Guidance
6 Committee comments
6 Committee comments
6.1 The Committee concluded that the evidence of efficacy was adequate only after prolonged debate about the design of the available randomised trials. The trials included an initial phase before randomisation in which the device was left 'on'. There was concern that any beneficial effect of the device might therefore have been carried over into the control period, so reducing the symptoms in that phase of the trial. The Committee also noted the possibility of a placebo response.
6.2 The Committee recognised that gastroparesis can be a very debilitating condition with very few treatment options, and it noted patient commentaries describing substantial improvements in quality of life with gastroelectrical stimulation.