The story accurately quantifies the potential benefits of delivering lidocaine via a specialized procedure performed by an interventional radiologist, and it rightfully cautions against the limitations of a small, short-term study presented at a scientific meeting. But there’s no discussion of what it costs to thread a spaghetti-sized catheter into your sinuses each month to deliver the drug, nor is it clear how lidocaine compares with the slew of pain medications already out there for migraine sufferers. It’s great that the piece quotes an independent headache expert, who provides some useful context on the procedure, but one wishes he had delivered a bit more critical perspective on the research.
More than 37 million Americans suffer from migraines, according to the National Headache Foundation, and patients are given a range of medications to treat their symptoms. However, none of these drugs works for everyone all the time. A safe, effective and long-lasting treatment that decreases patients’ chronic dependence on drugs and reduces their overuse would prove to be valuable.
There was no discussion of costs in the article. A search of 4 percent lidocaine yielded a price tag of $524.25 for 100 mL, suggesting that the costs of the lidocaine itself (they used 2 mL for each nostril, or 4 mL total) would not be significant. The main cost would be the imaging and procedure fees for the interventional radiologist. It’s not clear what those would amount to, but it wouldn’t be a trivial sum.
The story was on point with the reduction of pain levels. It mentioned that a single outpatient treatment seemed to reduce migraine pain levels by “about 35 percent for up to a month after the procedure,” which was close to the 36 percent reduction rate researchers saw on day 30. The article also explained very well the range of “pain scores” that patients experienced during the study, such as pain levels recorded from a day to a week to a month after the procedure. We’d note that in headache research, investigators usually also record the frequency of headaches as well, since this is an important quality of life measure for patients. It’s not clear why that outcome wasn’t measured in this study.
There was no mention of any harms in the story. Lead author Dr. Kenneth Mandato commented on the nasal spray as being “safe, convenient and innovative.” Such statements without any mention of the drug’s potential harms gave the story an overly positive spin. Side effects of lidocaine include flushing or redness of the skin and bleeding at the application site. And while the procedure may be ” simple” and “minimally invasive” to an interventional radiologist, anyone who’s had these catheters wending into their sinus cavities may not agree.
The story just barely fell short on this one. To its credit, the story noted that the findings were a result of a small, ongoing study of 112 patients and should be viewed as preliminary until published in a peer-reviewed journal. That’s excellent context. The story also pointed out that about 6 percent of patients failed to respond to the treatment and that more research needed to be done for a longer period of time on more patients to see if the benefits hold up.
But where the piece fell short was in addressing the study’s lack of a control group. All the patients suffered from headaches, and it seemed they knew what drug they were receiving via the catheter. An experiment without a control group could skew the results in favor of the intervention via a placebo effect – a limitation that really should have been addressed. Also, the press release issued for the study mentions that the investigator may do a definitive randomized, controlled trial in the future. It would have helped to include this detail to help put the evidence in perspective.
The article did not engage in disease mongering.
The article provided an independent source not connected to the research. Dr. Richard Lipton, director of the Montefiore Headache Center in New York City, was quoted saying the findings were “promising” and “very dramatic.” He does mention that the results need to be replicated in a larger, longer study. This would have been a good opportunity for the story to address some of the drug’s harms, the lack of a control group in the study, as well as other migraine treatments.
The article mentioned that the new procedure was a “clear simple alternative to standard migraine treatments,” but it did not detail what those treatments were. And what’s simple about image-guided therapy and a spaghetti-sized catheter? The story could have added that a whole range of medications exist to treat migraines, such as pain relievers like aspirin, to preventative medications like anti-seizure drugs, to Botox.
The availability of lidocaine (Xylocaine) was not in question, as the drug has been synthesized since the 1940s. It is now widely available in pharmacies. The bigger issue would be finding a specialist every month to deliver these infusions. Is it a procedure that any interventional radiologist could perform? Would they need any special training? The story doesn’t establish whether one can request this procedure right now or if it’s something headache sufferers will need to wait for.
Lidocaine as a drug intervention to treat migraines is not a new concept. Here is a similar study from 1999, in which patients suffering from migraines received drops of 4 percent lidocaine in their nostrils. The story didn’t mention this context.
The story is not based solely on this press release, although the language in both reports was similar. Original reporting was demonstrated through the quotes from the two doctors – Dr. Kenneth Mandato and Dr. Richard Lipton.