Treatment for osteoarthritis thrown into question

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Treatment for osteoarthritis thrown into question

David Spurgeon Quebec

Patients receiving arthroscopic lavage or debridement for osteoarthritis of the knee in a controlled trial reported no better pain relief than patients who received only skin incisions without the actual surgery.

The randomised, placebo controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis was conducted with 180 patients by researchers from the US Department of Veterans Affairs, Baylor College of Medicine and International Survey Research, both in Houston, and Laguna Honda Hospital, San Francisco (New England Journal of Medicine 2002;347:81-8). Both real and placebo surgeries were performed by Dr Bruce Moseley, a clinical associate professor of orthopaedics at Baylor College. Ethical issues were critically assessed by Dr Baruch Brody, director of the Center for Medical Ethics and Health Policy at Baylor College.

Of 324 people who met the study’s inclusion criteria, 144 (44%) declined to participate when they understood they might not receive the actual surgery. The 180 patients who participated stated in writing that they realised they might receive only placebo surgery.

Participants were randomised into three groups. One group received debridement, in which worn, torn, or loose cartilage was cut away and removed with the aid of an arthroscope. The second group underwent arthroscopic lavage, in which the bad cartilage was flushed out. The third group underwent simulated arthroscopic surgery, where small incisions were made but no instruments were inserted and no cartilage was removed.

In two years of follow up, patients in all three groups reported moderate improvements in pain and ability to function, but neither of the groups that had actual surgery reported less pain or better function than the placebo group. In fact, patients in the placebo group reported better outcomes at certain points during follow up than the patients who underwent debridement.

Lead investigator Dr Nelda Wray, a health services researcher at Baylor College, said that the risks of each type of surgery should be examined. "The results also make us question whether the more than $1bn spent on these procedures might be put to better use," she said.

It is estimated that more than 650 000 arthroscopic debridement or lavage procedures are done each year in the United States, at a cost of about $5000 (£3175; €4947) each.

"This study has important policy implications," said Dr Wray. "We have shown that the entire driving force behind this billion dollar industry is the placebo effect. The healthcare industry should rethink how to test whether surgical procedures, done purely for the relief of subjective symptoms, are more efficacious than a placebo."

In an accompanying editorial Dr David Felson of Boston University and Dr Joseph Buckwalter of the University of Iowa said that the importance of the Moseley study is shown by comparison with earlier studies. "Inclusion of a sham-arthroscopy group with the use of blinding provides evidence of much higher quality than that which was available from the other well-performed trials."

And in a commentary entitled "Is Placebo Surgery Unethical?" Sam Horng and Franklin Miller, of the US National Institutes of Health, said that "the trial conducted by Moseley et al exemplifies the ethically justified use of placebo surgery … Trials of surgical procedures that include the use of placebo surgery should be conducted before the procedure becomes standard treatment, provided that these trials meet the ethical requirements that are appropriate for clinical research."

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