “second line treatment to be used following the medication” and so one wonders if this is due to the harms involved with this type of surgery which can include fatigue, skin problems, and difficulty swallowing, none of which are mentioned in the news release. At a minimum, if there weren’t any side effects among the patient volunteers, the release could have stated that there weren’t any. Additionally, since the treatment involves radiation and radiation can promote cancer, the study should have mentioned this and why or why not it is an issue with this specific treatment.
The two questionnaires, the EuroQOL 5-Dimension and Patient Health Questionnaire 9 were administered before and after the radiosurgery. Before and after comparisons of self-reported outcomes are among the lower forms of evidence.
Limitations of this type of evidence should have been noted. Many patients could have been improved by factors not directly related to the surgery and we won’t know this without a control or comparison group. Though the piece does describe the study and what it measured (quality of life and depression), it doesn’t explicitly state that these findings aren’t compared to other treatments. Moreover, it isn’t clear what treatments patients in this study had previously or were currently taking at the time of the radiation treatment. For example, had they tried an anti-seizure medicine that is commonly used for trigeminal neuralgia and were they still taking it? One could then have asked if taking it at baseline, were they able to stop it? So while the information provided is helpful, other key pieces of data are left out and their absence makes it hard for the reader to put these results into context.
There is no obvious disease mongering here.The statement that the pain is a 15 on a 0-10 scale borders comes close. The release provides helpful context on what trigeminal neuralgia is and the problems with some current treatments.
The release doesn’t name the funder of the study. There’s also no mention of potential conflicts of interest, other than that Dr. Chao does the procedure.
Although the release comments on medicines used for treating trigeminal neuralgia, their mention focuses on very severe side effects. However, no information is provided about the use of these medicines in the patients participating in this study. Only by directly comparing different forms of treatment can one determine their relative benefits. It is also worth mentioning that some patients will have spontaneous improvement, so it isn’t clear if it was the radiation treatment, or just the passage of time that helped.
The authors suggest in the release that the radiation treatments should be used more, which implies it is not in wide use: “it [radiosurgery] is often overlooked or delayed as a treatment because there is a lack of capability and experience with the method.” This statement highlights that this may actually not be possible due to lack of trained clinicians.
The news release directly addresses the novelty of the procedure in these statements:
According to the new study, radiosurgery, which is normally a second line treatment to be used following the medication, helps improve quality of life and reduce depression in patients with TN. By considering it earlier as a treatment option, doctors could help improve the lives of patients with TN more quickly.
“We knew radiosurgery results in pain relief, but we didn’t know if the patients actually felt better,” said Dr. Samuel Chao, corresponding author of the study.
There were no major infractions in terms of unjustifiable language, yet unjustifiable conclusions based on the type and size of the study being presented here.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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