Are surgery and other invasive procedures for chronic pain and obesity more effective than placebo?
Researchers from Samueli Institute, National Institutes of Health, Harvard Medical School, Houston Methodist Hospital, the University of Maryland and the University of Munich, Germany collaborated to find out as they performed a systematic review of 55 studies (encompassing more than 3,500 patients) comparing patient outcomes from actual surgical procedures to outcomes after “sham” procedures that mimicked the ritual and process of surgery without actually performing the procedure.
Outcomes for surgery were about the same as placebo in procedures for pain, and marginally better in cases of obesity. The results of the systematic review, which was published this month in the journal BMJ Open, have implications for clinical research and practice by arguing against the continued use of ineffective, invasive procedures—especially in the field of chronic pain—until more rigorous research is done on these procedures.
Minimally invasive surgical procedures have expanded for treating conditions such as low-back pain, arthritis, endometriosis, Parkinson’s disease, gastroesophageal reflux and obesity, but rarely are these procedures evaluated using rigorous research designs using randomized, placebo controlled trials, the gold standard of medical research.
Invasive procedures incorporate many factors that contribute to the placebo effect, including a hospital-like setting, multiple authoritative providers, frequent suggestions about expected outcomes, a physical invasion of the body, and an elaborate ritual of treatment delivery and recovery.
“For all its miraculous advances in the last century, we have too much reverence for surgery and steer patients too often to invasive procedures they do not need and that may actually cause them harm,” explained Wayne B. Jonas, MD, President and CEO of Samueli Institute and lead author of the study. “Our health care system rewards procedures and pills and may ignore whether there is rigorous evidence that they are safe and effective.”
Given the large number of invasive and surgical procedures performed routinely in the U.S. it is noteworthy that researchers could find only 55 sham-controlled studies in the entire literature. The authors recommend an increase in well-designed, sham-controlled surgical trials to avoid the continued use of ineffective invasive procedures.