Home Forums Other Specialities Orthopaedics Placebo Controlled Study in Surgery

Viewing 1 post (of 1 total)
  • Author
  • #3204

    About 40 years ago as a junior doctor going through a surgical rotation in UK, I came across a young woman who was listed for laparotomy for undiagnosed abdominal pain. She had many tattoos on her body and a few surgical incision scars. I then assisted my chief who operated on her. I was flabbergasted when he made a 3″ skin incision on her abdomen and immediately started to close the wound without going any deeper. When I asked him to explain, he said the young lady in her 20s was investigated thoroughly and nothing had been found. She had already had 4 or 5 operations in the past and she would not rest until she was offered surgery. Following the operation all her symptoms would disappear. She would then return a few months later with some similar symptom and would insist on further surgery. She would not leave him alone until she was operated again! Relief of her symptoms – was that a “Placebo Effect” of surgery? Would this be permitted today? Surely NHS will not permit it. The main reason so few surgical studies had been conducted was concern over ethics. Giving a patient a placebo pill does not expose them to risk; performing sham surgery does. However, I was surprised when I read an article about placebo study in the surgical field from an important centre here in UK.

    Persistent shoulder pain which occurs in people over the age of 50 is caused when the muscle tendon rubs on the inferior surface of the acromion when the arm is abducted. For many years now shoulder surgeons have been operating on these patients using an arthroscope to shave off a little bit of bone on the inferior surface of the acromion along with removing some inflamed tissue in the region. This supposedly increased the space for the tendon to move without rubbing on the adjacent bone. The procedure called Subacromial decompression is now done on a large number of patients in UK and in USA. It is estimated that it costs the NHS about £150m every year.

    Prof. Andy Carr had done a number of these operations in the past. He would normally shave off 5 mm of bone. Sometimes would remove more bone. After a while he became curious when results were similar irrespective of what he did. He wondered if there was a “Placebo” effect here. He thought a study on this issue was necessary. The study would consist of 3 groups. The first would receive regular surgery. The second set would get “placebo surgery”, with all the surgical procedures identical to the normal operation except that no bone or tissue would be removed. Patients in these two groups would not know if they’d had the real or sham surgery. The third group would receive no treatment.

    At the university some argued that it was unethical and almost criminal to undertake sham surgery while others argued that it was unethical not to test surgical procedures of questionable merit. Finally, after going through a number of published papers the group agreed for the study. The trial began in September 2012. 51 surgeons at 32 hospitals in the UK signed up for the study.

    In the summer of 2012 Carol Brennan saw her doctor for severe pain in her right shoulder that was not relieved by medication or physiotherapy. As all her activities became restricted her doctor referred her to Prof. Carr. Carr told her that as her pain had lasted so long he could operate on her. However, he wanted to know if she would take part in a study that was being undertaken on patients with persistent shoulder pain. He explained what that study would involve. Ms. Brennan agreed to take part.

    She was assigned to the “surgery group” and she was pleased about that. In January 2014 she was operated when she had the usual two small incisions used for arthroscopy. What she did not know was that the arthroscope was used to look in to the shoulder but no bone or tissue was removed (no decompression done). Following surgery, she continued to have pain for a couple of months and then it started to ease. She was able to move the shoulder more at 6 months and at 1 year the pain score had reduced from 9 to 2 when Brennan thought she was cured. she assumed that she had not been in the placebo group. Three years later, in 2017, she bumped into Carr at a social occasion in their village. By then, the trial was over, and Carr could reveal to her the truth. She had received sham surgery. She could not believe it.

    The results of Carr’s study was published in the Lancet in November 2017. The groups that received genuine surgery (90 patients) and placebo surgery (94 patients) reported substantial improvement six months and one year after the operation. This suggested that the “treatment effect” of the surgery was not due to the removal of bone and soft tissue. The third group of 90 patients, who had received no treatment – not even physiotherapy or pain relief – also reported feeling much better but not to the same extent.

    This small difference in improvement between the surgical and non-surgical groups was explained that it could be due to a number of factors, including a “surgical placebo effect” of the procedure, the rest and physiotherapy that were prescribed to patients following the operation. The most plausible conclusion, they said, was that shoulder decompression surgery “does not provide patients with a clinically important benefit”.
    Carr’s findings were backed up when the British Medical Journal published a ten-year study of shoulder decompression surgery in Finland. Again, the conclusion was that the operation was ineffective. (Reported in TNMGC 2nd July 2019) – http://www.tnmgc.com/discus/viewtopic.php?f=11&t=1167

    In Germany, where 92,000 shoulder decompression operations are performed a year, seven professional surgical associations issued a joint statement criticising the design and conclusions of the British trial, which it said had “no consequences” for the health system there.

    NHS England have now announced that steps were being taken to reduce 17 routine procedures that were “ineffective or risky”, including shoulder decompressions and arthroscopic knee surgery for arthritis.

    Professor Andrew Jonathan Carr is Nuffield Professor of Orthopaedics and head of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford since 2001.

Viewing 1 post (of 1 total)
  • You must be logged in to reply to this topic.