Letters Section Editor: Stephen J. Lurie,
MD, PhD, Senior Editor.
In Reply: We agree with Dr Heckerling that
sham surgery can be ethical and often is necessary for the appropriate investigation
of new surgical procedures. There is an important distinction, however, between
sham surgery and the implantation of pacemakers for the purpose of controlling
vasovagal syncope. Sham surgery implies that the intervention has no therapeutic
potential. In our study, the control patients actually received a functional
pacemaker, which was temporarily deactivated for the purpose of the study.
At the time of initiation of our trial there was considerable evidence that
pacemaker therapy was beneficial for the management of vasovagal syncope.
In fact, the practice guidelines published by major organizations recommend
the use of pacemaker therapy in this setting.1
Connolly SJ, Wilkoff BL, Morillo C, Sheldon R, Gent M, Roberts RS, Ellenbogen KA, for the VPS II Investigators . Ethical Aspects in Trials of Implantable Medical Devices—Reply. JAMA. 2003;290(12):1579. doi:10.1001/jama.290.12.1579-a