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Back surgery poser

Trial
The problem
What does it mean?


There are bad days, and then there are days when someone asks you to pick the bones out of a randomised trial of back surgery compared with usual care. What we want is a large, high quality randomised trial, which gives a clear answer. Some of us might be backing surgery, others analgesics and sympathy, but all of us want the answer. Two studies, one a randomised trial [1], the other a cohort of patients refusing to participate [2] do little but confuse us more.


Trial


In all 1,244 patients with lumbar intervertebral disk herniation were enrolled out of 1,991 eligible (747 refused to participate). Of these, 501 were enrolled into a randomised trial, and 743 in an observational study (which included surgery and usual care. Follow up was for two years.


The problem


In the randomised trial, not everyone in the surgery group had surgery, and quite a lot of those not assigned to surgery had it anyway. The percentage in each group having surgery was quite similar, as Figure 1 shows. Not surprisingly, the outcomes in both groups were much the same.



Figure 1: Actual surgery in RCT groups





Most of the observational cohort had surgery (528/743), and did better than those who did not. In fact, in all four groups, the only consistent difference was that those not randomised and not having surgery did less well than all others.


What does it mean?


The papers come with erudite editorials, providing lots of perspective. Perhaps the only suggestion is that it will need a sham surgery trial to sort this lot out, but that may run into ethical storms. The one approach not mooted is the large, prospective, high quality, registry study, which might help us figure which patients do best from back surgery.


References:

  1. JN Weinstein. Surgical vs nonoperative treatment for lumbar disk herniation: the spine patient outcome research trial (SPORT) - a randomized trial. JAMA 2006 296: 2441-2450.
  2. JN Weinstein. Surgical vs nonoperative treatment for lumbar disk herniation: the spine patient outcome research trial (SPORT) observational cohort. JAMA 2006 296: 2451-2459.

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