Back in the 1950s, bilateral ligation of internal mammary arteries was treatment of choice for patients with angina pectoris. Doctor Cobb was skeptical about the effectiveness of this procedure hence, decided to compare a group of patients who underwent this surgery with another group of participants whom he performed all other procedures except ligating internal mammary arteries. Despite being ethically questionable, this study is considered to be the first documented placebo-controlled randomized double blinded clinical trial in surgery. Interestingly, it was later found that there was no significant improvement in patients due to this surgery compared to placebo.
Comparing an intervention (medicine or surgical procedure) with a fake counterpart in order to check the superiority of intervention is the concept behind Placebo controlled studies. For any placebo controlled surgical trials, the procedure we perform should meet these two criteria: definition of surgery and the definition of placebo. Any medical intervention that involves changes in anatomy and requires skin incision or use of endoscopic procedures is surgical intervention. In order to fit with the definition of placebo, these surgeries should have been performed following all procedural aspects excluding actual penetration of intended anatomical structure.
Surgical randomized trials are less commonly practiced in the research community.
Steps of Performing Placebo Controlled Surgical Trials
