New Procedure Gives Hope to Asthma Sufferers
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New Procedure Gives Hope to Asthma Sufferers
Our Review Summary
This piece reports on a potential new treatment, bronchial thermoplasty, for use in management of asthma. This treatment should be of greatest interest to those patients whose asthma is not well controlled with currently available therapies.
It would have been best to point out that study of bronchial thermoplasty in this group has only just started and it will be necessary to see whether it is effective and safe in the long term before it is added to the treatment possibilities for this chronic disease. This approach is currently not available in the U.S. outside of the clinical trial sites. After completion of the trial, the FDA must still approve use of this medical device for this purpose, before this therapy will be available to patients.
Starting with the opening that “many people with asthma live with the fear that the next breath they take might be their last” is disease mongering. Going onto describe that “many have to inhale large doses of steroids” just compounds the sense of urgency that is not justified.
The evidence was not presented accurately. The evidence referred to in the piece was a study in Canada where the treatment was described as having been tested on “dozens” of people. These results came from the study of 16 subjects in an uncontrolled, open-label study designed to assess safety. Although there are a few other studies in the literature, including several done in dogs, the piece specifically made mention of the results “released this week.” In addition, at the very begining, the piece reported that the “procedure is now the subject of 17 clinical trials in the United States,” when, in fact, it should have reported that there is currently a single clinical trial with 17 sites in the U.S. and 12 sites outside the U.S.
Harms and benefits were not quantified. Costs were not mentioned. And the story failed to adequately put this idea into the context of successful existing approaches for most people.
Criteria
Not Satisfactory
There was no estimate for the cost of treatment mentioned.
Not Satisfactory
The benefits of treatment – the need for less medication to control asthma and a reduction in the number of asthmatic attacks were not quantified. If the story had covered these facts, it would have reported that the difference in the need for medication was not statistically significant. The paper reported that a significant number of study participants (10 out of 15) experienced more days without symptoms of asthma at 12 weeks after treatment.
Not Satisfactory
The side effects of treatment, mild coughing and wheezing, were mentioned. It would have been useful to include that the initial coughing following treatment was experienced by nearly all (94%) of the subjects in the study, and that a sizable proportion of subjects (more than half) had shortness of breath, wheezing, asthmatic attack, and chest discomfort after treatment. These side-effects might be especially worrisome for someone with asthma.
Not Satisfactory
The evidence referred to in the piece was a study in Canada where the treatment was described as having been tested on “dozens” of people. These results came from the study of 16 subjects in an uncontrolled, open-label study designed to assess safety. Although there are a few other studies in the literature, including several done in dogs, the piece specifically made mention of the results “released this week.” In addition, at the very begining, the piece reported that the “procedure is now the subject of 17 clinical trials in the United States,” when, in fact, it should have reported that there is currently a single clinical trial with 17 sites in the U.S. and 12 sites outside the U.S.
Not Satisfactory
Starting with the opening that “many people with asthma live with the fear that the next breath they take might be their last” is disease mongering. Going onto describe that “many have to inhale large doses of steroids” just compounds the sense of urgency that is not justified.
Not Satisfactory
The piece included comments from a single patient, and a physician who is the principal investigator at one of the clinical test sites. It would have been useful to include perspective from a pulmonologist not directly involved in the clinical testing of this device.
Not Satisfactory
The only other asthma treatment option mentioned was large doses of steroids inhaled twice daily. The was no mention of anti-inflammatory, bronchodilating, or leukotriene modifying medication which are successful at controlling asthma symptoms for a majority of patients. It was not mentioned that new treatment described may be of benefit to those patients for whom standard treatment is not sufficient, or for those patients with difficulty adhering to such treatment.
Not Satisfactory
Although the piece mentioned the start of a clinical trial, it neglected to provide the detail necessary for a view to understand that this treatment is currently not available in the U.S. outside of the clinical trial sites. This trial is in recruitment phase.
After completion of the trial, the FDA must still approve use of this medical device for this purpose, before this therapy will be available to patients.
The piece should have, at the very least, mentioned that bronchial thermoplasty is currently only an investigational device.
Satisfactory
This piece described a new approach to management of asthma.
Satisfactory
Does not appear to rely exclusively on a press release.
Total Score: 2 of 10 Satisfactory
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