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Patient-swimmer testimonial unbalances PR release on Viagra study

Study suggests sildenafil may relieve severe form of edema in swimmers

Our Review Summary

swimmerThis news release describes a small study of individuals prone to swimming-induced pulmonary edema (SIPE, fluid in the lung) that found that giving them a dose of sildenafil (sold under the brand name Viagra) dilated blood vessels and prevented the cold water-induced constriction that may cause the problem. The study involved 10 individuals with a history of SIPE and 20 control subjects.

The news release, based on the study published in the journal Circulation, describes the condition and the study parameters nicely but then overwhelms the cautionary comments appropriate for such a modest design with an enthusiastic testimonial from a participant who felt the medicine was a life-changer. The release would be stronger if it had added some quantification of the benefits and relied less on a patient testimonial to make its case.

 

Why This Matters

A treatment for swimming-induced pulmonary edema likely won’t matter to most of us recreational swimmers since the incidence of the condition seems low and confined to serious, competitive swimmers and divers. However, the subset of individuals diagnosed with the problem may find the availability of a medication attractive — if it stands up to the rigor of larger studies.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Cost is not mentioned in the release.

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

Not Satisfactory

Although the press release indicates that measures of pulmonary arterial pressure “were no longer as elevated” in individuals who received sildenafil, the document got no more specific than that. The author described the benefit very vaguely in this statement:

“It appears that the drug, which dilates the blood vessels, could be creating more capacity in the blood vessels in the arms and legs, reducing the tendency for blood to redistribute to the thorax, and therefore reducing the high pressure in the pulmonary vessels.”

We’re also concerned with the glowing anecdote that the release uses to illustrate the drug’s benefits. The study itself looked at pulmonary arterial pressure and had nothing to say about sildenafil’s ability to prevent bouts of SIPE during competition. Nevertheless, this study participant gushes,

“I have successfully raced in 20 triathlons since I started taking sildenafil, including five ultra events that require 10-kilometer swims,” Calder-Becker said. “I have not had an incident since then. I didn’t want to give up racing — this is something my husband and I do together, and we travel together to competitions — so it has meant everything to me to continue.”

The anecdote goes well beyond the limited parameters of the study and overwhelms any cautions regarding the limitations of current evidence.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

Although the study itself is silent on the potential harms seen in the subjects treated with sildenafil, we think that the story should have noted that explicitly. Are four-hour erections an issue that swimmers need to be concerned about? Harmful side effects of ingesting sildenafil certainly exist but are not broached here.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The news release describes the published study in some detail, and the first author goes on record calling for larger studies “to replicate the results and learn more about possible adverse side effects of the drug.”

Does the news release commit disease-mongering?

Not Satisfactory

The release offers no information about the incidence of this condition among swimmers and divers and, because this condition is rare, it could unnecessarily raise some alarms. And while it makes clear that the symptoms of swimming-induced pulmonary edema “often” disappear over the course of 24 hours in the subset of swimmers and divers who have the condition, it also notes that the problem can be fatal, again without providing any incidence data. The reader will likely be more concerned than she or he should be.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The funders are mentioned, although the release makes no effort to clarify possible conflicts of interest. The study on which this news release is based states that the principle investigators have no conflicts of interest.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

Information about possible treatment alternatives (for example, diuretics or oxygen) is not provided.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The very first sentence of the release characterizes sildenafil as “readily available.” Indeed it is. It is Viagra ™.

Does the news release establish the true novelty of the approach?

Satisfactory

The release notes that the drug is already used as a treatment for another lung condition — pulmonary arterial hypertension — so this application would be an extension of sildenafil to another lung condition. Health professionals have speculated in the past on the ability of drugs such as sildenafil to help individuals cope with swimming-induced pulmonary edema. The published research notes that this study tested that hypothesis.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

We found no language in the release that was clearly out of bounds. As noted above, however, we’re concerned that cautionary language is overwhelmed by an enthusiastic testimonial from a swimmer who believes she has benefited from using the drug.

Total Score: 5 of 10 Satisfactory

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