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Conduct asthma trial correctly

The QEH is reported to be recruiting for a trial of Fenzian, a device which is marketed as allowing patients to “remain free of asthma symptoms and off all medication”.

Asthma is an increasing problem across the world, including in Barbados and any effort to treat it should be welcomed. Having said this, the trial in Barbados must be carried out correctly and in accordance with good scientific practice, or it will prove nothing.

I hope therefore, that the QEH has carried out its proper due diligence on this trial before giving the go-ahead and in particular has reviewed the following issues:

* Fenzian is said in the Barbados Today article to have received “approval from the US Federal Food and Drug Administration”. The FDA gave notice in 2004 that Fenzian fell within a class of devices which did not require FDA approval before it could be marketed.

I am not sure that this is the same as “approval”. It should also be noted that the application was for treatment for relief of chronic pain through nerve stimulation – not for the treatment of asthma.

* A clinical trial to see whether Fenzian works as a treatment for asthma is already being carried out by the University of California. The results of the five-week study carried out in 2009 were due to be published in 2011 but have not yet been released. Is it good use of resources to proceed with a trial of Fenzian in Barbados before the results of the UCLA study have been published?

* Proper scientific trials need to correct for the placebo effect by which patients are documented to have an improvement in a medical condition in response to a sham treatment. In this case, the results from the use of the Fenzian device should be compared with a sham machine which does nothing. Does the QEH trial use a sham machine?

* Scientific trials should be carried out blind, or double blind with the patients and investigators not knowing which device is which. This is to prevent the results being affected by conscious or subconscious bias. Is this how the QEH trial is to be carried out?

I sincerely hope the Fenzian machine proves to have some measurable effect on asthma. Whether this trial proves anything will depend entirely on whether it is conducted properly. If it isn’t, it won’t prove whether Fenzian works and the study will have wasted time and money.

– Andrew Hemsley

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