“Shows promise” – trumpets the headline.
In a tiny sample of 24 men, with more questions raised than answered.
The story allows supporters to say that the new approach, which involves using extreme cold to destroy nerve tissue (a technique known as cryoablation), “could someday become a standard treatment” for PE. But the study discussed here doesn’t come close to the evidence needed to justify such a bold claim. The story also didn’t apply quite enough scrutiny to statistics regarding the prevalance of PE (which struck us as disease-mongering), nor did it explain whether the improvement in stamina reported by the researchers made a difference in the men’s sexual satisfaction – or that of their partners. Those significant concerns aside, we thought the story did a good job of explaining the nuts and bolts of how the procedure works. We also liked that it raised questions about the durability of the treatment and potential for long-term adverse effects.
While many men report that they have had trouble ejaculating early at one time or another, it doesn’t appear that there is really any “normal” amount of time it should take. Some men are quick, others are slow — and the amount of time considered appropriate can vary from individual to individual and across cultures. That’s important background to consider in any discussion of new treatments for PE. Because while some men and their partners clearly suffer significant impairment related to PE and would benefit from new treatments, others who might be labeled “premature” would be better off not knowing that such a syndrome exists. As we explore new treatments for those who truly suffer impairment, we should strive to avoid pathologizing the normal range of human behavior.
The company estimates that this procedure costs about $3500 — a cost which obviously would rise if the procedure has to be repeated in order to maintain efficacy as suggested in the story. But we wish the story had more explicitly addressed this: costs that could reach $14,000 a year if effects wear off within 3 months. It also would have been interesting to see some comparison of this cost with that of drug therapy and/or psychological counseling.
The story tells us that men in the study lasted three times longer after the procedure, an increase from 36 seconds to 110 seconds. While this is important information to communicate, it is arguably just as important to tell us how this increase in stamina affected the men’s satisfaction with their performance. While definitions vary, ejaculation is typically considered “premature” only if it causes distress or dissatisfaction. So treatments need to be judged on the basis of whether they improve the individual’s subjective perception of their performance. Is an additional 80 seconds of intercourse enough to make a difference in how these men felt about their sexual experiences? (Or how their partners felt?) The story does tell us that all men “improved on at least one sexual-related symptom,” but it doesn’t tell us which symptoms were affected or how much improvement was seen.
The story states that there were “no side effects” from the procedure, but then goes on to explain that three men reported that their erections weren’t as firm after the procedure. Call us picky, but wouldn’t that count as a side effect? We were pleased to see some mention of the potential for nerve damage if the procedure needs to be repeated in order to maintain its effectiveness. But there should have been some acknowledgment that this study was far too small to accurately assess potential harms of the procedure. A mixed bag, but enough concerns were raised to give the benefit of the doubt on this one.
The story gets far ahead of itself when it allows “supporters” of the procedure to claim that it “could someday become a standard treatment for” PE. (We note that this is the second story by WebMD within a few days out of the same conference that allowed supporters of a new idea to claim their idea could become a standard treatment someday. Here’s the other one.) The statement is technically correct, but then again it’s also true that the reviewers of this story “could someday” be voted “sexiest men alive” by People Magazine, too. But you wouldn’t want to go public with such a prediction. Similarly, we think it’s too early to talk about a new standard of treatment when the best available supporting evidence comes from a small, uncontrolled experiment — the kind that can be easily skewed by placebo effects. We would be much more confident in the study’s findings had it compared the treatment against a “sham” cryoablation procedure performed on a control group. And we wish the story had warned readers about the limitations of uncontrolled studies when evaluating a treatment’s potential benefits.
The story’s estimate of PE prevalence (20% to 38%) is in line with the figures reported in a 2006 review of the literature. We wish such stories would cite prevalence sources – as we just did.
We also think the story could have mentioned that there is considerable uncertainty about these numbers due to the fact that there is no standard definition of PE. We think that estimates at the higher end of this range are likely overstating the scope of the problem. In one study that reported a 32.5% overall prevalence of PE, for example, about half of participants said that their PE symptoms caused them little or no distress. And if you’re including men who suffer no distress in your population of PE “sufferers,” that smacks of medicalizing people who are exhibiting a normal range of behavior. In other words, disease-mongering.
The story notifies us that the study was funded by Galil Medical, and that one of the sources consults for them. It also obtains a comment from an independent expert, who adds some important context regarding the uncertain long-term safety of the procedure.
The story mentions antidepressants, anesthetic ointments and cream, and behavioral therapies as alternatives for PE.
It’s clear that this procedure is not currently available to the typical patient.
The story doesn’t exaggerate the novelty of the procedure.
This story does not rely excessively on any press release.