Research with patients is challenging and can be very rewarding and I mean not only for the researcher. To my opinion research ads value to patient care. Usually patients participating in research are better cared for, their treatment is more according to well documented and evaluated protocols. Monitoring makes wait and see impossible.
Results from these patient centered trials benefits patient care at the short and long term. If a treatment center publishes their results these results are usually implemented in their treatment protocols.
There is also a downside to this. Trials usually also means a lot of testing and blood samples to be drawn. I think these disadvantages out ways the benefits in patient care. One restriction is that study design should be good enough to make the results worthwhile. I hate it when authors excuse the lack of a control group or placebo group as can be read in a recent post about Vagus Nerve Stimulation research
The authors mention the argument sometimes used that it is unethical to use a controlled design with a sham condition. We are talking about patients treated with 3-7 different antidepressants and/or ECT. Mostly ill for years. I think it unethical to conduct another uncontrolled trial which will help our knowledge about the efficacy of VNS no further. Besides implanting a VNS is not peanuts nor going to a protocol of up to 1 year.
When preparing a lecture this dilemma about study design came to my mind. I have never seen a sample used for so many publications in high ranking medical journals than the patients taking part in a Vagus Nerve Stimulation research.
The research and follow up in 222 patients was used for several publications. The first publication was a terrific placebo controlled comparison of VNS with placebo. There was no significant difference between both groups. After that the patient sample was used for a follow-up of 12 months in total. Data from this sample is used in at least 3 other studies but all open and uncontrolled. Adding nothing or little to our knowledge for the use of VNS in depressed patients.
What do you think?
See also on this blog: VNS for depression an update