Sham or no sham: the debate continues

We read with interest the systematic review and meta-analysis conducted by Schulman et  al1 that measured rates of adverse events in patients assigned to the sham-control arm in published randomized endoscopic intervention trials. The overall rate of serious adverse events was 1.7%, the majority of which were surgery/intensive care unit admission, post-ERCP pancreatitis, and perforat ion. The authors concluded that “investigators should reconsider use of sham-controlled trial designs for endoscopic intervention, while maintaining an emphasis on sound RCT designs.”
Source: Gastrointestinal Endoscopy - Category: Gastroenterology Authors: Tags: Letter to the Editor Source Type: research