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Sham surgery
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Sham surgery
Sham surgery (or placebo surgery) is a faked surgical intervention that omits the step thought to be therapeutically necessary.
In clinical trials of surgical interventions, sham surgery is an important scientific control. This is because it isolates the specific effects of the treatment as opposed to the incidental effects caused by anesthesia, the incisional trauma, pre- and postoperative care, and the patient's perception of having had a regular operation. Thus sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect.
A number of studies done under Institutional Review Board-approved settings have delivered important and surprising results. With the progress in minimally invasive surgery, sham procedures can be more easily performed as the sham incision can be kept small similarly to the incision in the studied procedure.
A review of studies with sham surgery found 53 such studies: in 39 there was improvement with the sham operation and in 27 the sham procedure was as good as the real operation. Sham-controlled interventions have therefore identified interventions that are useless but had been believed by the medical community to be helpful based on studies without the use of sham surgery.
In 1939 Fieschi introduced internal mammary ligation as a procedure to improve blood flow to the heart. Not until a controlled study was done two decades later could it be demonstrated that the procedure was only as effective as the sham surgery.
In neurosurgery, cell-transplant surgical interventions were offered in many centers in the world for patients with Parkinson disease until sham-controlled experiments involving the drilling of burr holes into the skull demonstrated such interventions to be ineffective and possibly harmful. Subsequently, over 90% of surveyed investigators believed that future neurosurgical interventions (e.g. gene transfer therapies) should be evaluated by sham-controlled studies as these are superior to open-control designs, and have found it unethical to conduct an open-control study because the design is not strong enough to protect against the placebo effect and bias. Kim et al. point out that sham procedures can differ significantly in invasiveness, for instance in neurosurgical experiments the investigator may drill a burr hole to the dura mater only or enter the brain. In March 2013 a sham surgical study of a popular but biologically inexplicable venous balloon angioplasty procedure for multiple sclerosis showed the surgery was no better than placebo.
Moseley and coworkers studied the effect of arthroscopic surgery for osteoarthritis of the knee establishing two treatment groups and a sham-operated control group. They found that patients in the treatment group did no better than those in the control group. The fact that all three groups improved equally points to the placebo effect in surgical interventions.
In a 2016 study it was found that arthroscopic partial meniscectomy does not offer any benefit over sham surgery in relieving symptoms of knee locking or catching in patients with degenerative meniscal tears.
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Sham surgery AI simulator
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Sham surgery
Sham surgery (or placebo surgery) is a faked surgical intervention that omits the step thought to be therapeutically necessary.
In clinical trials of surgical interventions, sham surgery is an important scientific control. This is because it isolates the specific effects of the treatment as opposed to the incidental effects caused by anesthesia, the incisional trauma, pre- and postoperative care, and the patient's perception of having had a regular operation. Thus sham surgery serves an analogous purpose to placebo drugs, neutralizing biases such as the placebo effect.
A number of studies done under Institutional Review Board-approved settings have delivered important and surprising results. With the progress in minimally invasive surgery, sham procedures can be more easily performed as the sham incision can be kept small similarly to the incision in the studied procedure.
A review of studies with sham surgery found 53 such studies: in 39 there was improvement with the sham operation and in 27 the sham procedure was as good as the real operation. Sham-controlled interventions have therefore identified interventions that are useless but had been believed by the medical community to be helpful based on studies without the use of sham surgery.
In 1939 Fieschi introduced internal mammary ligation as a procedure to improve blood flow to the heart. Not until a controlled study was done two decades later could it be demonstrated that the procedure was only as effective as the sham surgery.
In neurosurgery, cell-transplant surgical interventions were offered in many centers in the world for patients with Parkinson disease until sham-controlled experiments involving the drilling of burr holes into the skull demonstrated such interventions to be ineffective and possibly harmful. Subsequently, over 90% of surveyed investigators believed that future neurosurgical interventions (e.g. gene transfer therapies) should be evaluated by sham-controlled studies as these are superior to open-control designs, and have found it unethical to conduct an open-control study because the design is not strong enough to protect against the placebo effect and bias. Kim et al. point out that sham procedures can differ significantly in invasiveness, for instance in neurosurgical experiments the investigator may drill a burr hole to the dura mater only or enter the brain. In March 2013 a sham surgical study of a popular but biologically inexplicable venous balloon angioplasty procedure for multiple sclerosis showed the surgery was no better than placebo.
Moseley and coworkers studied the effect of arthroscopic surgery for osteoarthritis of the knee establishing two treatment groups and a sham-operated control group. They found that patients in the treatment group did no better than those in the control group. The fact that all three groups improved equally points to the placebo effect in surgical interventions.
In a 2016 study it was found that arthroscopic partial meniscectomy does not offer any benefit over sham surgery in relieving symptoms of knee locking or catching in patients with degenerative meniscal tears.