Sham surgery

Sham surgery (commonly known as placebo surgery) is a fictitious surgical intervention that excludes the step believed to be the actual therapeutic action. Much like placebo medications in pharmaceutical trials, sham surgeries play a crucial role in clinical trials of surgical interventions.

Surgery

Rationale and Purpose

Sham surgeries act as an essential scientific control in clinical trials for surgical procedures.

By using a sham surgery:

• The specific effects of the surgery are distinguished from incidental effects such as anesthesia reactions, trauma from the incision, pre- and post-operative care, and psychological impacts like the patient's belief of having undergone a genuine operation.
• It aids in countering biases, especially the placebo effect, ensuring that observed outcomes are attributable to the surgery itself rather than extraneous factors.

Human Research

Under the guidance of Institutional Review Boards (IRBs), several studies involving sham surgeries have yielded significant insights. The advent of minimally invasive surgical techniques has facilitated sham procedures, as the incisions can be as small as those in actual procedures.

A comprehensive review identified 53 studies involving sham surgeries. In 39 of these, there was notable improvement after the sham operation, and in 27, the sham procedure's outcomes were equivalent to the genuine surgical procedure. This highlights the importance of sham-controlled studies in debunking previously held medical beliefs based on non-sham-controlled research.

Examples

Cardiovascular Diseases

In 1939, Fieschi pioneered internal mammary ligation to enhance heart blood flow. However, a controlled study two decades later revealed that this procedure's effectiveness was on par with its sham counterpart.

CNS Disease

For patients with Parkinson's disease, cell-transplant surgical interventions were prevalent until sham-controlled tests indicated that these procedures might be ineffective or even harmful. A significant portion (over 90%) of surveyed researchers opined that future neurosurgical treatments should undergo evaluation through sham-controlled studies, as these studies offer superior design against biases. It's essential to note the variation in invasiveness across sham procedures. For example, while some sham procedures might involve drilling up to the dura mater, others might penetrate the brain.

Orthopedic Diseases

Research by Moseley et al. on arthroscopic surgery for knee osteoarthritis established that treatment groups did not show improved results compared to the sham-operated control group. This finding underscores the placebo effect in surgical procedures. Moreover, other studies have highlighted the limited benefits of surgeries like arthroscopic partial meniscectomy for specific symptoms over sham surgeries.

Animal Research

In animal models, sham surgeries have been an integral part of surgical experimentation. Historically, such procedures allowed for the removal or alteration of organs, helping in deductions regarding organ functionality. Sham surgeries also serve as controls when innovating new surgical protocols.

Ethical Considerations

Given the nature of sham surgeries, ethical considerations are paramount. It is essential to ensure that participants are adequately informed and that the potential risks are minimized. Furthermore, sham surgeries can only be justified if they provide substantial scientific value that could not be achieved through less invasive means.

See Also

• Placebo effect
• Clinical trials
• Surgical procedures
• Ethical considerations in medical research

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